Treatment with ciprofloxacin for one or two weeks in women with acute pyelonephritis.

ISRCTN ISRCTN73338924
DOI https://doi.org/10.1186/ISRCTN73338924
EudraCT/CTIS number 2005-004992-39
Secondary identifying numbers 2005-004992-39
Submission date
07/06/2006
Registration date
20/07/2006
Last edited
15/08/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Torsten Sandberg
Scientific

Department of Infectious Diseases
Sahlgrenska University Hospital
Göteborg
S-416 85
Sweden

Study information

Study designA randomised, double blind, placebo-controlled multi centre study with parallel groups.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymSTRAMA/Py2005
Study objectivesThe null hypothesis to be tested: the difference in the proportion of patients with clinical failure or symptomatic recurrence ten to 14 days after completed treatment is larger than 10% when seven and 14 days of treatment are compared.

Pleaes note that the anticipated end date of this trail has been updated from 31/01/2008 to 31/12/2008.
Ethics approval(s)Approved by the Research Ethics Committee at Götebrog University 23/12/2005.
Health condition(s) or problem(s) studiedAcute pyelonephritis in women
InterventionAll patients are treated with ciprofloxacin 500 mg twice daily orally for seven days. Half of the study group will continue treatment with ciprofloxacin 500 mg twice daily for another seven days while the other half will be treated with placebo during the same period.

Added as of 24/10/2008: The anticipated end date of recruitment is 31/12/2008. The last follow-up visit will be approximately two months (42-63 days) after inclusion of the participant into the trial.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Ciprofloxacin
Primary outcome measureClinical and bacteriological efficacy of seven and 14 days treatment with ciprofloxacin 500 mg twice daily in women with acute pyelonephritis. Outcome will be measured ten to 14 days after ciprofloxacin treatment has been discontinued.
Secondary outcome measuresThe accumulated clinical and bacteriological efficacy will be assessed five to seven weeks after ciprofloxacin treatment is discontinued.
Overall study start date23/02/2006
Completion date31/12/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants260 patients
Key inclusion criteria1. Women 18 years of age or older with suspected acute pyelonephritis
2. Fever of 38 degrees Celsius or more
3. Flank pain and/or costo-vertebral angle tenderness and/or voiding difficulties
4. Signed informed consent
Key exclusion criteria1. Pregnancy
2. Breast-feeding
3. Women of a fertile age who are not using adequate contraceptives
4. Known hypersensitivity to fluoroquinolones
5. Antibiotic treatment within the last 72 hours
6. Patient with permanent indwelling urinary catheter or intermittent catheterization of the urinary bladder
7. Patient previously included in this study
8. Patient with known renal insufficiency (creatinine clearance <30 ml/min)
9. Patient with epilepsy
10. Patient treated with antacids, sucralfate, zinc or theophylline
11. Other reason according to the investigator´s discretion
Date of first enrolment23/02/2006
Date of final enrolment31/12/2008

Locations

Countries of recruitment

  • Sweden

Study participating centre

Department of Infectious Diseases
Göteborg
S-416 85
Sweden

Sponsor information

Swedish Institute for Infectious Disease Control, Strama (Sweden)
Research organisation

Swedish Strategic Programme for the Rational Use of Antimicrobial Agents
Swedish Institute for Infectious Disease Control
Solna
S-171 82
Sweden

ROR logo "ROR" https://ror.org/05x4m5564

Funders

Funder type

Research organisation

Swedish Institute for Infectious Disease Control, Strama (Sweden), Swedish Strategic Programme for the Rational Use of Antimicrobial Agents

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 04/08/2012 Yes No