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NCT Number: NCT07206992

Assessment of a 24-hour Preoperative Course of Antibiotic Therapy for Endoscopic Urological Surgery in Case of Positive Urine Culture

Endourology poses the problem of post-operative infections. The need to obtain a negative urine culture prior to surgery is accepted, and the effectiveness of this measure in reducing the risk of post-operative infection has been proven.

Current French recommendations are unanimous in favour of preventive treatment for asymptomatic bacteriuria (positive urine culture) prior to urological procedures involving contact with urine. These same recommendations specify that treatment should be brief, with a preoperative course of antibiotics lasting 48 hours.

However, the scientific literature on the subject does not provide an answer to the question of whether 48 hours is the optimal duration of preoperative antibiotic treatment to avoid the risk of postoperative infection.

In this context, it is interesting to evaluate a duration of preoperative antibiotic therapy limited to 24 hours, as no study can confirm that 24 hours of treatment is insufficient to prevent post-operative infection.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Endourology poses the problem of post-operative infections. The need to obtain a negative urine culture prior to surgery is accepted, and the effectiveness of this measure in reducing the risk of post-operative infection has been proven.

Current French recommendations are unanimous in favour of preventive treatment for asymptomatic bacteriuria (positive urine culture) prior to urological procedures involving contact with urine. These same recommendations specify that treatment should be brief, with a preoperative course of antibiotics lasting 48 hours.

However, the scientific literature on the subject does not provide an answer to the question of whether 48 hours is the optimal duration of preoperative antibiotic treatment to avoid the risk of postoperative infection. Studies have shown that a single parenteral administration of antibiotics in the context of asymptomatic bacteriuria prior to urological surgery is effective in preventing post-operative infection. Furthermore, in some practical situations related to the time taken for the laboratory to return urine culture results, preoperative antibiotic therapy has been limited to 24 hours without any infections developing.

In this context, it is interesting to evaluate a duration of preoperative antibiotic therapy limited to 24 hours, as no study can confirm that 24 hours of treatment is insufficient to prevent post-operative infection.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients over 18 years of age
  • Patients scheduled for urological endoscopy for one of the following indications: endoscopic surgery of the upper urinary tract (diagnostic, for treatment of stones or ureteral strictures), endoscopic prostate surgery (with or without laser: enucleation, vaporisation, resection), endoscopic surgery of the bladder and urethra (particularly tumours, strictures and foreign bodies) and ureteral stent surgery
  • Patients with a positive preoperative urine culture (presence of bacteria at more than 103/mL)
  • Asymptomatic patients (no signs of urinary tract infection in particular)
  • Patients affiliated with or covered by a social security scheme
  • French-speaking patients who have signed an informed consent form

Exclusion criteria

  • Patient participating in another clinical trial
  • Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
  • Patient with an immune deficiency
  • Patient presenting symptoms of preoperative pyelonephritis (fever)

Treatment and study plan

24 hours antibiotics

Drug

Antibiotic therapy will start 24 hours before urological surgery

48 hours antibiotics

Drug

Antibiotic therapy will start 48 hours before urological surgery

Primary outcomes

  1. Post-operative infectious complications.

    Time frame: One month

    Post-operative infectious complications will be assessed as %. Post-operative infection will be defined as:

    • A fever (T>38°C) / hypothermia (T<36°C) with no other cause other than urological, OR lower back pain, OR lower urinary tract symptoms that appeared or persisted at least 7 days after the procedure.

    AND

    • A positive urine culture (leukocyturia >or= 10^4/ml and positive urine culture >10^3 cfu/ml for a uropathogen)

Study contacts

Contact information is provided by the study sponsor or research team.

Dorian LEGRAVEREND, MD

CONTACT

[email protected]

+ 33 1 53 20 06 88

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: ANTIBIURO

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 3, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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