Mass Azithromycin and Malaria Parasitemia in Niger: Results from a Community-Randomized Trial

O’Brien, Kieran; Cotter, Sun Y.; Amza, Abdou; Kadri, Boubacar; Nassirou, Baido; Stoller, Nicole E.; Zhou, Zhaoxia; Cotter, Chris; West, Sheila K.; Bailey, Robin L.; Rosenthal, Philip J.; Gaynor, Bruce D.; Porco, Travis C.; Lietman, Thomas M.

doi:10.4269/ajtmh.16-0487

Cited by 10 publications

(15 citation statements)

References 24 publications

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“…Azithromycin has also been shown to prevent malaria infections, although its efficacy appears to be inferior to that of doxycycline [2, 3]. Malaria outcomes have been measured during studies of mass azithromycin distributions for trachoma, with reductions in malaria parasitemia observed in some studies but not in others [9, 13, 23, 24]. The present study improved upon previous studies of mass azithromycin distribution in that it was placebo controlled and enforced strict masking procedures both in the field and by laboratory staff.…”

Section: Discussionmentioning

confidence: 99%

Biannual mass azithromycin distributions and malaria parasitemia in pre-school children in Niger: A cluster-randomized, placebo-controlled trial

et al. 2019

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Background Mass azithromycin distributions have been shown to reduce mortality in preschool children, although the factors mediating this mortality reduction are not clear. This study was performed to determine whether mass distribution of azithromycin, which has modest antimalarial activity, reduces the community burden of malaria. Methods and findings In a cluster-randomized trial conducted from 23 November 2014 until 31 July 2017, 30 rural communities in Niger were randomized to 2 years of biannual mass distributions of either azithromycin (20 mg/kg oral suspension) or placebo to children aged 1 to 59 months. Participants, field staff, and investigators were masked to treatment allocation. The primary malaria outcome was the community prevalence of parasitemia on thick blood smear, assessed in a random sample of children from each community at study visits 12 and 24 months after randomization. Analyses were performed in an intention-to-treat fashion. At the baseline visit, a total of 1,695 children were enumerated in the 15 azithromycin communities, and 3,029 children were enumerated in the 15 placebo communities. No communities were lost to follow-up. The mean prevalence of malaria parasitemia at baseline was 8.9% (95% CI 5.1%–15.7%; 52 of 552 children across all communities) in the azithromycin-treated group and 6.7% (95% CI 4.0%–12.6%; 36 of 542 children across all communities) in the placebo-treated group. In the prespecified primary analysis, parasitemia was lower in the azithromycin-treated group at month 12 (mean prevalence 8.8%, 95% CI 5.1%–14.3%; 51 of 551 children across all communities) and month 24 (mean 3.5%, 95% CI 1.9%–5.5%; 21 of 567 children across all communities) than it was in the placebo-treated group at month 12 (mean 15.3%, 95% CI 10.8%–20.6%; 81 of 548 children across all communities) and month 24 (mean 4.8%, 95% CI 3.3%–6.4%; 28 of 592 children across all communities) ( P = 0.02). Communities treated with azithromycin had approximately half the odds of parasitemia compared to those treated with placebo (odds ratio [OR] 0.54, 95% CI 0.30 to 0.97). Parasite density was lower in the azithromycin group than the placebo group at 12 and 24 months (square root–transformed outcome; density estimates were 7,540 parasites/μl lower [95% CI −350 to −12,550 parasites/μl; P = 0.02] at a mean parasite density of 17,000, as was observed in the placebo arm). No significant difference in hemoglobin was observed between the 2 treatment groups at 12 and 24 months (mean 0.34 g/dL higher in the azithromycin arm, 95% CI −0.06 to 0.75 g/dL; P = 0.10). No serious adverse events were reported in either group, and among children aged 1 to 5 months, the most commonly reported nonserious adverse events (i.e., diarrhea, vomiting, and rash) were less common in the azithromycin-treated communities. Limitations of the trial include the timing of the treatments and monitoring visits, both of...

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Section: Discussionmentioning

confidence: 99%

Biannual mass azithromycin distributions and malaria parasitemia in pre-school children in Niger: A cluster-randomized, placebo-controlled trial

et al. 2019

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“…The results of this study are consistent with previously-reported results from 24 different communities randomized to annual versus biannual mass azithromycin distribution over a 36-month period in the same study. 11 In these studies, samples were collected during the high transmission season. It is possible that multiple mass azithromycin distributions increase selection of azithromycin-resistant strains, although we were unable to assess this here.…”

Section: Discussionmentioning

confidence: 99%

“…1 However, there was no significant difference in malaria prevalence or parasitemia during the high transmission season between three annual compared with six biannual mass azithromycin distributions in a different set of communities. 11 Here, we report 36-month malaria parasitemia outcomes from the same trial collected during the peak transmission season after 3 annual or 6 biannual azithromycin distributions in the same communities in which a decrease in parasitemia prevalence was previously noted during the low transmission season following two mass azithromycin distributions compared with a single mass azithromycin distribution.…”

Section: Introductionmentioning

confidence: 86%

“…Two previous substudies of a randomized controlled trial of mass azithromycin distribution for trachoma control in Niger found conflicting results comparing annual and biannual mass azithromycin for malaria. 1,11 Compared with a single mass azithromycin distribution, two mass azithromycin distributions (6 months apart) was shown to lead to a significant reduction in malaria parasitemia. 1 However, there was no significant difference in malaria prevalence or parasitemia during the high transmission season between three annual compared with six biannual mass azithromycin distributions in a different set of communities.…”

Section: Introductionmentioning

confidence: 99%

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Annual Versus Biannual Mass Azithromycin Distribution and Malaria Parasitemia During the Peak Transmission Season Among Children in Niger

Oldenburg

Amza

Kadri

et al. 2018

Pediatric Infectious Disease Journal

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“…Azithromycin has modest activity against malaria by targeting the plasmodial apicoplast. 7 , 8 Although studies of mass azithromycin distribution for trachoma control have yielded mixed results, 9 – 12 a study of biannual mass azithromycin distribution for child mortality demonstrated a significant decrease in malaria parasitemia in communities receiving azithromycin compared with those receiving placebo. 13 Any relationship between malaria and malnutrition could potentially be affected by distribution of azithromycin to children given the overall effect in a reduction in malaria parasitemia.…”

Section: Introductionmentioning

confidence: 99%

Malaria Parasitemia and Nutritional Status during the Low Transmission Season in the Presence of Azithromycin Distribution among Preschool Children in Niger

Arzika

Maliki

Boubacar

et al. 2020

The American Journal of Tropical Medicine and Hygiene

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The relationship between malaria and malnutrition is complicated, and existence of one may predispose or exacerbate the other. We evaluated the relationship between malaria parasitemia and nutritional status in children living in communities participating in a cluster-randomized trial of biannual azithromycin compared with placebo for prevention of childhood mortality. Data were collected during the low malaria transmission and low food insecurity season. Parasitemia was not associated with weight-for-height Z-score (24 months: P = 0.11 azithromycin communities, P = 0.75 placebo communities), weight-for-age Z-score (24 months: P = 0.83 azithromycin, P = 0.78 placebo), height-for-age Z-score (24 months: P = 0.30 azithromycin, P = 0.87 placebo), or mid-upper arm circumference (24 months: P = 0.12 azithromycin, P = 0.56 placebo). There was no statistically significant evidence of a difference in the relationship in communities receiving azithromycin or placebo. During the low transmission season, there was no evidence that malaria parasitemia and impaired nutritional status co-occur in children.

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Mass Azithromycin and Malaria Parasitemia in Niger: Results from a Community-Randomized Trial

Cited by 10 publications

References 24 publications

Biannual mass azithromycin distributions and malaria parasitemia in pre-school children in Niger: A cluster-randomized, placebo-controlled trial

Biannual mass azithromycin distributions and malaria parasitemia in pre-school children in Niger: A cluster-randomized, placebo-controlled trial

Annual Versus Biannual Mass Azithromycin Distribution and Malaria Parasitemia During the Peak Transmission Season Among Children in Niger

Malaria Parasitemia and Nutritional Status during the Low Transmission Season in the Presence of Azithromycin Distribution among Preschool Children in Niger

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