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NCT02891915 · ClinicalTrials.gov registry record · Phase 4
Trial to Evaluate Beta-Lactam Antimicrobial Therapy of Community Acquired Pneumonia in Children
A Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 4
- Development phase
- 385
- Enrollment target
NCT02891915: Completed Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02891915 is a Phase 4 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 385 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02891915, a Phase 4 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 385 participants
- Enrollment target
Study Summary
This is a multi-center, randomized, double-blind, placebo-controlled, superiority clinical trial will test the effectiveness of short (5-day) vs.standard (10-day) course therapy in children who are diagnosed with CAP and initially treated in outpatient clinics, urgent care facilities, and emergency departments. Primary objective is to compare the composite overall outcome (Desirability of Outcome Ranking, DOOR) among children 6-71 months of age with CAP assigned to a strategy of short course (5 days) vs standard course (10 days) outpatient beta-lactam therapy at Outcome Assessment Visit #1 (Study Day 8 +/- 2 days)
Primary Outcome
DOOR is a composite endpoint created using clinical outcomes from the first 5 days and at Outcome Assessment Visit #1 (OAV #1). It is based on adequate clinical response at OAV #1, solicited symptoms from first 5 days and number of days of antibiotics use for worsening pneumonia from the first 5 days of the study.
Interventions
- OTHER Placebo
- DRUG Amoxicillin
- DRUG Amoxicillin-clavulanate
- DRUG Cefdinir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 385 participants |
| Start Date | 2016-12-02 |
| Est. Completion | 2019-12-16 |
| Phase | Phase 4 |
What the finished NCT02891915 record still lists
NCT02891915 is an interventional study that assigns participants to a tested intervention. The registered 385 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 (26% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02891915 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02891915 about?
NCT02891915 is a clinical study titled "Trial to Evaluate Beta-Lactam Antimicrobial Therapy of Community Acquired Pneumonia in Children". This is a multi-center, randomized, double-blind, placebo-controlled, superiority clinical trial will test the effectiveness of short (5-day) vs.standard (10-day) course therapy in children who are diagnosed with CAP and initially treated in outpatient clinics, urgent care facilities, and emergency ...
What is the current status of trial NCT02891915?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 385 participants. The study started on 2016-12-02. Estimated completion is 2019-12-16.
What interventions are being tested in trial NCT02891915?
The interventions under investigation include: Placebo (OTHER), Amoxicillin (DRUG), Amoxicillin-clavulanate (DRUG), Cefdinir (DRUG).
Who is sponsoring clinical trial NCT02891915?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02891915's enrollment target sits among peer trials
385 222nd of 2000 higher than 1,779 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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