A Randomized Study Evaluating the Effectiveness of Oseltamivir Initiated at the Time of Hospital Admission in Adults Hospitalized With Influenza-Associated Lower Respiratory Tract Infections.

Abstract

Background:

Influenza-associated hospitalizations result in high morbidity and mortality. We sought to determine if early empiric anti-influenza therapy improves outcomes of hospitalized patients with influenza-associated lower respiratory tract infections (I-LRTIs).

Methods:

This was a randomized, unblinded, trial of adult patients hospitalized with I-LRTIs in Kentucky during 2009-2012. Patients were randomized to group A (standard of care) or group B (standard of care plus oseltamivir as early as possible but within 24 hours of enrollment). The primary outcome was development of clinical failure (composite variable including failure to reach clinical improvement within 7 days, transfer to intensive care 24 hours after admission, or rehospitalization or death within 30 days). Intent-to-treat (ITT) (all LRTI) and per-protocol (PP) (I-LRTI) analyses were done.

Results:

A total of 1107 patients were enrolled and included in the ITT analysis, 556 in group A and 551 in group B. The median time from symptom onset to hospital admission was 5 days (interquartile range, 5) for both groups; oseltamivir was initiated median day 6 in group B. There was no difference in the development of clinical failure (group A, 25%, and group B, 24%; P = .561). In the PP analysis, 11 of 45 (24%) patients in group A and 4 of 29 (14%) patients in group B had clinical failure (P = .414).

Conclusions:

Initiation of oseltamivir more than 5 days after illness onset did not reduce clinical failures among hospitalized patients with I- LRTIs. However, we did not enroll our projected sample size of I-LRTI.

Clinical Trials Registration:

NCT01248715.

• Authors: Julio Ramirez, Paula Peyrani, Timothy Wiemken, Sandra S Chaves, Alicia M Fry
• Journal: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America (Clin Infect Dis) Vol. 67 Issue 5 Pg. 736-742 (08 16 2018) ISSN: 1537-6591 [Electronic] United States
• PMID: 29659754 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Antiviral Agents
• Oseltamivir

Topics

• Adult
• Aged
• Aged, 80 and over
• Antiviral Agents (therapeutic use)
• Female
• Hospitalization
• Humans
• Influenza, Human (drug therapy)
• Length of Stay
• Male
• Middle Aged
• Oseltamivir (therapeutic use)
• Prospective Studies
• Respiratory Tract Infections (drug therapy)
• Time-to-Treatment
• Treatment Failure
• Treatment Outcome