- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02826447
Investigative Mathematical Modeling of Hospital Transmission of Hepatitis C (IMMHoTHep)
ANRS 12320 IMMHoTHep : Investigative Mathematical Modeling of Hospital Transmission of Hepatitis C
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní místa
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Cairo, Egypt
- Nábor
- Ain Shams University Teaching Hospital
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Kontakt:
- Ghada A Ismail, Professor
- E-mail: ghada.ismail@yahoo.com
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Vrchní vyšetřovatel:
- Wagida Anwar, Professor
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Dílčí vyšetřovatel:
- Ghada A Ismail, Professor
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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.
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Per-day risk of HCV acquisition for a hospitalized patient
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Laura Temime, Professor, Conservatoire national des Arts et Métiers
- Vrchní vyšetřovatel: Wagida Anwar, Professor, Ain shams university
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ANRS 12320
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