FOSFOMYCIN for Acute bacterial prostatitis

Inclusion criteria

• {"criterion_text":"- Male (born male) ≥ 18 years of age"}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- Receive appropriate empirical intravenous antibiotics for ≥24 - ≤96 h."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Be able to understand and comply with protocol requirements, instructions, and restrictions."}
• {"criterion_text":"- Be likely to complete the study as planned."}
• {"criterion_text":"- 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.)."}
• {"criterion_text":"- Absence of exclusion criteria and able to provide consent for data collection and analysis."}

Exclusion criteria

• {"criterion_text":"- Allergy to ciprofloxacin, fosfomycin or cefixime"}
• {"criterion_text":"- Chronic undwelling urinary catheter"}
• {"criterion_text":"- Fever presenting within 24 h of urinary tract manipulation"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Presence of prostatic abscess"}
• {"criterion_text":"- Presence of metastatic infectious foci."}
• {"criterion_text":"- Isolation of enterobacterales microorganism in urine culture or blood culture resistant at two or more of the following drugs (ciprofloxacin, or fosfomycin, or cefixime)"}
• {"criterion_text":"- Isolation of polymicrobial microorganisms, clinically relevant, in urine or blood culture."}
• {"criterion_text":"- Creatinine clearance < 10 ml /min or estimated glomerular filtration rate < 10 ml/min/1.73m2"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Clinical cure assessed 6-10 days post end-of-treatment; defined as 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)."}

Other endpoints

• {"endpoint_text":"- To evaluate the clinical cure (resolution of urinary symptoms) 24-36 days post end-of-treatment.","definition_or_measurement_approach":"Clinical cure assessed 24-36 days post end-of-treatment (resolution of urinary symptoms)."}
• {"endpoint_text":"- To evaluate the microbiological cure at 6-10 days and 24-36 days post end-of-treatment.","definition_or_measurement_approach":"Microbiological cure assessed by urine and/or blood culture at 6-10 days and 24-36 days post end-of-treatment."}
• {"endpoint_text":"- To evaluate combined clinical and microbiological cure at 6-10 days and 24-36 days post end-of-treatment.","definition_or_measurement_approach":"Combined clinical and microbiological cure assessed at 6-10 days and 24-36 days post end-of-treatment."}
• {"endpoint_text":"- To evaluate relapse within 24-36 days and 80-100 days post end-of treatment","definition_or_measurement_approach":"Relapse assessed within 24-36 days and again within 80-100 days post end-of-treatment."}
• {"endpoint_text":"- To evaluate reinfection within 24-36 days and 80-100 days post end of-treatment.","definition_or_measurement_approach":"Reinfection assessed within 24-36 days and 80-100 days post end-of-treatment."}
• {"endpoint_text":"- To evaluate adverse events possible or probable related to study protocol until 30 days of end of treatment.","definition_or_measurement_approach":"Adverse events related to study protocol collected and evaluated up to 30 days after end of treatment."}
• {"endpoint_text":"- To evaluate the acquired resistance at 24-36 days post end-of treatment","definition_or_measurement_approach":"Acquired resistance assessed at 24-36 days post end-of-treatment (microbiological testing)."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Rectal colonization by multidrug resistant organisms assessed at baseline, 6-10 days and 24-36 days post end-of-treatment; comparison between antimicrobial arms."}

Spain

Earliest CTIS Part Ii Submission Date

18-07-2024

Latest Decision Or Authorization Date

24-04-2026

Processing Time Days

645

Number Of Sites

9

Number Of Participants

276

Primary sponsor

Full Name

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain

Third parties

• {"country":"","full_name":"Instituto de Salud Carlos III","duties_or_roles":"Source of monetary support","organisation_type":""}