Treatment's Duration of Acute Uncomplicated Pyelonephritis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00873626
• Date of registration: 31/03/2009
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Treatment's Duration of Acute Uncomplicated Pyelonephritis DTP
• Scientific title: Randomized Controled Multicentric Trial, of Non Inferiority, Comparing Two Durations of Antibiotherapy (5 Days Versus 10 Days) in COMMUNAUTARY Acute Uncomplicated Pyelonephritis.
• Date of first enrolment: June 2009
• Target sample size: 310
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00873626
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Louis BERNARD, MD PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Fever

Urinary Tract Infection

Intervention(s)

Drug: levofloxacin, ciprofloxacin and ofloxacin (fluoroquinolones)

Primary Outcome(s)

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(s)

Assess the changes in sensitivity to antibiotics (fluoroquinolones) in the nasal flora, pharyngeal and digestive. [Time Frame: 35 DAYS]

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]

Assessing the tolerance of the antibiotic, the presence of adverse events related to drug [Time Frame: 35 DAYS]

Identifying risk factors for failure of antibiotic treatment (co-morbidities, bacteremia) [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]

To assess adherence to treatment, the proportion of patients observant good, average and low observant [Time Frame: 35 DAYS]

Secondary ID(s)

P071208

Source(s) of Monetary Support

Please refer to primary and secondary sponsors