Mechanisms
malaria, PCR-diagnosed malaria infections
MALARIA
As the investigation into the mechanisms of action of azithromycin centers on the dose-dependent impact at an individual level, specifically the underlying mechanisms of azithromycin’s function following administration, the two treatment arms may be consolidated for analysis. The mechanisms of azithromycin’s action shall be investigated through testing the following hypotheses:Reduction in the prevalence of PCR-diagnosed malaria infections between day 0 and day 14 is greater in infants in villages receiving two-dose or four-dose AZI MDA regimen than in infants in villages receiving placebo MDA regimen.Among those who test positive on day 0, the proportion of positive PCR test for malaria on day 14 is lower among infants who receive AZI MDA than among children who receive respective placebo.Reduction of intensity of subclinical malaria (expressed in parasite density) between day 0 and day 14 is greater in infants in villages receiving two-dose or four-dose AZI MDA regimen than in infants in villages receiving placebo MDA regimen.Increase in mean blood hemoglobin concentration between day 0 and day 14 is greater in infants in villages receiving two-dose or four-dose AZI MDA regimen than in infants in villages receiving placebo MDA regimen.Reduction in mean CRP concentration between day 0 and day 14 is greater in infants in villages receiving two-dose or four-dose AZI MDA regimen than in infants in villages receiving placebo MDA regimen.Among infants with elevated CRP concentration (CRP > 5 μg/mL) at day 0, reduction in the prevalence of elevated CRP concentration is greater among infants who receive AZI MDA than among children who receive respective placebo.Reduction in mean AAT, mean NEO, mean MPO concentrations, and EE score, between day 0 and day 14 is greater in infants in villages receiving two-dose or four-dose AZI MDA regimen than in infants in villages receiving placebo MDA regimen.Among infants with elevated AAT/MPO/NEO concentration (AAT > 270 µg/g; MPO > 2000 ng/L; NEO > 70 nmol/L) at day 0, reduction in the prevalence of elevated AAT/MPO/NEO concentration is greater among infants who receive AZI MDA than among children who receive respective placebo.