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

Primary Purpose

Pyelonephritis Acute

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Ceftriaxone
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pyelonephritis Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de NiceRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ceftriaxone treatment

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 29, 2017
Last Updated
December 18, 2017
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT03179384
Brief Title
Impact on the Intestinal Microbiota of Treatment With Ceftriaxone in Women's Acute Community Pyelonephritis
Acronym
CEFIMPACT
Official Title
Impact on the Intestinal Microbiota of Treatment With Ceftriaxone in Women's Acute Community Pyelonephritis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 26, 2017 (Actual)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pyelonephritis Acute

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ceftriaxone treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ceftriaxone
Intervention Description
ceftriaxone (1g intravenous or 1g/35mL intramuscular) will be given to patients during 7 days
Primary Outcome Measure Information:
Title
Emergence of ceftriaxone-resistant Enterobacteriaceae
Description
The emergence of ceftriaxone-resistant Enterobacteriaceae at 28 days after cessation of treatment on rectal swab.
Time Frame
at 28 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elisa DEMONCHY, MD
Phone
492035462
Ext
+33
Email
demonchy.e@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisa DEMONCHY, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Study Director
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisa DEMONCHY, MD

12. IPD Sharing Statement

Learn more about this trial

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

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