Epidemiology of Acute Bacterial Uncomplicated Cystitis in General Practice (BaCyst)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00958295
Recruitment Status : Completed
First Posted : August 13, 2009
Last Update Posted : October 22, 2015
Information provided by (Responsible Party):
University Hospital, Rouen

Brief Summary:

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.

Condition or disease
Acute Uncomplicated Bacterial Cystitis

Study Type : Observational
Actual Enrollment : 362 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Epidemiology of Acute Bacterial Uncomplicated Cystitis in General Practice: Description and Prediction by Urine Dipstick Test
Study Start Date : March 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Bacterial epidemiology of acute uncomplicated cystitis [ Time Frame: march 2010 ]

Secondary Outcome Measures :
  1. Comparison of urine dipstick tests and urine culture results [ Time Frame: march 2010 ]

Biospecimen Retention:   Samples Without DNA
Bacterial strains isolated in urine cultures

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult female, no comorbidities.

Inclusion Criteria:

  • female
  • >18 years old
  • urinary symptoms

Exclusion Criteria:

  • fever
  • lumbar pain
  • co-morbidities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00958295

Louviers, France, 27400
Sponsors and Collaborators
University Hospital, Rouen
Principal Investigator: Manuel ETIENNE, MD Infectious diseases department, rouen university hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Hospital, Rouen Identifier: NCT00958295     History of Changes
Other Study ID Numbers: 2008/119/HP
First Posted: August 13, 2009    Key Record Dates
Last Update Posted: October 22, 2015
Last Verified: December 2012

Keywords provided by University Hospital, Rouen:
urinary tract infection

Additional relevant MeSH terms:
Urinary Bladder Diseases
Urologic Diseases