The effect of various types of preventive antibiotics (prophylaxis) on getting an infection after prostate tissue examination (biopsy).

Phase 1

• Conditions: Antimicrobial prophylaxis for patients undergoing prostate biopsy concerning infectious complications.; MedDRA version: 20.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: PTClassification code 10064736Term: Antibiotic prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.1Level: PTClassification code 10004857Term: Biopsy prostateSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2017-002938-23-NL
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-14
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 1618

Inclusion Criteria

- Men suspect of prostate cancer undergoing transrectal prostate biopsy as part of standard of care, in the Radboud university medical center (Radboudumc), Catharina hospital or Canisius Wilhelmina hospital
- Subject is able and willing to sign the Informed Consent Form.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 618

Exclusion Criteria

- Inability to receive ciprofloxacin prophylaxis for any reason (e.g. documented history of sensitivity to medicinal products or excipients similar to those found in the antibiotic prophylaxis, relevant history or presence of cardiovascular disorders (specific relevant QTc time prolongation), relevant drug interaction).
- Inability to receive either co-trimoxazole, fosfomycin and pivmecillinam/augmentin prophylaxis for any reason (e.g. documented history of sensitivity to medicinal products or excipients similar to those found in the antibiotic prophylaxis, relevant drug interaction).
- Inability to understand the nature of the trial and the procedures required.
- Individuals with an urinary tract infection or acute prostatitis within 14 days prior to transrectal prostate biopsy.
- Individuals who received antibiotics within 14 days prior to transrectal prostate biopsy.
- Individuals who fail to send a rectum swab to the microbiology laboratory.
- Individuals whose rectal swab shows no growth on a Colombia blood agar (growth control).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified