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
Scientific
Liverpool School of Tropical Medicine
Liverpool
L3 5QA
United Kingdom
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
L3 5QA
United Kingdom
Sponsor information
UK Government - Department for International Development (UK)
Government
Government
1 Palace Street
London
SW1E 5HE
United Kingdom
M-Smith@dfid.gov.uk | |
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 |