Malaria
Conditions
Interventions
Antimalarial monoclonal antibodies and Placebo chemoprevention
Placebo antimalarial monoclonal antibodies and dihydroartemisininpiperaquine
Sponsors
Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged =5.0 g/dl or PCV >=15% 5. Clinically stable, able to take 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 before hospitalisation) 6. Provision of informed consent by parent or guardian
Exclusion criteria
Exclusion criteria: 1. Recognised specific other causes of severe anaemia (i.e., trauma, haematological malignancy, known bleeding disorders, such as haemophilia) 2. Sickle cell anaemia/sickle cell disease 3. Body weight <5 kg 4. Fever (=37.5oC) on the day of enrolment is not an exclusion criterion as long as the child is considered clinically stable. 5. HIV infection or on daily cotrimoxazole prophylaxis. 6. Previous enrolment in the present study 7. Children who are scheduled to receive any of the four doses of the malaria vaccine within 6 months after enrolment. 8. Received any RTS,S or R21 malaria vaccine primary series or booster dose within the last 14 days inclusive 9. On or eligible for cotrimoxazole prophylaxis for HIV infection or HIV exposure 10. Children with sickle cell disease because they are eligible for daily proguanil 11. Known hypersensitivity to artemether-lumefantrine or dihydroartemisininpiperaquine 12. Anticipated to reside for more than 1 month of the 6-month (26 weeks) intervention period outside of the catchment area (e.g. boarding school) 13. Use or known need at enrolment for concomitant prohibited medication during the first 6 months post-discharge 14. Ongoing or planned participation in another clinical trial involving ongoing or scheduled treatment with prohibited medicinal products or active follow-up during the first 26 weeks post-discharge 15. A known need at the time of enrolment for scheduled surgery during the first 6 months post-discharge 16. Suspected non-compliance with the follow-up schedule and protocol in the opinion of the investigator 17. Known heart conditions or family history of congenital prolongation of the QTc interval, or taking medicinal products that are known to prolong the QTc interval
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical malaria defined as an illness accompanied by measured fever =37.5°C or a history of fever (subjective or objective) in the previous 24 hours, accompanied by any level of asexual parasitaemia detected by microscopy or RDT (pLDH or HRP2- band). The HRP2-band results will only be considered when microscopy or the RDT pLDH band results are unavailable. | — |
Secondary
| Measure | Time frame |
|---|---|
| First or only episode of clinical malaria from 3 to 26 weeks post-discharge, inclusive, by time-to-event analysis;Clinical malaria with parasite density >5,000/microlitre (3-26 weeks post-discharge);Sick-child clinic visits for any reason (all-cause) (3-26 weeks post-discharge);Sick-child clinic visits unrelated to malaria (all-cause minus primary outcome) (3-26 weeks post-discharge);Readmission for any reason;Cause-specific readmissions (severe malaria, severe anaemia, severe malarial anaemia, severe non-malarial anaemia, readmissions for severe malaria or severe anaemia [composite], readmission for other reasons) (3-26 weeks post-discharge);Death from any cause (3-26 weeks post-discharge);Readmission or death from any cause (composite) (3-26 weeks post-discharge).;Prevalence of malaria infection detected by microscopy, RDT or PCR (composite) at 6 months;Prevalence of malaria infection detected by microscopy at 6 months;Prevalence of malaria infection detected by RDT (any band) at 6 months;Prevalence of malaria infection detected by PCR at 6 months;Mean Hb at 6 months;Prevalence of any anaemia (Hb<11 g/dL), mild anaemia (Hb 10.0-10.99 g/dl), moderate anaemia (Hb 7.0-9.99 g/dL) and moderate-severe anaemia (Hb<7.0 g/dL) at 6 months;Mean Z-scores for mid-upper arm circumference (MUAC) for-age, weight-for-age, height-for-age, and height-for-weight (using the WHO child growth standards) at 6 months;Prevalence of mild (Z-score <-2) and severe (Z-score <-3) of low MUAC-for-age, low weight-for-age, low height-for-age, and low height-for-weight at 6 months;The incidence of the primary and key secondary endpoints from 27-52 weeks postdischarge and the prevalence and mean scores at 12 months of the same endpoints assessed at 6 months post-discharge;The incidence of clinical malaria and readmission due to severe malaria from 27 to 52 weeks post-discharge and the prevalence of malaria infection and parasite densities at 12 months | — |
Countries
Kenya
Contacts
Public ContactIwaret Otiti
Research Scientist
Outcome results
None listed