Impact on the Intestinal Microbiota of Treatment With Ceftriaxone in Women's Acute Community Pyelonephritis (CEFIMPACT)

November 15, 2023 updated by: Centre Hospitalier Universitaire de Nice

Acute pyelonephritis (APN) corresponds to infections of the renal parenchyma. The annual incidence of these infections is estimated at 4-6 million cases in France, with 60 to 90% of patients managed in general city medicine. The ceftriaxone, parenteral third-generation cephalosporin (C3G), occupies an important place in the antibiotic treatment of these infections: this is the recommended probabilistic treatment, and in some situations the treatment can be continued in its entirety via a Ceftriaxone monotherapy.

The aim of the last antibiotic plan is to avoid the use of antibiotic therapies with a high selection capacity (cephalosporins, penicillins, fluoroquinolones, etc.) and thus reduce the incidence and prolongation over time of the digestive carriage of multi-resistant bacteria .

To date, there have been few studies evaluating the impact of ceftriaxone on the emergence of multi-resistant bacteria on an individual scale, with rather heterogeneous results (13-86% C3G resistance).

Thus, before considering randomized studies comparing the ecological impact of different molecules or therapeutic regimens in the treatment of ANP, it is necessary to have a precise and rigorous evaluation of the ecological impact of the molecule reference in this indication.

The investigators propose a study to evaluate the impact on the digestive flora at 1 month of a ceftriaxone antibiotic therapy (7 days) in the management of acute pyelonephritis in women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Nice, France, 06003
        • CHU de Nice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female
  • Over 18 years old
  • Admitted to the emergency department with a diagnosis of PNA (simple or at risk of complications, without signs of seriousness)

Exclusion Criteria:

  • Hypersensitivity to ceftriaxone, to another cephalosporin or to any of the excipients
  • A history of severe hypersensitivity (eg anaphylactic reaction) to another class of antibacterial agent in the beta-lactam family (penicillins, monobatams and carbapenems)
  • Severe pyelonephritis, including obstructive APN
  • Pyelonephritis in patients with a urinary catheter
  • Antibiotic treatment in the previous 6 months
  • Chronic dialysis patient
  • Patient with hepatic impairment
  • Pregnancy or breast-feeding in progress

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ceftriaxone treatment
Drug: Ceftriaxone
ceftriaxone (1g intravenous or 1g/35mL intramuscular) will be given to patients during 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emergence of ceftriaxone-resistant Enterobacteriaceae
Time Frame: at 28 days
The emergence of ceftriaxone-resistant Enterobacteriaceae at 28 days after cessation of treatment on rectal swab.
at 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Study Director: Elisa DEMONCHY, MD, Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2017

Primary Completion (Actual)

February 5, 2019

Study Completion (Actual)

February 5, 2019

Study Registration Dates

First Submitted

May 29, 2017

First Submitted That Met QC Criteria

June 6, 2017

First Posted (Actual)

June 7, 2017

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-AOI-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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