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

Primary Purpose

Urinary Tract Infections

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

cefditoren pivoxil

Ciprofloxacin

About this trial

This is an interventional treatment trial for Urinary Tract Infections focused on measuring Cystitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Cefditoren pivoxil

Ciprofloxacin

Outcomes

Primary Outcome Measures

Microbiological efficacy

Secondary Outcome Measures

Clinical efficacy

Full Information

NCT ID

NCT00598403

First Posted

January 9, 2008

Last Updated

June 28, 2010

Sponsor

Tedec-Meiji Farma, S.A.

1. Study Identification

Unique Protocol Identification Number

NCT00598403

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2010

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Tedec-Meiji Farma, S.A.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Tract Infections

Keywords

Cystitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

611 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Cefditoren pivoxil

Arm Title

Arm Type

Active Comparator

Arm Description

Ciprofloxacin

Intervention Type

Drug

Intervention Name(s)

cefditoren pivoxil

Other Intervention Name(s)

Meiact, Spectracef, Telo

Intervention Description

400 mg, oral, single dose during 3 days

Intervention Type

Drug

Intervention Name(s)

Ciprofloxacin

Other Intervention Name(s)

Ciprofloxacino Mabo

Intervention Description

250 mg, oral, twice a day for 3 days

Primary Outcome Measure Information:

Title

Microbiological efficacy

Time Frame

5-9 days post-therapy

Secondary Outcome Measure Information:

Title

Clinical efficacy

Time Frame

5-9 days post-therapy

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials: