Condition category
Infections and Infestations
Date applied
01/05/2015
Date assigned
10/06/2015
Last edited
01/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Melba Gomes

ORCID ID

Contact details

World Health Organization
Geneva
1211
Switzerland

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 measures

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

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

Sponsor information

Organisation

World Health Organization

Sponsor details

1211 Avenue Appia
Geneva
Geneva 27
Switzerland

Sponsor type

Other

Website

Funders

Funder type

Government

Funder name

European Commission Directorate-General for Research and Innovation

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

Belgium

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes