Post-discharge Malaria Chemoprevention(PMC) Study

• Status: Completed
• Trial end date: 2018-12-12
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the efficacy and safety of 3 months of malaria chemoprevention post-discharge using dihydroartemisinin piperaquine (DHA-P) in children under 5 years of age admitted with severe anemia. One half will receive monthly DHA-P and the other half placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Liverpool School of Tropical Medicine
• Collaborators: Kenya Medical Research Institute; Makerere University; The Research Council of Norway
• Treatments: Artemisinins; Artenimol; Dihydroartemisinin; Piperaquine

Criteria

Inclusion Criteria:

• Pre-study screening

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 59.5 months

3. Body weight >5 kg

4. Resident in catchment area Enrolment in study(t=0)

1. Fulfilled the pre-study screening eligibility criteria

2. Aged < 59.5 months

3. Clinically stable, able to take oral medication

4. Subject 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 know cardiac problems

7. Provision of informed consent by parent or guardian Randomisation (t=2 weeks)

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:

• Pre-study screening

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 2 weeks 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 Enrolment in study (t=0)

1. Previous enrolment in the present study

2. Known hypersensitivity to study drug

3. Sickle cell disease

4. Use or known need at the time of enrolment for concomitant prohibited medication during the 14 weeks PMC treatment period.

5. Ongoing or planned participation in another clinical trial involving ongoing or scheduled treatment with prohibited medicinal products or active follow-up during the course of the study (6 months from enrolment)

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. Know heart conditions, or family history of congenital prolongation of the QTc interval.

9. Taking medicinal products that are known to prolong the QTc interval Randomisation (t=2 weeks)

1. Used dihydroartemisinin since enrolment

2. Use or known need at the time of randomisation for concomitant prohibited medication during the 14 weeks PMC 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