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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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (65% lower). 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.
Primary Outcome
Symptom evaluation during the 2015-2016 influenza season as recorded through FLU-PRO™: a daily diary developed to assess occurrence and severity of influenza symptoms. Item responses: 1. Not at all 2. A little bit 3. Somewhat 4. Quite a bit 5. Very much
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 |
What the finished NCT02609399 record still lists
NCT02609399 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Oseltamivir is the first listed.
NCT02609399 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02609399's enrollment target sits among peer trials
180 466th of 2000 higher than 1,525 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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