Condition category
Urological and Genital Diseases
Date applied
07/06/2006
Date assigned
20/07/2006
Last edited
15/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Torsten Sandberg

ORCID ID

Contact details

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

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 measures

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

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

Organisation

Swedish Institute for Infectious Disease Control, Strama (Sweden)

Sponsor details

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

Sponsor type

Research organisation

Website

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22726802

Publication citations

  1. 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.

Additional files

Editorial Notes