Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Broad-spectrum antibiotics | Children diagnosed with an acute respiratory tract infections (ARTI) and prescribed Broad-spectrum antibiotics. |
| |
| Narrow-spectrum | Children diagnosed with an acute respiratory tract infections (ARTI) and prescribed Narrow-spectrum antibiotics. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Broad-spectrum antibiotics | Drug | Amoxicillin-clavulanate, azithromycin, cefdinir, cefprozil, cefuroxime axetil, cefadroxil, cephalexin |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5-10 days after ARTI diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| Missed School or Daycare From Illness | Among children who attend school or daycare, child had to miss school or day care due to illness | 5-10 days after ARTI diagnosis |
| Required Additional Childcare |
Not provided
Inclusion Criteria:
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.
Exclusion Criteria:
Not provided
Not provided
Child diagnosed with an ARTI and prescribed antibiotics during an outpatient visit in the CHOP primary care network.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey S Gerber, MD, PhD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Narrow Spectrum Antibiotic | Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic |
| FG001 | Broad-Spectrum Antibiotic | Children diagnosed with an ARTI and prescribed a Broad-spectrum antibiotic |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Narrow Spectrum Antibiotics | Child prescribed with the following at time of diagnosis: Acute otitis media: Amoxicillin Acute sinusitis: Amoxicillin Streptococcal pharyngitis: Penicillin or Amoxicillin |
| BG001 | Non-narrow Spectrum Antibiotics |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 1 subject did not respond to enough of the questions to obtain a score; 41 children missing race and ethnicity were excluded | Posted | Geometric Mean | Standard Deviation | scores on a scale | 5-10 days after ARTI diagnosis |
|
Up to 20 days from ARTI diagnosis
Adverse events were assessed at the interview that occurred between day 14 and day 20 after diagnosis. Subjects with missing data due to incomplete interviews or withdrawal/loss to follow-up prior to that interview are not included. All-cause mortality and SAEs could be determined for all subjects via reviews of electronic health records.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Narrow Spectrum Antibiotic | Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey Gerber | Children's Hospital of Philadelphia | (267) 426-8775 | gerberj@email.chop.edu |
Not provided
| ID | Term |
|---|---|
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Narrow-spectrum antibiotics | Drug | Amoxicillin, Penicillin |
|
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.
| 5-10 days after ARTI diagnosis |
| Experience Side Effects | Child experienced a side effect including: rash, diarrhea or upset stomach/vomiting | 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. | 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. | Days 5-10 Interview |
Child prescribed with the following at time of diagnosis: Acute otitis media: Amoxicillin-Clavulanate, Azithromycin, Cefdinir, Cefprozil, Cefuroxime Axetil Acute sinusitis: Amoxicillin-Clavulanate, Azithromycin, Cefdinir, Cefprozil, Cefuroxime Axetil Streptococcal pharyngitis: Amoxicillin-Clavulanate, Azithromycin, Cefadroxil, Cefdinir, Cefprozil, Cefuroxime Axetil, Cephalexin |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Children diagnosed with an ARTI and prescribed a narrow-spectrum antibiotic |
| OG001 | Broad Spectrum Antibiotic | Children diagnosed with an ARTI and prescribed a broad spectrum antibiotic |
|
|
|
| Secondary | Missed School or Daycare From Illness | Among children who attend school or daycare, child had to miss school or day care due to illness | Among children who attend school or daycare; 41 children missing race and ethnicity were excluded | Posted | Count of Participants | Participants | 5-10 days after ARTI diagnosis |
|
|
|
|
| Secondary | 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. | Among children who attend school or daycare; 41 children missing race and ethnicity were excluded | Posted | Count of Participants | Participants | 5-10 days after ARTI diagnosis |
|
|
|
|
| Secondary | Experience Side Effects | Child experienced a side effect including: rash, diarrhea or upset stomach/vomiting | Question was asked in the 14-20 interview so some subjects were lost to follow-up; 41 children missing race and ethnicity were excluded | Posted | Count of Participants | Participants | 14-20 days after ARTI diagnosis |
|
|
|
|
| Secondary | 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. | Among subjects who reported having at least one symptom at the time of diagnosis; 41 children missing race and ethnicity were excluded | Posted | Count of Participants | Participants | 3 days after ARTI diagnosis |
|
|
|
|
| Secondary | 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. | 41 children missing race and ethnicity excluded; 1 child did not complete PedsQL | Posted | Count of Participants | Participants | Days 5-10 Interview |
|
|
|
|
| 0 |
| 1,604 |
| 0 |
| 1,604 |
| 345 |
| 1,367 |
| EG001 | Broad Spectrum Antibiotic | Children diagnosed with an ARTI and prescribed a broad spectrum antibiotic | 0 | 868 | 0 | 868 | 258 | 726 |
| Rash | General disorders | Systematic Assessment |
|
| Upset stomach and/or vomiting | General disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Superiority or Other |
| Superiority or Other |
| Superiority or Other |
| Superiority or Other |
| Superiority |