Condition category
Infections and Infestations
Date applied
20/04/2005
Date assigned
21/06/2005
Last edited
10/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr David Lalloo

ORCID ID

Contact details

Liverpool School of Tropical Medicine
Liverpool
L3 5QA
United Kingdom
dlalloo@liverpool.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

This study will look at the effectiveness and cost-effectiveness of Chlorproguanil-Dapsone (CPG-DDS/Lapdap) in comparison to standard Sulfadoxine-pyrimethamine (SP) and another new antimalarial combination, artemether-lumefantrine (Co-artem) and will assess the influence of poor compliance upon the clinical response to CPG-DDS and Co-artem.

Ethics approval

No ethics information provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Uncomplicated malaria

Intervention

1. Sulfadoxine-pyrimethamine
2. Chlorproguanil-dapsone (Lapdap)
3. Artemether-lumefantrine (Co-artem)

Intervention type

Drug

Phase

Not Applicable

Drug names

Sulfadoxine-pyrimethamine, Chlorproguanil-dapsone (Lapdap), Artemether-lumefantrine (Co-artem)

Primary outcome measures

Investigation of the effect of incomplete compliance with three doses of CPG-DDS upon the effectiveness of CPG-DDS in an operational setting.

Secondary outcome measures

1. Comparison of the effectiveness of CPG-DDS, SP and AM-LU
2. Measurement of the degree of compliance with CPG-DDS and AM-LU
3. Observation of Adverse Events (AEs) to all three treatments
4. Modelling of the relative cost effectiveness of CPG-DDS, SP and AM-LU in this setting in Malawi

Overall trial start date

01/05/2004

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Adults and children over the age of six months (and who weigh more than 10 kg) with uncomplicated falciparum malaria
Inclusion criteria:
1. Febrile illness
2. Asexual forms of P falciparum on blood slide

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

1500

Participant exclusion criteria

1. Severe malaria (as defined in World Health Organisation [WHO] guidelines)
2. Clinical evidence of a co-existing infection
3. Hb lower than 7 g/dl
4. Known pregnancy or positive pregnancy test (females over the age of 12)
5. Known G6PD deficiency, HbE or porphyria
6. Breast feeding mothers

Recruitment start date

01/05/2004

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Malawi

Trial participating centre

Liverpool School of Tropical Medicine
Liverpool
L3 5QA
United Kingdom

Sponsor information

Organisation

UK Government - Department for International Development (UK)

Sponsor details

1 Palace Street
London
SW1E 5HE
United Kingdom
M-Smith@dfid.gov.uk

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Department for International Development (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19709418

Publication citations

  1. Results

    Bell DJ, Wootton D, Mukaka M, Montgomery J, Kayange N, Chimpeni P, Hughes DA, Molyneux ME, Ward SA, Winstanley PA, Lalloo DG, Measurement of adherence, drug concentrations and the effectiveness of artemether-lumefantrine, chlorproguanil-dapsone or sulphadoxine-pyrimethamine in the treatment of uncomplicated malaria in Malawi., Malar. J., 2009, 8, 204, doi: 10.1186/1475-2875-8-204.

Additional files

Editorial Notes