Skip to main content

Table 1 Clinical studies evaluating the efficacy and safety of the six-dose regimen of artemether/lumefantrine

From: The clinical efficacy of artemether/lumefantrine (Coartem®)

Study number

A025[10]

A026[11]

A028[12]

A2403[13]

B2303[14]

A2401[15]

Design

Randomized double-blind

Randomized open-label

Randomized open-label

Open-label

Randomized investigator blind

Open-label

Comparator

Four-dose regimen

MASa

MASa

-

Dispersible formulation

-

Patients

Adults & children (>2 years)

Adults & children (≥ 2 years)

Adults & adolescents (>12 years)

Infants & children (5 to 25 kg)

Infants & children (5 to <35 kg)

Adult non-immune travellers

N AL/total Geography

120/359b

150/200

164/219

310

452/899

165

 

Thailand

Thailand

Thailand

Kenya

Kenya

EU

    

Tanzania

Tanzania

Colombia

    

Nigeria

Mali

 
     

Benin

 
     

Mozambique

 

28-day PCR-corrected cure rate (evaluable pts)

96.9%

97.7%

95.5%

96.7%

97.8%

96.0%

Median time to fever clearance (h) (mITT popn)

35 (n = 59)

22 (n = 87)

29 (n = 76)

7.8 (n = 309)

7.8 (n = 311)

36.5 (n = 100)

Median time to parasite clearance (h) (mITT popn)

43.6 (n = 118)

48 (n = 149)

29.3 (n = 164)

24.0 (n = 310)

34.9 (n = 452)

41.8 (n = 162)

  1. aStudy was not designed to compare AL with mefloquine + artesunate; bAL over 60 hours; c28-day cure rate was a secondary endpoint. Abbreviations: AL, artemether/lumefantrine; MAS, mefloquine + artesunate.