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NCT02609399 · ClinicalTrials.gov registry record · Phase 4
ED Influenza Therapeutic Pilot Study: Oseltamivir vs. Peramivir
A Phase 4 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 4
- Development phase
- 180
- Enrollment target
NCT02609399: Completed Phase 4 study, sponsored by Johns Hopkins University.
NCT02609399 is a Phase 4 study that has completed, run by Johns Hopkins University. The registered enrollment target is 180 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02609399, a Phase 4 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 180 participants
- Enrollment target
Study Summary
This pilot study is designed to demonstrate the feasibility of utilizing Emergency Departments (EDs) as a primary site for subject enrollment in clinical trials evaluating influenza therapeutics, and to provide pilot data for future clinical trial design and planning. Primary Objective: To prospectively enroll high-risk subjects with laboratory-confirmed influenza into a randomized, open label study of oral versus IV influenza therapeutic to include symptom evaluation and outcome assessments. Secondary Objective 1: To identify influenza positive patients utilizing a previously established triage-based assessment and rapid testing algorithm for suspected influenza infection. Secondary Objective 2: To retrospectively evaluate all potentially eligible patients for potential enrollment biases. Secondary Objective 3: To create a repository of residual nasopharyngeal samples collected from ED patients with suspected influenza illness.
Interventions
- DRUG Oseltamivir
- DRUG Peramivir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2015-11-01 |
| Est. Completion | 2018-05-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02609399
The ClinicalTrials.gov registry entry for NCT02609399 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Oseltamivir is the first listed.
NCT02609399 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02609399 about?
NCT02609399 is a clinical study titled "ED Influenza Therapeutic Pilot Study: Oseltamivir vs. Peramivir". This pilot study is designed to demonstrate the feasibility of utilizing Emergency Departments (EDs) as a primary site for subject enrollment in clinical trials evaluating influenza therapeutics, and to provide pilot data for future clinical trial design and planning. Primary Objective: To prospect...
What is the current status of trial NCT02609399?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 180 participants. The study started on 2015-11-01. Estimated completion is 2018-05-31.
What interventions are being tested in trial NCT02609399?
The interventions under investigation include: Oseltamivir (DRUG), Peramivir (DRUG).
Who is sponsoring clinical trial NCT02609399?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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