Clinical Efficacy of oral Fosfomycin Trometamol and Cefixime in the Treatment of Acute Bacterial Prostatitis (CEFOSPROST): a comparative, randomized, open, multicenter trial.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Male Urogenital Diseases [C12]

Trial duration

4 Dec 2024 → ongoing

Decision date (initial)

2024-08-21

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Instituto de Salud Carlos III

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the clinical cure (resolution of urinary symptoms) 6-10 days post end-of-treatment. Clinical cure is defined as a patient alive with reduction of all initial local and systemic febrile UTI related symptoms. Obstructive urinary symptoms may persist if the investigator considers it is not due to the infection.

Secondary objectives 8

1. To evaluate the clinical cure (resolution of urinary symptoms) 24-36 days post end-of-treatment.
2. To evaluate the microbiological cure at 6-10 days and 24-36 days post end-of-treatment.
3. To evaluate combined clinical and microbiological cure at 6-10 days and 24-36 days post end-of-treatment.
4. To evaluate relapse within 24-36 days and 80-100 days post end-of treatment
5. To evaluate reinfection within 24-36 days and 80-100 days post end of-treatment.
6. To evaluate adverse events possible or probable related to study protocol until 30 days of end of treatment.
7. To evaluate the acquired resistance at 24-36 days post end-of treatment
8. To compare the impact of the different antimicrobials in the rectal colonization by multidrug resistant microorganisms at baseline, 6-10 days and 24-36 days post end-of treatment.

Conditions and MedDRA coding

Acute bacterial prostatitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Male (born male) ≥ 18 years of age
2. Diagnosed with acute bacterial prostatitis, defined when all the following criteria are fulfilled: a)acute presentation of voiding symptoms (irritative and/or obstructive). b)temperature of ≥ 37.8°C. c)the presence of bacteriuria or/and leukocyturia in a clean-catch midstream urine specimen without prostate massage d)the absence of data suggestive of pyelonephritis (costovertebral angle tenderness).
3. Receive appropriate empirical intravenous antibiotics for ≥24 - ≤96 h.
4. Isolation of enterobacterales microorganism in urine culture > 1000 CFU/ml or blood culture sensitive to at least two of the following drugs (ciprofloxacin, or fosfomycin, or cefixime). Susceptibility of enterobacterales will be assessed according “EUCAST Clinical Breakpoint Tables v. 14.0, valid from 2024-01-01” for Enterobacterales, taking into account that for cefixime will be used the criteria established for uncomplicated urinary tract infection (UTI), and that for Enterobacterales other than E. coli, they are not considered sensitive to fosfomycin, so they cannot be randomized to this arm.
5. Be able to understand and comply with protocol requirements, instructions, and restrictions.
6. Be likely to complete the study as planned.
7. Be considered appropriate candidates for participation in a clinical trial with oral medication (e.g., no active substance abuse, acute major organ disease, or planned long-term work assignments out of the country, etc.).
8. Absence of exclusion criteria and able to provide consent for data collection and analysis.

Exclusion criteria 9

1. Allergy to ciprofloxacin, fosfomycin or cefixime
2. Chronic undwelling urinary catheter
3. Fever presenting within 24 h of urinary tract manipulation
4. Cases suggestive of chronic bacterial prostatitis (CBP) defined as (i) bacterial prostatitis of long duration (symptoms lasting more than 4 weeks) or (ii) two or more episodes of acute prostatitis caused by the same organism during the last 12 months.
5. Presence of prostatic abscess
6. Presence of metastatic infectious foci.
7. Isolation of enterobacterales microorganism in urine culture or blood culture resistant at two or more of the following drugs (ciprofloxacin, or fosfomycin, or cefixime)
8. Isolation of polymicrobial microorganisms, clinically relevant, in urine or blood culture.
9. Creatinine clearance < 10 ml /min or estimated glomerular filtration rate < 10 ml/min/1.73m2

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Clinical cure: patient alive with reduction of all initial local and systemic febrile UTI related symptoms and without additional systemic antibiotic therapy for UTI (except antibiotic prophylaxis) at 6-10 days post-end of treatment.

Investigational products

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

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Sponsor organisation

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Address

Passeig De La Vall D'Hebron 119-129

City

Barcelona

Postcode

08035

Country

Spain

Scientific contact point

Organisation

Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron

Contact name

Dr. Joaquín Burgos

Public contact point

Organisation

Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron

Contact name

Investigator Coordinator

Locations

1 EU/EEA country · 9 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Documents 14 files

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

Application history

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