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NCT02554383 · ClinicalTrials.gov registry record · Phase 3
Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?
A Phase 3 study, sponsored by Nader Shaikh.
- Completed
- Registry status
- Phase 3
- Development phase
- 515
- Enrollment target
NCT02554383: Completed Phase 3 study, sponsored by Nader Shaikh.
NCT02554383 is a Phase 3 study that has completed, run by Nader Shaikh. The registered enrollment target is 515 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02554383, a Phase 3 study, has completed, sponsored by Nader Shaikh.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 515 participants
- Enrollment target
Study Summary
The objective of this trial is to determine whether certain subgroups of children with acute sinusitis exist in whom antibiotic therapy can be appropriately withheld.
Primary Outcome
The Pediatric Rhinosinusitis Symptom Scale (PRSS) is a 8 item scale assessing symptoms of sinusitis. Parents are asked how their child has been doing over the last 24 hours by rating each of 8 symptoms - stuffy nose, runny nose, daytime cough, tiredness, irritability, trouble breathing through the nose, nighttime cough \& trouble sleeping - as none, almost none, a little, some, a lot \& an extreme amount with respective scores of 0, 1, 2, 3, 4 \& 5. The 8 ratings were summed to obtain a PRSS sco
Interventions
- DRUG Placebo
- DRUG Amoxicillin-clavulanate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 515 participants |
| Start Date | 2016-02 |
| Est. Completion | 2023-03-09 |
| Phase | Phase 3 |
What the finished NCT02554383 record still lists
NCT02554383 is an interventional study that assigns participants to a tested intervention. The registered 515 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02554383 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02554383 about?
NCT02554383 is a clinical study titled "Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?". The objective of this trial is to determine whether certain subgroups of children with acute sinusitis exist in whom antibiotic therapy can be appropriately withheld.
What is the current status of trial NCT02554383?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 515 participants. The study started on 2016-02. Estimated completion is 2023-03-09.
What interventions are being tested in trial NCT02554383?
The interventions under investigation include: Placebo (DRUG), Amoxicillin-clavulanate (DRUG).
Who is sponsoring clinical trial NCT02554383?
This trial is sponsored by Nader Shaikh, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02554383's enrollment target sits among peer trials
515 724th of 2000 higher than 1,277 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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