Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bacteriuria | — | UNRESOLVED | — |
| Perioperative Complication | — | UNRESOLVED | — |
| Prostate Biopsy | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Sepsis | — | UNRESOLVED | — |
| Urinary Tract Infections | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cotrimoxazole | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cotrimoxazole
- description
- The treatment group will receive Cotrimoxazole Forte 960 mg PO q.d. 4 hours before the biopsy procedure.
- interventionNames
- Drug: Cotrimoxazole
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- The placebo group will receive placebo q.d. 4 hours before the biopsy procedure.
- interventionNames
- Drug: Placebo
Primary outcomes (3)
- measure
- Incidence of infection complications
- timeFrame
- 24 hours
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available