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

NCT02554383 | Completed Phase 3 Results DMC

• 2 other identifiers: STUDY20110386U01AI118506
• Study Type: interventional
• Target: 515
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

pediatrics; antibiotics; placebo

Outcome Measures

Primary Outcomes (2)

• The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment

  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 score. Scores ranged from 0-40. Higher scores indicate greater severity. The parent completed the scale on Day 1 (enrollment) \& electronically on diaries evenings Days 2-11. Pathogens cultured were Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis.

  Days 2 to 11

• The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment

  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 score. Scores ranged from 0-40. Higher scores indicate greater severity. The parent completed the scale on Day 1 (enrollment) \& electronically on diaries evenings Days 2-11. Nasal discharge, either yellow or green, was considered colored.

  Days 2 to 11

Secondary Outcomes (5)

• The Distribution of Children Experiencing Treatment Failure (TF)

  Day of enrollment to the day of the follow-up visit. The mean length of actual follow-up was 13.4 days. For each child with incomplete follow-up, multiple imputation was used and PRSS scores for the remaining days were imputed.

• The Distribution of Children Developing Acute Otitis Media (AOM) Over the First 10 Days of Follow-up

  Days 2 to 11, where Day 1 is day of enrollment. The mean number of days of follow-up in this interval was 9.8.

• The Distribution of Children Receiving a Systemic Antibiotic Over the First 10 Days of Follow-up

  Days 2 to 11, where Day 1 is day of enrollment. The mean number of days of follow-up in this interval was 9.8.

• The Distribution of Children for Whom Diarrhea or Generalized Rash Was Reported

  Day 1 through Day 23.

• The Distribution of Children Compliant With Study Medication

  Days 1 to 11, where Day 1 is day of enrollment

Other Outcomes (1)

• The Distribution of Children With a Nonsusceptible Pathogen at the Follow-up Visit

  The follow-up visit. The mean number of days from enrollment to the follow-up visit was 13.4.

Study Arms (2)

Treatment A

ACTIVE COMPARATOR

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

Drug: Amoxicillin-clavulanate

Treatment B

PLACEBO COMPARATOR

Placebo made to match the study antibiotic will be taken bid orally for 10 days

Drug: Placebo

Interventions

Amoxicillin-clavulanate DRUG

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

Also known as: Augmentin-Extra strength

Treatment A

Placebo DRUG

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

Treatment B

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Meets criteria for "persistent" or "worsening" presentations of sinusitis
• Baseline score ≥9 on the Pediatric Rhinosinusitis Symptom Scale

You may not qualify if:

• Severe presentation (≥3 days of colored nasal discharge and fever ≥39°C
• Asthma/allergic rhinitis explains symptoms
• Allergy to amoxicillin-clavulanate
• Immotile cilia syndrome
• Cystic fibrosis
• Immunodeficiency
• Parental inability to read/write English or Spanish
• Other concurrent infection (e.g., pneumonia, acute otitis media, streptococcal pharyngitis)
• Systemic toxicity
• Wheezing on exam
• Antibiotic use within 15 days

Sponsors & Collaborators

• Nader Shaikh: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (6)

Kentucky Pediatric/Adult Research

Bardstown, Kentucky, 40004, United States

Location

Cyn3rgy Research

Gresham, Oregon, 97030, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

WVU Medicine Pediatric and Adolescent Group Practice

Morgantown, West Virginia, 26501, United States

Location

American Family Children's Hospital

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• 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.

  PMID: 37490085 DERIVED

MeSH Terms

Conditions

Sinusitis; Respiratory Tract Infections

Interventions

Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Nader Shaikh
• Organization: University of Pittsburgh

nader.shaikh@chp.edu

412-692-8111

Study Officials

• Nader Shaikh, MPH, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Ellen R Wald, MD

  University of Wisconsin, American Family Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Pediatrics, University of Pittsburgh School of Medicine

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: September 18, 2015
• Study Start: February 1, 2016
• Primary Completion: March 31, 2022
• Study Completion: March 9, 2023
• Last Updated: June 29, 2023
• Results First Posted: June 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

US (6)