Uncomplicated cysititis in women
Conditions
Interventions
Trade Name: Fosfocina (R) 500 mg. cápsulas
Product Name: Fosfocina (R) 500 mg. cápsulas
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: FOSFOMYCIN CALCIUM
CAS Number: 26016-98-8
Concentration
Sponsors
Laboratorios ERN, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adult women (=18 years) with initial uncomplicated urinary tract infection (uUTI). • Must have = two of the following signs of uUTI: o Urinary frecuency o Urinary urgency o Dysuria (pain of burning on urination) o Suprapubic pain • Mid-stream urine specimen with dipstick analysis positive for both: o Nitrite. o Leukocyte esterase (evidence of pyuria) • Using effective barrier contraception (there will be a pregnancy test by determining urine ß-HCG levels in Visit 0) • Subject able to communicate effectively and provide written informed consent. 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 360 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: • Clinical evidence of renal pathology (fever and renal first percussion positive…). • Patients with galactose intolerance, with glucose-galactose malabsorption or with insufficiency of sucrase isomaltase • Women with gynaecological infections and cUTI. • Pregnant or nursing woman. • Taking part in another clinical trial during the two months prior to the current trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess that the efficacy of fosfomycin calcium in the clinical and microbiological resolution of the uUTI in women is non-inferiority to the efficacy of fosfomycin trometamol.;Secondary Objective: The secondary objective of this study is to monitor the safety and tolerability of the dose regimen of oral fosfomycin calcium capsules when administered in adult women with uUTI.;Primary end point(s): Clinical (resolution of symptoms of uUTI) and microbiological response (bacterial pathogen reduced to <103 CFU/mL. in urine culture) in the microbiological-ITT population;Timepoint(s) of evaluation of this end point: Visita 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of subjects with continued clinical and microbiologic success assessed at Visit 1 (TOC visit);Timepoint(s) of evaluation of this end point: Visit 1 (TOC visit) | — |
Countries
Spain
Contacts
Public ContactUnidad de Ensayos Clínicos
Bioaraba
Outcome results
None listed