Influenza A in immucompromised patients
Conditions
Interventions
- Nasopharyngeal swabs (or washes)
- Peripheral venous blood samples will be drawn from indwelling catheters or by
direct venipuncture into collection tubes
- TCAD (Amantadine 75 mg q8h orally, Riba
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age *18 years, male or female. 2. Able to provide informed consent 3. Immunocompromised. 4. Positive influenza subtype-specific PCR test for influenza A H3N2 or H1N1 virus. 5. Female patients must be surgically sterile or clinically post-menopausal for at least 2 years, or, if of child-bearing potential or perimenopausal who use any sort of contraceptives
Exclusion criteria
Exclusion criteria: 1. Nausea 2. Use of antiviral influenza medications within 10 days. 3. Creatinine clearance less than 30 ml/min. 4. Current clinical evidence of a recognized or suspected uncontrolled non-influenza infectious illness with onset prior to screening. 5. Known hypersensitivity to amantadine, ribavirin, oseltamivir. 6. Women who are pregnant (positive serum or urine pregnancy test), who are attempting to become pregnant, or who are breast-feeding. 7. Psychiatric or cognitive illness or recreational drug/alcohol use. 8. Seizure disorder or history of seizure activity within 12 months prior to study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Descriptive statistics of adverse events (AEs), drug specific AEs, and AEs resulting in treatment interruption (CTC grading scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Viral load as a function of time as measured by qPCR and culture (TCID50 or PFU/ml) 2. Proportion of patients not shedding replicating virus at days 5 +/-1 and 10 +/-1 (defined as negative virus culture). 3. Proportion of patients not shedding viral nucleic acids at days 5 +/-1 and 10 +/-1 (defined as having RNA copies below detection limit of 1,000 copies per ml by RTPCR). 4. Viral resistance as a function of drug exposure, as measured by sequencing and in vitro susceptibility testing 5. Duration of symptoms as defined in symptom survey 6. Frequency of confirmed pneumonia (radiographically with or without laboratory/microbiological testing) 7. Duration of hospitalization 8. Days on O2/supplemental needs as measured by O2 saturation 9. Number of ICU admissions and duration 10. Days on ventilation 11. Number of deaths 12. PK of TCAD in influenza A infected immunocompromised patients | — |
Countries
Netherlands
Outcome results
None listed