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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00958295
First received: August 12, 2009
Last updated: December 24, 2012
Last verified: December 2012
  Purpose

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
Acute Uncomplicated Bacterial Cystitis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Bacterial epidemiology of acute uncomplicated cystitis [ Time Frame: march 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of urine dipstick tests and urine culture results [ Time Frame: march 2010 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Bacterial strains isolated in urine cultures


Enrollment: 362
Study Start Date: March 2009
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult female, no comorbidities.

Criteria

Inclusion Criteria:

  • female
  • >18 years old
  • urinary symptoms

Exclusion Criteria:

  • fever
  • lumbar pain
  • co-morbidities
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00958295

Locations
France
JULIENNE Pascal
Louviers, France, 27400
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Manuel ETIENNE, MD Infectious diseases department, rouen university hospital
  More Information

No publications provided by University Hospital, Rouen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00958295     History of Changes
Other Study ID Numbers: 2008/119/HP
Study First Received: August 12, 2009
Last Updated: December 24, 2012
Health Authority: France: Ministere de l'enseignement et de la Recherche

Keywords provided by University Hospital, Rouen:
urinary tract infection
cystitis

Additional relevant MeSH terms:
Cystitis
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on November 20, 2014