Acute Otitis MediaCEARINCT02297815
Comparative Effectiveness of Antibiotics for Respiratory Infections
An observational study of Acute Otitis Media and Acute Sinusitis, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The purpose of this study is to identify and use patient centered outcomes to compare narrow-spectrum and broad-spectrum antibiotics for the treatment of common acute respiratory tract infections (ARTIs) in children. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Acute Otitis Media, Acute Sinusitis, Group A Streptococcal Pharyngitis
- What is being tested?
- Broad-spectrum antibiotics and Narrow-spectrum antibiotics
- How many people
- 2,472 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Apr 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Child diagnosed with an ARTI and prescribed antibiotics during an outpatient visit in the CHOP primary care network.
Who may be able to join
- We included children between six months and 12 years old, diagnosed with an ARTI (acute otitis media, acute sinusitis, Group A streptococcal [GAS] pharyngitis) using International Classification of Diseases diagnosis codes and prescribed an antibiotic. For GAS pharyngitis, the child also had a positive rapid streptococcal test.
Who cannot join
- Diagnosed with multiple ARTIs
- Diagnosed with another non-ARTI bacterial infection
- Prescribe antibiotics in the past 30 days
- Non-English speaking families
- If GAS pharyngitis diagnosis, age < 3 years
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Comparative Effectiveness of Broad vs. Narrow Spectrum Antibiotics for Acute Respiratory Tract Infections in Children
The purpose of this study is to identify and use patient centered outcomes to compare narrow-spectrum and broad-spectrum antibiotics for the treatment of common acute respiratory tract infections (ARTIs) in children.
Read the detailed description
Outpatient, ARTIs account for the vast majority of antibiotic exposure to children, and roughly half of these antibiotic prescriptions are inappropriate. Although unnecessary antibiotic prescribing for viral infections has significantly decreased, there has been a substantial increase in prescribing of broad-spectrum antibiotics to treat ARTIs when narrow-spectrum antibiotics are indicated. Primary care providers, patients, and caregivers would benefit from studies assessing the implications of alternate antibiotic regimens for these common infections. Specifically, it remains unclear if treating common ARTIs with broad-spectrum antibiotics leads to an improvement in patient outcomes compared to treatment with narrow-spectrum antibiotics, particularly considering the increasing threat posed by antimicrobial resistance. Because of the lack of large comparative effectiveness studies with patient-centered outcomes addressing this issue, professional guidelines and expert recommendations are conflicting, and, as a result, practice patterns vary considerably. Therefore, using patient-centered outcomes, we aim to compare narrow-spectrum and broad-spectrum antibiotics for the treatment of common ARTIs in children. To accomplish this, we will perform a prospective cohort study of children receiving antibiotics for ARTI across a comprehensive pediatric healthcare network. We will conduct telephone interviews with parent's of children who receive antibiotic treatment for an ARTI. We will assess previously identified patient-centered outcomes included a health-related quality of life measure, occurrence of side effects, missed school/daycare, parent missed commitments and/or required additional childcare and symptoms were still present on day 3 after diagnosis.
- Being tested
- Broad-spectrum antibiotics, Narrow-spectrum antibiotics
- Keywords
- antibiotic use, effectiveness, acute respiratory infections, pediatrics
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broad-spectrum antibioticsDrug
Amoxicillin-clavulanate, azithromycin, cefdinir, cefprozil, cefuroxime axetil, cefadroxil, cephalexin
Narrow-spectrum antibioticsDrug
Amoxicillin, Penicillin
| Study group | Role | What they receive |
|---|---|---|
| Broad-spectrum antibiotics | Children diagnosed with an acute respiratory tract infections (ARTI) and prescribed Broad-spectrum antibiotics. Receives: Drug: Broad-spectrum antibiotics | |
| Narrow-spectrum | Children diagnosed with an acute respiratory tract infections (ARTI) and prescribed Narrow-spectrum antibiotics. Receives: Drug: Narrow-spectrum antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Related Quality of Life Score
The health related quality of life score was obtained using the PedsQL(TM) (Mapi Research Trust, Lyon, France. www.pedsql.org) Parent-Proxy Report Generic Core Scales and Parent Report Infant Scales administered during the 5-10 day interview. Briefly, the PedsQL(TM) is a 23-item questionnaire assessing developmentally appropriate metrics (questions vary by age group: 1-12 months, 13-24 months, 2-4 years, 5-7 years, 8-12 years) related to core dimensions of health and role functioning. Our primary outcome was the Total Scale Score, which is a summary score of physical, emotional, social, and school functioning. The score range is zero to 100 and higher scores indicate a better health-related quality of life.
Measured: 5-10 days after ARTI diagnosis
Secondary outcomes (5)
Missed School or Daycare From Illness
Among children who attend school or daycare, child had to miss school or day care due to illness
Measured: 5-10 days after ARTI diagnosis
Required Additional Childcare
Among children who attend school or daycare, parent or another caretaker had to miss work or an obligation due to child's illness OR additional childcare had to be sought for the child.
Measured: 5-10 days after ARTI diagnosis
Experience Side Effects
Child experienced a side effect including: rash, diarrhea or upset stomach/vomiting
Measured: 14-20 days after ARTI diagnosis
Symptoms Present on Day 3
During 5-10 day interview, parents were asked about symptoms related to child's illness (otitis media: fever, ear pain, decreased appetite; sinusitis: fever, face/head pain, decreased appetite; pharyngitis: throat pain, fever, decreased appetite). Parent was asked if symptoms was present at diagnosis. If yes, had the symptom resolved. If yes, when. We assessed whether symptoms present at day 3 after diagnosis.
Measured: 3 days after ARTI diagnosis
Sleep Disturbance
The PedsQL questionnaire includes one or two questions, depending on age, about sleep. For children <24 months, parents are asked the frequency (never, almost never, sometimes, often, almost always) their child has (1) "difficulty falling asleep" and (2) "difficulty sleeping through the night." For children ≥2 years, parents are asked the frequency their child has "trouble sleeping." We categorized children as either without sleep disturbance ("Never" for each sleep question) or with sleep disturbance. Outcome measure shows the number of participants with sleep disturbance.
Measured: Days 5-10 Interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Otitis MediaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey S Gerber, MD, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297815
- Sponsor's protocol ID
- 13-010595
- Acronym
- CEARI
- Status last verified
- Apr 2019
- First submitted
- 17 Nov 2014
- Last updated
- 8 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Broad vs. Narrow Spectrum Antibiotics for Acute Respiratory Tract Infections in Children
- ClinicalTrials.gov ID
- NCT02297815
- Acronym / sponsor ID
- CEARI / 13-010595
- Keywords
- antibiotic use, effectiveness, acute respiratory infections, pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,472 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 21 Nov 2014 (estimated)
- Results
- Posted 8 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify and use patient centered outcomes to compare narrow-spectrum and broad-spectrum antibiotics for the treatment of common acute respiratory tract infections (ARTIs) in children.
Detailed description
Outpatient, ARTIs account for the vast majority of antibiotic exposure to children, and roughly half of these antibiotic prescriptions are inappropriate. Although unnecessary antibiotic prescribing for viral infections has significantly decreased, there has been a substantial increase in prescribing of broad-spectrum antibiotics to treat ARTIs when narrow-spectrum antibiotics are indicated. Primary care providers, patients, and caregivers would benefit from studies assessing the implications of alternate antibiotic regimens for these common infections. Specifically, it remains unclear if treating common ARTIs with broad-spectrum antibiotics leads to an improvement in patient outcomes compared to treatment with narrow-spectrum antibiotics, particularly considering the increasing threat posed by antimicrobial resistance. Because of the lack of large comparative effectiveness studies with patient-centered outcomes addressing this issue, professional guidelines and expert recommendations are conflicting, and, as a result, practice patterns vary considerably. Therefore, using patient-centered outcomes, we aim to compare narrow-spectrum and broad-spectrum antibiotics for the treatment of common ARTIs in children. To accomplish this, we will perform a prospective cohort study of children receiving antibiotics for ARTI across a comprehensive pediatric healthcare network. We will conduct telephone interviews with parent's of children who receive antibiotic treatment for an ARTI. We will assess previously identified patient-centered outcomes included a health-related quality of life measure, occurrence of side effects, missed school/daycare, parent missed commitments and/or required additional childcare and symptoms were still present on day 3 after diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Broad-spectrum antibiotics | – | Drug: Broad-spectrum antibioticsChildren diagnosed with an acute respiratory tract infections (ARTI) and prescribed Broad-spectrum antibiotics. |
| Narrow-spectrum | – | Drug: Narrow-spectrum antibioticsChildren diagnosed with an acute respiratory tract infections (ARTI) and prescribed Narrow-spectrum antibiotics. |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Child diagnosed with an ARTI and prescribed antibiotics during an outpatient visit in the CHOP primary care network.
Key inclusion criteria (1 listed)
- We included children between six months and 12 years old, diagnosed with an ARTI (acute otitis media, acute sinusitis, Group A streptococcal [GAS] pharyngitis) using International Classification of Diseases diagnosis codes and prescribed an antibiotic. For GAS pharyngitis, the child also had a positive rapid streptococcal test.
Key exclusion criteria (5 listed)
- Diagnosed with multiple ARTIs
- Diagnosed with another non-ARTI bacterial infection
- Prescribe antibiotics in the past 30 days
- Non-English speaking families
- If GAS pharyngitis diagnosis, age < 3 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Broad-spectrum antibioticsAmoxicillin-clavulanate, azithromycin, cefdinir, cefprozil, cefuroxime axetil, cefadroxil, cephalexin | Drug | Broad-spectrum antibiotics |
| Narrow-spectrum antibioticsAmoxicillin, Penicillin | Drug | Narrow-spectrum |
Primary outcome
Health Related Quality of Life Score
Time frame: 5-10 days after ARTI diagnosis
The health related quality of life score was obtained using the PedsQL(TM) (Mapi Research Trust, Lyon, France. www.pedsql.org) Parent-Proxy Report Generic Core Scales and Parent Report Infant Scales administered during the 5-10 day interview. Briefly, the PedsQL(TM) is a 23-item questionnaire assessing developmentally appropriate metrics (questions vary by age group: 1-12 months, 13-24 months, 2-4 years, 5-7 years, 8-12 years) related to core dimensions of health and role functioning. Our primary outcome was the Total Scale Score, which is a summary score of physical, emotional, social, and school functioning. The score range is zero to 100 and higher scores indicate a better health-related quality of life.
5 secondary outcomes
Missed School or Daycare From Illness
Time frame: 5-10 days after ARTI diagnosis
Required Additional Childcare
Time frame: 5-10 days after ARTI diagnosis
Experience Side Effects
Time frame: 14-20 days after ARTI diagnosis
Symptoms Present on Day 3
Time frame: 3 days after ARTI diagnosis
Sleep Disturbance
Time frame: Days 5-10 Interview
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey S Gerber, MD, PhD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Otitis Media and Acute Sinusitis, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Related Quality of Life Score (time frame: 5-10 days after ARTI diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2019.