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Oral antibiotics benefit infants with fast breathing
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Placebo was not equivalent to oral amoxicillin for treating infants with isolated fast breathing, according to data from a randomized trial. Further, the data safety monitoring board stopped the trial in response to a higher failure rate and two deaths in the placebo cohort.
Based on their findings, researchers suggest amoxicillin may benefit low-income communities where hospitalizing a newborn may not be feasible.
“WHO Integrated Management Care of Childhood Illness tools recommend that infants with a respiratory rate [60 or more] breaths per minute should be referred to hospital,” Shiyam S. Tikmani, MBBS, MSc, of the department of pediatrics and child health, Aga Khan University, Karachi, Pakistan, and colleagues wrote. “This recommendation is often regarded as impractical in resource-limited settings. Social, cultural and economic factors prevent parents from accepting or adhering to the advice.”
Tikmani and colleagues conducted a randomized equivalence trial in low-income communities in Karachi. They randomly assigned infants aged 60 days or younger with fast breathing to oral amoxicillin (n = 423) or placebo (n = 426) twice a day for 1 week. Follow-up examinations occurred on days 3, 8, 11 and 14, and the primary endpoint was treatment failure by day 8.
A data safety monitoring board assigned to monitor the safety of participants stopped the trial after an interim analysis due to high treatment failures and two deaths in the placebo arm.
Twenty-five infants (5.9%) in the placebo arm experienced treatment failure vs. 12 (2.8%) in the amoxicillin cohort. Tikmani and colleagues reported the risk difference between the proportion of treatment failure across cohorts was 3.1 (95% CI, 0.3-5.8). Adverse events included four infants in each arm experiencing loose stools and one with a generalized rash in the placebo group. The researchers reported 15 relapses (3.6%) in the amoxicillin arm and 17 (4.1%) in the placebo cohort.
“[This study] suggests that treatment with oral antibiotics is beneficial and that this can be carried out in an ambulatory setting,” Tikmani and colleagues wrote. “This study has significant public health implications, particularly in communities where the acceptance of referral may be poor. … Treatment with oral amoxicillin in ambulatory settings may save lives by improving compliance with treatment; it may also reduce the burden on the health care system and reduce the cost of transportation, medicines and medical supplies.”
The results of this study bolster the evidence behind WHO’s 2015 guideline for managing possible serious bacterial infection with simple antibiotic regimens in this patient population, Fyezah Jehan, MBBS, MCPS, FCPS, of the department of pediatrics and child health at Aga Khan University, and Shamim Qazi, MBBS, DCH, MSc, MD, of the department of maternal, newborn, child and adolescent health at WHO, wrote in an accompanying editorial. However, they note the use of oral amoxicillin for isolated fast breathing in infants with pneumonia living in low-income communities has limitations.
“While outpatient oral amoxicillin is affordable, universally accessible and has better medication compliance, it may not be as safe among premature infants or those with very low birth weight, in whom respiratory distress may be caused by conditions other than infections.” – by Andy Polhamus
Disclosure: Qazi reports he is a member of the data safety monitoring board for this study. No other researchers nor Jehan and Qazi report any relevant financial disclosures.
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