Phase 2
N=87
Oseltamivir Treatment for Children Less Than 24 Months of Age With Influenza
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00391768 ↗Enrolled (actual)
87
Serious AEs
9.2%
Results posted
Jun 2011
Primary outcome: Primary: Oseltamivir Carboxylate AUC12 (Area Under the Curve). — 6; 1; 3; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- oseltamivir (Tamiflu®) (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oseltamivir Carboxylate AUC12 (Area Under the Curve). |
6; 1; 3; 0; 2; 0 | — |
| SECONDARY Overall Reported Adverse Events (AEs) Thought to be Associated With Study Therapy. |
3; 0; 0; 0; 2; 0 | — |
| SECONDARY Number and Characteristics of Adverse Events (AEs) Described as Neurological Events. |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY Incidence of Treatment Emergent AEs and Drug Related AEs by Cohort and Toxicity Grade |
3; 0; 0; 0; 3; 0 | — |
| SECONDARY Incidence of Treatment Emergent AEs and Drug Related AEs by Cohort Leading to Discontinuation of Study Medication |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Incidence of All Serious Adverse Events by Cohort and System Organ Class (SOC) |
2; 0; 1; 2; 2; 1 | — |
| SECONDARY Correlation of Clearance of Viral RNA by Culture With Pharmacokinetic Parameters by Cohort |
0.67; NA; 0.40; 0.62; 0.09; 0.30 | 0.07 |
| SECONDARY Correlation of Clearance of Viral RNA by Polymerase Chain Reaction (PCR) to Pharmacokinetic Parameters by Cohort. |
0.57; NA; 0.21; 0.90; 0.28; 0.04 | — |
Summary
The purpose of this study is to learn how to treat influenza in children less than 2 years of age. Tamiflu®, the drug being studied, is approved for treatment of children 1 year of age and older with influenza. Researchers want to learn more about the activity of Tamiflu® in the body to determine a dose of that is safe, well-tolerated, and effective in young children with influenza. Children less than 24 months of age with confirmed influenza will receive Tamiflu® 2 times a day for 5 days. Older participants will be enrolled first and younger children will be enrolled after the safety data is reviewed for older participants. Study procedures include blood samples, swabs from inside the nose, and body and nervous system evaluations. Participants may be involved in study related procedures for up to 37 days.
Eligibility Criteria
Inclusion Criteria
- Signed informed consent from parent(s) or legal guardian(s).
- Age:
Cohort I: 12 - 23 mo. Cohort II: 9 - 11 mo. Cohort III: 6 - 8 mo. Cohort IV: 3 - 5 mo. Cohort V: 0 - 2 mo.
- Confirmed laboratory diagnosis of influenza by viral culture or rapid influenza diagnostic test within 96 hours prior to study enrollment.
- Duration of influenza symptoms less than or equal to 96 hours.
Exclusion Criteria
- Concomitant vomiting illness that would preclude ability to take drug.
- Immunocompromised subject (e.g., malignancy, congenital agammaglobulinemia, HIV).
- Documented renal impairment (e.g., polycystic renal disease, nephrectomy, renal transplantation, renal agenesis, dialysis requirement, renal failure, nephrotic syndrome at any time prior to enrollment, current receipt of diuretic therapy).
- Documented hepatic impairment (e.g., congenital hepatitis, biliary atresia, cholelithiasis).
- Gastrointestinal abnormality which might hinder absorption of an oral medication.
- Current receipt of inotropic drugs (e.g., epinephrine, norepinephrine, dopamine, dobutamine).
- History of seizures.
- Documented congenital malformations of the central nervous system defined at birth (e.g., hydranencephaly, prosencephaly, spina bifida).
Data sourced from ClinicalTrials.gov (NCT00391768). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.