Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-25 @ 3:10 AM
NCT ID:
NCT07082205
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
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
9 Years
Study:
NCT07082205
Study Brief:
Protocol Section:
NCT07082205