Trial of Artesunate Combination Therapy in Pakistan

A randomised, double-blind placebo controlled study of the efficacy of chloroquine or sulphadoxine-pyrimethamine alone and in combination with primaquine or artesunate for the treatment of uncomplicated falciparum malaria.

Arms:

• CQ
• CQ+primaquine
• CQ+ artesunate
• SP
• SP+primaquine
• SP+artesunate

Patients were allocated to treatment groups using a pseudo-randomised table split by age and sex.

Primary outcomes:

• Clinical and parasitological cure/treatment failure by day 28.

Secondary outcomes:

• time to resolution of fever
• time to clearance of trophozoites
• time to clearance of gametocytes
• gametocyte carriage on or after day 7 after treatment

All clinical assessments and slide readings were carried out by staff blind to treatment arm. Slides were double read.

Inclusion criteria

• presentation at basic health unit with suspected clinical malaria
• mono-infection infection with P. falciparum confirmed by microscopy
• over 2 years of age (no upper age restriction)
• weight over 5 kg (no upper weight restriction)
• if of child bearing age then non-pregnant and willing to remain so for the duration of the study
• greater than 1 asexual parasite per 10 fields
• understands and is willing to sign the consent form
• a resident in the study site willing to collaborate for a full period of follow-up
• no signs of severe malaria

Exclusion criteria

• other serious disease (e.g., cardiac, renal or hepatic)
• in women of child bearing age, pregnancy
• allergy to any of the study drugs or related compounds
• reports to have used any malaria drugs in the last 21 days
• other species of malaria seen
• signs of severe malaria