Urinary Tract InfectionPhase 4DTPNCT00873626
Treatment's Duration of Acute Uncomplicated Pyelonephritis
A Phase 4 study testing levofloxacin, ciprofloxacin and ofloxacin (fluoroquinolones) in people with Urinary Tract Infection and Fever, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Urinary Tract Infection, Fever
- What is being tested?
- levofloxacin, ciprofloxacin and ofloxacin (fluoroquinolones)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2009to Aug 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 ...)
Show all 18Show fewer
- 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).
Trial locations and contacts
2 sites in 1 country.
France2 sites
University hospital of Garches
Garches, 92380
university hospital of TOURS
Tours
About this study
Official title: Randomized Controled Multicentric Trial, of Non Inferiority, Comparing Two Durations of Antibiotherapy (5 Days Versus 10 Days) in COMMUNAUTARY Acute Uncomplicated Pyelonephritis.
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.
Read the 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.
- Conditions
- Urinary Tract Infection, Fever
- Being tested
- levofloxacin, ciprofloxacin and ofloxacin (fluoroquinolones)
- Keywords
- Urinary tract infection, treatment duration, acute pyelonephritis, good use of antibiotics
- Medical subject headings
- Urinary Tract Infections, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levofloxacin, ciprofloxacin and ofloxacin (fluoroquinolones)Drug
Also called randomised duration therapy
Levofloxacin 500mg : 1/j Ofloxacin : 200mgX2/j Ciprofloxacin 500mg X2/j
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | fluoroquinolones 5 days Receives: Drug: levofloxacin, ciprofloxacin and ofloxacin (fluoroquinolones) |
| 2 | Active comparator | fluoroquinolones 10 days Receives: Drug: levofloxacin, ciprofloxacin and ofloxacin (fluoroquinolones) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 35 DAYS
Secondary outcomes (6)
Evaluate the effectiveness bacteriological (ECBU negative direct examination and culture) of treatment to 30 ± 5 days of the end of antibiotherapy
Measured: 35 DAYS
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,
Measured: 35 DAYS
Identifying risk factors for failure of antibiotic treatment (co-morbidities, bacteremia)
Measured: 35 DAYS
Assessing the tolerance of the antibiotic, the presence of adverse events related to drug
Measured: 35 DAYS
To assess adherence to treatment, the proportion of patients observant good, average and low observant
Measured: 35 DAYS
Assess the changes in sensitivity to antibiotics (fluoroquinolones) in the nasal flora, pharyngeal and digestive.
Measured: 35 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louis BERNARD, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873626
- Sponsor's protocol ID
- P071208
- Acronym
- DTP
- Status last verified
- Jun 2011
- First submitted
- 31 Mar 2009
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controled Multicentric Trial, of Non Inferiority, Comparing Two Durations of Antibiotherapy (5 Days Versus 10 Days) in COMMUNAUTARY Acute Uncomplicated Pyelonephritis.
- ClinicalTrials.gov ID
- NCT00873626
- Acronym / sponsor ID
- DTP / P071208
- Conditions
- Urinary Tract Infection, Fever
- Keywords
- Urinary tract infection, treatment duration, acute pyelonephritis, good use of antibiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 1 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: levofloxacin, ciprofloxacin and ofloxacin (fluoroquinolones)fluoroquinolones 5 days |
| 2 | Active comparator | Drug: levofloxacin, ciprofloxacin and ofloxacin (fluoroquinolones)fluoroquinolones 10 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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),
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levofloxacin, ciprofloxacin and ofloxacin (fluoroquinolones)Also: randomised duration therapyLevofloxacin 500mg : 1/j Ofloxacin : 200mgX2/j Ciprofloxacin 500mg X2/j | Drug | 1, 2 |
Primary outcome
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
6 secondary outcomes
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
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
Identifying risk factors for failure of antibiotic treatment (co-morbidities, bacteremia)
Time frame: 35 DAYS
Assessing the tolerance of the antibiotic, the presence of adverse events related to drug
Time frame: 35 DAYS
To assess adherence to treatment, the proportion of patients observant good, average and low observant
Time frame: 35 DAYS
Assess the changes in sensitivity to antibiotics (fluoroquinolones) in the nasal flora, pharyngeal and digestive.
Time frame: 35 DAYS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis BERNARD, MD PhD principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing levofloxacin, ciprofloxacin and ofloxacin (fluoroquinolones) in people with Urinary Tract Infection and Fever, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2014.