@article {866, title = {Effect of a single dose of oral azithromycin on malaria parasitaemia in children: a randomized controlled trial.}, journal = {Malar J}, volume = {20}, year = {2021}, month = {2021 Aug 31}, pages = {360}, abstract = {

BACKGROUND: Azithromycin has recently been shown to reduce all-cause childhood mortality in sub-Saharan Africa. One potential mechanism of this effect is via the anti-malarial effect of azithromycin, which may help treat or prevent malaria infection. This study evaluated short- and longer-term effects of azithromycin on malaria outcomes in children.

METHODS: Children aged 8 days to 59 months were randomized in a 1:1 fashion to a single oral dose of azithromycin (20\ mg/kg) or matching placebo. Children were evaluated for malaria via thin and thick smear and rapid diagnostic test (for those with tympanic temperature >= 37.5\ {\textdegree}C) at baseline and 14 days and 6 months after treatment. Malaria outcomes in children receiving azithromycin versus placebo were compared at each follow-up timepoint separately.

RESULTS: Of 450 children enrolled, 230 were randomized to azithromycin and 220 to placebo. Children were a median of 26 months and 51\% were female, and 17\% were positive for malaria parasitaemia at baseline. There was no evidence of a difference in malaria parasitaemia at 14 days or 6 months after treatment. In the azithromycin arm, 20\% of children were positive for parasitaemia at 14 days compared to 17\% in the placebo arm (P = 0.43) and 7.6\% vs. 5.6\% in the azithromycin compared to placebo arms at 6 months (P = 0.47).

CONCLUSIONS: Azithromycin did not affect malaria outcomes in this study, possibly due to the individually randomized nature of the trial. Trial registration\ This study is registered at clinicaltrials.gov (NCT03676751; registered 19 September 2018).

}, issn = {1475-2875}, doi = {10.1186/s12936-021-03895-9}, author = {Coulibaly, Boubacar and Sie, Ali and Dah, Clarisse and Bountogo, Mamadou and Ouattara, Mamadou and Compaor{\'e}, Adama and Nikiema, Moustapha and Tiansi, J{\'e}r{\^o}me Nankon{\'e} and Sibiri, Nestor Demb{\'e}l{\'e} and Brogdon, Jessica M and Lebas, Elodie and Doan, Thuy and Porco, Travis C and Lietman, Thomas M and Oldenburg, Catherine E} } @article {776, title = {Poultry Ownership and Genetic Antibiotic Resistance Determinants in the Gut of Preschool Children.}, journal = {Am J Trop Med Hyg}, year = {2021}, month = {2021 Mar 22}, abstract = {

Zoonotic transmission is likely a pathway for antibiotic resistance. Data from a randomized trial of pediatric antibiotic administration were secondarily evaluated to determine if poultry ownership was significantly associated with the presence of gut genetic antibiotic resistance determinants among 118 children in Burkina Faso. Antimicrobial resistance (AMR) determinants were classified using DNA sequencing. We measured the relationship between genetic resistance determinants and chicken ownership using a logistic regression model adjusted for confounding variables. Children in households reporting poultry ownership had four times the odds of tetracycline resistance determinants in the gut compared with those without household poultry (OR: 4.08, 95\% CI: 1.08-15.44, P = 0.04). There was no statistically significant difference found for other antibiotic classes. Understanding the origins of antibiotic resistance may help spur the development of interventions to combat the global AMR crisis.

}, issn = {1476-1645}, doi = {10.4269/ajtmh.20-1384}, author = {Brogdon, Jessica M and Sie, Ali and Dah, N Clarisse and Ouermi, Lucienne and Coulibaly, Boubacar and Lebas, Elodie and Zhong, Lina and Chen, Cindi and Lietman, Thomas M and Keenan, Jeremy D and Doan, Thuy and Oldenburg, Catherine E} } @article {781, title = {Single-dose azithromycin for child growth in Burkina Faso: a randomized controlled trial.}, journal = {BMC Pediatr}, volume = {21}, year = {2021}, month = {2021 Mar 17}, pages = {130}, abstract = {

BACKGROUND: In lower resource settings, previous randomized controlled trials have demonstrated evidence of increased weight gain following antibiotic administration in children with acute illness. We conducted an individually randomized trial to assess whether single dose azithromycin treatment causes weight gain in a general population sample of children in Burkina Faso.

METHODS: Children aged 8 days to 59 months were enrolled in November 2019 and followed through June 2020 in Nouna Town, Burkina Faso. Participants were randomly assigned to a single oral dose of azithromycin (20 mg/kg) or matching placebo. Anthropometric measurements were collected at baseline and 14 days and 6 months after enrollment. The primary anthropometric outcome was weight gain velocity in g/kg/day from baseline to 14 days and 6 months in separate linear regression models.

RESULTS: Of 450 enrolled children, 230 were randomly assigned to azithromycin and 220 to placebo. Median age was 26 months (IQR 16 to 38 months) and 51\% were female. At 14 days, children in the azithromycin arm gained a mean difference of 0.9 g/kg/day (95\% CI 0.2 to 1.6 g/kg/day, P = 0.01) more than children in the placebo arm. There was no difference in weight gain velocity in children receiving azithromycin compared to placebo at 6 months (mean difference 0.04 g/kg/day, 95\% CI - 0.05 to 0.13 g/kg/day, P = 0.46). There were no significant differences in other anthropometric outcomes.

CONCLUSIONS: Transient increases in weight gain were observed after oral azithromycin treatment, which may provide short-term benefits.

CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov NCT03676751 . Registered 19/09/2018.

}, issn = {1471-2431}, doi = {10.1186/s12887-021-02601-7}, author = {Sie, Ali and Coulibaly, Boubacar and Dah, Clarisse and Bountogo, Mamadou and Ouattara, Mamadou and Compaor{\'e}, Guillaume and Brogdon, Jessica M and Godwin, William W and Lebas, Elodie and Doan, Thuy and Arnold, Benjamin F and Porco, Travis C and Lietman, Thomas M and Oldenburg, Catherine E} } @article {216, title = {Adverse Events and Clinic Visits following a Single Dose of Oral Azithromycin among Preschool Children: A Randomized Placebo-Controlled Trial.}, journal = {Am J Trop Med Hyg}, year = {2020}, month = {2020 Dec 21}, abstract = {

Biannual mass azithromycin distribution reduces all-cause child mortality in some settings in sub-Saharan Africa; however, adverse events and short-term infectious outcomes following treatment have not been well characterized. Children aged 0-59 months were recruited in Nouna Town, Burkina Faso, and randomized 1:1 to a single directly observed oral 20 mg/kg dose of azithromycin or placebo. At 14 days after treatment, caregivers were interviewed about adverse event symptoms their child experienced since treatment and if they had sought health care for their child. All children had tympanic temperature measured at the 14-day visit. We compared adverse events and clinic visits using logistic regression models between azithromycin- and placebo-controlled children. Of 450 children enrolled, 230 were randomized to azithromycin and 220 to placebo. On average, children were aged 28 months, and 50.9\% were female. Caregivers of 20\% of children reported that their child experienced at least one adverse event, with no significant difference between study arms (19.9\% azithromycin; 20.0\% placebo, logistic regression = 0.96). Vomiting was more often reported by caregivers of azithromycin-treated children than by those of placebo-treated children (7.2\% azithromycin, 1.9\% placebo, logistic regression = 0.01). There were no significant differences in other adverse events or clinic visits. Adverse events following a single oral dose of azithromycin in preschool children were rare and mild. Azithromycin administration appears safe in this population.

}, issn = {1476-1645}, doi = {10.4269/ajtmh.20-1002}, author = {Sie, Ali and Dah, Clarisse and Bountogo, Mamadou and Ouattara, Mamadou and Nebie, Eric and Coulibaly, Boubacar and Brogdon, Jessica M and Godwin, William W and Lebas, Elodie and Doan, Thuy and Arnold, Benjamin F and Porco, Travis C and Lietman, Thomas M and Oldenburg, Catherine E} } @article {231, title = {A double-masked placebo-controlled trial of azithromycin to prevent child mortality in Burkina Faso, West Africa: Community Health with Azithromycin Trial (CHAT) study protocol.}, journal = {Trials}, volume = {20}, year = {2019}, month = {2019 Dec 04}, pages = {675}, abstract = {

BACKGROUND: Biannual, mass azithromycin distribution has previously been shown to reduce all-cause child mortality in sub-Saharan Africa. Subgroup analysis suggested that the strongest effects were in the youngest children, leading to the hypothesis that targeting younger age groups might be an effective strategy to prevent mortality. We present the methods of two randomized controlled trials designed to evaluate mass and targeted azithromycin distribution for the prevention of child mortality in Burkina Faso, West Africa.

METHODS/DESIGN: The Child Health with Azithromycin Treatment (CHAT) study consists of two nested, randomized controlled trials. In the first, communities are randomized in a 1:1 fashion to biannual, mass azithromycin distribution or placebo. The primary outcome is under-5 all-cause mortality measured at the community level. In the second, children attending primary healthcare facilities during the first 5-12 weeks of life for a healthy child visit (e.g., for vaccination) are randomized in a 1:1 fashion to a single orally administered dose of azithromycin or placebo. The primary outcome is all-cause mortality measured at 6 months of age. The trial commenced enrollment in August 2019.

DISCUSSION: This study is expected to provide evidence on two health systems delivery approaches (mass and targeted treatment) for azithromycin to prevent all-cause child mortality. The results will inform global and national policies related to azithromycin for the prevention of child mortality.

TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03676764. Registered on 19 September 2018; prospectively registered pre results.

}, keywords = {Anti-Bacterial Agents, Azithromycin, Child Mortality, Child, Preschool, Double-Blind Method, Humans, Infant, Outcome Assessment, Health Care, Randomized Controlled Trials as Topic, Sample Size}, issn = {1745-6215}, doi = {10.1186/s13063-019-3855-9}, author = {Sie, Ali and Ouattara, Mamadou and Bountogo, Mamadou and Bagagnan, Cheik and Coulibaly, Boubacar and Boudo, Valentin and Lebas, Elodie and Brogdon, Jessica M and Lin, Ying and B{\"a}rnighausen, Till and Porco, Travis C and Doan, Thuy and Lietman, Thomas M and Oldenburg, Catherine E} }