Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02809131 | Perioperative Antibiotic Therapy to Prevent Cardiac Implantable Electronic Device Infections. | PHASE3 | COMPLETED | 1,010 | — | — | Apr 1, 2016 | Sep 30, 2021 | May 9, 2022 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Saline irrigation | EXPERIMENTAL | Saline irrigation |
| Antibiotic irrigation and PO antibiotics | ACTIVE_COMPARATOR | Antibacterial irrigant (polymyxinB/bacitracin) and postoperative oral antibiotics (cephalexin, clindamycin, or levofloxacin) |
| Name | Type | Description |
|---|---|---|
| polymixin/bacitracin | DRUG | Antibacterial irrigation |
| cephalexin, or levofloxacin, or clindamycin | DRUG | Post operative oral antibiotics |
| Saline | DRUG | Saline irrigation |
Inclusion Criteria: * Age ≥18 years old * Able to give informed consent * At least 2 of the following risk factors for infection: * Diabetes mellitus * Chronic kidney disease (estimated creatinine clearance \<30 ml/min * Therapeutic anticoagulation * Chronic heart failure * Chronic use o...