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
-
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.