zithromax and Growth-Disorders

Stunting among children in low-resource settings is associated with enteric pathogen carriage and micronutrient deficiencies. Our goal was to test whether administration of scheduled antimicrobials and daily nicotinamide improved linear growth in a region with a high prevalence of stunting and enteric pathogen carriage.. We performed a randomized, 2 × 2 factorial, double-blind, placebo-controlled trial in the area around Haydom, Tanzania. Mother-child dyads were enrolled by age 14 days and followed with monthly home visits and every 3-month anthropometry assessments through 18 months. Those randomized to the antimicrobial arm received 2 medications (versus corresponding placebos): azithromycin (single dose of 20 mg/kg) at months 6, 9, 12, and 15 and nitazoxanide (3-day course of 100 mg twice daily) at months 12 and 15. Those randomized to nicotinamide arm received daily nicotinamide to the mother (250 mg pills months 0 to 6) and to the child (100 mg sachets months 6 to 18). Primary outcome was length-for-age z-score (LAZ) at 18 months in the modified intention-to-treat group. Between September 5, 2017 and August 31, 2018, 1,188 children were randomized, of whom 1,084 (n = 277 placebo/placebo, 273 antimicrobial/placebo, 274 placebo/nicotinamide, and 260 antimicrobial/nicotinamide) were included in the modified intention-to-treat analysis. The study was suspended for a 3-month period by the Tanzanian National Institute for Medical Research (NIMR) because of concerns related to the timing of laboratory testing and the total number of serious adverse events (SAEs); this resulted in some participants receiving their final study assessment late. There was a high prevalence of stunting overall (533/1,084, 49.2%). Mean 18-month LAZ did not differ between groups for either intervention (mean LAZ with 95% confidence interval [CI]: antimicrobial: -2.05 CI -2.13, -1.96, placebo: -2.05 CI -2.14, -1.97; mean difference: 0.01 CI -0.13, 0.11, p = 0.91; nicotinamide: -2.06 CI -2.13, -1.95, placebo: -2.04 CI -2.14, -1.98, mean difference 0.03 CI -0.15, 0.09, p = 0.66). There was no difference in LAZ for either intervention after adjusting for possible confounders (baseline LAZ, age in days at 18-month measurement, ward, hospital birth, birth month, years of maternal education, socioeconomic status (SES) quartile category, sex, whether the mother was a member of the Datoga tribe, and mother's height). Adverse events (AEs) and SAEs were overall similar between treatment groups for both the nicotinamide and antimicrobial interventions. Key limitations include the absence of laboratory measures of pathogen carriage and nicotinamide metabolism to provide context for the negative findings.. In this study, we observed that neither scheduled administration of azithromycin and nitazoxanide nor daily provision of nicotinamide was associated with improved growth in this resource-poor setting with a high force of enteric infections. Further research remains critical to identify interventions toward improved early childhood growth in challenging conditions.. ClinicalTrials.gov NCT03268902.

Topics: Adult; Anti-Infective Agents; Azithromycin; Child Development; Double-Blind Method; Drug Administration Schedule; Female; Growth Disorders; Humans; Infant; Infant, Newborn; Intestinal Diseases, Parasitic; Niacinamide; Nitro Compounds; Pregnancy; Tanzania; Thiazoles

We showed earlier that presumptive infection treatment in pregnancy reduced the prevalence of neonatal stunting in a rural low-income setting. In this article, we assess how these gains were sustained and reflected in childhood growth, development, and mortality.. We enrolled 1320 pregnant Malawian women in a randomized trial and treated them for malaria and other infections with either 2 doses of sulfadoxine-pyrimethamine (SP) (control), monthly SP, or monthly sulfadoxine-pyrimethamine and 2 doses of azithromycin (AZI-SP). Child height or length and mortality were recorded at 1, 6, 12, 24, 36, 48, and 60 months and development at 60 months by using Griffith's Mental Development Scales.. Throughout follow-up, the mean child length was 0.4 to 0.7 cm higher (. Provision of AZI-SP rather than 2 doses of SP during pregnancy reduced the incidence of stunting in childhood. AZI-SP during pregnancy also had a positive effect on child development and may have reduced postneonatal mortality.

Topics: Adult; Anti-Bacterial Agents; Antimalarials; Azithromycin; Child Development; Child Health; Child Mortality; Child, Preschool; Drug Combinations; Female; Fetal Death; Follow-Up Studies; Growth Disorders; Humans; Incidence; Infant; Malaria; Malawi; Pregnancy; Pregnancy Complications, Infectious; Pregnancy Complications, Parasitic; Prevalence; Pyrimethamine; Rural Population; Sulfadoxine

To assess whether intermittent preventive treatment of pregnant women (IPTp) with sulfadoxine-pyrimethamine (SP) and azithromycin (AZI) in a malaria-endemic area leads to sustained gains in linear growth and development in their offspring.. Follow-up study of a randomised trial.. Mangochi District in rural southern Malawi.. 1320 pregnant women and their offspring.. IPTp monthly with SP and twice with AZI (AZI-SP group), monthly with SP but no AZI (monthly SP), or twice with SP (control). No intervention was given to children.. Cognitive performance using Raven's Coloured Progressive Matrices (CPM) at 13 years of age; mean height and height-for-age Z-score (HAZ), cumulative incidence and prevalence of stunting (HAZ <-2); weight, body mass index, mid-upper-arm circumference and head circumference.. At approximately 13 years of age, the mean CPM score was 14.3 (SD 3.8, range 6-29, maximum 36), with no differences between groups. Children in the AZI-SP group were on average 0.4 cm (95% CI -0.9 to 1.7, p=0.6) taller than those in the control group. For cumulative incidence of stunting, the HR in the AZI-SP group was 0.72 (95% CI 0.61 to 0.84, p<0.001) compared with the control and 0.76 (95% CI 0.65 to 0.90, p<0.001) compared with the monthly SP groups. There was no intergroup difference in stunting prevalence or anthropometric measurements.. In rural Malawi, maternal intensified infection control during pregnancy reduces offspring's cumulative incidence of ever being stunted by 13 years of age. In this study, there was no evidence of a positive impact on cognitive performance.. NCT00131235.

Topics: Anti-Bacterial Agents; Antimalarials; Azithromycin; Child; Drug Combinations; Female; Follow-Up Studies; Growth Disorders; Humans; Pregnancy; Pregnancy Complications, Parasitic