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

NCT04985110 | Unknown Phase 2

• 1 other identifier: 21-02-0154
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Antibiotic prophylaxis; Transperineal prostate biopsy; Randomized controlled trial

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Rate of readmission

  7 days

• Rate of readmission

  14 days

Study Arms (2)

Cotrimoxazole

EXPERIMENTAL

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

Drug: Cotrimoxazole

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Cotrimoxazole DRUG

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

Cotrimoxazole

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Dr. Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Bacteriuria; Urinary Tract Infections; Sepsis

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Agus Rizal A. H. Hamid, M.D, Ph.D.

  Universitas Indonesia - Cipto Mangunkusumo Hospital

  PRINCIPAL INVESTIGATOR

• Harun Wijanarko Kusuma Putra, M.D, B.Med.Sci(Hons)

  Universitas Indonesia - Cipto Mangunkusumo Hospital

  STUDY CHAIR

• 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 DIRECTOR

Central Study Contacts

Agus Rizal A. H. Hamid, MD, PhD

CONTACT

+628111803377; rizalhamid.urology@gmail.com

Harun Wijanarko Kusuma Putra, MD, B.Med.Sci(Hons)

CONTACT

+6281808912288; harun.wijanarko@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Main Researcher

Model Details: 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.

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 2, 2021
• Study Start: July 6, 2021
• Primary Completion: July 6, 2023
• Study Completion: July 6, 2023
• Last Updated: August 5, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)