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| Sponsor: | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Information provided by (Responsible Party): | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00873626 |
Purpose
The purpose of this study is to compare the efficacy of 5 days versus 10 days treatment duration in uncomplicated acute pyelonephritis.
Acute pyelonephritis is a common disease and the treatment duration is not found on scientific evidence. If a short treatment is equal to standard duration, it will possible to shortening antibiotherapy with ecologic and economic advantage.
| Condition | Intervention | Phase |
|---|---|---|
|
Urinary Tract Infection Fever |
Drug: levofloxacin, ciprofloxacin and ofloxacin (fluoroquinolones) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Controled Multicentric Trial, of Non Inferiority, Comparing Two Durations of Antibiotherapy (5 Days Versus 10 Days) in COMMUNAUTARY Acute Uncomplicated Pyelonephritis. |
| Enrollment: | 310 |
| Study Start Date: | June 2009 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
fluoroquinolones 5 days
|
Drug: levofloxacin, ciprofloxacin and ofloxacin (fluoroquinolones)
Levofloxacin 500mg : 1/j Ofloxacin : 200mgX2/j Ciprofloxacin 500mg X2/j
Other Name: randomised duration therapy
|
|
Active Comparator: 2
fluoroquinolones 10 days
|
Drug: levofloxacin, ciprofloxacin and ofloxacin (fluoroquinolones)
Levofloxacin 500mg : 1/j Ofloxacin : 200mgX2/j Ciprofloxacin 500mg X2/j
Other Name: randomised duration therapy
|
State of the issue and objective of the research The acute pyelonephritis (AP) represent the most frequent COMMUNAUTARY bacterial infection. Currently, usual recommended duration of antibiotherapy for this disease is from 10 to 21 days. The duration of treatment is not based on scientific evidence. Shortening duration of antibiotherapy would improve patient's life quality of and compliance and reduce side effects, duration of hospitalization, cost of treatment and probably limit bacterial resistance.
The main objective of this study is to compare the rates of clinical and microbiological cure at 30 ± 5 days after the end of antibiotherapy in uncomplicated AP of young women, according to the duration of antibiotic treatment: 5 days versus 10 days.
Methods of observation or investigation restraint Non-inferiority multicenter trial, randomized in 2 parallel groups evaluating antibiotic treatment (5d vs 10d) in the uncomplicated AP.
Recruitment and follow-up: The management of the patient will initially be provided by emergency room department or the hospital clinic. After signing the consent and inclusion (J0), the patient will receive an initial assessment, the initiation of antibiotic therapy and care. Then it will be:
Randomisation will take place in J0. Finally, in all cases, a final visit will be set at J30 ± 5Day.
Research will multicenter (26 centers at most) and led by principal investigator (Pr. Louis Bernard) and the scientific coordinator (Dr. AURELIEN DINH) At the end of the study, all data will be destroyed.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| France | |
| University hospital of Garches | |
| Garches, France, 92380 | |
| university hospital of TOURS | |
| Tours, France | |
| Principal Investigator: | Louis BERNARD, MD PhD | Assistance Publique - Hôpitaux de Paris |
More Information
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00873626 History of Changes |
| Other Study ID Numbers: | P071208 |
| Study First Received: | March 31, 2009 |
| Last Updated: | December 12, 2011 |
| Health Authority: | France: Ministry of Health |
|
Urinary tract infection treatment duration acute pyelonephritis good use of antibiotics |
|
Pyelonephritis Urinary Tract Infections Nephritis, Interstitial Nephritis Kidney Diseases Urologic Diseases Pyelitis Infection Ciprofloxacin Ofloxacin |
Fluoroquinolones Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Infective Agents Therapeutic Uses Anti-Bacterial Agents Anti-Infective Agents, Urinary Renal Agents |