Status:
TERMINATED
Randomized Trial on Effectiveness of ACTs in Ghana
Lead Sponsor:
Bernhard Nocht Institute for Tropical Medicine
Collaborating Sponsors:
Presbyterian Health Service (PHS)
Kumasi Centre for Collaborative Research (KCCR)
Conditions:
Malaria, Falciparum
Eligibility:
All Genders
6-59 years
Phase:
PHASE4
Brief 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
Detailed Description
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 h...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT00374205
Start Date
September 1 2006
End Date
October 1 2007
Last Update
November 27 2007
Active Locations (1)
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1
Agogo Presbyterian Hospital
Agogo, Asante Akim North District, Ghana