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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12285821

Enrollment

1500

Registered

2005-06-21

Start date

2004-05-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uncomplicated malaria Infections and Infestations Malaria

Interventions

1. Sulfadoxine-pyrimethamine 2. Chlorproguanil-dapsone (Lapdap) 3. Artemether-lumefantrine (Co-artem)

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Investigation of the effect of incomplete compliance with three doses of CPG-DDS upon the effectiveness of CPG-DDS in an operational setting.	—

Secondary

Measure	Time frame
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	—

Countries

Malawi

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026