Comparing antibiotic durations to prevent infections after pacemaker installation
Comparison Effect Between a Single Dose Prophylaxis Antibiotics Given One Day and Three Days Towards Healing and Risk of Infection in Permanent Pacemaker (PPM) Installation: a Preliminary Study
This study is testing whether a single dose of antibiotics or a three-day course is better at preventing infections after getting a pacemaker.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Brawijaya Academic / other |
| Locations | 1 site (Malang, Jawa Timur) |
| Trial ID | NCT06355115 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of two different durations of prophylactic antibiotics in preventing infections following the implantation of permanent pacemakers (PPM). It aims to compare a single dose of cefazolin against a three-day course to determine which regimen is more effective in reducing the risk of infective complications. The study will also explore patient-specific factors that may influence the choice of antibiotic duration. By addressing the variability in clinical practices, this trial seeks to establish a more standardized approach to antibiotic prophylaxis in PPM procedures.
Who should consider this trial
Good fit: Ideal candidates include adult patients aged 18 to 100 who are scheduled for their first permanent pacemaker installation and are medically stable.
Not a fit: Patients with acute illnesses, certain comorbidities, or those who have recently used antibiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved protocols for antibiotic use, reducing the risk of infections and complications for patients undergoing pacemaker implantation.
How similar studies have performed: Previous studies have shown varying results regarding antibiotic prophylaxis duration, indicating that this approach is still under investigation and not yet standardized.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Case inclusion criteria 1. Adult patients, aged 18 to 100 years old, with indications for PPM (single or double chamber) installation. 2. The patient is scheduled to undergo PPM installation for the first time 3. The patient is willing to undergo routine follow-ups and visits 4. Patients who are medically stable and do not have any acute illnesses that could interfere with the study outcomes. Exclusion Criteria: 1. Patients with fever before the Procedure 2. Skin disease 3. Patients on anticoagulants or receiving bridging heparin 4. Patients who used antibiotics 30 days before the PPM installation was carried out 5. Patients with end stage renal failure 6. Patients with uncontrolled Diabetes Mellitus 7. Patients with a history of infective endocarditis 8. Patients with a history of moderate to severe valvular heart disease 9. Patients with congenital heart disease 10. Patients with non-cardiac comorbid diseases whose life expectancy is \< 1 year 11. Illness or physical disorder that causes the patient to be unable or limited to carry out physical activities 12. Patients with a history of autoimmune disease, and confirmed autoimmune disease 13. Patients on long-term steroid use 14. The patient refused follow-up
Where this trial is running
Malang, Jawa Timur
- RSUD Dr. Saiful Anwar — Malang, Jawa Timur, Indonesia (Recruiting)
Study contacts
- Principal investigator: Icmi D Rochmawati, M.D. — University of Brawijaya
- Study coordinator: Icmi D Rochmawati, M.D.
- Email: icmidianr@hotmail.com
- Phone: +62 857-6822-8899
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.