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

Sponsor

Indonesia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04985110

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Prostate Biopsy Perioperative Complication Bacteriuria Urinary Tract Infections Sepsis	Drug: Cotrimoxazole Drug: Placebo	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

The randomization process will be conducted before the study started. Computers will generate random numbers, which will put the participants into two groups. These numbers can only be accessed by the clinical research supporting unit team, while the investigators, surgeons, residents, nurses, and pharmacologists involved will be blinded to this information. To ensure patient blinding, the placebo will be manufactured as identical capsules.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 6, 2021

Anticipated Primary Completion Date :

Jul 6, 2023

Anticipated Study Completion Date :

Jul 6, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Incidence of infection complications [24 hours]
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.
Incidence of infection complications [7 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 7 days postoperatively.
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

Rate of readmission [7 days]
The rate of readmission will also be assessed in 7 days postoperatively.
Rate of readmission [14 days]
The rate of readmission will also be assessed in 14 days postoperatively.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. Cipto Mangunkusumo Hospital	Jakarta Pusat	DKI Jakarta	Indonesia	10430

Sponsors and Collaborators

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