Lassa Fever
Conditions
Interventions
Ribavirin Irrua regimen
Favipiravir
Sponsors
Bernhard Nocht Institute for Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age = 18 years Lassa fever confirmed by PCR Written informed consent
Exclusion criteria
Exclusion criteria: Inability to give consent (e.g. unconscious patients/ cognitively impaired patients) Women who plan to get pregnant within the upcoming 6 months Severe malnutrition (BMI 150 IU/l o ACVPU score = V or P or U (corresponds to GCS = 12) o Severe central nervous system features (e.g. seizures, restlessness, confusion or coma) o O2 Saturation < 90% o Hematocrit <30 % o Severe anaemia requiring blood transfusion Inability to take oral drug (e.g. encephalopathy, severe vomiting) Patients who already received ribavirin or favipiravir within the preceding 7 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Description of classical pharmacokinetic parameters of favipiravir (e.g. Cmax, Tmax, AUC, T1/2, VOD, etc.) in patients with PCR confirmed LF;Proportion of drug related AEs and SAEs- Safety and tolerability of ribavirin and favipiravir in investigated regimens | — |
Secondary
| Measure | Time frame |
|---|---|
| Mutagenicity of ribavirin and favipiravir measured via nucleotide exchange rate in individual Lassa virus genomes ;Description of RNA concentrations, infectious titers and serological status during treatment ;PK modelling and simulation of different loading regimens to characterise time to target concentration attainment;Relationship between drug exposure (AUC, Cl/F) and i. Viral elimination dynamics (elimination rate constant), including time to viral clearance ii. Length of hospital stay iii. Mortality iv. Blood component therapy use ;Co-variates impacting on drug exposure | — |
Countries
Nigeria
Contacts
Public ContactMirjam Groger
Project Coordinator
Outcome results
None listed