CClinicalTrials.gg
CompletedNCT03179384CEFIMPACTUpdated Nov 18, 2023

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

A Phase 4 interventional study of Ceftriaxone in Pyelonephritis Acute, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.

Sponsored by Centre Hospitalier Universitaire de Nice · Phase 4, Interventional, and Other

Phase
Phase 4
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Pyelonephritis Acute

Browse trials for

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts 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

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
04

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    ceftriaxone treatment

    Drug: Ceftriaxone

Interventions

  • DrugCeftriaxone

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

05

What researchers measure

Primary outcomes

  1. Emergence of ceftriaxone-resistant Enterobacteriaceae

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

    Time frame: at 28 days

06

Study locations

1 site
  • CHU de Nice
    Nice, 06003, France
07

Registry details

Key details

Study ID
NCT03179384
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Jun 7, 2017
Start date
Jun 26, 2017
Primary completion
Feb 5, 2019
Completion
Feb 5, 2019
Last update
Nov 18, 2023

Study contacts

Elisa DEMONCHY, MD
study director · Centre Hospitalier Universitaire de Nice

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion