Efficacy and Safety of Cefditoren Pivoxil Versus Ciprofloxacin in Acute Uncomplicated Cystitis

Study Overview
=================
Brief Summary
-----------------
The main objective of the study is to comparatively assess the efficacy and tolerability of the drugs under study in the treatment of acute uncomplicated cystitis.

Detailed Description
-----------------
Urinary tract infections (UTI) are one of the most frequent reasons of surgery visits in Primary Care. More than 95 percent of UTIs are monomicrobial, although the microorganisms implied are varied, and the range of effective drugs could be extensive. The species most frequently isolated is Escherichia coli, with prevalence ranking between 85 and 90 percent of documented cases. E. coli has developed resistance to different antibiotics. Cefditoren is situated as a good candidate for the treatment of uncomplicated UTIs due to its spectrum of activity against E. coli. The study has been designed in accordance with the guidelines and recommendations in force to assess the efficacy of cefditoren pivoxil against ciprofloxacin, a drug which despite the increasing rate of resistance in some countries, continues to be a drug of choice for the treatment of uncomplicated UTIs.

Official Title
-----------------
Multicentre, Prospective, Comparative, Randomized, Double-blind, Double-dummy Study to Assess the Efficacy and Safety of Cefditoren Pivoxil vs. Ciprofloxacin in Uncomplicated Acute Cystitis

Conditions
-----------------
Urinary Tract Infections

Intervention / Treatment
-----------------
* Drug: cefditoren pivoxil
* Drug: Ciprofloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-pregnant adult females (>= 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 (>= 103 CFU/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 Exclusion Criteria: Males Woman who are pregnant, nursing or not using a medically accepted, effective method of birth control Three or more episodes of uncomplicated acute infections of the urinary tract during the past 12 months Symptoms starting >4 days prior to admission Body temperature >= 38.3ºC, back pain, chills or other manifestations suggestive of upper urinary infection Evidence of structural or functional alterations of the urinary tract, such as calculi, stenosis, primary renal disease (eg. polycystic renal disease) or neurogenic bladder Underlying disease predisposing to complicated urinary tract infections such as diabetes mellitus, immunosuppression, leucopenia, heart insufficiency, liver impairment and neoplastic processes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cefditoren pivoxil | Drug: cefditoren pivoxil<br>* 400 mg, oral, single dose during 3 days<br>* Other names: Meiact, Spectracef, Telo;|
| Active Comparator: 2<br>Ciprofloxacin | Drug: Ciprofloxacin<br>* 250 mg, oral, twice a day for 3 days<br>* Other names: Ciprofloxacino Mabo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological efficacy |  | 5-9 days post-therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficacy |  | 5-9 days post-therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cystitis