protocolSection identificationModule nctId: NCT06355115, orgStudyIdInfo id: 400/218/K.3/302/2023, briefTitle: Prophylactic Antibiotics Duration Towards Healing and Risk of Infection in Permanent Pacemaker (PPM) Installation, acronym: PACE-PRO, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Brawijaya, class: OTHER, collaborators name: Saiful Anwar Hospital, descriptionModule briefSummary: 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:1. What is the efficacy of different durations of prophylactic antibiotics (single dosage vs 3-day dosage) in preventing infective complications following PPM implantations?2. What factors may influence the optimum use of prophylactic antibiotics for individual patients undergoing PPM implantation to minimize the risk of infective complications?Researchers will compare a single dosage vs a 3-day dosage of prophylactic antibiotics following the PPM implantation procedure to see the risk of device-related infections.Participants will:* Be given a single-dose or 3-days dose of antibiotic regarding the PPM installations.* Visit the clinic for follow-ups and tests., conditionsModule conditions: Pacemaker Complication, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Cefazolin 1000 MG Injection, outcomesModule primaryOutcomes measure: Number of participants with early pocket infection (EPI), primaryOutcomes measure: Number of participants with late pocket infection (LPI), primaryOutcomes measure: Number of participants with infective endocarditis (IE), primaryOutcomes measure: Number of participants who underwent pacemaker revision, secondaryOutcomes measure: Level of C-reactive protein (mg/dl), secondaryOutcomes measure: Level of procalcitonin (mcg/dl), secondaryOutcomes measure: Erythrocyte sedimentation rate (ESR) (mm/hour), secondaryOutcomes measure: Neutrophil-to-leukocyte ratio (NLR), secondaryOutcomes measure: Neutrophil count (cells/mm3), secondaryOutcomes measure: Leukocyte count (cells/mm3), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RSUD Dr. Saiful Anwar, status: RECRUITING, city: Malang, state: Jawa Timur, zip: 65112, country: Indonesia, contacts name: RSUD Dr. Saiful Anwar, role: CONTACT, phone: 0341-362101, email: staf-rsu-drsaifulanwar@jatimprov.go.id, geoPoint lat: -7.9797, lon: 112.6304, hasResults: False