Prophylactic Antibiotics Duration Towards Healing and Risk of Infection in Permanent Pacemaker (PPM) Installation

NCT06355115 | Recruiting Phase 2

• 1 other identifier: 400/218/K.3/302/2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The insertion of a permanent pacemaker (PPM) is frequently a life-saving procedure. However, the implantation process could sometimes lead to a rare but serious infection. Therefore, administering prophylactic antibiotics to prevent infections before they occur, is a useful strategy to lower the risk of such infections. Nonetheless, the optimal duration of prophylactic antibiotics for PPM remains uncertain. Individual study results are ambiguous and debatable due to the fact that each center has its own policy governing the regimen for prophylactic antibiotic use. Accordingly, the goal of this clinical trial is to assess and compare the effectiveness of two types of widely used prophylactic antibiotic durations in relation to the risk of infections following PPM implantations. The main questions it aims to answer are:

• Be given a single-dose or 3-days dose of antibiotic regarding the PPM installations.
• Visit the clinic for follow-ups and tests.

Conditions

Pacemaker Complication

Keywords

permanent pacemakers; infections; prophylactic antibiotics

Outcome Measures

Primary Outcomes (4)

• Number of participants with early pocket infection (EPI)

  EPI refers to a post-operative complication characterized by wound infection or infection of the device pouch within the initial weeks or month following surgical procedure. Manifestations of early pocket infections include local signs of inflammation such as erythema, edema, warmth, and tenderness at the implantation site, occasionally accompanied by purulent discharge or systemic symptoms such as fever.

  0-30 days

• Number of participants with late pocket infection (LPI)

  LPI refers to a post-operative complication characterized by wound infection or infection of the device pouch within the following months following surgical procedure. Manifestations of late pocket infections are similar to those of EPI, which include local signs of inflammation such as erythema, edema, warmth, and tenderness at the implantation site, occasionally accompanied by purulent discharge or systemic symptoms such as fever.

  1-3 months

• Number of participants with infective endocarditis (IE)

  IE following the implantation of PPM is characterized by bacteremia due to device infection, lead vegetation, right infective endocarditis. Diagnosis is established through history taking and physical examination and the visualization of vegetations by Transthoracic Echocardiography (TTE).

  1 year

• Number of participants who underwent pacemaker revision

  Pacemaker revision or reimplantation due to infective complications.

  1 year

Secondary Outcomes (6)

• Level of C-reactive protein (mg/dl)

  3 days

• Level of procalcitonin (mcg/dl)

  3 days

• Erythrocyte sedimentation rate (ESR) (mm/hour)

  3 days

• Neutrophil-to-leukocyte ratio (NLR)

  3 days

• Neutrophil count (cells/mm3)

  3 days

Study Arms (2)

Three days dose prophylaxis

ACTIVE COMPARATOR

Intravenous (iv) injection of Cefazolin 1 gram 1-hour pre-procedure followed by iv injection of Cefazolin 1 gram every 12 hours for 3 days post-procedure (6 doses)

Drug: Cefazolin 1000 MG Injection

Single dose prophylaxis

EXPERIMENTAL

Intravenous injection of Cefazolin 1 gram 1-hour pre-procedure

Drug: Cefazolin 1000 MG Injection

Interventions

Cefazolin 1000 MG Injection DRUG

Cefazolin 1000 mg given intravenously

Single dose prophylaxis; Three days dose prophylaxis

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients, aged 18 to 100 years old, with indications for PPM (single or double chamber) installation.
• The patient is scheduled to undergo PPM installation for the first time
• The patient is willing to undergo routine follow-ups and visits
• Patients who are medically stable and do not have any acute illnesses that could interfere with the study outcomes.

You may not qualify if:

• Patients with fever before the Procedure
• Skin disease
• Patients on anticoagulants or receiving bridging heparin
• Patients who used antibiotics 30 days before the PPM installation was carried out
• Patients with end stage renal failure
• Patients with uncontrolled Diabetes Mellitus
• Patients with a history of infective endocarditis
• Patients with a history of moderate to severe valvular heart disease
• Patients with congenital heart disease
• Patients with non-cardiac comorbid diseases whose life expectancy is \< 1 year
• Illness or physical disorder that causes the patient to be unable or limited to carry out physical activities
• Patients with a history of autoimmune disease, and confirmed autoimmune disease
• Patients on long-term steroid use
• The patient refused follow-up

Sponsors & Collaborators

• University of Brawijaya: lead
• Saiful Anwar Hospital: collaborator

Study Sites (1)

RSUD Dr. Saiful Anwar

Malang, East Java, 65112, Indonesia

RECRUITING

MeSH Terms

Conditions

Infections

Interventions

Cefazolin; Injections

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Icmi D Rochmawati, M.D.

  University of Brawijaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Icmi D Rochmawati, M.D.

CONTACT

+62 857-6822-8899; icmidianr@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Cardiologist

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: April 9, 2024
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)