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COMPLETED
NCT07902427
PHASE4

Oral Fosfomycin as Sequential Oral Treatment for Multidrug-Resistant Escherichia Coli in Acute Bacterial Prostatitis

Sponsor: Hospital Mutua de Terrassa

View on ClinicalTrials.gov

Summary

FOS-PROST was a prospective, non-randomized, controlled phase IV clinical trial designed to evaluate the clinical and microbiological efficacy of oral fosfomycin trometamol as sequential antibiotic therapy in patients with acute bacterial prostatitis caused by multidrug-resistant \*Escherichia coli\*. According to the study protocol, patients with multidrug-resistant \*E. coli\* were assigned to receive oral fosfomycin trometamol, whereas patients with non-multidrug-resistant \*E. coli\* were assigned to receive conventional oral antibiotic treatment with ciprofloxacin or trimethoprim-sulfamethoxazole, according to antimicrobial susceptibility testing. All patients received 1 to 5 days of appropriate intravenous antibiotic therapy before switching to oral treatment. Fosfomycin trometamol was administered at a standard dose of 3 g once daily. The planned total duration of antibiotic treatment was 21 days in both groups, including intravenous and oral therapy. During study conduct, some patients with non-multidrug-resistant \*E. coli\* also received fosfomycin. All patients with multidrug-resistant \*E. coli\* received fosfomycin. Clinical and microbiological outcomes were compared between treatment groups. Secondary objectives included evaluating carbapenem consumption, hospital length of stay, safety, recurrence, and fosfomycin pharmacokinetics.

Official title: Oral Fosfomycin as Sequential Oral Treatment for Multidrug-Resistant Escherichia Coli in Acute Bacterial Prostatitis: The FOS-PROST Study

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

88

Start Date

2022-01-25

Completion Date

2026-06-30

Last Updated

2026-10-28

Healthy Volunteers

No

Interventions

DRUG

Fosfomycin Trometamol Salt

Oral fosfomycin trometamol, 3 g every 24 hours, administered as sequential antibiotic therapy after 1 to 5 days of appropriate intravenous antibiotic treatment, once clinical stability and oral tolerance were achieved. The planned total duration of antibiotic treatment, including intravenous and oral therapy, was 21 days. Dose adjustments for renal impairment were specified in the protocol.

DRUG

control group

Oral ciprofloxacin, 500 mg every 12 hours, administered as sequential antibiotic therapy according to antimicrobial susceptibility testing, following 1 to 5 days of appropriate intravenous antibiotic treatment. The planned total duration of antibiotic therapy was 21 days.

DRUG

control group

Oral trimethoprim-sulfamethoxazole, 160 mg/800 mg every 12 hours, administered as sequential antibiotic therapy according to antimicrobial susceptibility testing, following 1 to 5 days of appropriate intravenous antibiotic treatment. The planned total duration of antibiotic therapy was 21 days.

Locations (7)

Hospital del Mar

Barcelona, Barcelona, Spain

Hospital Universitari Parc Taulí

Sabadell, Barcelona, Spain

Hospital de Sant Joan Despí Moisès Broggi

Sant Joan Despí, Barcelona, Spain

Hospital Universitari Mutua Terrassa

Terrassa, Barcelona, Spain

Hospital de Terrassa

Terrassa, Catalonia, Spain

Clínica Universidad de Navarra

Pamplona, Navarre, Spain

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, Spain