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Investigative Mathematical Modeling of Hospital Transmission of Hepatitis C (IMMHoTHep)

7. april 2017 opdateret af: ANRS, Emerging Infectious Diseases

ANRS 12320 IMMHoTHep : Investigative Mathematical Modeling of Hospital Transmission of Hepatitis C

This project is a prospective observational cohort study to quantify the risk of acquiring Hepatitis C virus (HCV) infection for patients and healthcare workers in Ain Shams University Teaching Hospital, Cairo, Egypt through: 1) identifying typical patient trajectories within the hospital; and 2) assessing the ward-specific risk based on the type and number of procedures performed and the prevalence of HCV viremia in patients within each ward.

Studieoversigt

Status

Ukendt

Detaljeret beskrivelse

Hepatitis C virus (HCV) is a blood-borne virus and its major route of transmission include blood transfusion, medical injection and procedure, and injecting drug use. In Egypt, the origin of the HCV epidemic has been attributed to a mass treatment of schistosomiasis between 1960 and 1984, when intravenous injections with antimony salts were given to 3-5 million people older than 6 years of age. Insufficient sterilization of needles and syringes was considered to be responsible for HCV transmission at that time. In order to control the spread of HCV in Egypt, the Egyptian Ministry of Health and Population established the National Committee for the Control of Viral Hepatitis. By 2008, this committee developed a National Control Strategy for Viral Hepatitis which has recommended prevention and education campaigns targeting general population and also healthcare workers (HCW). In their occupational environment, HCWs are frequently exposed to multiple blood-borne pathogens, including HCV. Several risk factors for HCV acquisition among patients and HCWs within a hospital ward have been identified, including a high prevalence of HCV infection in the ward, understaffing, workplace characteristic, and human factors such as inexperience or unfamiliar with equipment. However, to the investigators' knowledge, the overall risk of HCV acquisition associated with hospital stay has never been evaluated in Egypt. Also, control measures to reduce the risk of HCV transmission in hospital settings, based on a global assessment of healthcare provider logistics and performance, have never been proposed in Egypt.

In this project, the investigators assume that HCV will be transmitted to both hospital staff and patients. Given the slow dynamics of the HCV epidemic, the investigators further hypothesize that, in the short term, the prevalence of HCV viremia among patients will be constant. Therefore, the investigators are led to conclude that HCV transmission risk may be inferred from a detailed description of individual trajectories of patients or staff within the hospital.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

550

Kontakter og lokationer

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

Studiesteder

      • Cairo, Egypten
        • Rekruttering
        • Ain Shams University Teaching Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Wagida Anwar, Professor
        • Underforsker:
          • Ghada A Ismail, Professor

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

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

500 patients staying at least 24 hours in one of the following departments of the Ain Shams University Teaching Hospital: surgery, internal medicine, gynecology/obstetrics and toxicology.

50 healthcare workers working in one of departments cited above.

Beskrivelse

Inclusion Criteria for patients:

  • Aged 21 years or older
  • Staying in the hospital more than 24 hours
  • Provided a written informed consent to participate

Inclusion Criteria for healthcare workers:

  • Aged 21 or older
  • Provided a written informed consent to participate

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Patients
500 patients who are going to be hospitalized for at least 24 hours at Ain Shams University Teaching Hospital in the following departments: surgery, internal medicine, gynecology/obstetrics and toxicology.
Healthcare workers
50 healthcare workers working at Ain Shams University Teaching Hospital in the following departments: surgery, internal medicine, gynecology/obstetrics and toxicology.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Per-day risk of HCV acquisition for a hospitalized patient
Tidsramme: 1 day
Per-day risk of HCV acquisition for a hospitalized patient
1 day
Per-week risk of HCV acquisition for a healthcare worker through occupational blood exposure
Tidsramme: 1 week
Per-week risk of HCV acquisition for a healthcare worker through occupational blood exposure
1 week

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Estimation of the number of HCV acquisitions among patients and HCWs prevented over a 1-year period following the implementation of various control strategies, using a mathematical modeling approach
Tidsramme: 1 year
Estimation of the number of HCV acquisitions among patients and HCWs prevented over a 1-year period following the implementation of various control strategies,
1 year

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Laura Temime, Professor, Conservatoire national des Arts et Métiers
  • Ledende efterforsker: Wagida Anwar, Professor, Ain shams university

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)

21. februar 2017

Primær færdiggørelse (Forventet)

1. april 2018

Studieafslutning (Forventet)

1. april 2018

Datoer for studieregistrering

Først indsendt

30. juni 2016

Først indsendt, der opfyldte QC-kriterier

5. juli 2016

Først opslået (Skøn)

11. juli 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. april 2017

Sidst verificeret

1. april 2017

Mere information

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 .

Kliniske forsøg med Exposure to Hepatitis C Virus

Abonner