Phase 4 N=475 Randomized Double-blind Prevention

A Study of Oseltamivir (Tamiflu) for the Seasonal Prophylaxis of Influenza in Immunocompromised Participants

Influenza

Bottom Line

View on ClinicalTrials.gov: NCT00412737 ↗

Enrolled (actual)

475

Serious AEs

8.6%

Results posted

Sep 2009

Primary outcome: Primary: Number of Participants With Laboratory-Confirmed Clinical Influenza, ITT Population — 7; 5 participants — p=0.772

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Oseltamivir (Drug); Placebo (Drug)
Age: Pediatric, Adult, Older Adult · 1+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: May 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Laboratory-Confirmed Clinical Influenza, ITT Population	7; 5	0.772
SECONDARY Number of Participants With Laboratory Confirmed Clinical Influenza, Per Protocol (PP) Population	6; 4	0.534
SECONDARY Number of Participants With Laboratory Confirmed Clinical Influenza, Intent-to-treat Virus Negative at Baseline (ITTNAB) Population	7; 4	0.381
SECONDARY Number of Participants With Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Confirmed Clinical Influenza, ITT Population	7; 2	—
SECONDARY Number of Participants With RT-PCR Confirmed Clinical Influenza, ITTNAB Population	7; 1	—
SECONDARY Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITT Population	8; 5	—
SECONDARY Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITTNAB Population	8; 4	—

Summary

This 2 arm study will evaluate the efficacy and safety of oseltamivir in the seasonal prophylaxis of influenza in immunocompromised participants (as represented by transplant recipients). Transplant recipients enrolled when influenza is circulating in the community will be randomized to receive oseltamivir syrup or capsules 30 milligrams (mg) to 75 mg daily (depending on body weight) or placebo for 12 weeks. Influenza symptoms and safety data will be recorded throughout the study.

Eligibility Criteria

Inclusion Criteria

Negative rapid diagnostic test for influenza at baseline;
Immunocompromised participant (liver and/or kidney recipient or allogenic hematopoietic stem cell transplant).

Exclusion Criteria

Symptoms suggestive of influenza-like illness; but not limited to fever, cough, or nasal congestion;
Influenza vaccination in 6 weeks prior to randomization;
Positive rapid diagnostic test for influenza;
Solid organ transplant within 6 months of randomization;
Antiviral treatment for influenza in 2 weeks prior to randomization.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00412737). 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.