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Evaluation of Therapeutic Management in ESBL-infected Patients or Carriers by Providing and Sharing a Free Tool - the "ESBL toolKIT"and Interventional Study of a Prospective Cohort of HIV+ Patients Searching for Possible Sexual Transmission Factors in ESBL Carriers

NCT02011009 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-07-24

No results posted yet for this study

Summary

Bacterial resistance to antibiotics is a major public health problem. The epidemiology of enteric bacteria including E. coli is changing rapidly with the global spread of a resistance mechanism type beta-lactamase extended spectrum (ESBL), responsible for resistance to almost all penicillins and cephalosporins. The resistance is up to 75% for Quinolones, 67% for Cotrimoxazole and 30-50% for Aminoglycosides.

The main phenomena causing this problem are:

* The selection pressure by antibiotics, in their use in humans or animals
* The hand transmission via the digestive reservoir (faeces)
* Easy spread of resistance mechanism in Enterobacteriaceae due to transferable genetic support (plasmid)

In this context, we decided to implement a cross-border study to improve and accelerate the management, diagnosis and treatment of patients with ESBL in close collaboration between medical and paramedical staff in hospitals, laboratories and private medical offices.

The objective of this study is to standardize diagnostic and therapeutic measures allowing a better and rapid treatment of patients and thus prevent the appearence of ESBL bacteria in the PACA region and Liguria by providing a tool : The "Kit ESBL".

The " ESBL ToolKIT" (also translated into Italian) includes:

* Information on epidemiological data
* A checklist edited for extra-hospital use (private practitioners, health care units other than hospitals)
* A checklist edited for hospital use
* A leaflet BMR for the patient explaining the problematic as well as hygiene measures
* Therapeutical protocols for hospital use and extra hospital use
* An sample letter for the attending physician

The objective of this prospective multicenter cohort study is to evaluate the use of this kit, and to measure its impact on:

* The prescription of appropriate antibiotics
* The measures taken to prevent man to man transmission
* The quality of information provided to the patient

In this context we are also performing a multicentre prospective interventional cohort of HIV+ patients searching for possible sexual transmission factors in ESBL (extended-spectrum ß-lacatamase-producing bacteria) carriers.

We will also try to determine if other sexually transmitted infections associated (syphilis, gonorrhea and chlamydia) are contributing factors to ESBL carriage.

So far there is no data documented on ESBL-carriage in a population of HIV-positive patients.

Conditions

  • AIDS Patients

Interventions

OTHER

HIV seropositive patients

During a routine visit, a self-administered anal swab will be proposed as well as an anonymous questionnaire about sexual practices. In addition to usual outpatient treatment an examination and an evaluation of a possible sexually transmitted infection (STI) will be realized. Some questions about risk factors traditionally associated with carriage of resistant bacteria will also be investigated with the aid of the questionnaire such as: use of antibiotics during the year, travel in areas at risk.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Principal Investigators

  • MONDAIN Véronique, Ph · Service d'Infectiologie - Hôpital Archet - 151 route St Ginestière - 06 202 Nice

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-11-30
Completion
2016-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02011009 on ClinicalTrials.gov