Acute bacterial prostatitis due to multi-drug resistant Escherichia coli
Conditions
Interventions
Trade Name: FOSFOMICINA QUALIGEN 3 g GRANULADO PARA SOLUCION ORAL EFG, caja de 2 sobres
Product Name: Fosfomicina-trometamol
Pharmaceutical Form: Granules for oral solution
INN or Proposed INN: FOSFOM
Sponsors
Hospital Universitari Mutua Terrassa
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Male adult patients (18 years of age or older) with acute prostatitis due to multi-drug resistant (MDR) Escherichia coli susceptible to fosfomycin. Diagnosis of prostatitis requires prostatic-specific antigen (PSA) elevation> 4 µg/L and the presence of at least one microbiological criterion and two clinical criteria among the following: Microbiological criteria (at least 1): Urine culture with >100,000 cfu/mL of MDR E. coli with MIC to fosfomycin 70 years) with no other apparent cause. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 56 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 65
Exclusion criteria
Exclusion criteria: - Allergy or known intolerance to fosfomycin. - Polymicrobial bacteria or urine culture. - Clinical criteria of acute pyelonephritis (fist-positive renal percussion, obstruction of the urinary tract, abscess renal). - Anatomical alterations of the urinary tract. - Urinary infections associated with urinary catheters. - Undrained prostatic abscess. - Another concomitant infection. - Patients who have not reached clinical stability after 5 days of parenteral treatment. - Patients with septic shock at the time of randomization. - Polycystic kidney disease. - History of chronic prostatitis. - Immunosuppressed patients (kidney transplant, liver cirrhosis, patients on renal replacement therapy, chronic treatment with corticosteroids, which receive active chemotherapy, use of anti-TNF) - Terminal situation or estimated life expectancy of less than 90 days or in purely palliative treatment of their base disease. - Patients who are participating in another clinical trial with active treatment. - MIC to fosfomycin superior to that established by the inclusion criteria of the study. - Patients who refuse to give consent to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess clinical and microbiological cure in patients with acute bacterial prostatitis due to multi-drug resistant Escherichia coli treated with oral fosfomycin-trometamol;Secondary Objective: - Assessment of use of carbapenems. - Assessment of length of stay. - Pharmacokinetic study.;Primary end point(s): - Clinical cure will be assess by a clinical team as the resolution of all symptoms of prostatitis that were present at the time of diagnosis (fever, symptoms of the lower urinary tract (irritative sypmtoms: urgency, urinary frequency...) and perineal pain (spontaneous or during urination). - Microbiological cure requires negative urine culture at days 5-7 after the EOT.;Timepoint(s) of evaluation of this end point: - Clinical cure: at the end of therapy (21 +/- 5 days). - Microbiological cure: 7 days (+/- 3 days) after EoT. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Carbapenemic DDD per 100 stays in the experimental group versus the control group. - Length of hospital stay (days) in the experimental group versus the control group. - Fosfomycin pharmacokinetic parameters ([Cmax], [Cmin], AUC, clearance, volume of distribution).;Timepoint(s) of evaluation of this end point: - 6 months after the end of recruitment period. | — |
Countries
Spain
Contacts
Public ContactUIMI
Unidad de Investigación Clínica en Enfermedades Infecciosas
Outcome results
None listed