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 designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesThis 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) studiedUncomplicated malaria
Intervention1. Sulfadoxine-pyrimethamine
2. Chlorproguanil-dapsone (Lapdap)
3. Artemether-lumefantrine (Co-artem)
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Sulfadoxine-pyrimethamine, Chlorproguanil-dapsone (Lapdap), Artemether-lumefantrine (Co-artem)
Primary outcome measureInvestigation of the effect of incomplete compliance with three doses of CPG-DDS upon the effectiveness of CPG-DDS in an operational setting.
Secondary outcome measures1. 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 date01/05/2004
Completion date31/12/2006

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participants1500
Key inclusion criteriaAdults 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 criteria1. 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 enrolment01/05/2004
Date of final enrolment31/12/2006

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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