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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03179384
Acronym
CEFIMPACT
Enrollment
9
Registered
2017-06-07
Start date
2017-06-26
Completion date
2019-02-05
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pyelonephritis Acute

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.

Interventions

DRUGCeftriaxone

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

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Emergence of ceftriaxone-resistant Enterobacteriaceaeat 28 daysThe emergence of ceftriaxone-resistant Enterobacteriaceae at 28 days after cessation of treatment on rectal swab.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026