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

Pyelonephritis Acute Clinical Trial

— CEFIMPACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03179384
• Other study ID #: 16-AOI-02
• Status: Completed
• Phase: Phase 4
• Start date: June 26, 2017
• Est. completion date: February 5, 2019

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 5, 2019
• Est. primary completion date: February 5, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pyelonephritis
• Pyelonephritis Acute

Intervention

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

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emergence of ceftriaxone-resistant Enterobacteriaceae	The emergence of ceftriaxone-resistant Enterobacteriaceae at 28 days after cessation of treatment on rectal swab.	at 28 days