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

NCT02554383 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 515

Last updated 2023-06-29

Study results available
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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.

Conditions

  • Sinusitis
  • Respiratory Tract Infections

Interventions

DRUG

Amoxicillin-clavulanate

Amoxicillin-clavulanate (90/6.4 mg/kg/d in 2 divided dosed for 10 days)

DRUG

Placebo

placebo made to match the study antibiotic given twice a day orally for 10 days

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Nader Shaikh

    lead OTHER

Principal Investigators

  • Nader Shaikh, MPH, MD · University of Pittsburgh

  • Ellen R Wald, MD · University of Wisconsin, American Family Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2022-03-31
Completion
2023-03-09

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02554383 on ClinicalTrials.gov