Malaria Diarrhoea, Respiratory tract infections
Conditions
Interventions
Azithromycin
Sponsors
Training and Research Unit of Excellence
Eligibility
Sex/Gender
All
Inclusion criteria
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 medication, able to feed (for breastfeeding children) or eat (for older children) and able to sit unaided (for older children who were already able to do so prior to hospitalisation)
Exclusion criteria
Exclusion criteria: Exclusion criteria for enrolment into pre-study screening period 1. Recognised specific other cause of severe anaemia (e.g. trauma, haematological malignancy, known bleeding disorder). 2. Known sickle cell disease. 3. Anticipated to reach the 5th birthday (60 months of age) within 1 week from enrolment (i.e. prior to randomization). 4. Child will reside for more than 25% of the 6 months study period (i.e. 6 weeks or more) outside of catchment area. 5. Hereditary polymorphisms, other than sickle cell disease, that are known to provide protection against severe forms of malaria 6. Cotrimoxazole prophylaxis (usually due to HIV infection or exposure) Exclusion criteria for enrolment: 1. Previous enrolment in the present study 2. Known hypersensitivity to study medication 3. Known sickle cell disease 4. Use or known need at the time of enrolment for concomitant prohibited medication during the 17 weeks intervention period 5. Ongoing or planned participation in another clinical trial 6. A known need at the time of enrolment for scheduled surgery during the subsequent course of the study (6 months from enrolment) 7. Suspected non-compliance with the follow-up schedule 8. Known heart conditions, or family history of congenital prolongation of the QTc interval. 9. Taking other medicinal products that are known to prolong the QTc interval Exclusion criteria for randomisation: 1. Used AZ since enrolment 2. Use or known need at the time of randomisation for concomitant prohibited medication during the 16 weeks PDMC treatment period. 3. Enrolled, or known agreement to enrol into another clinical trial involving ongoing or scheduled treatment with medicinal products during the course of the study (6 months from enrolment) 4. A known need at the time of randomisation for scheduled surgery during the subsequent course of the study (6 months from enrolment) 5. Suspected non-compliance with the follow-up schedule 6. Withdrawal of consent since enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-malaria sick-child clinic visits (SCCV) by 26 weeks from randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause sick-child clinic visits by 26 weeks from randomization;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;All-cause hospital readmission by 26 weeks from randomization;All-cause mortality by 26 weeks from randomization;Serious adverse events, excluding primary and secondary efficacy outcomes, 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.;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 | — |
Countries
Kenya, Malawi, Uganda
Contacts
Public ContactKamija Phiri
Director
Outcome results
None listed