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

Phase 2

• Conditions: Perioperative Complication; Prostate Biopsy; Bacteriuria; Urinary Tract Infections; Prostate Cancer; Sepsis
• Interventions: Drug: Placebo; Drug: Cotrimoxazole

• Registration Number: NCT04985110
• Lead Sponsor: Indonesia University

Brief 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.

Detailed Description

Prostate cancer screenings will be conducted in all patients aged \>45 years with lower urinary tract symptoms (LUTS) through PSA test and digital rectal examination (DRE). Those with PSA levels of 4.0 ng/mL or higher or other abnormal findings on DRE will be recommended to undergo transperineal prostate biopsy. In addition, participants will be offered to participate in this clinical trial, in which participants will be randomly assigned into two groups: one group will receive prophylactic antibiotic, while the other group will receive placebo.

The randomization process will be conducted before the biopsy procedure. Computers will generate random numbers, which will put the participants into two groups. These numbers can only be accessed by the research monitor (Clinical Research Supporting Unit of IMERI FMUI), while the investigators, surgeons, residents, and nurses involved will be blinded to this information. To ensure patient blinding, the placebo and cotrimoxazole forte 960 mg will be reformed as identical as possible in capsule preparation.

The primary outcomes of this clinical trial are the rate of perioperative infection complications, including bacteriuria, urinary tract infection (UTI), UTI with fever (febrile UTI), and sepsis, in 24 hours, 7 days, and 14 days postoperatively. The secondary outcomes of this clinical trial are the rate of readmission.

Study Timeline

• Status Verified: 2021-07
• Study Start: 2021-07-06
• Study First Submitted: 2021-07-26
• Study First Submitted QC: 2021-07-26
• Last Update Submitted: 2021-07-30
• Study First Posted: 2021-08-02
• Last Update Posted: 2021-08-05
• Primary Completion: 2023-07-06
• Study Completion: 2023-07-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 78

Inclusion Criteria

• Patient with lower urinary tract symptoms aged >45 years with either PSA levels of 4.0 ng/mL or higher or abnormal findings on digital rectal examination (DRE)
• Patient with a negative initial urine culture / urinalysis test

Exclusion Criteria

• Patients who refuses to undergo transperineal prostate biopsy
• Patients who refuses to participate in the research
• Patient who is unable to communicate effectively
• Patient with a documented history of cotrimoxazole allergy
• Patient who has consumed antibiotics for other indications prior to undergoing prostate biopsy
• Patient with urinary tract infection symptoms prior to undergoing prostate biopsy
• Patient with a history of immunodeficiency disorders or long-term corticosteroid use
• Patient with a history of prostate cancer
• Patient with a history of prior prostate biopsy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	The placebo group will receive placebo q.d. 4 hours before the biopsy procedure.
Cotrimoxazole	Cotrimoxazole	The treatment group will receive Cotrimoxazole Forte 960 mg PO q.d. 4 hours before the biopsy procedure.

Primary Outcome Measures

Name	Time	Method
Incidence of infection complications	14 days	The rate of infection complications, including bacteriuria, urinary tract infection (UTI), UTI with fever (febrile UTI), and sepsis, will be measured in both treatment and placebo groups in 14 days postoperatively.

Secondary Outcome Measures

Name	Time	Method
Rate of readmission	14 days	The rate of readmission will also be assessed in 14 days postoperatively.

Trial Locations

Locations (1)

Dr. Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia