Status:
COMPLETED
Anti-Malarial Drug Resistance in Cameroon
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
University of Yaounde
Conditions:
Malaria
Eligibility:
All Genders
6-59 years
Phase:
PHASE2
PHASE3
Brief 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 characterist...
Detailed Description
The objectives of this study are:- . * to evaluate the therapeutic efficacy of amodiaquine(AQ), Fansidar(SP) and the combination amodiaquine/Fansidar in three sites in Cameroon namely, Garoua (Sahel-...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
755 Patients enrolled
Trial Details
Trial ID
NCT00146718
Start Date
August 1 2003
End Date
May 1 2005
Last Update
January 12 2017
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