Trial Outcomes & Findings for Perioperative Antibiotic Therapy to Prevent Cardiac Implantable Electronic Device Infections. (NCT NCT02809131)
NCT ID: NCT02809131
Last Updated: 2022-05-09
Results Overview
The primary study endpoint will be the number of patients with CIED infection resulting in complete CIED system removal, antibiotic therapy in patients who are not candidates for system removal, or death due to CIED infection.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1010 participants
Primary outcome timeframe
6 months
Results posted on
2022-05-09
Participant Flow
Participant milestones
| Measure |
Saline Irrigation
Saline Irrigation in patients undergoing a cardiac implantable electronic devices (CIED) procedure who have at least 2 CIED infection risk factors
|
Antibiotic Irrigation and Oral Antibiotics
Antibacterial irrigant (polymyxinB/bacitracin) and postoperative oral antibiotics (cephalexin, clindamycin, or levofloxacin) in patients undergoing a cardiac implantable electronic devices (CIED) procedure who have at least 2 CIED infection risk factors
|
|---|---|---|
|
Overall Study
STARTED
|
505
|
505
|
|
Overall Study
COMPLETED
|
445
|
445
|
|
Overall Study
NOT COMPLETED
|
60
|
60
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Perioperative Antibiotic Therapy to Prevent Cardiac Implantable Electronic Device Infections.
Baseline characteristics by cohort
| Measure |
Saline Irrigation
n=505 Participants
Saline Irrigation in patients undergoing a cardiac implantable electronic devices (CIED) procedure who have at least 2 CIED infection risk factors
|
Antibiotic Irrigation and Oral Antibiotics
n=505 Participants
Antibacterial irrigant (polymyxinB/bacitracin) and postoperative oral antibiotics (cephalexin, clindamycin, or levofloxacin) in patients undergoing a cardiac implantable electronic devices (CIED) procedure who have at least 2 CIED infection risk factors
|
Total
n=1010 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.44 years
STANDARD_DEVIATION 11.2 • n=99 Participants
|
70.42 years
STANDARD_DEVIATION 11.9 • n=107 Participants
|
70.43 years
STANDARD_DEVIATION 11.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
136 Participants
n=99 Participants
|
146 Participants
n=107 Participants
|
282 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
369 Participants
n=99 Participants
|
359 Participants
n=107 Participants
|
728 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
477 Participants
n=99 Participants
|
470 Participants
n=107 Participants
|
947 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
53 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
107 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
433 Participants
n=99 Participants
|
431 Participants
n=107 Participants
|
864 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
505 Participants
n=99 Participants
|
505 Participants
n=107 Participants
|
1010 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe primary study endpoint will be the number of patients with CIED infection resulting in complete CIED system removal, antibiotic therapy in patients who are not candidates for system removal, or death due to CIED infection.
Outcome measures
| Measure |
Saline Irrigation
n=505 Participants
Saline Irrigation in patients undergoing a cardiac implantable electronic devices (CIED) procedure who have at least 2 CIED infection risk factors
|
Antibiotic Irrigation and Oral Antibiotics
n=505 Participants
Antibacterial irrigant (polymyxinB/bacitracin) and postoperative oral antibiotics (cephalexin, clindamycin, or levofloxacin) in patients undergoing a cardiac implantable electronic devices (CIED) procedure who have at least 2 CIED infection risk factors
|
|---|---|---|
|
Number of Patients With a Major Cardiac Implantable Electronic Devices (CIED) Infection
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 6 monthsA minor superficial infection of the incision that does not involve the generator pocket, does not result in any systemic symptoms or signs, and is treated with either observation or a short course of oral antibiotics
Outcome measures
| Measure |
Saline Irrigation
n=505 Participants
Saline Irrigation in patients undergoing a cardiac implantable electronic devices (CIED) procedure who have at least 2 CIED infection risk factors
|
Antibiotic Irrigation and Oral Antibiotics
n=505 Participants
Antibacterial irrigant (polymyxinB/bacitracin) and postoperative oral antibiotics (cephalexin, clindamycin, or levofloxacin) in patients undergoing a cardiac implantable electronic devices (CIED) procedure who have at least 2 CIED infection risk factors
|
|---|---|---|
|
Number of Patients With a Minor Cardiac Implantable Electronic Devices (CIED) Infection
|
5 Participants
|
5 Participants
|
Adverse Events
Saline Irrigation
Serious events: 5 serious events
Other events: 245 other events
Deaths: 34 deaths
Antibiotic Irrigation and Oral Antibiotics
Serious events: 6 serious events
Other events: 218 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
Saline Irrigation
n=505 participants at risk
Saline Irrigation in patients undergoing a cardiac implantable electronic devices (CIED) procedure who have at least 2 CIED infection risk factors
|
Antibiotic Irrigation and Oral Antibiotics
n=505 participants at risk
Antibacterial irrigant (polymyxinB/bacitracin) and postoperative oral antibiotics (cephalexin, clindamycin, or levofloxacin) in patients undergoing a cardiac implantable electronic devices (CIED) procedure who have at least 2 CIED infection risk factors
|
|---|---|---|
|
Infections and infestations
Infection
|
0.99%
5/505 • Number of events 5 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
1.2%
6/505 • Number of events 6 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
Other adverse events
| Measure |
Saline Irrigation
n=505 participants at risk
Saline Irrigation in patients undergoing a cardiac implantable electronic devices (CIED) procedure who have at least 2 CIED infection risk factors
|
Antibiotic Irrigation and Oral Antibiotics
n=505 participants at risk
Antibacterial irrigant (polymyxinB/bacitracin) and postoperative oral antibiotics (cephalexin, clindamycin, or levofloxacin) in patients undergoing a cardiac implantable electronic devices (CIED) procedure who have at least 2 CIED infection risk factors
|
|---|---|---|
|
Infections and infestations
Tenderness, erythema, or warmth at the pulse generator site
|
0.40%
2/505 • Number of events 2 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.20%
1/505 • Number of events 1 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Infections and infestations
Purulent discharge
|
0.79%
4/505 • Number of events 4 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.20%
1/505 • Number of events 1 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Infections and infestations
Positive blood culture identifying a coagulase negative staphylococcus
|
0.00%
0/505 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.20%
1/505 • Number of events 1 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Infections and infestations
Vegetation adherent to CIED hardware
|
0.40%
2/505 • Number of events 2 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.40%
2/505 • Number of events 2 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Infections and infestations
Purulent material within pulse generator pocket
|
0.00%
0/505 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.20%
1/505 • Number of events 1 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Surgical and medical procedures
Allergic Reaction to pouch
|
0.20%
1/505 • Number of events 1 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/505 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Infections and infestations
Infection
|
3.8%
19/505 • Number of events 19 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
4.0%
20/505 • Number of events 20 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Surgical and medical procedures
Wound hematoma
|
4.4%
22/505 • Number of events 22 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
5.3%
27/505 • Number of events 27 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Surgical and medical procedures
Lead dislodgement
|
1.2%
6/505 • Number of events 6 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.40%
2/505 • Number of events 2 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/505 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.20%
1/505 • Number of events 1 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Product Issues
Other device related complication
|
0.79%
4/505 • Number of events 4 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
2.4%
12/505 • Number of events 12 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
General disorders
Other non device related complication
|
36.0%
182/505 • Number of events 182 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
29.5%
149/505 • Number of events 149 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Cardiac disorders
Heart transplant
|
0.40%
2/505 • Number of events 2 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/505 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
General disorders
Other
|
0.20%
1/505 • Number of events 1 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.20%
1/505 • Number of events 1 • Baseline up to 6 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
Additional Information
Christopher R. Ellis, MD, FACC, FHRS
Vanderbilt University Medical Center
Phone: (615)-936-2523
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place