Clinical trial • Phase IV • Infectious Disease

FOSFOMYCIN for Acute bacterial prostatitis (Escherichia coli, multidrug-resistant)

Phase IV trial of FOSFOMYCIN for Acute bacterial prostatitis (Escherichia coli, multidrug-resistant).

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Acute bacterial prostatitis (Escherichia coli, multidrug-resistant)
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
21-01-2025
First CTIS Authorization Date
21-01-2025

Trial design

Controls treated with conventional oral therapy (ciprofloxacin or cotrimoxazole); no dose or schedule specified. Phase IV trial across 3 sites in Spain.

Comparator
Controls treated with conventional oral therapy (ciprofloxacin or cotrimoxazole); no dose or schedule specified.
Real World Control
Yes
Target Sample Size
244

Stratification factors

  • sex
  • age
  • clinical diagnosis

Eligibility

Recruits 244 No vulnerable population selected. Participants are males aged 18 years or older. Informed consent is obtained from participants themselves; no assent procedures described..

Vulnerable Population
No vulnerable population selected. Participants are males aged 18 years or older. Informed consent is obtained from participants themselves; no assent procedures described.

Inclusion criteria

  • {"criterion_text":"- 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

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

Endpoints

Primary endpoints

  • {"endpoint_text":"- Determinar la eficacia del tratamiento secuencial con fosfomicina-trometamol (FT) por vía oral de las prostatitis agudas bacterianas (PAB) por Escherichia coli multiresistente (MR) 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.","definition_or_measurement_approach":"Comparison versus a prospective control group of patients with PAB due to sensitive E. coli treated with approved therapeutic alternatives (as stated in the main objective)."}

Recruitment

Planned Sample Size
244
Recruitment Window Months
62
Consent Approach
Informed consent obtained from participants (adult males ≥18). Patient information sheet is listed ('HOJA DE INFORMACION AL PACIENTE'). No assent procedures described. Documents appear to be in Spanish; no additional languages specified.

Geography

Total Number Of Sites
3
Total Number Of Participants
244

Spain

Earliest CTIS Part Ii Submission Date
12-12-2024
Latest Decision Or Authorization Date
21-01-2025
Processing Time Days
40
Number Of Sites
3
Number Of Participants
244

Sites

Site Name
Parc Tauli Hospital Universitari
Department Name
infectious diseases
Principal Investigator Name
Aina Gomila
Principal Investigator Email
afarre@tauli.cat
Contact Person Name
Aina Gomila
Contact Person Email
afarre@tauli.cat
Site Name
Consorci Sanitari De Terrassa
Department Name
937231010
Principal Investigator Name
Marta Andres
Principal Investigator Email
recerca@CST.CAT
Contact Person Name
Marta Andres
Contact Person Email
recerca@CST.CAT
Site Name
Consorci Mar Parc De Salut De Barcelona
Department Name
infectious diseases
Principal Investigator Name
Silvia Inés Gómez-Zorrilla
Principal Investigator Email
contractes@researchmar.net
Contact Person Name
Silvia Inés Gómez-Zorrilla
Contact Person Email
contractes@researchmar.net

Sponsor

Primary sponsor

Full Name
Fundacio Assistencial De Mutua De Terrassa Fpc
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
FOSFOMYCIN
Active Substance
FOSFOMYCIN
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Maximum Dose
3 g per day (max total 63 g)

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