Full Text View
Tabular View
No Study Results Posted
Related Studies
Epidemiology of Acute Bacterial Uncomplicated Cystitis in General Practice (BaCyst)
This study is currently recruiting participants.
Verified by University Hospital, Rouen, August 2009
First Received: August 12, 2009   No Changes Posted
Sponsor: University Hospital, Rouen
Information provided by: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00958295
  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: Case-Only, 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

Biospecimen Description:

Bacterial strains isolated in urine cultures


Estimated Enrollment: 400
Study Start Date: March 2009
Estimated Study Completion Date: March 2010
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958295

Contacts
Contact: Rouen University hospital

Locations
France
JULIENNE Pascal Recruiting
Louviers, France, 27400
Contact: Pascal JULIENNE, MD     +33232400705        
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Manuel ETIENNE, MD Infectious diseases department, rouen university hospital
  More Information

No publications provided

Responsible Party: Infectious Diseases Department, Rouen University Hospital ( Dr Manuel ETIENNE, MD )
Study ID Numbers: 2008/119/HP
Study First Received: August 12, 2009
Last Updated: August 12, 2009
ClinicalTrials.gov Identifier: NCT00958295     History of Changes
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:
Urologic Diseases
Urinary Bladder Diseases
Cystitis

ClinicalTrials.gov processed this record on February 08, 2010