Study: Giving infants azithromycin at well visits does not improve mortality
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Key takeaways:
- Mass antibiotic dosing to reduce childhood mortality has produced mixed results.
- A new study showed that treating infants individually with azithromycin at well visits did not lower mortality.
Treating infants with azithromycin at well-child visits did not reduce mortality during a yearslong study in Burkina Faso, according to findings published Wednesday in The New England Journal of Medicine.
It was the latest in a series of studies testing the effect of routine administration of antibiotics on childhood mortality, beginning with the MORDOR trial, which demonstrated that giving children azithromycin twice a year for 4 years reduced mortality by 14.5%.
The second phase of that trial showed that mass administration of azithromycin remained effective in the third year after implementation. Subsequent studies have produced mixed results, however, including one that showed adding azithromycin to antimalarial agents did not prevent hospitalizations or death but did have a modest impact on the overall burden of infectious diseases.
According to one of the authors of the latest study, they suspected that mass drug administration “may be more logistically feasible if it were efficacious to deliver the azithromycin in the clinic.”
“In a lot of health systems, infants have regular contact points through vaccination or well-child visits,” Catherine E. Oldenburg, ScD, MPH, an infectious disease epidemiologist and associate professor at the University of California, San Francisco, told Healio. “The idea here was to test whether administering a dose of azithromycin during infancy at a clinic at the time that they're having a well visit would reduce mortality.”
Oldenburg and colleagues enrolled 32,877 infants from September 2019 through October 2022 and randomly assigned 16,416 to receive a single dose of azithromycin at 20 mg per kg of bodyweight. The other 16,461 received placebo.
Over the course of the study, 82 infants in the azithromycin group and 75 in the placebo group died before age 6 months (HR = 1.09; 95% CI, 0.8-1.49) — an absolute difference in mortality of 0.04 percentage points (95% CI, 0.1 to 0.21).
The evidence showed no effect of azithromycin on mortality in any of the prespecified subgroups, including subgroups defined according to age, sex and baseline weight, and no difference between the two trial groups in the incidence of adverse events.
Oldenburg said they were surprised by the findings. In the study, they offered a possible explanation for the varying results in similar trials.
“If mass communitywide distributions of azithromycin for the prevention of death continue to show a benefit, the mechanism may be a reduction in transmission of pathogens,” they wrote. “Individual-level treatment may not result in the same effects for prevention of death as have been observed with community-wide treatment, although the wide confidence interval was consistent with a range of effects and precludes a negative conclusion.”
Once concern with these types of trials is that they may promote antimicrobial resistance.
Oldenburg said they collected samples to test for resistance.
“The data aren't processed or available yet, but that is something that we do monitor quite closely in all of our studies,” Oldenburg said.
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