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Treatment with ciprofloxacin for one or two weeks in women with acute pyelonephritis.
ISRCTN ISRCTN73338924
DOI 10.1186/ISRCTN73338924
ClinicalTrials.gov identifier
EudraCT number 2005-004992-39
Public title Treatment with ciprofloxacin for one or two weeks in women with acute pyelonephritis.
Scientific title
Acronym STRAMA/Py2005
Serial number at source 2005-004992-39
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval Approved by the Research Ethics Committee at Götebrog University 23/12/2005.
Study design A randomised, double blind, placebo-controlled multi centre study with parallel groups.
Countries of recruitment Sweden
Disease/condition/study domain Acute pyelonephritis in women
Participants - 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
Participants - 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
Anticipated start date 23/02/2006
Anticipated end date 31/12/2008
Status of trial Completed
Patient information material
Target number of participants 260 patients
Interventions 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.
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.
Secondary outcome measure(s) The accumulated clinical and bacteriological efficacy will be assessed five to seven weeks after ciprofloxacin treatment is discontinued.
Sources of funding Swedish Institute for Infectious Disease Control, Strama (Sweden), Swedish Strategic Programme for the Rational Use of Antimicrobial Agents
Trial website
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22726802
Contact name Prof  Torsten  Sandberg
  Address Department of Infectious Diseases
Sahlgrenska University Hospital
  City/town Göteborg
  Zip/Postcode S-416 85
  Country Sweden
Sponsor Swedish Institute for Infectious Disease Control, Strama (Sweden)
  Address Swedish Strategic Programme for the Rational Use of Antimicrobial Agents
Swedish Institute for Infectious Disease Control
  City/town Solna
  Zip/Postcode S-171 82
  Country Sweden
Date applied 07/06/2006
Last edited 15/08/2012
Date ISRCTN assigned 20/07/2006
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