Cistitis aguda no complicada en mujeres no embarazadas: patología caracterizada por disuria, dolor suprapúbico, polaquiuria y/o tenesmo en combinación con bacteriuria y piuria. Sin patología renal asociada, disfunción urológica u obstrucción. Acute uncomplicated cystitis in non-pregnant women: pathology characterized by dysuria, suprapubic pain, frequency and/or urgency in combination with bacteriuria and pyuria. No renal pathology, urological dysfunction or obstruction is present. MedDRA vers
Conditions
Interventions
Trade Name: Meiact®
Pharmaceutical Form: Tablet
INN or Proposed INN: CEFDITOREN
CAS Number: 104145951
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceu
Sponsors
TEDEC-MEIJI FARMA, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Non-pregnant adult females (> or =18) Clinical signs and symptoms of uncomplicated acute cystitis (dysuria, urgency, frequency, suprapubic pain) with symptoms starting =72 hours prior the study entry. Positive pre-treatment clean-catch midstream urine culture (> or =103CFU/ml) and pyuria (10 leukocytes/mm3 or more than 5 leukocytes/field 40x magnification) within the 48 hours prior to inclusion in the study. In vitro susceptibility testing of the isolated uropathogen to the drugs under study. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Males. Pregnancy or lactation. Three or more episodes of uncomplicated acute infections of the urinary tract during the past 12 months. Symptoms starting >=96 hours prior to admission Body temperature >= 38.3ºC, back pain, chills or other manifestations suggestive of upper urinary infection. Structural or functional alterations of the urinary tract (calculi, stenosis, primary renal disease, neurogenic bladder). Underlying disease predisposing to complicated urinary tract infections (diabetes mellitus, immunosuppresion, leucopenia, heart insufficiency, liver impairment and neoplasic processes).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of the drugs under study: - Microbiological efficacy (primary efficacy parameter) - Clinical efficacy Evaluar la eficacia de los fármacos del estudio: - Eficacia microbiológica (criterio principal de eficacia) - Eficacia clínica ;Secondary Objective: To assess the tolerability of the drugs.;Primary end point(s): The primary endpoint of the study is bacteriological eradication in the per Protocol Population (PP) at the 5-9 days post-therapy visit. | — |
Countries
Greece, Spain
Outcome results
None listed