Trial of Artesunate Combination Therapy in Pakistan

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is an evaluation of the benefit of adding artesunate to existing first and second line antimalarial therapies in Pakistan.

A placebo controlled trial was carried out to assess two potential benefits of Artesunate Combination Therapy (ACT): efficacy and potential for transmission reduction.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: London School of Hygiene and Tropical Medicine
• Collaborator: HealthNet TPO
• Treatments: Artemisinins; Artesunate; Chloroquine; Chloroquine diphosphate; Fanasil, pyrimethamine drug combination; Primaquine; Pyrimethamine; Sulfadoxine

Criteria

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