A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.

A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.

Malaria

Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.

Azithromycin

Placebo

Centre de Recherche en santé de nouna

Gut and Azithromycin Mechanisms in Infants and Children II

A rapid diagnostic test will be administered to all children to determine malaria status

Clinical malaria will be defined by a positive rapid diagnostic test and fever.

University of California, San Francisco

Centre de Recherche en Sante de Nouna, Burkina Faso

Individually randomized placebo-controlled trial of azithromycin vs. placebo to establish the efficacy and safety of azithromycin.

Quadruple: (Participant, Care Provider, Investigator, Outcomes Assessor)

a single dose of Azithromycin will be administered to infants between their 8-27th days of life

a single dose of placebo will be administered to infants between their 8-27th days of life

Childhood Mortality

a single dose of Placebo will be administered to infants between their 8-27th days of life

Centre de Recherche En Santé de Nouna

Neonates and Azithromycin, an Innovation in the Treatment of Children in Burkina Faso

All-cause Mortality Rate in infants at 6 months of age

All-cause Mortality Rate in infants at 12 months of age

Caregivers will be asked if the child is dead or alive at 365 days of life

Change in weight from baseline to day 180

Change in height from baseline to day 180

Proportion of infants developing infantile hypertrophic pyloric stenosis between 2 to 8 weeks after treatment

Caregivers will be asked if their child experienced any symptoms for pyloric stenosis since the last visit.

De-identified data will be available as per the Bill and Melinda Gates open access policy. Individual participant data will be available that underline the reported results (texts, tables, figures, and appendices). The study protocol and statistical analysis plan will also be made available. The data will be available following publication in accordance with the BMGF guidelines.

Bill and Melinda Gates Foundation

individually randomized trial of azithromycin versus placebo to establish the efficacy and safety of administration of a dose of azithromycin during the neonatal period

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Child Growth

Diversity of Microbiome

Child Mortality

Resistance Bacterial

Oral suspension of placebo for azithromycin

Centre de Recherche en Sante de Nouna

MORDOR II Burkina Faso: Longitudinal Trial

Gut and Azithromycin Mechanisms in Infants and Neonates

Simpson's diversity estimated from next generation sequencing

Presence of macrolide genetic resistance determinants measured using DNA-seq from rectal swabs from 50 children

WAZ. Weight will be measured at all follow-ups and weight-for-age z-scores will be calculated. Weight measured in g/kg/day.

Height or length will be measured at all follow-ups and height-for-age z-scores will be calculated.

Vital status will be assessed at all follow-up time points. Mortality will be defined as death within the study period. Date of death will be collected.

Blood smears (thin and thick) for malaria will be collected at all follow-ups to determine malaria infection status.

Caregivers will be asked if the child has been taken to the health post since the last visit and why

Measured using BugFACS from whole blood and stool

To be measured using mid-upper arm circumference

L-1 norm distance on bacterial reads (intestinal) from rectal swabs of 50 children

L-2 norm distance on bacterial reads (intestinal) from rectal swabs of 50 children

Changes in normalized reads for Campylobacter species using DNA-seq from rectal swabs of 50 children

Chao1 total resistance gene determinant richness using DNA-seq from rectal swabs of 50 children

Individually randomized placebo-controlled trail of azithromycin vs. placebo to establish the efficacy and safety of azithromycin.

Bi-annual Mass Azithromycin distribution to all children 1-60 months old in participating communities

Bi-annual Mass Placebo distribution to all children 1-60 months old in participating communities

Targeted placebo to children 5 to 12 weeks old at vaccine visit or other healthy child visit

Targeted azithromycin to children 5 to 12 weeks old at vaccine visit or other healthy child visit

biannual azithromycin in eligible communities to children 1 to 59 months old Targeted azithromycin to children aged 5 to 8 weeks old at the vaccine visit

biannual placebo in eligible communities to children 1 to 59 months old Targeted placebo to children aged 5 to 8 weeks old at the vaccine visit

Placebos

Community Health Azithromycin Trial in Burkina Faso

All-cause mortality as determined by biannual census among children aged 1-59 months

All-cause mortality as determined by a follow-up visit for individually randomized children at healthy child visits

Malaria parasitemia as measured by thin and thick smears in a random sample of children at 36 months

Weight-for-height Z-score in children 1-59 months at 36 months

Height-for-age Z-score in children 1-59 months at 36 months

Mid-upper arm circumference in children 1-59 months at 36 months

Hemoglobin concentration in children 1-59 months at 36 months

Nasopharyngeal macrolide resistance in children aged 1-59 months at 36 months

Measured via passive surveillance of clinics in study catchment area

Proportion of E. coli isolates resistant to macrolides and to antibiotics commonly used to treat pediatric infection among children aged 1-59 months at 36 months

Change in length from baseline to 6 months

Change in weight from baseline to 6 months

De-identified data will be available as per the Bill and Melinda Gates open access policy. Community based data will be available that underline the reported results (texts, tables, figures, and appendices). The study protocol and statistical analysis plan will also be made available. The data will be available following publication in accordance with the BMGF guidelines

All eligible communities in Nouna District will be randomized in a 1:1 fashion to biannual azithromycin or placebo. Targeted treatment (vaccine visit) will be randomized 1:1 individually to azithromycin or placebo. Randomization will be conducted by T. Porco. Procedural and algorithmic details are provided in an appendix to the Statistical Analysis Plan.

The trial sites will be masked to outcomes, so the responsibility for monitoring interim analysis will fall on the DSMC

Azithromycin 10mg/kg for one day, then 5mg/kg for four days, a total of five days of experimental treatment.

5 days of taste/appearance/bottle-matched placebo

Pneumonia

Diarrhea

Co-infection

Death

Malnutrition

5 days of taste/appearance/bottle-matched inactive substance

trachoma/diarrhea

Gut and Azithromycin Mechanisms in Infants and Children II

Neonates and Azithromycin, an Innovation in the Treatment of Children in Burkina Faso

MORDOR II Burkina Faso: Longitudinal Trial

Community Health Azithromycin Trial in Burkina Faso

Azithromycin to Prevent Post-discharge Morbidity and Mortality in Kenyan Children

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