Fosfomycin as an Oral Alternative Therapy in the Treatment of Acute Bacterial Prostatitis Caused by Multidrug-Resistant Escherichia Coli. Pilot Study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacio Assistencial De Mutua De Terrassa Fpc

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Decision date (initial)

2025-01-21

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-520012-18-00

EudraCT number

2019-003792-19

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Phase IV, prospective, interventional clinical trial to demonstrate the efficacy of oral fosfomycin-tromethamol in the treatment of acute multidrug-resistant Escherichia coli bacterial prostatitis compared to a prospective control group of sensitive E. coli BAP treated with approved therapeutic alternatives.

Secondary objectives 4

1. To determine, in cases of PAB caused by multidrug-resistant E. coli without oral therapeutic options other than fosfomycin, comparing with an observational control group of patients with PAB due to sensitive E. coli treated with conventional oral therapy, collected prospectively, the savings in the use of carbapenems in DDD due to an episode of prostatitis
2. To determine, comparing with an observational control group of patients with PAB due to sensitive E. coli treated with conventional oral therapy, collected prospectively, the duration of hospital admission or admission in hospitalization at home.
3. To study the pharmacokinetics of oral FT through the determination of blood levels
4. Compare within patients of the experimental group the differences between PAB due to E. coli resistant to quinolones versus PBA due to E. coli sensitive to quinolones

Conditions and MedDRA coding

Prostatitis aguda bacteriana (PAB) por Escherichia coli multirresitente.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Casos: varones de 18 años o más con prostatitis aguda bacteriana con un urinocultivo y/o hemocultivo positivo por E. coli tratados con fosfomicina vía oral. Controles: varones de 18 años o más con prostatitis aguda bacteriana con urinocultivo o hemocultivos positivo por E. coli E. coli tratados con terapia convencional (ciprofloxacino o cotrimoxazol)

Exclusion criteria 17

1. Known allergy or intolerance to fosfomycin
2. Polymicrobial bacteremia or urine culture
3. Clinical criteria for acute pyelonephritis (positive fist-kidney percussion, urinary tract obstruction, kidney abscess).
4. Anatomical alterations of the urinary tract
5. Urinary infections associated with urinary catheters
6. Undrained prostatic abscess
7. Other concomitant infection
8. Patients who have not achieved clinical stability after 5 days of parenteral treatment
9. Patients with septic shock at the time of randomization
10. Polycystic kidney disease
11. History of known chronic prostatitis
12. Patient with 2 or more episodes of PAB in the previous year or 1 episode in the last 6 months
13. Immunocompromised patients (kidney transplant recipients, liver cirrhosis, patients on renal replacement therapy, chronic treatment with corticosteroids, receiving active chemotherapy, use of anti-TNF)
14. Terminal situation or estimated life expectancy of less than 90 days or in purely palliative treatment for their underlying illness
15. Patients who are participating in another clinical trial with active treatment
16. MIC to fosfomycin higher than that established by the study inclusion criteria.
17. Patients who refuse to give consent to participate in the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Determinar la eficacia del tratamiento secuencial con fosfomicina-trometamol (FT) por vía oral de las prostatitis agudas bacterianas (PAB) por Escherichia coli sensibles in vitro a la fosfomicina en pacientes con estabilidad clínica y que hayan recibido entre 1 y 5 días de antibioterapia parenteral previa con un antimicrobiano con actividad in vitro.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacio Assistencial De Mutua De Terrassa Fpc

Sponsor organisation

Fundacio Assistencial De Mutua De Terrassa Fpc

Address

Calle De San Antonio No 32

City

Terrassa

Postcode

08221

Country

Spain

Scientific contact point

Organisation

Fundacio Assistencial De Mutua De Terrassa Fpc

Contact name

Pilar Arcusa Solà

Public contact point

Organisation

Fundacio Assistencial De Mutua De Terrassa Fpc

Contact name

Pilar Arcusa Solà

Locations

1 EU/EEA country · 3 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 6 files

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

Application history

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