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

Pemberian Antibiotik Profilaksis Pada Biopsi Prostat Transperineal di RSUPN Dr. Cipto Mangunkusumo: Uji Klinis Acak Terkontrol

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Bacteriuria; Urinary Tract Infections; Prostate Cancer; Perioperative Complication; Prostate Biopsy
• Intervention / Treatment: Drug: Cotrimoxazole; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Agus Rizal A. H. Hamid, MD, PhD; Phone Number: +628111803377; Email: rizalhamid.urology@gmail.com
• Study Contact Backup: Name: Harun Wijanarko Kusuma Putra, MD, B.Med.Sci(Hons); Phone Number: +6281808912288; Email: harun.wijanarko@gmail.com

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Recruiting
      • Dr. Cipto Mangunkusumo Hospital
      • Contact: Agus Rizal AH Hamid, M.D., Ph.D.; Phone Number: +628111803377; Email: rizalhamid.urology@gmail.com
      • Contact: Yasmina Zahra Syadza, M.D.; Phone Number: +6281314731670; Email: syadza.yz@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cotrimoxazole; The treatment group will receive Cotrimoxazole Forte 960 mg PO q.d. 4 hours before the biopsy procedure.	Drug: Cotrimoxazole; The treatment group will receive Cotrimoxazole Forte 960 mg PO q.d. 4 hours before the biopsy procedure.
Placebo Comparator: Placebo; The placebo group will receive placebo q.d. 4 hours before the biopsy procedure.	Drug: Placebo; The placebo group will receive placebo q.d. 4 hours before the biopsy procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of infection complications	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 24 hours postoperatively.	24 hours
Incidence of infection complications	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 7 days postoperatively.	7 days
Incidence of infection complications	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.	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of readmission	The rate of readmission will also be assessed in 7 days postoperatively.	7 days
Rate of readmission	The rate of readmission will also be assessed in 14 days postoperatively.	14 days

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Agus Rizal A. H. Hamid, M.D, Ph.D., Universitas Indonesia - Cipto Mangunkusumo Hospital; Study Chair: Harun Wijanarko Kusuma Putra, M.D, B.Med.Sci(Hons), Universitas Indonesia - Cipto Mangunkusumo Hospital; Study Director: Syamsu Hudaya, M.D., Fatmawati General Hospital, Jakarta - Indonesia; Study Director: Hendy Mirza, M.D., Persahabatan Central General Hospital, Jakarta - Indonesia; Study Director: Dyandra Parikesit, B.Med.Sc., M.D., Universitas Indonesia, Depok - Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2021
• Primary Completion (Anticipated): July 6, 2023
• Study Completion (Anticipated): July 6, 2023

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): August 2, 2021

Study Record Updates

• Last Update Posted (Actual): August 5, 2021
• Last Update Submitted That Met QC Criteria: July 30, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Antibiotic prophylaxis; Transperineal prostate biopsy
• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urinary Tract Infections; Bacteriuria; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Anti-Infective Agents, Urinary; Renal Agents; Trimethoprim, Sulfamethoxazole Drug Combination
• Other Study ID Numbers: 21-02-0154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No