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NCT01248715 · ClinicalTrials.gov registry record · Phase 4
Rapid Empiric Treatment With Oseltamivir Study (RETOS)
A Phase 4 study, sponsored by University of Louisville.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,107
- Enrollment target
NCT01248715 is a Phase 4 study that has completed, run by University of Louisville. The registered enrollment target is 1,107 participants.
The verdict
NCT01248715, a Phase 4 study, has completed, sponsored by University of Louisville.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,107 participants
- Enrollment target
Study 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
Interventions
- DRUG oseltamivir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,107 participants |
| Start Date | 2010-11 |
| Est. Completion | 2016-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01248715
The ClinicalTrials.gov registry entry for NCT01248715 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 1,107 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Louisville, which has 217 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which oseltamivir is the first listed.
NCT01248715 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01248715 about?
NCT01248715 is a clinical study titled "Rapid Empiric Treatment With Oseltamivir Study (RETOS)". 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...
What is the current status of trial NCT01248715?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,107 participants. The study started on 2010-11. Estimated completion is 2016-05.
What interventions are being tested in trial NCT01248715?
The interventions under investigation include: oseltamivir (DRUG).
Who is sponsoring clinical trial NCT01248715?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
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