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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04985110
• Other study ID #: 21-02-0154
• Status: Recruiting
• Phase: Phase 2
• Start date: July 6, 2021
• Est. completion date: July 6, 2023

Study information

• Verified date: July 2021
• Source: Indonesia University
• Contact: Agus Rizal A. H. Hamid, MD, PhD
• Phone: +628111803377
• Email: rizalhamid.urology[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: July 6, 2023
• Est. primary completion date: July 6, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Cotrimoxazole
The treatment group will receive Cotrimoxazole Forte 960 mg PO q.d. 4 hours before the biopsy procedure.
• Placebo
The placebo group will receive placebo q.d. 4 hours before the biopsy procedure.

Locations

Country	Name	City	State
Indonesia	Dr. Cipto Mangunkusumo Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Rate of readmission	The rate of readmission will also be assessed in 7 days postoperatively.	7 days
Secondary	Rate of readmission	The rate of readmission will also be assessed in 14 days postoperatively.	14 days