Measuring malaria transmission after drug treatment

ISRCTN	ISRCTN11805747
DOI	https://doi.org/10.1186/ISRCTN11805747
Secondary identifying numbers	061910

Submission date: 31/01/2005
Registration date: 22/07/2005
Last edited: 04/02/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Background and study aims
Malaria is a serious tropical disease spread by mosquitoes. Previous studies monitoring the success of drug treatment in curing malaria in African children had found that drugs differed in whether the cured children were prevented from passing on malaria to mosquitoes. With the new generation of combination drugs becoming widely available in the early 2000s we sought to compare these with the older drugs, and to test whether these were more effective at not only curing the disease, but in preventing further mosquito infections.

Who can participate?
Children under 12 years of age who were brought to the Farafenni hospital, in The Gambia, for malaria treatment.

What does the study involve?
The children are randomly allocated to one of the study medications, and sent home with all the drugs they would need. Our health worker team then visits each child at home (by motorbike) on subsequent days to assist with the continuing treatment, and to monitor the cure by taking small finger-prick blood samples to test for persisting parasites. Seven days after treatment the children are brought in to the study clinic and lab for a thorough check, and those with any potentially infectious parasites in their blood after checking under the microscope are asked to give an additional blood sample. This sample is then used to experimentally feed mosquitoes to check whether this child is still potentially infectious to the insects which spread malaria.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Farafenni hospital in The Gambia

When is the study starting and how long is it expected to run for?
January 2000 to December 2003

Who is funding the study?
The Wellcome Trust and MRC Laboratories (UK)

Who is the main contact?
Dr Colin Sutherland
colin.sutherland@lshtm.ac.uk

Contact information

Dr Colin Sutherland
Scientific

London School of Hygiene & Tropical Medicine
Keppel St
London
WC1E 7HT
United Kingdom

Phone	+44 (0)20 7927 2338
Email	colin.sutherland@lshtm.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title	The impact of anti-malarial treatment upon the development and persistence of Plasmodium falciparum gametocytes in vitro and in vivo
Study hypothesis	That use of artemisinin combination chemotherapy for treating uncomplicated falciparum malaria in children will reduce transmissibility of malaria to mosquitoes, compared to other combinations or to monotherapies.
Ethics approval(s)	1. LSHTM Ethics Committee, 05/09/2000, ref: 708 2. Joint Gambia Government/MRC Laboratories Ethics Committee, 06/08/2000, ref: SCC/EC 838/798. Approved annually on 20/09/2001 (ref: SCC/EC 887/844) and 14/08/2002 (ref: SCC/EC 910)
Condition	Malaria
Intervention	Combination antimalarial therapy versus established monotherapy. Single-blind open-label randomised controlled trial run over three consecutive transmission seasons in Farafenni, The Gambia.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Artemisinin combination chemotherapy
Primary outcome measure	Major endpoints were: 1. Post-treatment gametocyte carriage over 28 days 2. Infectiousness to mosquitoes of children carrying gametocytes seven days after treatment
Secondary outcome measures	Minor endpoints were: 1. Clinical and parasitological drug efficacy over 28 days of follow-up
Overall study start date	01/01/2000
Overall study end date	31/12/2003

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	1 Year
Upper age limit	10 Years
Sex	Both
Target number of participants	600
Participant inclusion criteria	1. Children one to ten years of age (either sex) attending Farafenni Health Centre, The Gambia, from September to December in each of 2000, 2001 and 2002 2. Children with a temperature more than 37.5°C, or a history of fever 3. Blood-film positive for P. falciparum at a density greater than 500 parasites per ml 4. Signed informed consent was obtained
Participant exclusion criteria	1. An inability to take drugs orally 2. Treatment with antimalarial chemotherapy within the past two weeks 3. Carriage of circulating gametocytes at presentation 4. Any evidence of chronic disease or acute infection other than malaria 5. Domicile outside the study area (approximately 10 km radius) 6. Any signs or symptoms of severe malaria: 6.1. Severe anaemia (peripheral blood Packed Cell Volume [PCV] less than 20%) 6.2. Hyper-parasitaemia (more than 250,000 per ml peripheral blood) 6.3. Respiratory distress (respiratory rate more than 40 with two of the following: nasal flaring, intercostal indrawing, subcostal recession or grunting) 6.4. Repeated generalised convulsions (three or more per 24 hours or two witnessed seizures in 24 hours) 6.5. Haemoglobinuria (dark red/black urine) 6.6. Jaundice 6.7. Prostration 6.8. Circulatory collapse
Recruitment start date	01/01/2000
Recruitment end date	31/12/2003

Locations

Countries of recruitment

England
Gambia
United Kingdom

Study participating centre

London School of Hygiene & Tropical Medicine

London
WC1E 7HT
United Kingdom

Sponsor information

London School of Hygiene and Tropical Medicine (UK)
University/education

Research Grants and Contracts Office
Keppel Street
London
WC1E 7HT
England
United Kingdom

Phone	+44 (0)20 7827 2678
Email	Penny.Ireland@lshtm.ac.uk
Website	http://www.lshtm.ac.uk
"ROR"	https://ror.org/00a0jsq62

Funders

Funder type

Charity

The Wellcome Trust (UK) (grant ref: 061910)

No information available

MRC Laboratories (The Gambia) - Scientific Coordinating Committee (Projects: 838, 887 and 910)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	01/12/2002	Yes	No
Results article	results	01/07/2003	Yes	No
Results article	results	01/01/2004	Yes	No
Results article	results	01/10/2004	Yes	No
Results article	results	28/05/2008	Yes	No

Editorial Notes

04/02/2016: Publication reference added.