Treatment's Duration of Acute Uncomplicated Pyelonephritis (DTP)
Primary Purpose
Urinary Tract Infection, Fever
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
levofloxacin, ciprofloxacin and ofloxacin (fluoroquinolones)
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Tract Infection focused on measuring Urinary tract infection, treatment duration, acute pyelonephritis, good use of antibiotics
Eligibility Criteria
Inclusion Criteria:
- Women 18 to 65 years old
- Non-immunocompromised
- Conducting a medical examination prior
- Signature of informed consent in writing.
- Clinical signs of urinary tract infection (urinary burning, urgency, pollakiuria, dysuria, pyuria, lumbar or pelvic pain),
- A temperature> 38 ° C,
- A positive ECBU direct seed (s) sensitive (s) to the fluoroquinolones
Exclusion Criteria:
- Antibiotic therapy prior
- Presence of complications of PNA (abscesses, dilated excretory pathways, probe urinary bladder, neurological, transplant, kidney single functional or anatomical),
- An episode of PNA within 6 months,
- having fluoroquinolones in 6 months,
- Infection on urinary endo-material (prosthetic urethral, ureteral probe)
- The immunodepressed (known seropositivity for HIV, asplenia, diabetes neutropenia, agammaglobulinemia ...)
- Pregnancy and lactation,
- Allergy to antibiotics,
- Corticosteroids concomitantly taking fluoroquinolones,
- History of TENDINOPATHY with a fluoroquinolone
- History of epilepsy
- Deficit known as glucose-6-phosphate dehydrogenase
- Life expectancy <1 month
- Cognitive major
- Patient under guardianship, CURATORSHIP or without coverage,
- The need for immunosuppressive or corticosteroid therapy,
- The need for other concomitant antibiotic treatment, whatever the cause
- No affiliation to a social security scheme (beneficiary or beneficiary).
Sites / Locations
- University hospital of Garches
- university hospital of TOURS
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
fluoroquinolones 5 days
fluoroquinolones 10 days
Outcomes
Primary Outcome Measures
Compare the rates of clinical and microbiological cure at 30 ± 5 days of the end of antibiotherapy in acute uncomplicated pyelonephritis of young women, according to the duration of antibiotherapy: 5 days versus 10 days.
Secondary Outcome Measures
Evaluate the effectiveness bacteriological (ECBU negative direct examination and culture) of treatment to 30 ± 5 days of the end of antibiotherapy
Evaluate the clinical effectiveness of treatment: apyrexia and disappearance of clinical signs initial J2 ± 1; J5 ± 1, ± 1 of J10 beginning of treatment and 30 ± 5 days of the end of antibiotherapy,
Identifying risk factors for failure of antibiotic treatment (co-morbidities, bacteremia)
Assessing the tolerance of the antibiotic, the presence of adverse events related to drug
To assess adherence to treatment, the proportion of patients observant good, average and low observant
Assess the changes in sensitivity to antibiotics (fluoroquinolones) in the nasal flora, pharyngeal and digestive.
Full Information
NCT ID
NCT00873626
First Posted
March 31, 2009
Last Updated
November 5, 2014
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00873626
Brief Title
Treatment's Duration of Acute Uncomplicated Pyelonephritis
Acronym
DTP
Official Title
Randomized Controled Multicentric Trial, of Non Inferiority, Comparing Two Durations of Antibiotherapy (5 Days Versus 10 Days) in COMMUNAUTARY Acute Uncomplicated Pyelonephritis.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
People involved Patients with uncomplicated AP, will be offered to participate to the study after consultation in emergency room service or health service, in absence of non-inclusion criteria (immunodepression known, severe sepsis, allergy to antibiotics, pregnancy, lactation ...). In presence of abscesses, obstruction on the urinary tract, or infection on stranger material device requiring, in most cases, a medical-surgical treatment, they will not be eligible under the study.
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:
Either in a hospital service who will follow.
Either by ambulatory monitoring and regularly contacted (phone with voice server) to ensure proper development.
Randomisation will take place in J0. Finally, in all cases, a final visit will be set at J30 ± 5Day.
Origin and nature of the data collected - Reasons for them Data for the study duration of treatment of pyelonephritis are from information provided by patients. The nature of the data include: name, surname, date of birth, medical data (medical history, history of the disease, symptoms of infection) and telephone numbers of the patient. The collection of these numbers is essential for monitoring the patient.
Method for data flow These data will be confidential and only, the physician investigator, the scientific coordinator doctor, the doctor treating the patient and the clinical research fellow, will have access to this information. These data will be computerized and protected by a personal access code.
Duration and modalities of the research The duration of the research will be a maximum of 24 months (the duration is 12 months for inclusion and follow-up of 310 patients).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection, Fever
Keywords
Urinary tract infection, treatment duration, acute pyelonephritis, good use of antibiotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
310 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
fluoroquinolones 5 days
Arm Title
2
Arm Type
Active Comparator
Arm Description
fluoroquinolones 10 days
Intervention Type
Drug
Intervention Name(s)
levofloxacin, ciprofloxacin and ofloxacin (fluoroquinolones)
Other Intervention Name(s)
randomised duration therapy
Intervention Description
Levofloxacin 500mg : 1/j Ofloxacin : 200mgX2/j Ciprofloxacin 500mg X2/j
Primary Outcome Measure Information:
Title
Compare the rates of clinical and microbiological cure at 30 ± 5 days of the end of antibiotherapy in acute uncomplicated pyelonephritis of young women, according to the duration of antibiotherapy: 5 days versus 10 days.
Time Frame
35 DAYS
Secondary Outcome Measure Information:
Title
Evaluate the effectiveness bacteriological (ECBU negative direct examination and culture) of treatment to 30 ± 5 days of the end of antibiotherapy
Time Frame
35 DAYS
Title
Evaluate the clinical effectiveness of treatment: apyrexia and disappearance of clinical signs initial J2 ± 1; J5 ± 1, ± 1 of J10 beginning of treatment and 30 ± 5 days of the end of antibiotherapy,
Time Frame
35 DAYS
Title
Identifying risk factors for failure of antibiotic treatment (co-morbidities, bacteremia)
Time Frame
35 DAYS
Title
Assessing the tolerance of the antibiotic, the presence of adverse events related to drug
Time Frame
35 DAYS
Title
To assess adherence to treatment, the proportion of patients observant good, average and low observant
Time Frame
35 DAYS
Title
Assess the changes in sensitivity to antibiotics (fluoroquinolones) in the nasal flora, pharyngeal and digestive.
Time Frame
35 DAYS
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women 18 to 65 years old
Non-immunocompromised
Conducting a medical examination prior
Signature of informed consent in writing.
Clinical signs of urinary tract infection (urinary burning, urgency, pollakiuria, dysuria, pyuria, lumbar or pelvic pain),
A temperature> 38 ° C,
A positive ECBU direct seed (s) sensitive (s) to the fluoroquinolones
Exclusion Criteria:
Antibiotic therapy prior
Presence of complications of PNA (abscesses, dilated excretory pathways, probe urinary bladder, neurological, transplant, kidney single functional or anatomical),
An episode of PNA within 6 months,
having fluoroquinolones in 6 months,
Infection on urinary endo-material (prosthetic urethral, ureteral probe)
The immunodepressed (known seropositivity for HIV, asplenia, diabetes neutropenia, agammaglobulinemia ...)
Pregnancy and lactation,
Allergy to antibiotics,
Corticosteroids concomitantly taking fluoroquinolones,
History of TENDINOPATHY with a fluoroquinolone
History of epilepsy
Deficit known as glucose-6-phosphate dehydrogenase
Life expectancy <1 month
Cognitive major
Patient under guardianship, CURATORSHIP or without coverage,
The need for immunosuppressive or corticosteroid therapy,
The need for other concomitant antibiotic treatment, whatever the cause
No affiliation to a social security scheme (beneficiary or beneficiary).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis BERNARD, MD PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital of Garches
City
Garches
ZIP/Postal Code
92380
Country
France
Facility Name
university hospital of TOURS
City
Tours
Country
France
12. IPD Sharing Statement
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Treatment's Duration of Acute Uncomplicated Pyelonephritis
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