- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02826447
Investigative Mathematical Modeling of Hospital Transmission of Hepatitis C (IMMHoTHep)
ANRS 12320 IMMHoTHep : Investigative Mathematical Modeling of Hospital Transmission of Hepatitis C
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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Cairo, Egypten
- Rekrytering
- Ain Shams University Teaching Hospital
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Kontakt:
- Ghada A Ismail, Professor
- E-post: ghada.ismail@yahoo.com
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Huvudutredare:
- Wagida Anwar, Professor
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Underutredare:
- Ghada A Ismail, Professor
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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.
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Healthcare workers
50 healthcare workers working at Ain Shams University Teaching Hospital in the following departments: surgery, internal medicine, gynecology/obstetrics and toxicology.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Per-day risk of HCV acquisition for a hospitalized patient
Tidsram: 1 day
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Per-day risk of HCV acquisition for a hospitalized patient
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1 day
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Per-week risk of HCV acquisition for a healthcare worker through occupational blood exposure
Tidsram: 1 week
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Per-week risk of HCV acquisition for a healthcare worker through occupational blood exposure
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1 week
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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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
Tidsram: 1 year
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Estimation of the number of HCV acquisitions among patients and HCWs prevented over a 1-year period following the implementation of various control strategies,
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1 year
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Laura Temime, Professor, Conservatoire national des Arts et Métiers
- Huvudutredare: Wagida Anwar, Professor, Ain Shams University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ANRS 12320
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