Anti-Malarial Drug Resistance in Cameroon

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The project is a three-armed study designed to evaluate the efficacy of amodiaquine(AQ), sulphadoxine-pyrimethamine(SP) and(AQ+SP) in three sites in Cameroon that differ in their baseline characteristics for malaria. In addition, drug resistance will be determined by measurement of blood drug levels,and identification of molecular markers of resistance.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: London School of Hygiene and Tropical Medicine
• Collaborator: University of Yaounde
• Treatments: Amodiaquine; Antimalarials; Pyrimethamine; Sulfadoxine

Criteria

Inclusion criteria:

• Children 6-59 months of age

• Recorded temperature between 37.5oC and 39.5 oC

• Signs/symptoms of acute uncomplicated P. falciparum malaria.

• Positive microscopy for mono-infection with P falciparum malaria

• Asexual blood stage parasitaemia in the range 1,000 to 100,000 asexual parasites per ul

• Consent from parent or guardian of a child.

• No other apparent cause for the child's illness.

Exclusion criteria:

• Presence of signs of severe complicated falciparum malaria.

• Cerebral malaria (unrousable coma)

• Vomiting > twice within preceding 24 hours

• More than one convulsion within preceding 24 hours

• Inability to drink or breast-feed, or to take oral medication

• Haemoglobin less than 5g/dl or a hematocrit of less than 15%.

• Documented evidence of adequate treatment with drugs expected to be effective in the preceding 72 hours

• Presence of underlying diseases (cardiac, renal, hepatic,malnutrition, gastrointestinal)

• History of allergy to study drug

• Inability to attend for the stipulated follow-up visits,

• Difficulty in accessing the health facility, or any situation or condition which may compromise the patients ability to comply with the trial procedures.