Status:
COMPLETED
Tolerability and Efficacy of Artemether-Lumefantrine Versus Artesunate + Amodiaquine in Zanzibar
Lead Sponsor:
Professor Anders Björkman
Collaborating Sponsors:
Zanzibar Malaria Control Programme
World Health Organization
Conditions:
Plasmodium Falciparum Malaria
Eligibility:
All Genders
6-59 years
Phase:
PHASE4
Brief Summary
The primary objective of the study was to determine PCR corrected cure-rates up to day 42 in children with uncomplicated malaria, treated with either Artesunate + Amodiaquine or Coartem®. Secondary o...
Detailed Description
Combination therapy, the new strategy for malaria treatment, is based on the hypothesis that two (or more) components of different mechanisms of action protect each other from development of resistanc...
Eligibility Criteria
Inclusion
- Children age 6-59 months and body weight ≥6 kg (AQ+AS); 9-59 months and body weight ≥9 kg (AL)
- Fever or history of fever in the preceding 24 hours
- Parasitemia ≥2000 ≤200.000 parasites per µl
- Informed consent given by the child's parent or other adult guardian
Exclusion
- Signs of severe malaria or other danger signs, such as: 1.Unconsciousness; 2. Not able to sit or stand; 3.Severe anaemia (Hb ≤ 5 g/dl); 4.Convulsions; 5. Shock (systolic BP\<50 mmHg); 6. Not able to drink or breastfeed; 7. Vomiting 3 times or more the past 24 hrs
- Other diseases associated with fever
- History of allergy to test drugs
- History of intake of any drugs other than paracetamol and aspirin within 3 days
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2003
Estimated Enrollment :
408 Patients enrolled
Trial Details
Trial ID
NCT03764527
Start Date
November 1 2002
End Date
February 17 2003
Last Update
December 6 2018
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