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Oral Fosfomycin as Sequential Oral Treatment for Multidrug-Resistant Escherichia Coli in Acute Bacterial Prostatitis
Sponsor: Hospital Mutua de Terrassa
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
Conditions
Interventions
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.
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.
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