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Administration of Antibiotic Prophylaxis for Transperineal Prostate Biopsy in Cipto Mangunkusumo Hospital

NCT04985110 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2021-08-05

No results posted yet for this study

Summary

This randomized controlled trial aims to compare the rate of perioperative infection complications in transperineal prostate biopsy between the group that receives prophylactic antibiotic and the group that receives placebo. The types of infection studied included bacteriuria, urinary tract infection (UTI), UTI with fever (febrile UTI), and sepsis. This study hypothesized that the administration of prophylactic antibiotics during transperineal prostate biopsy would result in lower rates of perioperative infection complications.

Conditions

Interventions

DRUG

Cotrimoxazole

The treatment group will receive Cotrimoxazole Forte 960 mg PO q.d. 4 hours before the biopsy procedure.

DRUG

Placebo

The placebo group will receive placebo q.d. 4 hours before the biopsy procedure.

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • Agus Rizal A. H. Hamid, M.D, Ph.D. · Universitas Indonesia - Cipto Mangunkusumo Hospital

  • Harun Wijanarko Kusuma Putra, M.D, B.Med.Sci(Hons) · Universitas Indonesia - Cipto Mangunkusumo Hospital

  • Syamsu Hudaya, M.D. · Fatmawati General Hospital, Jakarta - Indonesia

  • Hendy Mirza, M.D. · Persahabatan Central General Hospital, Jakarta - Indonesia

  • Dyandra Parikesit, B.Med.Sc., M.D. · Universitas Indonesia, Depok - Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-06
Primary Completion
2023-07-06
Completion
2023-07-06

Countries

  • Indonesia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04985110 on ClinicalTrials.gov