Effect of Mass Distribution of Azithromycin for Trachoma Control on Overall Mortality in Ethiopian Children

Porco, Travis C.; Gebre, Teshome; Ayele, Berhan; House, Jenafir; Keenan, Jeremy D.; Zhou, Zhaoxia; Hong, Kevin C.; Stoller, Nicole E.; Ray, Kathryn J.; Emerson, Paul M.; Gaynor, Bruce D.; Lietman, Thomas M.

doi:10.1001/jama.2009.1266

Cited by 172 publications

(164 citation statements)

References 29 publications

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“…A cohort study and a cluster-randomized trial have showed that these distributions could reduce childhood mortality. 1,2 Cohort studies have suggested that azithromycin may reduce leading causes of childhood mortality, including respiratory disease, diarrhea, and malaria. [3][4][5][6][7] In areas with seasonal malaria transmission, repeated administration of antimalarial drugs to children during the transmission season (intermittent preventive therapy of children [IPTc]) 8,9 has been shown to reduce malaria transmission, although preventive therapy outside of the transmission season is not typically recommended.…”

Section: Introductionmentioning

confidence: 99%

Impact of Mass Azithromycin Distribution on Malaria Parasitemia during the Low-Transmission Season in Niger: A Cluster-Randomized Trial

Gaynor¹,

Amza²,

Kadri³

et al. 2014

The American Journal of Tropical Medicine and Hygiene

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Abstract.We assessed the effect of mass azithromycin treatment on malaria parasitemia in a trachoma trial in Niger. Twenty-four study communities received treatment during the wet, high-transmission season. Twelve of the 24 communities were randomized to receive an additional treatment during the dry, low-transmission season. Outcome measurements were conducted at the community-level in children 1-72 months of age in May-June 2011. Parasitemia was higher in the 12 once-treated communities (29.8%, 95% confidence interval [CI] = 21.5-40.0%) than in the 12 twicetreated communities (19.5%, 95% CI = 13.0-26.5%, P = 0.03). Parasite density was higher in once-treated communities (354 parasites/μL, 95% CI = 117-528 parasites/μL) than in twice-treated communities (74 parasites/μL, 95% CI = 41-202 parasites/μL, P = 0.03). Mass distribution of azithromycin reduced malaria parasitemia 4-5 months after the intervention. The results suggest that drugs with antimalaria activity can have long-lasting impacts on malaria during periods of low transmission.

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Section: Introductionmentioning

confidence: 99%

Impact of Mass Azithromycin Distribution on Malaria Parasitemia during the Low-Transmission Season in Niger: A Cluster-Randomized Trial

Gaynor¹,

Amza²,

Kadri³

et al. 2014

The American Journal of Tropical Medicine and Hygiene

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“…This investigation was prompted by the results of the TANA clinical trial for trachoma in Ethiopia, which found a large and significant mortality reduction with azithromycin compared with a group receiving no treatment (relative risk = 0.496). 2 The results of the survey, performed after the completion of TANA, suggest that experts believe azithromycin has a true mortality benefit. However, they believe that this benefit is more modest (mean relative risk = 0.83) than the results of the TANA trial (relative risk = 0.496).…”

Section: Discussionmentioning

confidence: 99%

“…the sample size was relatively small (82 total deaths out of 18,415 total children aged 1-9), and the resulting confidence intervals were wide. 2 Small trials with significant results tend to overestimate the effect size, for the simple reason that they could have only achieved significance with a large effect. The observed mortality reduction may be affected by some combination of systematic and random errors; experts may have taken these factors into account.…”

Section: Discussionmentioning

confidence: 99%

“…E-mail: tom.lietman@ucsf.edu a Bayesian posterior. 2 Probabilities of benefit were determined by calculating the area corresponding to a relative risk 1 for each of the figures. We interpreted all distributions as expressing degrees of belief with appropriate centralized 95% credible intervals (CrI).…”

Section: Methodsmentioning

confidence: 99%

“…1 The Trachoma Amelioration in Northern Amhara (TANA) study found that distribution of azithromycin to entire communities to treat and prevent blinding trachoma significantly reduced childhood mortality. 2,3 Some degree of mortality reduction is plausible, since the antibiotic has activity against the three most common causes of childhood mortality in the developing world 4 : malaria, 5,6 diarrhea, 7 and respiratory infections. 6,8 Several other population-level interventions, such as vaccination, 9 nutrient supplementation, 10 and exposure limitation have been shown to reduce childhood mortality in the developing world, but with more modest reductions.…”

Section: Introductionmentioning

confidence: 99%

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The Effect of Mass Azithromycin Distribution on Childhood Mortality: Beliefs and Estimates of Efficacy

See

O’Brien

Keenan

et al. 2015

The American Journal of Tropical Medicine and Hygiene

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Abstract.A cluster-randomized trial demonstrated that mass oral azithromycin distribution reduced childhood mortality 49.6% (Trachoma Amelioration in Northern Amhara [TANA]). The relative risk of childhood mortality was then estimated using two approaches: an expert survey and a Bayesian analysis. The survey asked public health experts to estimate the true effect of mass azithromycin distribution on childhood mortality. The Bayesian estimation used the TANA study's results and prior estimates of the efficacy of other effective population-level interventions. The experts believed mass azithromycin reduces childhood mortality (relative risk = 0.83, 95% credible intervals [CrI] = 0.70-1.00). The Bayesian analysis estimated a relative risk of 0.71 (95% CrI = 0.39-0.93). Both estimates suggest that azithromycin may have a true mortality benefit, though of a smaller magnitude than found in the single available trial. Prior information about nonantibiotic, population-level interventions may have informed the expert's opinions. Additional trials are needed to confirm a mortality benefit from mass azithromycin.

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Effect of Intrapartum Azithromycin vs Placebo on Neonatal Sepsis and Death

Roca

Camara

Bognini

et al. 2023

JAMA

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ImportanceNeonatal sepsis is a leading cause of neonatal mortality. New interventions are needed to decrease neonatal sepsis and mortality in regions with highest burden.ObjectiveTo evaluate the efficacy of intrapartum azithromycin to reduce neonatal sepsis or mortality, as well as neonatal and maternal infections.Design, Setting, and ParticipantsThis double-blind, placebo-controlled, randomized clinical trial enrolled and followed up birthing parents and their infants at 10 health facilities in The Gambia and Burkina Faso, West Africa, between October 2017 and May 2021.InterventionsParticipants were assigned at random to receive oral azithromycin (2 g) or placebo (ratio 1:1) during labor.Main Outcomes and MeasuresThe primary outcome was a composite of neonatal sepsis or mortality, with the former defined based on microbiologic or clinical criteria. Secondary outcomes were neonatal infections (skin, umbilical, eye and ear infections), malaria, and fever; postpartum infections (puerperal sepsis, mastitis), fever, and malaria; and use of antibiotics during 4-week follow-up.ResultsThe trial randomized 11 983 persons in labor (median age, 29.9 years). Overall, 225 newborns (1.9% of 11 783 live births) met the primary end point. The incidence of neonatal mortality or sepsis was similar in the azithromycin and placebo groups (2.0% [115/5889] vs 1.9% [110/5894]; risk difference [RD], 0.09 [95% CI, −0.39 to 0.57]), as was the incidence of neonatal mortality (0.8% vs 0.8%; RD, 0.04 [95% CI, −0.27 to 0.35]) and neonatal sepsis (1.3% vs 1.3%; RD, 0.02 [95% CI, −0.38 to 0.43]). Newborns in the azithromycin group compared with the placebo group had lower incidence of skin infections (0.8% vs 1.7%; RD, −0.90 [95% CI, −1.30 to −0.49]) and need for antibiotics (6.2% vs 7.8%; RD, −1.58 [95% CI, −2.49 to −0.67]). Postpartum parents in the azithromycin group had lower incidence of mastitis (0.3% vs 0.5%; RD, −0.24 [95% CI, −0.47 to −0.01]) and puerperal fever (0.1% vs 0.3%; RD, −0.19 [95% CI, −0.36 to −0.01]).Conclusions and RelevanceAzithromycin administered orally during labor did not reduce neonatal sepsis or mortality. These results do not support routine introduction of oral intrapartum azithromycin for this purpose.Trial RegistrationClinicalTrials.gov Identifier: NCT03199547

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Effect of Mass Distribution of Azithromycin for Trachoma Control on Overall Mortality in Ethiopian Children

Cited by 172 publications

References 29 publications

Impact of Mass Azithromycin Distribution on Malaria Parasitemia during the Low-Transmission Season in Niger: A Cluster-Randomized Trial

Impact of Mass Azithromycin Distribution on Malaria Parasitemia during the Low-Transmission Season in Niger: A Cluster-Randomized Trial

The Effect of Mass Azithromycin Distribution on Childhood Mortality: Beliefs and Estimates of Efficacy

Effect of Intrapartum Azithromycin vs Placebo on Neonatal Sepsis and Death

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