Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06448624
Other study ID # No.16114/EC/KEPK-RSDK/2024
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date April 1, 2024
Est. completion date January 2025

Study information

Verified date June 2024
Source Universitas Diponegoro
Contact Marco Wirawan Hadi, MD
Phone 024-8413476
Email marco.wirawan@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Effect of single dose & intrapocket prophylactic antibiotic to cardiac implantable electronic device-related infection & biomarkers


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date January 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Indication of CIED implantation - No infection at the time of implantation Exclusion Criteria: - Refuse to participate in the study - Allergy to ampicillin sulbactam - CIED debridement

Study Design


Intervention

Drug:
Ampicillin sulbactam 3 days
Ampicillin sulbactam 1.5 gram IV TID for 3 days after CIED implantation
Placebo 3 days
Placebo for 3 days after CIED implantation

Locations

Country Name City State
Indonesia Kariadi Central General Hospital Semarang Central Java

Sponsors (2)

Lead Sponsor Collaborator
Universitas Diponegoro Dr. Kariadi General Hospital Medical Center

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary CIED-related infection Event of superficial infection, pocket infection, infective endocarditis, or rehospitalization Baseline, 3 days, 7 days, and 28 days
Secondary Presepsin Delta level of Presepsin Baseline and 24 hours after CIED implantation
Secondary Interleukin-6 Delta level of Interleukin-6 Baseline and 24 hours after CIED implantation
Secondary Procalcitonin Delta level of Procalcitonin Baseline and 24 hours after CIED implantation
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05095324 - The Biomarker Prediction Model of Septic Risk in Infected Patients
Recruiting NCT05548933 - Effects of Non-surgical Periodontal Therapy on Severe Periodontitis and Hyperlipidemia
Active, not recruiting NCT03926572 - Acute Decompensation of Pulmonary Hypertension N/A
Recruiting NCT05372159 - Vanderbilt Memory and Aging Project
Completed NCT03173586 - Sugar Sweetened Beverage Intake and Biomarkers of Cardiometabolic Risk in US Women N/A
Completed NCT04554628 - Early Prediction of Acute Kidney Injury Among Patients Admitted to Surgical ICU N/A
Terminated NCT03250312 - The Effects of OMT on the Expression Patterns of Immune Cell Biomarkers N/A
Recruiting NCT04666766 - Detecting Traumatic Intracranial Hemorrhage With Microwaves and Biomarkers N/A
Completed NCT04573543 - The Role of Immune Semaphorins in NAFLD
Completed NCT03193671 - Evaluation and Implementation of New Biomarkers and Algorithms for Diagnosis of Ovarian Cysts/Tumors in the Pelvis N/A
Recruiting NCT06047132 - PREDICTIVE ABILITY OF A PANEL OF BIOMARKERS IN SALIVA IN HEALTHY AND PERIODONTALLY AFFECTED SUBJECTS
Completed NCT05361460 - Patients Experiences of Early Postoperative Cognition
Recruiting NCT05706194 - Early Neuroprognostication After OHCA
Recruiting NCT05138731 - Metabolomics Profiling of Coronary Heart Disease
Recruiting NCT06446895 - Biomarkers of Inflammation and Endothelial Dysfunction in Patients With Myocardial Infarction With Non-obstructive Coronary Arteries
Not yet recruiting NCT04563000 - Impact of Vitamin C on Biomarkers of Neurologic Injury in Survivors of Cardiac Arrest Phase 2
Completed NCT05138692 - Biomarkers and Outcome 1 and 10-15 Years After Severe Traumatic Brain Injury
Completed NCT02247999 - Improving Cervical Cancer Screening Among HIV-Infected Women in India
Active, not recruiting NCT02732301 - Postoperative Gastrointestinal Dysfunction After Cardiac Surgery - Occurrence and Search for Biomarkers
Not yet recruiting NCT03269019 - Thrombotic Biomarkers to Predict Thrombosis in Heparin-induced Thrombocytopenia N/A