Post-discharge Malaria Chemoprevention(PMC) Study

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.

Conditions

• Malaria
• Severe Anemia

Interventions

DRUG

dihydroartemisinin-piperaquine

Children in both arms will receive standard in-hospital care for severe anaemia (blood transfusion, often combined with quinine or artesunate IV/IM). All children will then receive a 3-day course of AL (whether they initially had malaria or not), which will be started in-hospital as soon as they are able to take oral medication, and will be completed at home after discharge. At 2 weeks after enrolment surviving children will be randomized to receive either a standard 3-day courses of dihydroartemisinin-piperaquine (Eurartesim®, Sigma Tau, Italy) or an identical placebo regimen at 2, 6 and 10 weeks after enrolment.

DRUG

dihydroartemisinin-piperaquine placebo

Children will receive standard in-hospital care for severe anaemia (blood transfusion, often combined with quinine or artesunate IV/IM). All children will then receive a 3-day course of AL (whether they initially had malaria or not), which will be started in-hospital as soon as they are able to take oral medication, and will be completed at home after discharge. At 2 weeks after enrolment surviving children will be randomized to receive either a standard 3-day courses of dihydroartemisinin-piperaquine (Eurartesim®, Sigma Tau, Italy) or an identical placebo regimen at 2, 6 and 10 weeks after enrolment.

Sponsors & Collaborators

• The Research Council of Norway

  collaborator OTHER

• Kenya Medical Research Institute

  collaborator OTHER

• Makerere University

  collaborator OTHER

• Liverpool School of Tropical Medicine

  lead OTHER

Principal Investigators

• Dr Titus K Kwambai, MSc · Liverpool School of Tropical Medicine

• Dr Simon K Kariuki, PhD · Kenya Medical Research Institute

• Dr Richard IDRO, PhD · Makerere University

• Dr Robert Opoka, M.Med · Makerere University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Max Age

60 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-05-20

Primary Completion

2018-10-24

Completion

2018-12-12

Countries

• Kenya
• Uganda

Study Locations