Plain English Summary
Background and study aims
Malaria is a serious tropical disease spread by infected mosquitoes. The main victims of malaria infection are African children aged 5 and under. Around 90% of all malaria deaths occur in Africa. If a person is bitten by an infected mosquito, they become infected with parasites (plasmodium species) which multiply in the liver and later infect a person’s red blood cells. The symptoms of malaria infection include high temperature, headaches and vomiting. The symptoms usually appear around 2 weeks after being infected, but they can sometimes take much longer to appear. Quick diagnosis and treatment of malaria is very important because malaria can become life-threatening very quickly, and fast treatment most often results in a full recovery. Malaria is categorised as either uncomplicated or severe (complicated); severe malaria is associated with complications such as organ failure or other blood abnormalities. Antimalarial medication is used to treat infection, and there are different types available which are given depending on various factors, such as the type of malaria infection and severity of symptoms. Some progress has been made in the fight against malaria, such as the improved availability of rapid diagnostic test (RDT) kits and artemisinin-based combination therapies (ACTs). The aim of this study is to test a malaria RDT package in the community to see how well it works, how cost-effective it is and whether it could work on a larger scale. The malaria RDT package used in this study aims to diagnose and treat both uncomplicated and severe malaria and will be available from participating community health sites for a 12 month period.
Who can participate?
Children aged 6-59 months with feverish illness in the previous 24 hours.
What does the study involve?
All children aged between 6 and 59 months with fever that attend community health sites during the 12 months of intervention are offered a RDT. Children who are diagnosed positive for uncomplicated malaria are treated with the ACT artemether-lumefantrine. Children with a fever or recent history of fever, and those who are unable to take oral medications, are treated with rectal artesunate for severe malaria.
What are the possible benefits and risks of participating?
Policies in the countries participating in the study are to test, treat and track post-treatment, and this study is following country policies for uncomplicated malaria. For severe illnesses, there is a risk that patients will not comply with referral advice to proceed to the hospital.
Where is the study run from?
1. Group Health Research in Action (Group de Recherche Action en Sante (GRAS)) (Burkina Faso)
2. Ministry of Health (Uganda)
3. University of Ibadan (Nigeria)
When is the study starting and how long is it expected to run for?
May 2015 to September 2015
Who is funding the study?
European Commission Directorate-General for Research and Innovation (Belgium)
Who is the main contact?
Dr M Gomes
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
A80550 A80553 A80556
Study information
Scientific title
Feasibility, acceptability and costs of diagnosis and management of uncomplicated and severe malaria in the community
Acronym
Study hypothesis
This is a non-randomised multi-centre community based intervention to assess the feasibility, acceptability and cost-effectiveness of a diagnostic and treatment package for malaria.
Ethics approval
World Health Organization Ethics Review Committee, 10/12/2009, refs: A80550-Nigeria, A80553-Burkina, A80556-Uganda.
Study design
Observational study of community based diagnosis and management of malaria.
Primary study design
Observational
Secondary study design
Epidemiological study
Trial setting
Community
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Uncomplicated and severe malaria
Intervention
For the 12 month intervention period:
1. Diagnosis at point of care with a rapid diagnostic test (RDT)
2. Treatment of uncomplicated RDT positive cases with artemeter-lumefantrine (artemisinin combination treatment) and treatment of severe cases with rectal artesunate
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
Feasibility, acceptability, costs of a diagnosis and treatment package in the community. Severe malaria cases are followed up (to monitor compliance with referral advice, and vital status/wellbeing at follow up), and uncomplicated cases are monitored for diagnosis and treatment.
Secondary outcome measures
Treatment seeking behaviour and promptness of access to diagnosis and care.
Overall trial start date
01/05/2015
Overall trial end date
30/09/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Febrile children aged 6 months to 59 months.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Unspecified. This is an observational study and the number of participants will depend upon malaria transmission.
Participant exclusion criteria
Age below 6 months or above 59 months.
Recruitment start date
01/09/2015
Recruitment end date
30/09/2015
Locations
Countries of recruitment
Uganda
Trial participating centre
Group Health Research in Action (Group de Recherche Action en Sante (GRAS))
Ouagadougou
-
Burkina Faso
Trial participating centre
Ministry of Health
Plot 6/P.O. Box 7272 Lourdel Rd
Kampala
-
Uganda
Trial participating centre
University of Ibadan
College of Medicine
Ibadan
-
Nigeria
Funders
Funder type
Government
Funder name
European Commission Directorate-General for Research and Innovation
Alternative name(s)
EC DG Research
Funding Body Type
private sector organisation
Funding Body Subtype
International organizations
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date.
Intention to publish date
30/12/2016
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2016 results in https://www.ncbi.nlm.nih.gov/pubmed/27941101 (added 22/01/2019)