A pragmatic trial examining the effect of compliance upon clinical effectiveness and cost effectiveness of Lapdap (CPG-DDS) when compared to sulfadoxine-pyrimethamine and Co-artem (AM-LU) for the treatment of uncomplicated falciparum malaria in Malawi

ISRCTN	ISRCTN12285821
DOI	https://doi.org/10.1186/ISRCTN12285821
Protocol serial number	N/A
Sponsor	UK Government - Department for International Development (UK)
Funder	Department for International Development (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr David Lalloo
Scientific

Liverpool School of Tropical Medicine
Liverpool
L3 5QA
United Kingdom

Email	dlalloo@liverpool.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	No ethics information provided at time of registration.
Health condition(s) or problem(s) studied	Uncomplicated malaria
Intervention	1. Sulfadoxine-pyrimethamine 2. Chlorproguanil-dapsone (Lapdap) 3. Artemether-lumefantrine (Co-artem)
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Sulfadoxine-pyrimethamine, Chlorproguanil-dapsone (Lapdap), Artemether-lumefantrine (Co-artem)
Primary outcome measure(s)	Investigation of the effect of incomplete compliance with three doses of CPG-DDS upon the effectiveness of CPG-DDS in an operational setting.
Key secondary outcome measure(s)	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
Completion date	31/12/2006

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	1500
Key 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
Key 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
Date of first enrolment	01/05/2004
Date of final enrolment	31/12/2006

Liverpool School of Tropical Medicine

Liverpool
L3 5QA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	26/08/2009		Yes	No