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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 (Calires)

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ClinicalTrials.gov Identifier: NCT02011009
Recruitment Status : Completed
First Posted : December 13, 2013
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Tracking Information
First Submitted Date  ICMJE November 8, 2013
First Posted Date  ICMJE December 13, 2013
Last Update Posted Date July 24, 2018
Actual Study Start Date  ICMJE November 2013
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2013)
enterobacteria ESBLs [ Time Frame: baseline ]
measure the carriage of antibiotic-resistant bacteria in HIV seropositive patients looking for potential factors associated with sexual transmission.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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 (Extended-spectrum ß-lacatamase-producing Bacteria) Carriers
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE AIDS Patients
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: BLSE
The main objective of this study is to measure the carriage of antibiotic-resistant bacteria (enterobacteria ESBLs) in HIV seropositive patients looking for potential factors associated with sexual transmission. As a matter of fact, there is currently a worldwide community epidemic outbreak of enteric bacteria resistant to antibiotics for which the modes of transmission are still not fully known. There are many open questions about the possibility of sexual transmission and this study aims to find an answer.
Intervention: Other: HIV seropositive patients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 20, 2018)
100
Original Estimated Enrollment  ICMJE
 (submitted: December 10, 2013)
150
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age > 18
  • HIV+ patient of the hospital's outpatient clinic
  • Signature of informed consent
  • Affiliation of the Social Security system

Exclusion criteria

  • Vulnerable Persons: minor patient, wardship (tutelage), no liberty to act and speak
  • Pregnancy and lactation: a urine pregnancy test will be performed for women of childbearing age. Results will be reported by the physician selected by the patient
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02011009
Other Study ID Numbers  ICMJE 13-PP-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire de Nice
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Nice
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: MONDAIN Véronique, Ph Service d'Infectiologie - Hôpital Archet - 151 route St Ginestière - 06 202 Nice
PRS Account Centre Hospitalier Universitaire de Nice
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP