Chemoprevention of malaria and other infectious disease in the post-discharge management of children with severe anaemia in Malawi, Kenya and Uganda

INTERVENTION: Azithromycin Azithromycin Placebo CONDITION: ; Malaria ; Diarrhoea, Respiratory tract infections Diarrhoea, Respiratory tract infections Malaria PRIMARY OUTCOME: Non‐malaria sick‐child clinic visits (SCCV) by 26 weeks from randomization SECONDARY OUTCOME: All‐cause hospital readmission by 26 weeks from randomization All‐cause mortality by 26 weeks from randomization All‐cause sick‐child clinic visits by 26 weeks from randomization Non‐severe adverse events by 26 weeks from randomization Non‐severe adverse events within 7 days after start of each course of azithromycin QTc prolongation measured by electro cardiogram (ECG) 4‐6 hours after 3rd dose of each course of azithromycin Readmission due to severe disease other than severe anaemia and severe malaria by 26 weeks from randomization Readmissions due to severe anaemia (defined as Hb <5g/dL or PCV <15% or requirement for blood transfusion based on other clinical indication) by 26 weeks from randomization Serious adverse events within 7 days after the start of each course of azithromycin, excluding primary and secondary efficacy outcomes. Serious adverse events, excluding primary and secondary efficacy outcomes, by 26 weeks from randomization INCLUSION CRITERIA: Inclusion criteria for enrolment into pre‐study screening period 1. Haemoglobin <5.0 g/dl or PCV < 15%, or requirement for blood transfusion for other clinical reasons on or during admission to the hospital 2. Aged less than 59.8 months 3. Body weight =5 kg 4. Resident in catchment area Inclusion criteria for enrolment: 1. Fulfilled the pre‐study screening eligibility criteria 2. Aged < 59.8 months 3. Clinically stable, able to take oral medication 4. participant completed blood transfusion(s) or became clinically stable without transfusion 5. Able to feed (for breastfeeding children) or eat (for older children) 6. Absence of known cardiac problems 7. Provision of informed consent by parent or guardian Inclusion criteria for randomisation: 1. Fulfilled enrolment eligibility criteria and was enrolled during recent admission 2. Aged <60 months 3. Still clinically stable, able to take to oral med