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

Completed

• Conditions: ncomplicated malaria; Infections and Infestations; Malaria

• Registration Number: ISRCTN12285821
• Lead Sponsor: K Government - Department for International Development (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06-21
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

Adults and children over the age of six months (and who weigh more than 10 kg) with uncomplicated falciparum malaria

1. Febrile illness
2. Asexual forms of P falciparum on blood slide

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
1. Comparison of the effectiveness of CPG-DDS, SP and AM-LU<br>2. Measurement of the degree of compliance with CPG-DDS and AM-LU<br>3. Observation of Adverse Events (AEs) to all three treatments<br>4. Modelling of the relative cost effectiveness of CPG-DDS, SP and AM-LU in this setting in Malawi