Results Summary and Professional Abstract

Results Summary

Results Summary

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What was the research about?

Antibiotics are the most commonly prescribed medicine in children. Narrow-spectrum antibiotics target a few types of bacteria. Broad-spectrum antibiotics target many types of bacteria. Both types work well to treat infections. But using broad-spectrum antibiotics when they’re not needed can create antibiotic-resistant bacteria that are hard to treat. They may also have side effects, such as diarrhea or rash.

In this study, the research team compared narrow-spectrum and broad-spectrum antibiotics to treat ear, sinus, and throat infections in children.

What were the results?

• Treating infections. Narrow-spectrum antibiotics worked as well as broad-spectrum antibiotics to treat infections. Symptoms improved the same amount in three days.
• Side effects. Children who took narrow-spectrum antibiotics had fewer side effects than those who took broad-spectrum antibiotics.
• Quality of life. There were no differences in quality of life between children who took broad- or narrow-spectrum antibiotics.

What did the research team do?

The research team did two studies. In both studies, children were ages 6 months to 12 years.

In the first, the research team looked at health records for 30,159 children who used broad- or narrow-spectrum antibiotics to treat ear, sinus, or throat infections. Of the children, 63 percent were white, 16 percent were mixed or another race, 12 percent were black, and 8 percent were Hispanic. The average age was 5, and 52 percent were boys. The team looked at how often treatment worked and whether patients had side effects in the month after diagnosis.

The second study included 2,472 children. All children had an ear, sinus, or throat infection. The research team interviewed parents and children about quality of life, how long symptoms lasted, and side effects after the children got antibiotics. Of the children, 59 percent were white, 23 percent were black, 8 percent were another race, and 9 percent were Hispanic. The average age was 5, and 52 percent were boys. All were patients at one of 31 children’s clinics in Pennsylvania or New Jersey.

Children, parents, and physicians helped plan and conduct the study.

What were the limits of the study?

Some children in the study may have had infections caused by viruses. Because antibiotics don’t treat viruses, the results could differ if only children with infections caused by bacteria were in the study.

Future research could study the two types of antibiotics in children with confirmed infections caused by bacteria.

How can people use the results?

Doctors and parents can use these results to make decisions about the type of antibiotic to use.

Professional Abstract

Professional Abstract

Objective

To compare the relative effectiveness of narrow- and broad-spectrum antibiotics in treating acute respiratory tract infections (ARTIs) in children

Study Design

Design Elements	Description
Design	Observational: cohort study
Population	Retrospective cohort: 30,159 children ages 6 months to 12 years with ARTIs Prospective cohort: 2,472 children ages 6 months to 12 years with ARTIs
Interventions/ Comparators	Narrow-spectrum antibiotics Broad-spectrum antibiotics
Outcomes	Retrospective cohort: treatment failure (primary), occurrence of side effects up to 30 days after diagnosis Prospective cohort: quality of life (primary), presence of symptoms beyond 72 hours of treatment, occurrence of side effects
Timeframe	Retrospective cohort: 30-day follow-up for primary outcome Prospective cohort: 20-day follow-up for primary outcome

Two observational cohort studies compared the effect of broad- and narrow-spectrum antibiotics on treatment failure, quality of life, and occurrence of side effects in children ages 6 months to 12 years with ARTIs, including acute otitis media, Group A streptococcal pharyngitis, and acute sinusitis.

For the retrospective study, researchers examined electronic health records for 30,159 children with ARTIs to determine the rate of treatment failure and side effects up to 30 days after diagnosis. Among children in the retrospective cohort, 63% were white, 16% were mixed or another race, 12% were black, and 8% were Hispanic. The average age was 5, and 52% were male.

For the prospective study, researchers enrolled 2,472 children ages 6 months to 12 years with ARTIs from 31 pediatric primary care practices in Pennsylvania and New Jersey. Among children in the prospective study, 59% were while, 23% were black, 8% were another race, and 9% were Hispanic. The average age was 5, and 52% were male. Researchers interviewed parents and children about quality of life, persistence of symptoms, and side effects.

Children, parents, and physicians helped plan and conduct the study.

Results

• Treatment failure rates: The rate of treatment failure was no different between children taking narrow- or broad-spectrum antibiotics.
• Symptom resolution: At 72 hours after diagnosis, the rate of symptom resolution was no different between children taking narrow- or broad-spectrum antibiotics.
• Side effects: The risk of side effects, including diarrhea, candidiasis, allergic reaction, and vomiting was significantly lower for children taking narrow-spectrum antibiotics compared with children taking broad-spectrum antibiotics (p<0.001).
• Quality of life. Narrow-spectrum antibiotics were associated with a higher health-related quality of life that was statistically (p=0.008) but not clinically different from broad-spectrum antibiotics.

Limitations

Some children may have had viral infections, which may limit the ability to detect between-group differences.

Conclusions and Relevance

Broad-spectrum antibiotics are not more effective than narrow-spectrum antibiotics in treating pediatric ARTIs. Narrow-spectrum antibiotics were associated with a lower risk of side effects.

Future Research Needs

Future research could restrict the study sample to children with confirmed bacterial infections.

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.

Videos

Choosing between Antibiotics for Acute Respiratory Tract Infections (ARTIs) in Children
Study Principal Investigator Jeffrey Gerber, MD, PhD, discusses what the findings of his study might suggest for clinicians and families in terms of the benefits and the risks of arrow- or broad-spectrum antibiotics for children with ARTIs.

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

Respiratory Diseases

Respiratory Infections

Intervention Strategies

Drug Interventions

Populations

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