Acute Uncomplicated Bacterial CystitisBaCystNCT00958295
Epidemiology of Acute Bacterial Uncomplicated Cystitis in General Practice
An observational study of Acute Uncomplicated Bacterial Cystitis, run by University Hospital, Rouen at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Acute Uncomplicated Bacterial Cystitis
- How many people
- 362 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2009to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult female, no comorbidities.
Who may be able to join
- female
- >18 years old
- urinary symptoms
Who cannot join
- fever
- lumbar pain
- co-morbidities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Acute Uncomplicated Bacterial Cystitis
- Keywords
- urinary tract infection, cystitis
- Medical subject headings
- Urinary Tract Infections, Cystitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial epidemiology of acute uncomplicated cystitis
Measured: march 2010
Secondary outcomes (1)
Comparison of urine dipstick tests and urine culture results
Measured: march 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Uncomplicated Bacterial CystitisStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuel ETIENNE, MD, Principal investigator, Infectious diseases department, rouen university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958295
- Sponsor's protocol ID
- 2008/119/HP
- Acronym
- BaCyst
- Status last verified
- Dec 2012
- First submitted
- 12 Aug 2009
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24612927
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Acute Bacterial Uncomplicated Cystitis in General Practice: Description and Prediction by Urine Dipstick Test
- ClinicalTrials.gov ID
- NCT00958295
- Acronym / sponsor ID
- BaCyst / 2008/119/HP
- Conditions
- Acute Uncomplicated Bacterial Cystitis
- Keywords
- urinary tract infection, cystitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 13 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult female, no comorbidities.
Key inclusion criteria (3 listed)
- female
- >18 years old
- urinary symptoms
Key exclusion criteria (3 listed)
- fever
- lumbar pain
- co-morbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bacterial epidemiology of acute uncomplicated cystitis
Time frame: march 2010
1 secondary outcome
Comparison of urine dipstick tests and urine culture results
Time frame: march 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2015.
- Derived from this study: PubMed 24612927Etienne 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel ETIENNE, MD principal investigator
Infectious diseases department, rouen university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Uncomplicated Bacterial Cystitis, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial epidemiology of acute uncomplicated cystitis (time frame: march 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00958295, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2015.