Treatment with ciprofloxacin for one or two weeks in women with acute pyelonephritis.
| ISRCTN | ISRCTN73338924 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73338924 |
| Clinical Trials Information System (CTIS) | 2005-004992-39 |
| Protocol serial number | 2005-004992-39 |
| Sponsor | Swedish Institute for Infectious Disease Control, Strama (Sweden) |
| Funder | Swedish Institute for Infectious Disease Control, Strama (Sweden), Swedish Strategic Programme for the Rational Use of Antimicrobial Agents |
- 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
Scientific
Department of Infectious Diseases
Sahlgrenska University Hospital
Göteborg
S-416 85
Sweden
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A randomised, double blind, placebo-controlled multi centre study with parallel groups. |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | STRAMA/Py2005 |
| Study objectives | The 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) studied | Acute pyelonephritis in women |
| Intervention | All 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 type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ciprofloxacin |
| Primary outcome measure(s) |
Clinical 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. |
| Key secondary outcome measure(s) |
The accumulated clinical and bacteriological efficacy will be assessed five to seven weeks after ciprofloxacin treatment is discontinued. |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 260 |
| Key inclusion criteria | 1. 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 criteria | 1. 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 enrolment | 23/02/2006 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Department of Infectious Diseases
Göteborg
S-416 85
Sweden
S-416 85
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
