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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN73338924 |
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Date of registration:
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20/07/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment with ciprofloxacin for one or two weeks in women with acute pyelonephritis.
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Scientific title:
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Date of first enrolment:
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23/02/2006 |
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Target sample size:
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260 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN73338924 |
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Study type:
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Interventional |
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Study design:
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A randomised, double blind, placebo-controlled multi centre study with parallel groups. (Treatment)
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Phase:
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Torsten
Sandberg |
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Address:
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Department of Infectious Diseases
Sahlgrenska University Hospital
S-416 85
Göteborg
Sweden |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Acute pyelonephritis in women
Urological and Genital Diseases
Acute pyelonephritis in women
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Intervention(s)
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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.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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The accumulated clinical and bacteriological efficacy will be assessed five to seven weeks after ciprofloxacin treatment is discontinued.
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Secondary ID(s)
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2005-004992-39
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Source(s) of Monetary Support
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Swedish Institute for Infectious Disease Control, Strama (Sweden), Swedish Strategic Programme for the Rational Use of Antimicrobial Agents
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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