Efficacy and Safety Study of Short-term Antibiotic for Pyelonephritis in Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01390623
First received: July 7, 2011
Last updated: July 4, 2014
Last verified: July 2014
  Purpose

Urinary tract community infections are one of very frequent reason consultation and prescription. Urinary tract represents the second site of bacterial community infection after the respiratory system. The management of the acute uncomplicated pyelonephritis was simply codified in the past recommendations of the French Agency for Safety Health Products (AFSSAPS) in 2008. Treatment is based on two main families of antibiotics, fluoroquinolones with 7 days treatment and 3rd generation cephalosporins with 10 to 14 days treatment.

The practice of a short treatment with ceftriaxone intra venous relayed by cefixime orally provides a simplified treatment for patients, a reduced use of fluoroquinolones and a probable decrease in correlation with the emergence of fluoroquinolones resistance, and finally, a decrease in the cost of treatment of acute uncomplicated pyelonephritis.


Condition Intervention Phase
Acute Uncomplicated Pyelonephritis
Drug: Ceftriaxone
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety Study of Short Term Antibiotic During Seven Days With Ceftriaxone Intravenous the First Day Then Cefixime the Second Day Till the Seventh Day of Acute Uncomplicated Pyelonephritis in Women Between 18 and 65 Years Old

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Microbiological cure at the 9th day [ Time Frame: at the 9th day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Microbiological cure at the 3 rd day [ Time Frame: at the 3 rd day ] [ Designated as safety issue: Yes ]
  • Number of recurrence of acute pyelonephritis during the month after the treatment between the 9 th and the 37 th day [ Time Frame: between the 9 th and the 37 th day ] [ Designated as safety issue: Yes ]

Enrollment: 39
Study Start Date: July 2011
Study Completion Date: December 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ceftriaxone

    Patients will be included by investigators or coinvestigateurs, the day of consultation in the emergency adult department in Clermont-Ferrand city.

    The diagnosis of acute uncomplicated pyelonephritis is established in the emergency department based on the clinical, laboratory and imaging criteria.

Detailed Description:

Patients will be included by investigators or coinvestigateurs, the day of consultation in the emergency adult department in Clermont-Ferrand city.

The diagnosis of acute uncomplicated pyelonephritis is established in the emergency department based on the clinical, laboratory and imaging criteria.

Clinical, biological and radiological data will gathered during this consultation :

  • Clinical data: flank pain, fever, urinary symptoms,
  • Biological data: urine dipstick (BU No. 1), cytobacteriological urinary (ECBU No. 1), blood prélèvements (Blood count, creatinine, CRP)
  • Imagery: renal and bladder ultrasound. During the next consultations in the emergency department, respectively on day 3 (J3) of treatment and on day 9 (J9), urine tests (urinary dipsticks [BU No. 2 and No. 3] and cytobacteriological urinary [ECBU No. 2 and No. 3] will be realised. The clinical and biological management of patient will be performed by the same department to ensure a better comparability of biological results and a centralized real-time clinical data.

Patient follow-up will end with a phone call on day 37 (J37), and the rate of clinical relapses and / or biological occurred between day 9 and day 37.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women between 18 and 65 years old
  • Diagnosis of Acute Uncomplicated Pyelonephritis
  • Patient obliged to participate in the French national health and pensions system.
  • Patient who have read, understood and signed the consent

Exclusion Criteria:

  • Women who are pregnant
  • Men
  • One of these risk factor who define a complicated pyelonephritis:

Medical history of uro-nephrology problem Nephropathy Obstructive Uropathy Vesicoureteral reflux Post mictinal residue > 100mL Urinary fistula Catheter vesicle and urethral Kidney transplantation Immunodeficiency Diabetes

  • Recurrent pyelonephritis
  • Allergy of betalactam or cephalosporin
  • History of hypersensitivity reactions to antibiotic medications
  • Patient in terminal care
  • Trouble of cognitive function
  • Patient deprive of judicial or administrative freedom
  • Patient participating to another trial
  • Refusal to participate to the trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01390623

Locations
France
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Thierry MATHEVON University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01390623     History of Changes
Other Study ID Numbers: CHU-0098, 2010-023697-39
Study First Received: July 7, 2011
Last Updated: July 4, 2014
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Acute Uncomplicated Pyelonephritis
Short-term antibiotic
Ceftriaxone
Cefixime
Women
Efficacy

Additional relevant MeSH terms:
Pyelonephritis
Nephritis, Interstitial
Nephritis
Kidney Diseases
Urologic Diseases
Pyelitis
Anti-Bacterial Agents
Ceftriaxone
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on October 01, 2014