At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 515 enrolled
Drug / intervention
Amoxicillin-clavulanate +1 moredrug
Likely dose
Amoxicillin-clavulanate 6.4 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?
In Brief
A Phase 3 clinical trial evaluating Amoxicillin-clavulanate and Placebo for Sinusitis and Respiratory Tract Infections. Completed, enrolled 515 participants across 6 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSinusitis, Respiratory Tract Infections
CountriesUnited States
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2015
Enrollment StartFeb 2016
Primary CompletionMar 2022
Study CompletionMar 2023
TodayJul 2026
First PostedSep 18, 2015
Enrollment StartFeb 1, 2016
Primary CompletionMar 31, 2022
Study CompletionMar 9, 2023
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 10.8 years ago
Interventions
Amoxicillin-clavulanatedrug
Amoxicillin-clavulanate (90/6.4 mg/kg/d in 2 divided dosed for 10 days)
Placebodrug
placebo made to match the study antibiotic given twice a day orally for 10 days