NEW YORK (Reuters Health) – For children with community-acquired pneumonia (CAP), a lower dose and shorter course of amoxicillin works just as well as a higher dose and longer course, according to results of the CAP-IT noninferiority trial.
The best dose and duration of oral amoxicillin for children with CAP remains unclear, Dr. Julia Bielicki of St. George’s University of London and colleagues note in JAMA.
The CAP-IT trial enrolled 824 children (aged 6 months and older) with clinically diagnosed CAP who were prescribed oral amoxicillin at discharge from emergency departments and inpatient wards.
They were randomly allocated to oral amoxicillin at a lower dose (35 to 50 mg/kg/d) or higher dose (70 to 90 mg/kg/d) for a shorter duration (three days) or a longer duration (seven days).
Antibiotic re-treatment within 28 days (the primary outcome) occurred in 12.6% of children on the lower dose and 12.4% of those on the higher dose and in 12.5% of those on the three-day course and the seven-day course.
“Both comparisons met the prespecified 8% noninferiority margin,” the study team writes, which was confirmed in all prespecified sensitivity analyses.
There were no significant differences between groups by dose or duration for resolution of vomiting, fever, fast breathing, wheezing, interference with normal activity, reduced appetite, or phlegm production. Cough persisted for longer in the shorter- versus longer-duration group (median, 12 days vs. 10 days).
“Few trials have compared different durations of the same antibiotic for treatment of CAP in adults or children, and none to our knowledge have compared both dose and duration in the same trial for childhood CAP,” the study team notes.
“The CAP-IT study provides evidence that shorter 3-day courses of amoxicillin given twice daily are safe and effective even in young children with serious chest infections attending hospital,” Dr. Bielicki told Reuters Health by email.
“The study did not find lower doses to be disadvantageous in terms of clinical outcomes, side effects or emergency of resistance. In settings with low bacterial resistance, such as the U.K., CAP-IT supports use of a 6-dose treatment course, rather than 15 doses if the same antibiotic was given three times a day for 5 days as currently recommended,” Dr. Bielicki said.
She noted that the trial did not include children with complications identified during hospital assessment or with very severe disease.
“It should also be noted that this trial was done in a setting with relatively low antibiotic resistance levels, including in bacteria that typically cause serious chest infections. Therefore, the trial’s findings may not be applicable to settings with higher levels of bacterial antibiotic resistance or to children with complicated or very severe serious chest infections,” the researcher said.
The study had no commercial funding.
SOURCE: https://bit.ly/3GQkWDo JAMA, online November 2, 2021.
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