Artemisinin-based combination therapy for ... - The Cochrane Library

Hasugian 2005 IDN (Continued)
Blinding?
All outcomes
Incomplete outcome data addressed?
All outcomes
No An open-label trial. ’All slides were read by
a certified microscopist who was blinded to
treatment allocation’.
No The primary outcome data are unpublished
data including only participants with P. falciparum
mono or co-infection at baseline.
High losses to follow up in both groups
at day 42 (21% DHA-P vs 24.5 % AL6),
moderate at day 28 (16.6% DHA-P vs 18.8
% AL6).
Free of selective reporting? Yes All WHO outcomes reported. Day 42
outcomes may underestimate failure with
DHA-P due to its long half-life.
Free of other bias? Yes No other sources of bias identified
Hutagalung 2002 THA
Methods Trial design: An open-label randomized controlled trial
Follow up: Examination and malaria film daily until fever and parasites cleared then
weekly to day 42 or any other day they became unwell
P. vivax during follow up was treated with CQ and continued in follow up
Adverse event monitoring: At each visit a questionnaire on adverse events was completed
Participants Number: 490 randomized
Inclusion criteria: Weight > 10 kg, slide confirmed P. falciparum, informed consent
Exclusion criteria: Pregnancy, clinical or laboratory signs of severe illness and/or severe
and complicated malaria severe malaria, treatment with mefloquine in previous 63 days
Interventions 1. Artemether-lumefantrine, fixed dose combination, 20 mg/120 mg tablets (Coartem:
Novartis)
• < 15 kg 1 tablet twice daily for 3 days
• 15 to 24 kg 2 tablets twice daily for 3 days
• 25 to 34 kg 3 tablets twice daily for 3 days
• > 35 kg 4 tablets twice daily for 3 days
• Plus glass of chocolate milk with each dose
2. Artesunate plus mefloquine, loose combination (Artesunate: Guilan, Lariam: Hoffman-La
Roche)
• AS 4 mg/kg once daily for 3 days
• MQ 15 mg/kg on day 1 and 10 mg/kg on day 2
All doses supervized
Outcomes 1. Cure rates at days 42 and 28, PCR adjusted and unadjusted
2. P. vivax parasitaemia during follow up
3. Gametocyte development
4. Mean decrease in HCT by day 7
Artemisinin-based combination therapy for treating uncomplicated malaria (Review)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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