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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 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.
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)
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02891915
The ClinicalTrials.gov registry entry for NCT02891915 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 385 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02891915 reports 0 study locations.
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.
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