Randomized Trial on Effectiveness of ACTs in Ghana

• Status: Terminated
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effectiveness and safety of two Artemisinin Combination Therapies (ACTs) for the treatment of children with uncomplicated Plasmodium falciparum malaria

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bernhard Nocht Institute for Tropical Medicine
• Collaborators: Kumasi Centre for Collaborative Research (KCCR); Presbyterian Health Service (PHS); School of Medical Sciences Kumasi (SMS/KNUST)
• Treatments: Amodiaquine; Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Artesunate; Lumefantrine

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