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NCT02814916 · ClinicalTrials.gov registry record · Phase 3
Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 199
- Enrollment target
NCT02814916: Completed Phase 3 study, sponsored by AbbVie.
NCT02814916 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 199 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02814916, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 199 participants
- Enrollment target
Study Summary
To determine the safety and descriptive efficacy of dalbavancin for the treatment of acute bacterial skin and skin structure infections in children, aged birth to 17 years (inclusive), known or suspected to be caused by susceptible Gram-positive organisms, including methicillin-resistant strains of Staphylococcus aureus.
Primary Outcome
Audiologic testing was to be conducted in at least 20 children \< 12 years old, of which at least 9 children were \< 2 years old. Audiologic testing conducted on infants (\< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (t
Interventions
- DRUG Vancomycin
- DRUG Dalbavancin
- DRUG Cefadroxil
- DRUG Oxacillin
- DRUG Flucloxacillin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 199 participants |
| Start Date | 2017-03-30 |
| Est. Completion | 2024-01-01 |
| Phase | Phase 3 |
What the finished NCT02814916 record still lists
NCT02814916 is an interventional study that assigns participants to a tested intervention. The registered 199 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 (74% lower).
The record links to 0 conditions, and to 5 interventions - of which Vancomycin is the first listed.
NCT02814916 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02814916 about?
NCT02814916 is a clinical study titled "Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA". To determine the safety and descriptive efficacy of dalbavancin for the treatment of acute bacterial skin and skin structure infections in children, aged birth to 17 years (inclusive), known or suspected to be caused by susceptible Gram-positive organisms, including methicillin-resistant strains of ...
What is the current status of trial NCT02814916?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 199 participants. The study started on 2017-03-30. Estimated completion is 2024-01-01.
What interventions are being tested in trial NCT02814916?
The interventions under investigation include: Vancomycin (DRUG), Dalbavancin (DRUG), Cefadroxil (DRUG), Oxacillin (DRUG), Flucloxacillin (DRUG).
Who is sponsoring clinical trial NCT02814916?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02814916's enrollment target sits among peer trials
199 1388th of 2000 higher than 612 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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