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
Secondary identifying numbers	N/A

Submission date: 20/04/2005
Registration date: 21/06/2005
Last edited: 10/02/2010

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 of protocol

Not provided at time of registration

Contact information

Dr David Lalloo
Scientific

Liverpool School of Tropical Medicine
Liverpool
L3 5QA
United Kingdom

Email	dlalloo@liverpool.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Sulfadoxine-pyrimethamine, Chlorproguanil-dapsone (Lapdap), Artemether-lumefantrine (Co-artem)
Primary outcome measure	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 study start date	01/05/2004
Completion date	31/12/2006

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	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

Locations

Countries of recruitment

England
Malawi
United Kingdom

Study participating centre

Liverpool School of Tropical Medicine

Liverpool
L3 5QA
United Kingdom

Sponsor information

UK Government - Department for International Development (UK)
Government

1 Palace Street
London
SW1E 5HE
United Kingdom

Email	M-Smith@dfid.gov.uk
"ROR"	https://ror.org/05rf29967

Funders

Funder type

Government

Department for International Development (UK)

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