Table 2 Summary of secondary outcomes related to mechanisms of azithromycin action, growth, and morbidity
Biological specimen or measurements | Child age in months | Number of participants | Study visit | Timing of collection versus MDA | Method of assessments | |
|---|---|---|---|---|---|---|
Mechanism of azithromycin action | ||||||
- Blood malaria parasitemia and hemoglobin concentration - Blood C-reactive protein concentration | Blood | 4–11 | 1000 | MDA 4 | Paired (before and 14 days after) | From heel prick blood collected, hemoglobin and C-reactive protein concentrations tested with an on-site instrument (QuikRead Go®) Dried blood spots stored for later malaria diagnostics with real-time PCR method |
- Fecal neopterin, myeloperoxidase, and alpha-1-antitrypsin concentrations | Stool | 4–11 | 1000 | MDA 4 | Paired (before and 14 days after) | Fecal neopterin, myeloperoxidase, and alpha-1-antitrypsin concentrations determined with ELISA tests |
- Systemic and intestinal inflammation and immune function and development (future analysis, outcomes to be defined) | Plasma; peripheral blood mononuclear cells; stool; urine | 6–8 and 12–14 | 1350 + 1350 | MDA 6–8 and visit 9 | Before | Storage for future analysis |
Growth and nutritional status | ||||||
- Mean length-for-age Z-score (LAZ) - Mean weight-for-age Z-score (WAZ) - Mean weight-for-length Z-score (WHZ) - Mid-upper arm circumference Z-score (MUAC-Z) - Percentage of moderate or severe stunting (LAZ < −2/LAZ < −3) - Percentage of moderate or severe wasting (WLZ < −2/WLZ < −3) | Length, weight, MUAC | 6–8 and 12–14 | 1800 | MDA 6–8 | Before | Length assessed using commercial length board (ShorrBoard®, WEIGH AND MEASURE, LLC, Olney, Md, USA) and recorded to the nearest 1 mm. Weight assessed using an electronic infant weighing scale (SECA 354) with reading increments of 10g. MUAC measured with non-stretchable plastic insertion tapes and recorded to the nearest 1 mm. All measurements are done in triplicate |
Morbidity | ||||||
- 14-day period prevalence of fever with respiratory symptoms, fever without respiratory symptoms (proxy for malaria), and diarrhea | Caregiver-reported child morbidity | 4–14 | No upper limit | MDA 1–8 and visit 9 | Recall period is 14 days | Caregiver asked if a child has been ill in the preceding 14 days, with fever with respiratory symptoms, fever without respiratory symptoms, diarrhea, or any other symptoms |