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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03179384
Other study ID # 16-AOI-02
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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