Short- vs Standard-Course Outpatient Antibiotic Therapy for Community-Acquired Pneumonia in Children: The SCOUT-CAP Randomized Clinical Trial.
Abstract
<h4>Importance</h4>Childhood community-acquired pneumonia (CAP) is usually treated
with 10 days of antibiotics. Shorter courses may be effective with fewer adverse effects
and decreased potential for antibiotic resistance.<h4>Objective</h4>To compare a short
(5-day) vs standard (10-day) antibiotic treatment strategy for CAP in young children.<h4>Design,
setting, and participants</h4>Randomized double-blind placebo-controlled clinical
trial in outpatient clinic, urgent care, or emergency settings in 8 US cities. A total
of 380 healthy children aged 6 to 71 months with nonsevere CAP demonstrating early
clinical improvement were enrolled from December 2, 2016, to December 16, 2019. Data
were analyzed from January to September 2020.<h4>Intervention</h4>On day 6 of their
originally prescribed therapy, participants were randomized 1:1 to receive 5 days
of matching placebo or 5 additional days of the same antibiotic.<h4>Main outcomes
and measures</h4>The primary end point was the end-of-treatment response adjusted
for duration of antibiotic risk (RADAR), a composite end point that ranks each child's
clinical response, resolution of symptoms, and antibiotic-associated adverse effects
in an ordinal desirability of outcome ranking (DOOR). Within each DOOR rank, participants
were further ranked by the number of antibiotic days, assuming that shorter antibiotic
durations were more desirable. Using RADAR, the probability of a more desirable outcome
was estimated for the short- vs standard-course strategy. In a subset of children,
throat swabs were collected between study days 19 and 25 to quantify antibiotic resistance
genes in oropharyngeal flora.<h4>Results</h4>A total of 380 children (189 randomized
to short course and 191 randomized to standard course) made up the study population.
The mean (SD) age was 35.7 (17.2) months, and 194 participants (51%) were male. Of
the included children, 8 were Asian, 99 were Black or African American, 234 were White,
32 were multiracial, and 7 were of unknown or unreported race; 33 were Hispanic or
Latino, 344 were not Hispanic or Latino, and 3 were of unknown or unreported ethnicity.
There were no differences between strategies in the DOOR or its individual components.
Fewer than 10% of children in either strategy had an inadequate clinical response.
The short-course strategy had a 69% (95% CI, 63-75) probability of a more desirable
RADAR outcome compared with the standard-course strategy. A total of 171 children
were included in the resistome analysis. The median (range) number of antibiotic resistance
genes per prokaryotic cell (RGPC) was significantly lower in the short-course strategy
compared with the standard-course strategy for total RGPC (1.17 [0.35-2.43] vs 1.33
[0.46-11.08]; P = .01) and β-lactamase RGPC (0.55 [0.18-1.24] vs 0.60 [0.21-2.45];
P = .03).<h4>Conclusions and relevance</h4>In this study, among children responding
to initial treatment for outpatient CAP, a 5-day antibiotic strategy was superior
to a 10-day strategy. The shortened approach resulted in similar clinical response
and antibiotic-associated adverse effects, while reducing antibiotic exposure and
resistance.<h4>Trial registration</h4>ClinicalTrials.gov Identifier: NCT02891915.
Type
Journal articlePermalink
https://hdl.handle.net/10161/24319Published Version (Please cite this version)
10.1001/jamapediatrics.2021.5547Publication Info
Williams, Derek J; Creech, C Buddy; Walter, Emmanuel B; Martin, Judith M; Gerber,
Jeffrey S; Newland, Jason G; ... The DMID 14-0079 Study Team (2022). Short- vs Standard-Course Outpatient Antibiotic Therapy for Community-Acquired Pneumonia
in Children: The SCOUT-CAP Randomized Clinical Trial. JAMA pediatrics. 10.1001/jamapediatrics.2021.5547. Retrieved from https://hdl.handle.net/10161/24319.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
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Show full item recordScholars@Duke
Vance Garrison Fowler Jr.
Florence McAlister Distinguished Professor of Medicine
Determinants of Outcome in Patients with Staphylococcus aureus Bacteremia Antibacterial
ResistancePathogenesis of Bacterial Infections Tropical medicine/International Health
Emmanuel Benjamin Walter Jr.
Professor of Pediatrics
Dr. Emmanuel Walter, MD, MPH, Professor of Pediatrics, serves as the Duke Human Vaccine
Institute (DHVI) Chief Medical Officer and directs the Duke Vaccine and Trials Unit.
In these roles, Dr. Walter provides strategic and operational leadership for clinical
research conducted at the Institute. In addition, he provides oversight of regulatory
compliance for DHVI clinical research activities.
Dr. Walter has dedicated his career to advancing research and clinical practice in
vacci
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