Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?

Phase 3 Completed 515 enrolled Nader Shaikh National Institute of Allergy and Infectious Diseases (NIAID) · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2016-02
Primary completion: 2022-03-31
Completion: 2023-03-09

Publications

Shaikh N, Hoberman A, Shope TR, Jeong JH, Kurs-Lasky M, Martin JM, Bhatnagar S, Muniz GB, Block SL, Andrasko M, Lee MC, Rajakumar K, Wald ER. Identifying Children Likely to Benefit From Antibiotics for Acute Sinusitis: A Randomized Clinical Trial. JAMA. 2023 Jul 25;330(4):349-358. doi: 10.1001/jama.2023.10854.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Amoxicillin	Other / unclassified	90 mg/kg	Oral
Comparator	Clavulanate	Unknown	6.4 mg/kg	Oral

Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?

Summary

Timeline

Publications

Drugs

Indications