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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)

20. juli 2018 opdateret af: Centre Hospitalier Universitaire de Nice

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, Frankrig, 06200
        • MONDAIN

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
enterobacteria ESBLs
Tidsramme: baseline
measure the carriage of antibiotic-resistant bacteria in HIV seropositive patients looking for potential factors associated with sexual transmission.
baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. november 2013

Primær færdiggørelse (Faktiske)

1. november 2015

Studieafslutning (Faktiske)

1. januar 2016

Datoer for studieregistrering

Først indsendt

8. november 2013

Først indsendt, der opfyldte QC-kriterier

10. december 2013

Først opslået (Skøn)

13. december 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. juli 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juli 2018

Sidst verificeret

1. december 2013

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 13-PP-02

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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