Epidemiology of Acute Bacterial Uncomplicated Cystitis in General Practice

Acute Uncomplicated Bacterial Cystitis Clinical Trial

— BaCyst  

Official title:

Epidemiology of Acute Bacterial Uncomplicated Cystitis in General Practice: Description and Prediction by Urine Dipstick Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00958295
• Other study ID #: 2008/119/HP
• Status: Completed
• Phase: N/A
• First received: August 12, 2009
• Last updated: October 21, 2015
• Start date: March 2009
• Est. completion date: June 2010

Study information

• Verified date: December 2012
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministere de l'enseignement et de la Recherche
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 362
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• female

• >18 years old

• urinary symptoms

Exclusion Criteria:

• fever

• lumbar pain

• co-morbidities

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Uncomplicated Bacterial Cystitis
• Cystitis

Locations

Country	Name	City	State
France	JULIENNE Pascal	Louviers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial epidemiology of acute uncomplicated cystitis		march 2010	No
Secondary	Comparison of urine dipstick tests and urine culture results		march 2010	No