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

NCT03179384 | Completed Phase 4

• 1 other identifier: 16-AOI-02
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pyelonephritis Acute

Outcome Measures

Primary Outcomes (1)

• Emergence of ceftriaxone-resistant Enterobacteriaceae

  The emergence of ceftriaxone-resistant Enterobacteriaceae at 28 days after cessation of treatment on rectal swab.

  at 28 days

Study Arms (1)

ceftriaxone treatment

EXPERIMENTAL

Drug: Ceftriaxone

Interventions

Ceftriaxone DRUG

ceftriaxone (1g intravenous or 1g/35mL intramuscular) will be given to patients during 7 days

ceftriaxone treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06003, France

Location

MeSH Terms

Interventions

Ceftriaxone

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Elisa DEMONCHY, MD

  Centre Hospitalier Universitaire de Nice

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2017
• First Posted: June 7, 2017
• Study Start: June 26, 2017
• Primary Completion: February 5, 2019
• Study Completion: February 5, 2019
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

FR (1)