Comparing Broad- and Narrow-Spectrum Antibiotics for Children with Ear, Sinus, and Throat Infections

This project has results

Results Summary and Professional Abstract

Results Summary

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What was the research about?

Antibiotics are the most common prescription medicines given to children. Some antibiotics are narrow spectrum and some are broad spectrum. Narrow-spectrum antibiotics, like amoxicillin, kill only a few types of bacteria. Broad-spectrum antibiotics, like amoxicillin-clavulanate (Augmentin^®, Augmentin^® XR, and Augmentin^® ES-600), kill many types of bacteria. Both types work well to treat infections. But using broad-spectrum antibiotics when you don’t need them can create antibiotic-resistant bacteria that are hard to treat.

In this study, the research team compared narrow-spectrum and broad-spectrum antibiotics to treat children’s ear, sinus, and throat infections. The team wanted to know which type of antibiotic

Was better at helping children recover from ear, sinus, and throat infections
Would help children have a better quality of life
Would cause fewer side effects

What were the results?

Quality of life. Compared with children who took broad-spectrum antibiotics, those who took narrow-spectrum antibiotics reported a better quality of life, although the difference between the groups was small.
Side effects. Children who took narrow-spectrum antibiotics had fewer side effects, such as diarrhea, than those who took broad-spectrum antibiotics.
Symptoms that last for more than three days after starting antibiotics. Children who took both types of antibiotics had the same chances of feeling sick after three days.
Missing school or parents’ needing to provide childcare. The number of children who missed school or parents who needed to provide childcare was similar for children who took both types of antibiotics.

Who was in the study?

The study included 2,472 children ages 6 months to 12 years old. Each child had an ear, sinus, or throat infection and took an antibiotic to treat it. The children were patients at 1 of 31 children’s clinics in Pennsylvania or New Jersey.

What did the research team do?

At the start of the study, the research team interviewed 109 parents and 24 children. The team asked parents and children about treatment results that were important to them. Parents named four results. These results were poor sleep, missed school or parents’ missed work, taking a long time to feel better, and parents’ needing to provide childcare. These interviews informed the questions the team asked in the second part of the study.

Next, the research team identified children who had taken either narrow-spectrum or broad-spectrum antibiotics for ear, sinus, or throat infections. The team asked the parents and children about

Children’s quality of life
Children’s side effects and how long symptoms lasted
Children missing school or parents missing work
Parents’ needing to provide childcare while the child was sick

What were the limits of the study?

Some of the children in the study had viral infections instead of bacterial infections. Because antibiotics don’t work against viral infections, the results may change. Also, the research team called many parents and children, but only about 30 percent answered the phone. The team found that the people who answered their questions did not represent all children who were sick (for example, children of different ages, genders, or races). So, the results may not apply to all children.

Future research could compare narrow-spectrum and broad-spectrum antibiotics in children of different ages, genders, and races. Researchers could also study the two types of antibiotics in children with confirmed bacterial infections.

How can people use the results?

Doctors and parents can use these results to make decisions about the type of antibiotic to use. Narrow-spectrum antibiotics appear to work just as well as broad-spectrum antibiotics to treat most ear, sinus, and throat infections in children. Narrow-spectrum antibiotics lead to fewer side effects.

Professional Abstract

Objective

To compare the relative effectiveness of narrow-spectrum antibiotics (e.g., amoxicillin), which target the most common infectious bacteria, and broad-spectrum antibiotics (e.g., amoxicillin-clavulanate), which target a wider variety of bacteria, in children with acute respiratory tract infections (ARTIs). The study also compared quality of life and occurrence of side effects in children with ARTIs such as acute otitis media, group A streptococcal pharyngitis, and acute sinusitis.

Study Design

Design Elements	Description
Design	Observational: cohort study
Population	2,472 children ages 6 months to 12 years with ARTIs
Interventions/ Comparators	Narrow-spectrum antibiotics Broad-spectrum antibiotics
Outcomes	Primary: quality of life Secondary: occurrence of side effects, presence of symptoms on third day of treatment, missing school, parents’ need for additional childcare
Timeframe	5- to 10-day and 14- to 20-day follow-up after diagnosis for primary outcome

This observational prospective cohort study compared the effects of treatment with broad- and narrow-spectrum antibiotics on quality of life and occurrence of side effects in children with ARTIs.

The researchers conducted initial semistructured interviews with 109 parents and 24 children with suspected ARTIs to identify outcomes that are important to parents and children and to formulate interview questions for the prospective study. Parents identified disrupted sleep, missed school, slow symptom resolution, and parents missing work as important outcomes related to antibiotic use. In addition, parents discussed their concerns regarding treatment side effects. Children had concerns about missing school, missing sleep, and getting better slowly. For the prospective study, researchers enrolled 2,472 children ages 6 months to 12 years with clinician-diagnosed ARTIs from 31 pediatric primary care practices in Pennsylvania and New Jersey. Of these children, 65% received narrow-spectrum antibiotics, and the rest received broad spectrum. Researchers interviewed parents by phone 5 to 10 days after diagnosis and again 14 to 20 days after diagnosis and interviewed children once, 14 to 20 days after diagnosis. They measured quality of life based on interview responses using the Pediatric Quality of Life Inventory™ (PedsQL) and asked parents and children about the persistence of symptoms and the occurrence of side effects.

For all data analyses, researchers fully matched relevant covariates between the groups taking narrow- and broad-spectrum antibiotics, including age, sex, race, ethnicity, insurance status, and season.

Children affected by ARTIs, their parents, and physicians provided input to the study team regarding study design, monitoring, and potential strategies for disseminating study findings.

Results

Quality of life. Narrow-spectrum antibiotics were associated with a higher health-related quality of life PedsQL Total Scale Score (p=0.008).
Side effects. Narrow-spectrum antibiotics had a reduced risk of side effects (p<0.001).
Other secondary outcomes. Researchers found no significant differences between narrow- and broad-spectrum antibiotics concerning the number of children with symptoms persisting on the third day of treatment, the number of children missing school, or parents’ needing to provide additional childcare.

Limitations

Researchers reviewed clinician diagnoses and antibiotic prescription records to identify patients with bacterial ARTIs. Clinicians may not have known if patients had viral infections, which may limit researchers’ ability to detect between-group differences in benefits.

Only 30% of contacted families in the prospective study participated, and there were some differences in demographics between eligible and consenting participants. As a result, the findings may not be fully generalizable to all participants.

Conclusions and Relevance

In children with common pediatric ARTIs, broad-spectrum antibiotics appear to offer no benefit over narrow-spectrum antibiotics in quality of life, persistence of symptoms on the third day of treatment, missed school, and parents’ needing to provide childcare. Narrow-spectrum antibiotics had a significantly reduced risk of side effects. These results support existing expert recommendations to use narrow-spectrum antibiotics for most children with acute otitis media, streptococcal pharyngitis, and acute sinusitis.

Future Research Needs

Future research could restrict the study sample to patients with confirmed bacterial infections and compare narrow- and broad-spectrum antibiotic treatment in patient samples that are more representative of the general population.

Final Research Report

View this project's final research report.

Journal Articles

JAMA

Association of Broad- vs Narrow-Spectrum Antibiotics With Treatment Failure, Adverse Events, and Quality of Life in Children With Acute Respiratory Tract Infections

Journal of the Pediatric Infectious Diseases Society

What Parents Think About the Risks and Benefits of Antibiotics for Their Child's Acute Respiratory Tract Infection

More on this Project

PCORI Stories

Choosing the Right Antibiotic for a Child's Respiratory Infection
A narrative on this study, which compares the outcomes of treatment with targeted versus broader-spectrum bacteria-killing medications.

CME/CE Activity

Making Informed Decisions about the Treatment of Acute Respiratory Tract Infections in Children: New Evidence from a PCORI-Funded Study
This Continuing Medical Education/Continuing Education activity provides a better understanding of the findings from this PCORI-funded study and their relevance to making informed and responsible decisions about broad- versus narrow-spectrum antibiotics for children with acute respiratory tract infections (ARTIs). The activity is also designed to help clinicians educate parents about informed antibiotic choices when their children have bacterial ear, throat, or sinus infections.

Evidence for Decisions

Narrow- versus Broad-Spectrum Antibiotics for Common Infections in Children
When bacteria cause an ear, nose, or throat infection in children, a clinician may prescribe narrow- or broad-spectrum antibiotics. A PCORI-funded research study found a greater risk of side effects with broad-spectrum antibiotics, with no difference in symptom resolution between the two types.

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also confirms that the research has followed PCORI’s Methodology Standards. During peer review, experts who were not members of the research team read a draft report of the research. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. Reviewers do not have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve how the research team analyzed its results or reported its conclusions. Learn more about PCORI’s peer-review process here.

In response to peer review, the PI made changes including

Adding details about the sensitivity analyses that the author conducted, as these were mentioned in the Methodology Standards checklist but initially not described in the text of the report.
Addressing reviewer questions about whether the statistically significant difference found on the PedsQL (pediatric quality of life measure) was clinically meaningful. The researchers added cautions about interpreting the results from this measure because the measure was not originally designed to assess child quality of life following acute respiratory infection, and because the small differences between patients treated with narrow- and broad-spectrum antibiotics were unlikely to be clinically meaningful.
Noting an additional limitation of the study: the analyses did not account for baseline PedsQL measures and any chronic conditions.
Explaining that the sampling strategies were different for the patient-centered outcomes cohort and the clinician-centered outcomes cohort. This was because the researchers stratified the recruitment of patients for patient-centered outcomes cohort by diagnosis and antibiotic type, and oversampled certain strata to insure adequate numbers to conduct analyses. This was unnecessary for the inclusion of clinicians in the clinician-centered outcomes cohort.

Conflict of Interest Disclosures

View the COI disclosure form.

Project Details

Principal Investigator

Jeffrey Gerber, MD, PhD

Project Status

Completed; PCORI Public and Professional Abstracts, and Final Research Report Posted

Project Title

Comparative Effectiveness of Broad- versus Narrow-Spectrum Antibiotics for Acute Respiratory Tract Infections in Children

Board Approval Date

September 2013

Project End Date

June 2018

Organization

The Children's Hospital of Philadelphia

Year Awarded

2013

State

Pennsylvania

Year Completed

2018

Project Type

Research Project

Health Conditions

Infectious Diseases

Infectious Diseases - Other

Respiratory Diseases

Respiratory Infections

Intervention Strategies

Drug Interventions

Populations

Children -- 18 and under
Low Income
Racial/Ethnic Minorities
Urban

Funding Announcement

Assessment of Prevention, Diagnosis, and Treatment Options

Project Budget

$1,860,173

DOI - Digital Object Identifier

10.25302/8.2018.CE.13047279

Study Registration Information

HSRP20143536

NCT02297815

Page Last Updated:

July 29, 2019