Trial Outcomes & Findings for Integrated Outpatient Treatment of Opioid Use Disorder and Severe Injection Related Infections (NCT NCT04677114)
NCT ID: NCT04677114
Last Updated: 2026-04-28
Results Overview
Proportion of urine samples with negative urine drug screen for illicit opioid use
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
12 weeks after hospital discharge
Results posted on
2026-04-28
Participant Flow
Participant milestones
| Measure |
Buprenorphine Plus Outpatient Parenteral Antibiotic Therapy (BOPAT)
Patients with opioid use disorder (OUD) and severe, injection-related infections (SIRI) will be treated with buprenorphine and be discharged with outpatient parenteral antibiotic therapy (OPAT).
|
Treatment as Usual (TAU)
Patients with OUD and severe, injection-related infections (SIRI) will receive usual care.
|
|---|---|---|
|
12 Week
STARTED
|
36
|
35
|
|
12 Week
COMPLETED
|
23
|
19
|
|
12 Week
NOT COMPLETED
|
13
|
16
|
|
6 Month
STARTED
|
23
|
19
|
|
6 Month
COMPLETED
|
20
|
16
|
|
6 Month
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Buprenorphine Plus Outpatient Parenteral Antibiotic Therapy (BOPAT)
Patients with opioid use disorder (OUD) and severe, injection-related infections (SIRI) will be treated with buprenorphine and be discharged with outpatient parenteral antibiotic therapy (OPAT).
|
Treatment as Usual (TAU)
Patients with OUD and severe, injection-related infections (SIRI) will receive usual care.
|
|---|---|---|
|
12 Week
Lost to Follow-up
|
12
|
10
|
|
12 Week
Death
|
1
|
3
|
|
12 Week
Withdrawal by Subject
|
0
|
3
|
|
6 Month
Death
|
1
|
0
|
|
6 Month
Lost to Follow-up
|
1
|
3
|
|
6 Month
Incarcerated
|
1
|
0
|
Baseline Characteristics
Integrated Outpatient Treatment of Opioid Use Disorder and Severe Injection Related Infections
Baseline characteristics by cohort
| Measure |
Buprenorphine Plus Outpatient Parenteral Antibiotic Therapy (BOPAT)
n=36 Participants
Patients with opioid use disorder (OUD) and severe, injection-related infections (SIRI) will be treated with buprenorphine and be discharged with outpatient parenteral antibiotic therapy (OPAT).
|
Treatment as Usual (TAU)
n=35 Participants
Patients with OUD and severe, injection-related infections (SIRI) will receive usual care.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Age, Continuous
|
40 Years
STANDARD_DEVIATION 8.85 • n=9 Participants
|
42 Years
STANDARD_DEVIATION 9.18 • n=24 Participants
|
41 Years
STANDARD_DEVIATION 9.09 • n=23 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=9 Participants
|
13 Participants
n=24 Participants
|
27 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=9 Participants
|
22 Participants
n=24 Participants
|
44 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=9 Participants
|
35 Participants
n=24 Participants
|
71 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
3 Participants
n=24 Participants
|
4 Participants
n=23 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=9 Participants
|
32 Participants
n=24 Participants
|
67 Participants
n=23 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=9 Participants
|
35 participants
n=24 Participants
|
71 participants
n=23 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after hospital dischargePopulation: All participants were analyzed, including participants that did not complete the full 12 weeks.
Proportion of urine samples with negative urine drug screen for illicit opioid use
Outcome measures
| Measure |
Buprenorphine Plus Outpatient Parenteral Antibiotic Therapy (BOPAT)
n=422 Urine samples
Patients with opioid use disorder (OUD) and severe, injection-related infections (SIRI) will be treated with buprenorphine and be discharged with outpatient parenteral antibiotic therapy (OPAT).
|
Treatment as Usual (TAU)
n=397 Urine samples
Patients with OUD and severe, injection-related infections (SIRI) will receive usual care.
|
|---|---|---|
|
Illicit Opioid Use
|
0.434 Proportion of UDS samples
|
0.360 Proportion of UDS samples
|
SECONDARY outcome
Timeframe: up to 12 weeks (duration of IV antibiotic course as determined by treating physician)Population: All participants were analyzed, including participants that did not complete the full 12 weeks.
number of patients who completed recommended IV antibiotic therapy
Outcome measures
| Measure |
Buprenorphine Plus Outpatient Parenteral Antibiotic Therapy (BOPAT)
n=36 Participants
Patients with opioid use disorder (OUD) and severe, injection-related infections (SIRI) will be treated with buprenorphine and be discharged with outpatient parenteral antibiotic therapy (OPAT).
|
Treatment as Usual (TAU)
n=35 Participants
Patients with OUD and severe, injection-related infections (SIRI) will receive usual care.
|
|---|---|---|
|
Completion of Recommended IV Antibiotic Therapy
|
27 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after hospital dischargePopulation: All participants were analyzed, including participants that did not complete the full 12 weeks.
Self-reported number of days of illicit opioid abstinence
Outcome measures
| Measure |
Buprenorphine Plus Outpatient Parenteral Antibiotic Therapy (BOPAT)
n=36 Participants
Patients with opioid use disorder (OUD) and severe, injection-related infections (SIRI) will be treated with buprenorphine and be discharged with outpatient parenteral antibiotic therapy (OPAT).
|
Treatment as Usual (TAU)
n=35 Participants
Patients with OUD and severe, injection-related infections (SIRI) will receive usual care.
|
|---|---|---|
|
Abstinence From Illicit Opioid
|
66.7 Days
Standard Error 4.4
|
63.0 Days
Standard Error 5.5
|
SECONDARY outcome
Timeframe: 12 weeks after hospital dischargePopulation: All participants were analyzed, including participants that did not complete the full 12 weeks.
Self-reported number of days of injection use of any drug
Outcome measures
| Measure |
Buprenorphine Plus Outpatient Parenteral Antibiotic Therapy (BOPAT)
n=36 Participants
Patients with opioid use disorder (OUD) and severe, injection-related infections (SIRI) will be treated with buprenorphine and be discharged with outpatient parenteral antibiotic therapy (OPAT).
|
Treatment as Usual (TAU)
n=35 Participants
Patients with OUD and severe, injection-related infections (SIRI) will receive usual care.
|
|---|---|---|
|
Injection Drug Use
|
3.8 Days
Standard Error 1.6
|
7.1 Days
Standard Error 3.9
|
SECONDARY outcome
Timeframe: 12 weeks after hospital dischargePopulation: All participants were analyzed, including participants that did not complete the full 12 weeks.
Number of days patients remain in treatment.
Outcome measures
| Measure |
Buprenorphine Plus Outpatient Parenteral Antibiotic Therapy (BOPAT)
n=36 Participants
Patients with opioid use disorder (OUD) and severe, injection-related infections (SIRI) will be treated with buprenorphine and be discharged with outpatient parenteral antibiotic therapy (OPAT).
|
Treatment as Usual (TAU)
n=35 Participants
Patients with OUD and severe, injection-related infections (SIRI) will receive usual care.
|
|---|---|---|
|
Outpatient Treatment Retention
|
81.4 Days
Standard Error 4.8
|
62.3 Days
Standard Error 6.9
|
Adverse Events
Buprenorphine Plus Outpatient Parenteral Antibiotic Therapy (BOPAT)
Serious events: 14 serious events
Other events: 32 other events
Deaths: 2 deaths
Treatment as Usual (TAU)
Serious events: 20 serious events
Other events: 30 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Buprenorphine Plus Outpatient Parenteral Antibiotic Therapy (BOPAT)
n=36 participants at risk
Patients with opioid use disorder (OUD) and severe, injection-related infections (SIRI) will be treated with buprenorphine and be discharged with outpatient parenteral antibiotic therapy (OPAT).
|
Treatment as Usual (TAU)
n=35 participants at risk
Patients with OUD and severe, injection-related infections (SIRI) will receive usual care.
|
|---|---|---|
|
Infections and infestations
Acute sinusitis
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
0.00%
0/35 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Injury, poisoning and procedural complications
Adverse reaction to antibiotics
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Bacteremia
|
11.1%
4/36 • Number of events 4 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 2 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Cellulitis
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
COVID pneumonia
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
0.00%
0/35 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Injury, poisoning and procedural complications
Cytopenia
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Psychiatric disorders
Delirium/intoxication - stimulant
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
0.00%
0/35 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Metabolism and nutrition disorders
DKA
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
0.00%
0/35 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Embolization of valve vegetation
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
0.00%
0/35 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Nervous system disorders
Encephalopathy due to cirrhosis
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
0.00%
0/35 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Endocarditis
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
0.00%
0/35 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Endocarditis needing valve replace/repair
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
0.00%
0/35 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Injury, poisoning and procedural complications
Fatal overdose
|
5.6%
2/36 • Number of events 2 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
2.8%
1/36 • Number of events 3 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
0.00%
0/35 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Vascular disorders
Intracerebral hemorrhage
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Gastrointestinal disorders
Nausea/vomiting/diarrhea w/ hospitalization
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Newly flail tricuspid valve
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Injury, poisoning and procedural complications
Nonfatal overdose
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
17.1%
6/35 • Number of events 7 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Orthopedic surgery
|
5.6%
2/36 • Number of events 2 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
5.7%
2/35 • Number of events 2 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Osteomyelitis
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Pain related to SIRI resulting in hospitalization
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
5.7%
2/35 • Number of events 3 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Pneumocosis coli
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Pneumonia
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Prosthetic valve endocarditis
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 2 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Pulmonary embolism
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Septic arthritis
|
2.8%
1/36 • Number of events 2 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 3 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Nervous system disorders
Syncope
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
0.00%
0/35 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Valve replacement
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
11.4%
4/35 • Number of events 4 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Vertebral osteomyelitis
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
11.4%
4/35 • Number of events 4 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
Other adverse events
| Measure |
Buprenorphine Plus Outpatient Parenteral Antibiotic Therapy (BOPAT)
n=36 participants at risk
Patients with opioid use disorder (OUD) and severe, injection-related infections (SIRI) will be treated with buprenorphine and be discharged with outpatient parenteral antibiotic therapy (OPAT).
|
Treatment as Usual (TAU)
n=35 participants at risk
Patients with OUD and severe, injection-related infections (SIRI) will receive usual care.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Problem with abscess drain
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Immune system disorders
Rash
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Skin and subcutaneous tissue disorders
Rash from adhesive
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
5.7%
2/35 • Number of events 2 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Injury, poisoning and procedural complications
Rhabdomyolysis
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
0.00%
0/35 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Nervous system disorders
Seizure
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Skin abscess / cellulitis
|
8.3%
3/36 • Number of events 3 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Injury, poisoning and procedural complications
Skin photosensitivity
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Nervous system disorders
Stroke-like symptoms
|
5.6%
2/36 • Number of events 2 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
0.00%
0/35 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Psychiatric disorders
Suicidal thoughts
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Skin and subcutaneous tissue disorders
Sunburn
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
0.00%
0/35 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Injury, poisoning and procedural complications
Superficial venous thrombosis
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Endocrine disorders
Thyroid nodule
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Toe auto-amputation
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
URI +/- fever
|
8.3%
3/36 • Number of events 3 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
8.6%
3/35 • Number of events 6 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
UTI
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
General disorders
Weakness
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Metabolism and nutrition disorders
Weight loss
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Psychiatric disorders
Delirium/intoxication - stimulant
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Injury, poisoning and procedural complications
Difficult removing PICC
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Dosing error
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
General disorders
Drowsiness
|
5.6%
2/36 • Number of events 3 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
5.7%
2/35 • Number of events 2 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Injury, poisoning and procedural complications
DVT and thrombophlebitis
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Musculoskeletal and connective tissue disorders
Fall
|
5.6%
2/36 • Number of events 2 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
General disorders
Fatigue
|
5.6%
2/36 • Number of events 2 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Fever
|
8.3%
3/36 • Number of events 3 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
5.7%
2/35 • Number of events 2 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Fungal prosthetic valve IE
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Skin and subcutaneous tissue disorders
Hair loss
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Nervous system disorders
Headache not related to buprenorphine
|
8.3%
3/36 • Number of events 3 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Cardiac disorders
Heart block
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Gastrointestinal disorders
Heartburn
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
0.00%
0/35 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Renal and urinary disorders
Hematuria
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
0.00%
0/35 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Hemoptysis
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Injury, poisoning and procedural complications
Hematoma at surgical site
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Skin and subcutaneous tissue disorders
Hernia repair
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
0.00%
0/35 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Vascular disorders
Hypertension
|
5.6%
2/36 • Number of events 2 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
5.7%
2/35 • Number of events 2 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Metabolism and nutrition disorders
Hypoglycemia / Hyperglycemia
|
5.6%
2/36 • Number of events 2 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
0.00%
0/35 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Renal and urinary disorders
Hypokalemia / Hyperkalemia
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Renal and urinary disorders
Hypomagnesemia
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Vascular disorders
Hypotension
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
0.00%
0/35 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
General disorders
Injection-site reaction (Sublocade)
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Injury, poisoning and procedural complications
IV infiltrate
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
0.00%
0/35 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Injury, poisoning and procedural complications
Laceration
|
5.6%
2/36 • Number of events 2 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
0.00%
0/35 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Cardiac disorders
LE Edema
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
LE Edema
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
0.00%
0/35 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Vascular disorders
LE Edema
|
5.6%
2/36 • Number of events 2 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Musculoskeletal and connective tissue disorders
Limp
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Psychiatric disorders
Mood symptoms (depression/anxiety)
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
11.4%
4/35 • Number of events 4 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Gastrointestinal disorders
Mouth / dental pain
|
8.3%
3/36 • Number of events 3 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Muscle abscess
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Gastrointestinal disorders
Nausea / constipation
|
5.6%
2/36 • Number of events 2 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
5.7%
2/35 • Number of events 2 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Gastrointestinal disorders
Nausea/vomiting/diarrhea
|
16.7%
6/36 • Number of events 9 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
22.9%
8/35 • Number of events 9 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Nausea/vomiting/diarrhea
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Nervous system disorders
Neurologic symptoms related to substance use
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Psychiatric disorders
Opioid intoxication
|
5.6%
2/36 • Number of events 2 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Psychiatric disorders
Opioid withdrawal
|
16.7%
6/36 • Number of events 6 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Ottis media
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
0.00%
0/35 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Over-infusion of antibiotics
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Musculoskeletal and connective tissue disorders
Pain - Unrelated to SIRI
|
27.8%
10/36 • Number of events 14 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
17.1%
6/35 • Number of events 11 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Pain after I&D
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Injury, poisoning and procedural complications
Pain at chest tube site
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Pain related to SIRI
|
19.4%
7/36 • Number of events 8 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
31.4%
11/35 • Number of events 14 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Injury, poisoning and procedural complications
PICC Displacement
|
8.3%
3/36 • Number of events 3 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
8.6%
3/35 • Number of events 3 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Injury, poisoning and procedural complications
PICC misplacement
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Injury, poisoning and procedural complications
PICC not flushing / slow blood return
|
19.4%
7/36 • Number of events 8 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
0.00%
0/35 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
PICC retraction
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
0.00%
0/35 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Pneumothorax
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Immune system disorders
Possible allergy - swelling
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Injury, poisoning and procedural complications
Possible PICC misuse
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Blood and lymphatic system disorders
Cytopenia
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Injury, poisoning and procedural complications
Cytopenia
|
5.6%
2/36 • Number of events 2 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Gastrointestinal disorders
Abdominal distention
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Cardiac disorders
Agitation
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
0.00%
0/35 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Renal and urinary disorders
AKI
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Gastrointestinal disorders
Anemia
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Gastrointestinal disorders
Blood in stool
|
0.00%
0/36 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
Candidiasis (vaginal, intertrigo)
|
21.4%
3/14 • Number of events 3 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
15.4%
2/13 • Number of events 4 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
CLABSI
|
5.6%
2/36 • Number of events 2 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
0.00%
0/35 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
|
Infections and infestations
COVID Infection Not Needing Hospitalization
|
2.8%
1/36 • Number of events 1 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
8.6%
3/35 • Number of events 3 • From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place