PROSTABACT : Relevance of the treatment with antibiotics before endoscopic surgery of lower urinary symptoms related to prostate hypertrophy with polymicrobial bacterial culture performed before the surgery: a non-inferiority randomized trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Regional Universitaire De Tours

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Male Urogenital Diseases [C12]

Decision date (initial)

2025-02-17

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

DGOS

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Pharmacoeconomic

To demonstrate that not treating a patient with a polymicrobial UBC performed before BPH surgery is not inferior to treating him with antibiotic in terms of urinary tract infection incidence over a one-month post-surgery period.

Secondary objectives 6

1. To compare rate of patients whose procedure is cancelled in each group
2. To compare the infection characteristics in both groups
3. To describe the economy induced by not treating with antibiotics a polymicrobial UBC performed before endoscopic treatments of BPH
4. To evaluate, into a joint analysis, that not treating a patient with a polymicrobial UBC performed before BPH surgery is both clinically not inferior in terms of urinary tract infection incidence and not more expensive over a 1-month post-surgery period, than treating him.
5. To produce a budget impact analysis of a change in prescribing practices for polymicrobial UBC before endoscopic surgery of BPH, from the French Health Insurance perspective, over a 5-year period.
6. To compare the baseline urine microbiota of men who developed a post-operative infectious complication to those who did not.

Conditions and MedDRA coding

Benign Prostate Hyperplasia

Study design 4 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Adult men ≥ 18 years of age
2. Person affiliated to a French social security system or equivalent
3. Written informed consent obtained from the participant
4. Scheduled to have a surgery of lower urinary Tract Symptoms (LUTS) due to BPH, (Urolift, rezum, aquabeam, monopolar or bipolar Trans-uretral resection of the prostate, enucleation of the prostate (Holep, Greenlep, bipolep), simple prostatectomy)
5. With polymicrobial pre-operative urine culture (three or more pathogens identified).
6. Able to comply with the requirements of the study
7. Patients able to understand this clinical research

Exclusion criteria 10

1. Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: persons deprived of their liberty by judicial or administrative decision and persons subject to a legal protection measure: guardianship or trusteeship)
2. Patients already treated by antibiotic for non-urological situations
3. Concomitant participation in other pharmacological study
4. Patients in medical emergency
5. Mental state making the patient unable to understand this research
6. Patient being the investigator as well as any member of the team or close relative of the investigator directly involved in the trial, in particular assistant doctors, pharmacists, nurses, trial coordinator
7. Contraindications to antibiotic drugs administered in this study
8. Infection within 6 months before surgery
9. Hospitalisation within 6 months before surgery
10. Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, transplant, myeloma, lymphoma, known HIV and CD4<200/mm3)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence over a one-month post-operative period of a symptomatic urinary infection defined by the presence of symptoms validated by a blinded independent adjudication committee (urine burning, fever, urgencies… associated to a significant bacteriuria).

Secondary endpoints 6

1. Number of patients whose procedure is cancelled in each group
2. Infection characteristics (type of bacteria, clinical data, hospitalization…)
3. Cost of antibiotics used to treat with antibiotics a polymicrobial UBC performed before endoscopic treatments of BPH and in the one-month post-operative surgical treatment
4. Probability that the experimental strategy is clinically and economically non-inferior to the control strategy for different values of economic non-inferiority margin and for a constant clinical non-inferiority margin (10%).
5. Economic impact per year and per cumulative years of a change in prescribing practices for polymicrobial UBC before endoscopic surgery of BPH, from the French Health Insurance perspective, over a 5-year period.
6. Description of baseline urine microbiota in both groups (patients who developed an infection and patients who did not)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Regional Universitaire De Tours

Sponsor organisation

Centre Hospitalier Regional Universitaire De Tours

Address

2 Boulevard Tonnelle

City

Tours

Postcode

37000

Country

France

Scientific contact point

Organisation

Centre Hospitalier Regional Universitaire De Tours

Contact name

Pr Franck BRUYERE

Public contact point

Organisation

Centre Hospitalier Regional Universitaire De Tours

Contact name

Pr Franck BRUYERE

Locations

1 EU/EEA country · 14 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications