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

University of Indonesia (UI)

Status and phase: Unknown; Phase 2

Conditions: Perioperative Complication; Urinary Tract Infections; Prostate Biopsy; Bacteriuria; Prostate Cancer; Sepsis

Treatments: Drug: Placebo; Drug: Cotrimoxazole

Study type: Interventional

Funder types: Other

Identifiers

NCT04985110

21-02-0154

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 estimated patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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78 participants in 2 patient groups, including a placebo group

Cotrimoxazole

Experimental group

Description:

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

Treatment:

Drug: Cotrimoxazole

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo