Clinical trial NCT00958295: Epidemiology of Acute Bacterial Uncomplicated Cystitis in General Practice
Official title: Epidemiology of Acute Bacterial Uncomplicated Cystitis in General Practice: Description and Prediction by Urine Dipstick Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Uncomplicated Bacterial Cystitis
Keywords: urinary tract infection
cystitis
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2009-08-13
Enrollment: 362
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult female, no comorbidities.

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.


Eligibility criteria: Inclusion Criteria:

* female
* \>18 years old
* urinary symptoms

Exclusion Criteria:

* fever
* lumbar pain
* co-morbidities

Primary outcomes:
measure: Bacterial epidemiology of acute uncomplicated cystitis
timeFrame: march 2010
Secondary outcomes:
measure: Comparison of urine dipstick tests and urine culture results
timeFrame: march 2010
Other outcomes:
Locations:
city: Louviers
country: France
facility: JULIENNE Pascal
Study officials:
affiliation: Infectious diseases department, rouen university hospital
name: Manuel ETIENNE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Etienne M, Lefebvre E, Frebourg N, Hamel H, Pestel-Caron M, Caron F; Bacyst Study Group. Antibiotic treatment of acute uncomplicated cystitis based on rapid urine test and local epidemiology: lessons from a primary care series. BMC Infect Dis. 2014 Mar 11;14:137. doi: 10.1186/1471-2334-14-137.