- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00958295
Epidemiology of Acute Bacterial Uncomplicated Cystitis in General Practice (BaCyst)
Epidemiology of Acute Bacterial Uncomplicated Cystitis in General Practice: Description and Prediction by Urine Dipstick Test
Acute uncomplicated bacterial cystitis is common in general practice. Cystitis is at the second raw of antibiotic treatment indications. It has been now recommended not to perform any urine culture for more than 20 years; hence, the bacterial epidemiology of acute uncomplicated cystitis is surprisingly relatively unknown. The available bacteriological data mainly describe the epidemiology of complicated urinary tract infections or upper urinary tract infections, but the causative bacteria and the resistance rates might differ from those of uncomplicated cystitis. As an example, it is unknown to what extent Staphylococcus saprophyticus is the causative agent of uncomplicated cystitis.
Moreover, the urine dipstick test have been evaluated in laboratories. But their interpretation in current practice might not be so easy: in particular, the nitrite detection depends on the bacterial concentration. The nitrite detection, produced in enterobacteriaceae related infections might have therapeutical consequences: trométamol-fosfomycine is almost constantly active on enterobacteriaceae, but ineffective on staphylococci. Knowing the increasing prevalence of fluoroquinolone-resistant enterobacteriaceae, the use of fosfomycin in nitrite positive uncomplicated cystitis might preserve the susceptibility of fluoroquinolones during pyelonephritis.
This study will describe:
- the bacterial epidemiology of acute uncomplicated cystitis in general practice,
- the correlation in between urine dipstick and urine culture in general practice,
- the prediction of enterobacterial infection by the nitrite detection, AND
- the antibiotics prescribed by the practitioners for uncomplicated acute cystitis.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Louviers, France, 27400
- JULIENNE Pascal
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- female
- >18 years old
- urinary symptoms
Exclusion Criteria:
- fever
- lumbar pain
- co-morbidities
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Bacterial epidemiology of acute uncomplicated cystitis
Time Frame: march 2010
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march 2010
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Comparison of urine dipstick tests and urine culture results
Time Frame: march 2010
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march 2010
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Manuel ETIENNE, MD, Infectious diseases department, rouen university hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008/119/HP
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