Trial Outcomes & Findings for Postoperative Antibiotic Management Duration Following Surgery for Intravenous Drug Abuse (IVDA) Endocarditis (OPTIMAL) (NCT NCT05156437)
NCT ID: NCT05156437
Last Updated: 2026-05-05
Results Overview
Incidences of all-cause mortality at six (6) months post-surgery.
TERMINATED
PHASE4
5 participants
Six months
2026-05-05
Participant Flow
Participants were recruited from a population with substance use disorder and active or recent infective endocarditis requiring surgery. Recruitment and retention were difficult due to social instability, limited outpatient engagement, and challenges maintaining contact. Five participants enrolled, but all were lost to follow-up before completing therapy or reaching the first assessment, and no additional eligible participants could be retained.
Five participants were enrolled and assigned to two study arms (Group I: 4; Group II: 1). After surgery and treatment initiation, all were lost to follow-up before completing the six-week therapy period or reaching any follow-up visit, resulting in 0 completions. The only reason for non-completion was loss to follow-up; no participants withdrew consent, had adverse events, or were removed. All were classified as "Not Completed-Lost to Follow-up."
Participant milestones
| Measure |
Group II (Control Group)
Conventional two (2) weeks of postoperative inpatient IV antibiotic therapy followed by four (4) weeks of IV antibiotic therapy (inpatient or facility supervised if indwelling catheter utilized).
Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline: Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline
|
Group I (Experimental)
Two (2) weeks of postoperative inpatient IV antibiotic therapy followed by four (4) weeks of oral therapy with outpatient follow-up.
Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin: Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin
Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline: Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
Group II (Control Group)
Conventional two (2) weeks of postoperative inpatient IV antibiotic therapy followed by four (4) weeks of IV antibiotic therapy (inpatient or facility supervised if indwelling catheter utilized).
Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline: Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline
|
Group I (Experimental)
Two (2) weeks of postoperative inpatient IV antibiotic therapy followed by four (4) weeks of oral therapy with outpatient follow-up.
Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin: Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin
Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline: Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
Baseline Characteristics
Postoperative Antibiotic Management Duration Following Surgery for Intravenous Drug Abuse (IVDA) Endocarditis (OPTIMAL)
Baseline characteristics by cohort
| Measure |
Group I (Experimental)
n=4 Participants
Two (2) weeks of postoperative inpatient IV antibiotic therapy followed by four (4) weeks of oral therapy with outpatient follow-up.
Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin: Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin
Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline: Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline
|
Group II (Control Group)
n=1 Participants
Conventional two (2) weeks of postoperative inpatient IV antibiotic therapy followed by four (4) weeks of IV antibiotic therapy (inpatient or facility supervised if indwelling catheter utilized).
Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline: Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
5 Participants
n=114 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
4 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
5 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: Six monthsPopulation: All participants enrolled in the study were assigned to a study arm; however, all participants were lost to follow-up prior to the six-month assessment. As a result, no outcome data were collected for this measure in either arm, and no participants were included in the analysis population. No interim, partial, or alternative data were available for analysis.
Incidences of all-cause mortality at six (6) months post-surgery.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: One yearPopulation: All participants enrolled in the study were assigned to a study arm; however, all participants were lost to follow-up prior to the one-year assessment. As a result, no outcome data were collected for this measure in either arm, and no participants were included in the analysis population. No interim, partial, or alternative data were available for analysis.
Incidences of all-cause mortality at (12) months post-surgery.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Six monthsPopulation: All participants enrolled in the study were assigned to a study arm; however, all participants were lost to follow-up prior to the six-month assessment. As a result, no outcome data were collected for this measure in either arm, and no participants were included in the analysis population. No interim, partial, or alternative data were available for analysis.
Incidence of recurrent blood culture positive infection (6 month)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: One yearPopulation: All participants enrolled in the study were assigned to a study arm; however, all participants were lost to follow-up prior to the one-year assessment. As a result, no outcome data were collected for this measure in either arm, and no participants were included in the analysis population. No interim, partial, or alternative data were available for analysis.
Incidence of recurrent blood culture positive infection (1 year)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Six monthsPopulation: All participants enrolled in the study were assigned to a study arm; however, all participants were lost to follow-up prior to the six-month assessment. As a result, no outcome data were collected for this measure in either arm, and no participants were included in the analysis population. No interim, partial, or alternative data were available for analysis.
Incidence of cardiac re-operation (6 Month)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: One yearPopulation: All participants enrolled in the study were assigned to a study arm; however, all participants were lost to follow-up prior to the one-year assessment. As a result, no outcome data were collected for this measure in either arm, and no participants were included in the analysis population. No interim, partial, or alternative data were available for analysis.
Incidence of cardiac re-operation (1 Year)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Six monthsPopulation: All participants enrolled in the study were assigned to a study arm; however, all participants were lost to follow-up prior to the six-month assessment. As a result, no outcome data were collected for this measure in either arm, and no participants were included in the analysis population. No interim, partial, or alternative data were available for analysis.
Incidences of readmission for recurrent infection or cardiac re-operation (6 Month)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: One yearPopulation: All participants enrolled in the study were assigned to a study arm; however, all participants were lost to follow-up prior to the one-year assessment. As a result, no outcome data were collected for this measure in either arm, and no participants were included in the analysis population. No interim, partial, or alternative data were available for analysis.
Incidence of readmission for recurrent infection or cardiac re-operation (1 Year)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, an average of one yearPopulation: All participants enrolled in the study were assigned to a study arm; however, all participants were lost to follow-up prior to study completion. Because no participants completed the study, no cost of care data were collected, and no participants were included in the analysis population. No interim, partial, or alternative data were available for analysis.
Cost of care
Outcome measures
Outcome data not reported
Adverse Events
Group I (Experimental)
Group II (Control Group)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place