Rapid Empiric Treatment With Oseltamivir Study (RETOS)
Status:
Completed
Trial end date:
2016-05-01
Target enrollment:
Participant gender:
Summary
Current guidelines recommend early initiation of empiric antibiotic therapy to cover typical
and atypical bacteria that may cause community-acquired pneumonia (CAP). Influenza antiviral
therapy in patients with suspected or confirmed influenza. However, many clinicians do not
suspect influenza among patients with CAP or other acute lower respiratory tract illness
(LRTI) and often do not test for influenza. Additionally, results from currently available
diagnostic tests for influenza may be delayed and several tests have low sensitivity and will
give false negative results. Thus, anti-influenza treatment for patients with hospitalized
influenza CAP and LRTI is frequently initiated late if at all. There is an association
between delayed time to administration of empiric antibiotic therapy with increased clinical
failure and mortality. As a result, empiric antibiotic therapy for patients with suspect CAP
is begun within 4 - 6 hours of hospitalization. This has recently been demonstrated for
delayed antiviral treatment as well. We hypothesize that, as happens with early empiric
antibiotics for bacterial CAP, a standardized approach of adding early empiric anti-influenza
therapy during the influenza season to hospitalized patients with suspect CAP and LRTI will
improve clinical outcomes of patients with influenza associated CAP and LRTI.
To test our hypothesis we plan a prospective, randomized, multicenter clinical trial of
hospitalized patients with acute LRTI, including suspect CAP, during . If early
anti-influenza medications were not included on the patients admission orders, patients will
be randomized to standard care, including empiric antibacterial therapy as recommended by
ATS/IDSA guidelines plus standard influenza diagnostics and treatment (Standard of care)
versus early initiation of empiric antiinfluenza therapy plus standard care, e.g. empiric
antibacterial (oseltamivir group). The primary study outcome will be development of clinical
failure and selected clinical outcomes during the 30 days after enrollment. Other clinical
outcomes that will be compared between study groups include time to clinical stability,
duration of hospitalization, development of cardiovascular events, re-hospitalization,
short-term mortality (30 days), and long-term mortality (1 year). The secondary study outcome
will be the cost-effectiveness of the intervention.