Pharmacokinetics of the antiviral drug ribavirin in Lassa fever treatment

Phase 4

Completed

• Conditions: assa fever; Infections and Infestations

• Registration Number: ISRCTN11104750
• Lead Sponsor: Bernhard Nocht Institute for Tropical Medicine

Brief Summary

2020 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/32303517 protocol (added 21/04/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35881530/ outcome measures (added 05/10/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-06
• Study Completion: 2021-09-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Age = 18 years
2. Lassa fever confirmed by RT-PCR
3. Written informed consent
4. Anticipated treatment with intravenous ribavirin

Exclusion Criteria

1. Inability to give consent (e.g. unconscious patients/ cognitively impaired patients)
2. Critical illness (based on investigator’s clinical evaluation)
3. Severe malnutrition
4. Hemodialysis
5. History of hemophilia / bleeding disorder
6. Hematocrit <30 %
7. History of hemoglobinopathies (i.e., sickle-cell anaemia or thalassemia major)
8. Known intolerance to ribavirin
9. Known pregnancy
10. Women who plan to get pregnant within the upcoming 3 months
11. Patients who already received ribavirin within the last 7 days

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters (maximum concentration (Cmax), maximum time (Tmax), area under the curve (AUC), half-life time (T1/2), volume of distribution) using blood samples will be collected at 0.5, 1, 3, 5, 8, 12 and 24 hours after doses on day 1, day 4 and day 10 of ribavirin treatment using the Irrua dosing regimen

Secondary Outcome Measures

Name	Time	Method
<br> 1. Safety and tolerability of the Irrua Ribavirin regimen measured using clinical, hematological, and biochemical parameters:<br> 1.1. Clinical: every day from day 0 to day 10<br> 1.2. Haematology: standarad full blood count (hb; wbc; pla; diff) every 48 hours<br> 1.3. Biochemistry: creatinine; alt; ast; bun; ldh every 48 hours<br> 2. Viral kinetics in patients measured using at day 0, 5, 10<br> 3. LASV genome changes under the Irrua ribavirin regimen measured at day 0, 5, 10<br>