Malaria Clinical Trial
Official title:
An Individually Randomised Trial of Seasonal Malaria Chemoprevention Versus a Long-acting Artemisinin Combination Therapy for the Prevention of Malaria and Anaemia in Children Living in an Area of Extended Seasonal Transmission in Ghana.
In areas of Africa where malaria is only a problem during a short rainy season, monthly
courses of antimalarial drugs can provide very effective prevention of malaria in children.
This approach, called intermittent preventive treatment in children (IPTc) but now known as
Seasonal Malaria Chemoprevention (SMC), may also be useful in large areas of Africa where
malaria is transmitted for longer each year. It is uncertain if IPTc would be effective,
acceptable to communities or sustainable when delivered over a longer period, but this is an
important public health question of key interest to policy makers, because in areas with a
longer transmission season, the burden of malaria is typically higher than in highly
seasonal areas.
Another form of prevention that would be operationally easier for African countries to put
into practice would be to treat malaria patients with long-lasting antimalarials, which
protect children against further malaria episodes for several weeks. Because malaria
disproportionately affects certain high risk children more than others, causing repeated
attacks of fever and leading to severe anaemia, long-acting drugs may be a simple and
effective way to target limited resources at the individuals who most need protection. This
may be particularly beneficial where malaria is a seasonal problem, because repeated malaria
attacks will not only be borne by a few unfortunate children, but will also occur close
together in time.
The investigators propose a clinical trial to evaluate these two forms of chemoprevention in
Kumasi, Ghana, an area with an extended malaria transmission season. Children under 5 years
of age currently have access to diagnosis and treatment of malaria via by community based
health workers. Children enrolled in the study will receive either the standard
community-based diagnosis and treatment, treatment with a longer-acting artemisinin
combination therapy (ACT), or standard care plus five monthly courses of seasonal malaria
chemoprevention (SMC) during the peak in transmission.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04601714 -
Baseline Cohort Malaria Morbidity Study
|
||
| Withdrawn |
NCT04020653 -
A Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy (ACT) in Adult Patients With Uncomplicated Malaria
|
Phase 2 | |
| Terminated |
NCT04368910 -
Safety and Efficacy of Pyronaridine Artesunate Vs Chloroquine in Children and Adult Patients With Acute Vivax Malaria
|
Phase 3 | |
| Completed |
NCT03641339 -
Defining Skin Immunity of a Bite of Key Insect Vectors in Humans
|
N/A | |
| Completed |
NCT02544048 -
Markers of T Cell Suppression: Antimalarial Treatment and Vaccine Responses in Healthy Malian Adults
|
||
| Completed |
NCT00527163 -
Role of Nitric Oxide in Malaria
|
||
| Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
| Active, not recruiting |
NCT04704674 -
Community Dynamics of Malaria Transmission in Humans and Mosquitoes in Fleh-la and Marshansue, Salala District, Bong County, Liberia
|
||
| Completed |
NCT03276962 -
Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age
|
Phase 2 | |
| Completed |
NCT04966871 -
Safety, Tolerability and Efficacy of PfSPZ Vaccine Against Heterologous CHMI in US Malaria naïve Adults
|
Phase 1 | |
| Completed |
NCT00289185 -
Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants
|
Phase 2 | |
| Recruiting |
NCT03937817 -
Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
|
||
| Active, not recruiting |
NCT06153862 -
Africa Ready Malaria Screening
|
N/A | |
| Completed |
NCT04545905 -
Antenatal Care as a Platform for Malaria Surveillance: Utilizing Community Prevalence Measures From the New Nets Project to Validate ANC Surveillance of Malaria in Burkina Faso
|
||
| Recruiting |
NCT06278181 -
Diabetes, Metabolic Syndrome and Risk of Malaria in Cameroon
|
||
| Completed |
NCT02909712 -
Cardiac Safety of Dihydroartemisinin-Piperaquine Amongst Pregnant Women in Tanzania
|
Phase 2 | |
| Withdrawn |
NCT02793414 -
Diagnostic Utility of Volatile Organic Compounds in Human Breath for Acute Clinical Malaria in Ethiopia
|
||
| Withdrawn |
NCT02793388 -
A Trial on Supervised Primaquine Use in Ethiopia
|
Phase 4 | |
| Completed |
NCT02793622 -
Prevention of Malaria in HIV-uninfected Pregnant Women and Infants
|
Phase 3 | |
| Completed |
NCT02605720 -
Cardiac Safety of Repeated Doses of Dihydroartemisinin-Piperaquine for the Use in Mass Treatment Campaigns
|
Phase 3 |