Tolerability and Efficacy of CD+A Compared to AQ+SP for the Treatment of P.Falciparum Malaria in Rwandan Children

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

In 2005-2006, a clinical trial was carried out to test safety, tolerability and efficacy of the combination chlorproguanil-dapsone+artesunate (CD+A): 800 children aged 12-59 months with uncomplicated P. falciparum malaria randomly allocated to AQ+SP or CD+A were followed up until day 28 after treatment. Adverse events, clinical and parasitological outcomes were recorded.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: London School of Hygiene and Tropical Medicine
• Collaborator: Institute of Tropical Medicine, Belgium
• Treatments: Artemisinins; Artesunate; Chlorproguanil; Dapsone; Proguanil

Criteria

Inclusion Criteria:

• Age 12-59 months;

• Weight ≥5 kg;

• Monoinfection with P. falciparum;

• Parasite density between 2,000-200,000/µL;

• Fever (axillary body temperature =>37.5C) or history of fever in the preceding 24 hours;

• Packed Cell Volume (PCV) >21%.

Exclusion Criteria:

• Severe malaria;

• Mixed malaria infection;

• Any other concomitant illness or underlying disease;

• Known allergy to the study drugs being used in this trial;

• Clear history of adequate antimalarial treatment in the previous 72 hours.