NCT04985110

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Indonesia University · Academic / Other
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer
• Prostate Biopsy
• Perioperative Complication
• Bacteriuria
• Urinary Tract Infections
• Sepsis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-07-06
• Primary completion: 2023-07-06
• Completion: 2023-07-06
• First posted: 2021-08-02
• Last updated: 2021-08-05

Locations

1 site across 1 country: Indonesia