Status:
COMPLETED
Rapid Empiric Treatment With Oseltamivir Study (RETOS)
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
Centers for Disease Control and Prevention
Conditions:
Influenza
Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 pat...
Detailed Description
This will be both a prospective, randomized, unblinded clinical study of hospitalized patients with acute LRTI admitted in one of four institutions in Louisville, KY (rapid empiric treatment with osel...
Eligibility Criteria
Inclusion
- For oseltamivir and standard of care groups:
- 18 years of age or older
- No oseltamivir or zanamivir ordered in hospital admission orders
- Meets criteria for acute LRTI
- Signed informed consent.
Exclusion
- For oseltamivir and standard of care groups:
- Oseltamivir or zanamivir ordered in hospital admission orders
- Patients hospitalized for the LRTI for more than 24 hours before enrollment into the trial.
- Patients with mental conditions who are unlikely to comply with the study protocol and who cannot give informed consent and have no guardian or proxy.
- Patients who have had severe allergic reactions such as anaphylaxis or serious skin reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, or erythema multiforme to any component of oseltamivir (TAMIFLU).
- Prisoners
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
1107 Patients enrolled
Trial Details
Trial ID
NCT01248715
Start Date
November 1 2010
End Date
May 1 2016
Last Update
June 15 2023
Active Locations (5)
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1
Jewish Hospital
Louisville, Kentucky, United States, 40202
2
Norton Hospital
Louisville, Kentucky, United States, 40202
3
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
4
Rex Robley VA Medical Center
Louisville, Kentucky, United States, 40206