Randomized Trial on Effectiveness of ACTs in Ghana

Launched by BERNHARD NOCHT INSTITUTE FOR TROPICAL MEDICINE · Sep 8, 2006

Keywords

ClinConnect Summary

Childhood mortality related to Plasmodium falciparum malaria is on the rise with more than 1 million deaths per year in Sub-Saharan Africa. In the context of growing drug-resistance to antimalarials health officials are calling for rapid replacement of failing drugs by combining antimalarial drugs. Artemisinin Combination Antimalarial Therapies (ACTs) are in the focus of malaria control programmes and are recommended for first-line treatment in African countries. ACTs have been reported to be highly effective as artemisinin derivatives cause a rapid and substantial decrease in the parasite ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male and female outpatients aged 6 months to 59 months
• • Absence of severe malnutrition
• • A slide-confirmed P. falciparum asexual parasitaemia between 2,000/µl and 200,000/µl
• • A measured axillary temperature ≥ 37.5 °C or rectal/tympanic temperature ≥ 38.0 °C
• • Absence of general danger signs (unable to drink; repeated vomiting; recent history of convulsions; lethargic or unconscious state; unable to stand up or to sit)
• • Ability to tolerate oral therapy
• • Permanent residence in study area
• • Informed consent by the legal representative of the subject, if possible, the parents
• Exclusion Criteria:
• • Adequate anti-malarial treatment within the previous 7 days
• • Antibiotic treatment for a current infection
• • Previous participation in a clinical trial
• • Haemoglobin \< 5 g/dl
• • Leucocyte count: \> 15000/µl
• • Mixed plasmodial infection
• • Severe malaria as defined by WHO recommendations
• • Any other severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection) or concomitant disease masking assessment of response
• • History of allergy or intolerance against trial medication