A randomized, double blind, double dummy, parallel group, multicenter clinical trial to evaluate the safety and clinical and microbiologic efficacy of oral fosfomycin calcium in adult women with uUTI.
- Conditions
- ncomplicated cysititis in womenTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2021-002911-72-ES
- Lead Sponsor
- aboratorios ERN, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 384
•Adult women (=18 years) with initial uncomplicated urinary tract infection (uUTI).
•Must have = two of the following signs of uUTI:
oUrinary frecuency
oUrinary urgency
oDysuria (pain of burning on urination)
oSuprapubic pain
•Mid-stream urine specimen with dipstick analysis positive for both:
oNitrite.
oLeukocyte 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
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method