Clinical Trials Logo

Clinical Trial Summary

This cohort event monitoring will document real-life safety experiences following the intake of Injectable AS. Specifically, the study will record common adverse events that are associated with the use of Inj. AS and associating factors such as age and gender that make some of these events more likely. The sample size of 3000 patients will enable the documentation of causally-related events that occur at frequencies of 1 in 1000 or more. Since quinine, the previous gold standard for treating severe malaria may still be used by facilities in addition to artesunate and artemether, the study will concurrently monitor the safety of these products though focus of the study is the capture of adverse events following exposure to Inj. AS. The concurrent monitoring of both quinine and artemether will also enable treatment practices in the study areas to be documented.


Clinical Trial Description

Malaria is a preventable and treatable disease caused by Plasmodium species. In 2015, It was estimated that, about 1.8 million cases of malaria and about 400, 000 deaths were reported, 90% of which are in Africa. Those children who do not die may suffer brain damage or experience cognitive and learning deficits as a result of the disease severity. Though significant progress has been made in the last decade towards achieving global malaria targets, the disease burden is still relatively high in sub-Saharan African countries, especially among children <5 years of age.

Injectable artesunate (Inj. AS) is a life-saving medication indicated for the treatment of severe/complicated malaria either intravenously or intramuscularly. The current version (3rd edition) of the World Health Organization (WHO) Guidelines for the Treatment of Malaria strongly recommends, based on high-quality evidence, that adults and children with severe malaria should be treated with "intravenous or intramuscular artesunate". Injectable Artesunate is prequalified under the WHO Prequalification Scheme. It has received marketing authorization in nearly all malaria-endemic countries and millions of doses have been distributed for use in the management of severe malaria.

Despite the widespread usage of Inj. AS, the safety database for the product is nearly empty with the WHO Individual Case Safety Reports (ICSR) database containing only 2622 reports to artesunate including Inj AS. Inj AS is considered a safe product even though there have been reports of rare but serious haematological reactions in relation to its use including post-treatment haemolysis and subsequent anaemia, some of them life-threatening and requiring blood transfusion. Experts agree that the benefits of Inj. AS far outweigh any risks it may pose and this formed the basis for the WHO recommendation for the use of Inj. AS as the first product of choice for treating severe malaria except where it is not available and in which case parenteral artemether is recommended conditionally. In view of the millions of doses of Inj AS deployed and used each year, it is important to undertake focused, intensive safety surveillance of the medicine to obtain continuous evidence on its benefits-risk profile and also to prevent undocumented or rare but serious adverse events acting as barriers to its uptake.

Apart from the detailed well-collected safety information obtained during clinical trials, there is no published information on the real-life safety experience of Inj. AS in large cohorts of patients. This study is therefore designed to obtain real-life safety experience of Inj. AS when used in actual practice settings in 4 African countries - Ethiopia, Ghana, Malawi and Uganda. The study is designed as a prospective, observational, longitudinal cohort study of patients administered Inj AS in the course of normal clinical practice. The method used is cohort event monitoring which has been deployed for the study of antimalarials and is being suggested as a key method for several post-authorisation safety studies ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02817919
Study type Observational
Source African Collaborating Centre for Pharmacovigilance
Contact
Status Completed
Phase
Start date May 2016
Completion date March 2017

See also
  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
Withdrawn NCT02793414 - Diagnostic Utility of Volatile Organic Compounds in Human Breath for Acute Clinical Malaria in Ethiopia
Completed NCT02909712 - Cardiac Safety of Dihydroartemisinin-Piperaquine Amongst Pregnant Women in Tanzania Phase 2
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