Monoclonal Antibodies in Children With Severe Anaemia or Severe Malaria to Prevent Malaria After Hospital Discharge

Launched by LIVERPOOL SCHOOL OF TROPICAL MEDICINE · Jul 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to protect young children who have been hospitalized with severe anemia or severe malaria from getting malaria again after they leave the hospital. Malaria is a serious illness caused by a parasite, and children who have had severe malaria or very low blood levels (anemia) are at high risk of becoming sick again and needing to go back to the hospital. Right now, doctors give these children monthly medicine for three months after they leave the hospital to help prevent malaria, but it can be hard for families to keep up with this treatment and the protection only lasts about three and a half months. This study is testing a new treatment using special proteins called monoclonal antibodies that can be given as a single dose before the child leaves the hospital and might protect them for up to six months.

Children under 10 years old who were hospitalized with severe anemia or severe malaria and are now stable enough to take medicine by mouth may be eligible to join the study. After receiving regular hospital care and a short course of malaria medicine to clear any remaining infection, participants will be randomly assigned to one of two groups. One group will get the new antibody treatment by IV infusion before leaving the hospital, plus a placebo (inactive treatment) after discharge. The other group will get a placebo infusion before discharge and then take the usual monthly malaria medicine for three months after leaving the hospital. The study will follow the children for six months to see how well the antibody treatment works compared to the current monthly medicine in preventing malaria, hospital readmissions, and deaths. Parents or guardians will provide consent before their child joins, and the study carefully screens for other health conditions to make sure it is safe to participate. This trial offers a promising chance to make post-hospital malaria protection easier and longer-lasting for vulnerable children.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Inclusion criteria for enrolment into the pre-study screening period
• • Aged \<10 years of both sexes
• • Severe anaemia or severe malaria: Initially hospitalised with haemoglobin \<5.0 g/dl or PCV \<15%, or requirement for blood transfusion for other clinical reasons on or during admission to the hospital, or severe malaria, defined as a requirement for parenteral artesunate in the opinion of the treating clinician and the presence of microscopy or RDT confirmed Plasmodium infection
• • Resident in catchment area
• • Eligibility criteria for enrolment
• • Fulfilled the pre-study screening eligibility criteria
• • Post-transfusion haemoglobin \>=5.0 g/dl or PCV \>=15%
• • 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)
• • Provision of informed consent by parent or guardian Exclusion criteria for enrolment into the pre-study screening period
• Exclusion Criteria:
• • Exclusion criteria for enrolment into the pre-study screening period
• • Recognised specific other causes of severe anaemia (i.e., trauma, haematological malignancy, known bleeding disorders, such as haemophilia)
• • Sickle cell anaemia/sickle cell disease
• • Body weight \<5 kg
• • HIV infection or on daily cotrimoxazole prophylaxis
• • Exclusion criteria for enrolment
• • Previous enrolment in the present study
• • Children who are scheduled to receive any of the four doses of the malaria vaccine within 6 months after enrolment.
• • Received any RTS,S or R21 malaria vaccine primary series or booster dose within the last 14 days inclusive
• • On or eligible for cotrimoxazole prophylaxis for HIV infection or HIV exposure
• • Children with sickle cell disease because they are eligible for daily proguanil
• • Known hypersensitivity to artemether-lumefantrine or dihydroartemisinin-piperaquine
• • 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)
• • Use or known need at enrolment for concomitant prohibited medication during the first 6 months post-discharge
• • 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
• • A known need at the time of enrolment for scheduled surgery during the first 6 months post-discharge
• • Suspected non-compliance with the follow-up schedule and protocol in the opinion of the investigator
• • 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