Malaria Clinical Trial
— CHEMCHAOfficial title:
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)
NCT number | NCT04844099 |
Other study ID # | 19-105 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | April 9, 2021 |
Est. completion date | July 12, 2023 |
Verified date | September 2022 |
Source | Liverpool School of Tropical Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 723 |
Est. completion date | July 12, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 15 Years |
Eligibility | Inclusion criteria 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. Exclusion Criteria: 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 |
Country | Name | City | State |
---|---|---|---|
Malawi | Queen Elizabeth Hospital | Blantyre | |
Uganda | Jinja Regional Referral hospital | Jinja | |
Uganda | Kitgum General Hospital | Kitgum |
Lead Sponsor | Collaborator |
---|---|
Liverpool School of Tropical Medicine | Global Health Uganda LTD, Indiana University, Makerere University, University of Bergen, University of Malawi |
Malawi, Uganda,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of clinical malaria | An episode of malaria will be defined as a history of fever in the preceding 48hrs or documented axillary temperature =37.5 degrees centigrade plus microscopy confirmed Plasmodium falciparum malaria | 18 months | |
Secondary | All cause sick visits | The incidence of all cause sick visits | 18 months | |
Secondary | Incidence of malaria parasitaemia | The incidence of malaria parasitaemia | 18 months | |
Secondary | Malaria specific sick visits | The incidence of malaria-specific sick visits | 18 months | |
Secondary | All-cause and malaria-specific hospitalisation | The incidence of all-cause and malaria-specific hospitalisation | 18 months | |
Secondary | Sickle Cell Anaemia-related vaso-occlusive events | The incidence of SCA-related vaso-occlusive events (including severe pain events and dactylitis); acute chest syndrome, stroke and need for blood transfusion | 18 months | |
Secondary | Death | The incidence of death. | 18 months | |
Secondary | QTc prolongation | Change in Corrected QT interval (QTc) length and QTc-prolongation on four-monthly ECG recordings. | 18 months | |
Secondary | Serious cardiac adverse events | Incidence of serious cardiac adverse events (e.g., convulsions or syncope within 48 hours after drug intake) | 18 months | |
Secondary | Serious adverse events | Incidence of serious adverse events | 18 months | |
Secondary | Tolerance - vomiting | Vomiting the study drug within 30 min of administration;
Incidence of gastrointestinal complaints. |
18 months | |
Secondary | Other gastro-intestinal complaints | Incidence of gastrointestinal complaints. | 18 months | |
Secondary | Level of adherence | Level of adherence to study drugs | 18 months | |
Secondary | Provider costs | Provider costs of delivering the interventions and provider costs of managing malaria in SCA children. | 18 months | |
Secondary | Direct and indirect costs | Direct and indirect costs of patients receiving the interventions and managing cases of malaria. | 18 months | |
Secondary | Incremental cost-effectiveness | Incremental cost-effectiveness of replacing current standards of care (SP) with DP or DP+SP from the perspectives of the health care provider and the society. | 18 months |
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