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New treatment option for Malaria
Official title Monoclonal Antibodies in Children With Severe Anaemia or Severe Malaria to Prevent Malaria After Hospital Discharge
ClinicalTrials.gov ID: NCT07082205
What this study is testing
What is Antimalarial monoclonal antibodies?
Antimalarial monoclonal antibodies is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for malaria.
Also referred to as L9LS.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background and rationale: Hospitalised children with severe anaemia remain at high risk of dying or requiring hospital readmission for at least 6 months after discharge. In highly malaria-endemic settings, malaria is a major contributor to these post-discharge readmissions and deaths.
- Phase 3: a large, late-stage study
- Time commitment: about 6 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 9
You may be able to join if
- 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...
- Resident in catchment area Eligibility criteria for enrolment
- Fulfilled the pre-study screening eligibility criteria
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Kisumu, Nyanza, Kenya
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, up to 9 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kisumu, Nyanza, Kenya. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.