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

August 12, 2009
December 24, 2012
March 2009
May 2010   (final data collection date for primary outcome measure)
Bacterial epidemiology of acute uncomplicated cystitis [ Time Frame: march 2010 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00958295 on ClinicalTrials.gov Archive Site
Comparison of urine dipstick tests and urine culture results [ Time Frame: march 2010 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Epidemiology of Acute Bacterial Uncomplicated Cystitis in General Practice
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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Bacterial strains isolated in urine cultures

Non-Probability Sample

Adult female, no comorbidities.

Acute Uncomplicated Bacterial Cystitis
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
362
June 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • female
  • >18 years old
  • urinary symptoms

Exclusion Criteria:

  • fever
  • lumbar pain
  • co-morbidities
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00958295
2008/119/HP
No
University Hospital, Rouen
University Hospital, Rouen
Not Provided
Principal Investigator: Manuel ETIENNE, MD Infectious diseases department, rouen university hospital
University Hospital, Rouen
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP