Cardiovascular Function and Ribavirin Pharmacokinetics and Pharmacodynamics in Patients With Lassa Fever

Cardiovascular Function and Ribavirin Pharmacokinetics and Pharmacodynamics in Patients With Lassa Fever

Patrocinadores

Patrocinador principal: University of Oxford

Colaborador: National Institute for Health Research, United Kingdom
Kenema Government Hospital
London School of Hygiene and Tropical Medicine
Public Health England

Fuente University of Oxford
Resumen breve

Lassa fever carries a treated mortality in hospitalized patients of up to 50%. Lassa fever is often described as being characterized by vascular leak and shock in the terminal phase, but, whilst animal data supports this, there are limited data in humans. Therefore, an aim of this study therefore is to characterize cardiovascular function in patients with Lassa fever, with the ultimate goal of informing future trials of supportive or therapeutic strategies.

Ribavirin is the current standard of care. However, the efficacy of ribavirin has not been established in a randomised controlled trial (RCT). There is very limited pharmacokinetic (PK) data on ribavirin in patients with Lassa fever and the optimal dose of ribavirin for an RCT is unknown. Furthermore, there are various hypothesized mechanisms of action of ribavirin, none of which have been investigated in humans with Lassa fever. Further aims of this study therefore are to characterize the PK of ribavirin in Lassa fever, and identify any associations between ribavirin PK parameters, viral load and markers of immune/inflammatory status.

Estado general Recruiting
Fecha de inicio March 1, 2019
Fecha de Terminación October 2020
Fecha de finalización primaria October 2020
Tipo de estudio Observational
Resultado primario
Medida Periodo de tiempo
Cardiovascular function - primary Up to 28 days during hospitalisation
Ribavirin PK - primary Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action) - primary Up to 15 days during hospitalisation
Resultado secundario
Medida Periodo de tiempo
Cardiovascular function - secondary Up to 28 days during hospitalisation
Cardiovascular function - secondary Up to 28 days during hospitalisation
Cardiovascular function - secondary Up to 28 days during hospitalisation
Ribavirin PK - secondary Up to 15 days during hospitalisation
Ribavirin PK - secondary Up to 15 days during hospitalisation
Ribavirin PK - secondary Up to 15 days during hospitalisation
Ribavirin PK - secondary Up to 15 days during hospitalisation
Ribavirin PK - secondary Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action) Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action) Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action) Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action) Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action) Up to 15 days during hospitalisation
Ribavirin PD (mechanism of action) Up to 15 days during hospitalisation
Inscripción 100
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Ribavirin

Descripción: Standard of care: Intravenous administration of ribavirin at currently recommended dosages. Loading dose of 30 mg/kg (maximum 2 g), followed by 15 mg/kg (maximum 1 g) intravenously QDS for four days, followed by 7.5 mg/kg intravenously (maximum 500 mg) TDS for six days.

Etiqueta de grupo de brazo: Lassa fever

Elegibilidad

Método de muestreo: Probability Sample

Criterios:

Inclusion Criteria:

- Positive antigen or PCR test for Lassa fever

- Aged 10 years or above

Exclusion Criteria:

- Patients for end of life care only

Género: All

Edad mínima: 10 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Alex Salam, MD Principal Investigator University of Oxford
Contacto general

Apellido: Annelies Gillesen

Teléfono: +441865 612959

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Investigador: Kenema Government Hospital Donald Grant, MD +23278350065 [email protected] Donald Grant, MD Principal Investigator
Ubicacion Paises

Sierra Leone

Fecha de verificación

March 2019

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Condición Examinar
Grupo de brazo

Etiqueta: Lassa fever

Datos del paciente Undecided
Información de diseño del estudio

Modelo de observación: Cohort

Perspectiva de tiempo: Prospective

Fuente: ClinicalTrials.gov