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Table 2 Recent Artemisinin Combination Treatment (ACT) Studies in small children

From: Use of mefloquine in children - a review of dosage, pharmacokinetics and tolerability data

Reference[11–16]

Total No. of children

Age years/weight kg

No. of children treated

with mefloquine

Important findings

Faye B et al. [11]

A randomized trial of artesunate mefloquine versus artemether lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Senegalese children.

Am J Trop Med Hyg 82(1), 140-144, 2010

320

4-5 y

(10-20 kg)

160

The mefloquine (25 mg/kg) combination was effective > 96% and well tolerated. Even in very low weight children, vomiting in mefloquine arm was less than in comparator: 30% versus 36%

Sowunmi A et al. [12]

Therapeutic efficacy and effects of artesunate-mefloquine and mefloquine alone on malaria-associated anemia in children with uncomplicated Plasmodium falciparum malaria in southwest Nigeria.

Am J Trop Med Hyg 81(6), 979-986, 2009

342

<10 y

(7-46 kg)

342

Fever and parasite clearance were faster with artesunate-mefloquine (25 mg/kg) than with mefloquine (25 mg/kg) alone. Resolution of anemia was similar in both groups. Both regimens were effective and well tolerated.

Tietche F et al. [13]

Tolerability and efficacy of a pediatric granule formulation of artesunate-mefloquine in young children from Cameroon with uncomplicated falciparum malaria.

Am J Trop Med Hyg 82(6), 1034-1040, 2010

213

Mean age 3 y

(10-20 kg)

213

The combination was well tolerated and highly efficacious

Mayxay M et al, [14]

A phase III, randomized, non-inferiority trial to assess the efficacy and safety of dihydroartemisin-piperaquine versus artesunate-mefloquine in patients with uncomplicated Plasmodium falciparum malaria in Southern Laos.

Am J Trop Med Hyg, 83(6)1221-1229, 2010

205

< 15 y

69

Both regimens were effective, more adverse events were recorded for the AM group

Frey SG et al. [15]

Artesunate-mefloquine combination therapy in acute Plasmodium falciparum malaria in young children: a field study regarding neurological and neuropsychiatric safety.

Malaria J,9:291, 2010

220

10-20 kg

220

Mefloquine (125 mg/day) for 3 days (in combination with artesunate (50 mg/day) was well tolerated by small children with a low incidence of neurological and neuropsychiatric adverse events, mainly sleeping disorder. All events resolved spontaneously.

Ramharter M et al. [16]

Pharmacokinetics of two paediatric artesunate-mefloquine drug formulations in the treatment of uncomplicated falciparum malaria in Gabon.

J Antimicrob Chemother 60, 1091-1096, 2007

24

2-12 y

and

11-37 kg

24

Exploratory analysis of mefloquine plasma levels showed a trend towards higher concentrations in younger age groups. All children, regardless of formulation used, achieved therapeutic and post treatment prophylactic protective levels of mefloquine