Additional identifiers
EudraCT number
2005-004992-39
ClinicalTrials.gov number
Protocol/serial number
2005-004992-39
Study information
Scientific title
Acronym
STRAMA/Py2005
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.
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.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
Ciprofloxacin
Primary outcome measure
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 measures
The accumulated clinical and bacteriological efficacy will be assessed five to seven weeks after ciprofloxacin treatment is discontinued.
Overall trial start date
23/02/2006
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
260 patients
Participant 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
Recruitment start date
23/02/2006
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Sweden
Trial participating centre
Department of Infectious Diseases
Göteborg
S-416 85
Sweden
Sponsor information
Funders
Funder type
Research organisation
Funder name
Swedish Institute for Infectious Disease Control, Strama (Sweden), Swedish Strategic Programme for the Rational Use of Antimicrobial Agents
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22726802
Publication citations
-
Results
Sandberg T, Skoog G, Hermansson AB, Kahlmeter G, Kuylenstierna N, Lannergård A, Otto G, Settergren B, Ekman GS, Ciprofloxacin for 7 days versus 14 days in women with acute pyelonephritis: a randomised, open-label and double-blind, placebo-controlled, non-inferiority trial., Lancet, 2012, 380, 9840, 484-490, doi: 10.1016/S0140-6736(12)60608-4.