- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02826447
Investigative Mathematical Modeling of Hospital Transmission of Hepatitis C (IMMHoTHep)
ANRS 12320 IMMHoTHep : Investigative Mathematical Modeling of Hospital Transmission of Hepatitis C
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienkontakt
- Name: Laura Temime, Professor
- Telefonnummer: +33 1 53 01 80 11
- E-Mail: laura.temime@cnam.fr
Studieren Sie die Kontaktsicherung
- Name: Wagida Anwar, Professor
- E-Mail: wagidaanwar@gmail.com
Studienorte
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Cairo, Ägypten
- Rekrutierung
- Ain Shams University Teaching Hospital
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Kontakt:
- Ghada A Ismail, Professor
- E-Mail: ghada.ismail@yahoo.com
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Hauptermittler:
- Wagida Anwar, Professor
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Unterermittler:
- Ghada A Ismail, Professor
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Per-day risk of HCV acquisition for a hospitalized patient
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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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
Zeitfenster: 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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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Laura Temime, Professor, Conservatoire national des Arts et Métiers
- Hauptermittler: Wagida Anwar, Professor, ain shams University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- RNA-Virusinfektionen
- Viruserkrankungen
- Infektionen
- Durch Blut übertragene Infektionen
- Übertragbare Krankheiten
- Leberkrankheiten
- Flaviviridae-Infektionen
- Hepatitis, viral, menschlich
- Enterovirus-Infektionen
- Picornaviridae-Infektionen
- Hepatitis
- Hepatitis A
- Hepatitis C
Andere Studien-ID-Nummern
- ANRS 12320
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