Dihydroartemisinin-Piperaquine or Sulphadoxine-Pyrimethamine for the Chemoprevention of Malaria in Children With Sickle Cell Anaemia in Eastern and Southern Africa: a Double Blind Randomised Trial (CHEMCHA)

Study point of contact

Kamija Phiri, PhD
+265 999 957 048;
[email protected]
Richard Idro, PhD
+256 774274173
[email protected]

Age

6 to 15 Years

Genotypes

HbSS

Phase

Phase 2/Phase 3

Study type

Interventional

Gender

All

Interventions

Drug

Compensation

Unknown

About the study

Sickle Cell Anaemia (SCA) is an inherited disease that makes the body produce red blood cells
with abnormal sickle-shaped cells. The sickle-shaped cells are rigid, not flexible and break
up easily resulting in anaemia. The abnormal cells also stick to the vessel walls, causing a
blockage that slows or stops the flow of blood. When this happens, oxygen cannot reach nearby
tissues. The lack of oxygen can cause attacks of sudden, severe pain, called pain crises,
stroke or damage to important organs such as the spleen. All of these can lead to death.
These attacks can occur without warning and are often started and made worse by infections
such as malaria. Therefore, in many countries in Africa where malaria is common, children
with SCA are given malaria medicines to prevent the infection. However, many of the medicines
do not work effectively, are too difficult to take or they have side effects, resulting in
poor adherence.

The aim of this study is to find safe, acceptable and effective medicines for malaria
prevention in children with SCA in eastern and southern Africa. The investigators propose to
conduct a study to find out whether giving weekly doses of dihydroartemisinin-piperaquine,
also called DP, is safe, more effective, acceptable and cost-effective than the current
strategy of monthly sulphadoxine-pyrimethamine (SP) to prevent malaria in children with
sickle cell anaemia. Overall, 548 children aged 6 months to 15 years will be chosen randomly
to receive either weekly DP or monthly SP for about 18 months. To test if the study medicine
is effective, the study will compare the case burden of malaria. The investigators will also
monitor every child for any type of illness, blood transfusions and other complications of
sickle cell anaemia and admissions to the hospital. In addition, the study will evaluate the
impact of DP on the development of resistance by malaria parasites. The study will also
include nested safety studies on the effect of DP on the heart. All study participants will
receive all the other usual care and treatments, including patient education on home care,
and daily penicillin if younger than 5 years. If proven safe and efficacious,
chemoprophylaxis with DP may decrease the incidence of malaria in children with SCA, prevent
ill-health and deaths, and improve wellbeing.

participation requirements

1. Children ages 6 months – 15 years

2. Has a laboratory diagnosis of Sickle Cell Anaemia (HbSS) on haemoglobin
electrophoresis, High-Performance Liquid Chromatography or Iso-electric focusing;

3. Weighs ≥5kg;

4. The parent has provided written consent.

participation restrictions

1. Known chronic disease e.g. congenital heart disease;

2. Known red cell disorder e.g. thalassaemia, glucose-6-phosphate dehydrogenase
deficiency;

3. Known allergy to DP or SP;

4. Receiving daily cotrimoxazole prophylaxis;

5. Unlikely to comply with the follow-up schedule;

6. Participating in another trial