PMID- 14636982
OWN - NLM
STAT- MEDLINE
DCOM- 20040120
LR  - 20190922
IS  - 0001-706X (Print)
IS  - 0001-706X (Linking)
VI  - 89
IP  - 1
DP  - 2003 Dec
TI  - Randomised efficacy and safety study of two 3-day artesunate rectal 
      capsule/mefloquine regimens versus artesunate alone for uncomplicated malaria in 
      Ecuadorian children.
PG  - 47-53
AB  - The combination of artesunate and mefloquine is one of the most effective 
      treatments against multidrug-resistant falciparum malaria. Experience in children 
      is however limited. The objective of this study was to compare the efficacy and 
      safety of two artesunate/mefloquine combinations with artesunate monotherapy in 
      Ecuadorian children. A total of 150 children with an age between 2 and 12 years, 
      confirmed to have uncomplicated falciparum malaria, were randomly selected and 
      divided in three treatment groups of 50 patients each. Group 1 received 50 mg 
      rectal capsules alone (40 mg/kg total dose) administered over 6 days. Group 2 
      received 50 mg rectal capsules (30 mg/kg total dose) for 3 days combined with 
      mefloquine (20 mg/kg total dose) on day 1. Group 3 was treated with 50 mg rectal 
      capsules (30 mg/kg total dose) for 3 days, combined with mefloquine on days 1 and 
      3 (15-17 mg/kg total dose). Patients were continuously followed up and controlled 
      by clinical and laboratory examinations for 7 days as well as on days 14, 21 and 
      28. An additional parasite examination was performed at 2 months following 
      therapy. Clearance of parasitaemia was comparable between treatment groups. These 
      were 9.2, 9.2 and 8.3 h for Groups 1, 2 and 3, respectively. Cure rates at day 28 
      were 76, 96 and 94% and after 2 months 60, 88 and 80%, respectively. There were 
      no adverse events (AEs) reported during the study. Vital signs and laboratory 
      examinations revealed no changes of clinical relevance. It can be concluded that 
      the combination of artesunate rectal capsules with mefloquine is effective and 
      safe. Starting concomitant administration already on day 1 is well tolerated. 
      This combination significantly reduces the incidence of recrudescence compared to 
      artesunate monotherapy. Comparing the two tested artesunate/mefloquine regimens, 
      a total mefloquine dose of 20 mg/kg seems to be more effective compared to a 
      total dose of 15-17 mg/kg. Further studies seem to be warranted.
FAU - Gomez, E A
AU  - Gomez EA
AD  - Medical Sciences Faculty, Institute of Biomedicine, Catholic University, P.O. Box 
      593 04 4671, Guayaquil, Ecuador. egolandires@yahoo.es
FAU - Jurado, M H
AU  - Jurado MH
FAU - Cambon, N
AU  - Cambon N
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - Netherlands
TA  - Acta Trop
JT  - Acta tropica
JID - 0370374
RN  - 0 (Antimalarials)
RN  - 0 (Artemisinins)
RN  - 0 (Drug Combinations)
RN  - 0 (Sesquiterpenes)
RN  - 60W3249T9M (Artesunate)
RN  - TML814419R (Mefloquine)
SB  - IM
MH  - Administration, Rectal
MH  - Animals
MH  - Antimalarials/*therapeutic use
MH  - Artemisinins/administration & dosage/*therapeutic use
MH  - Artesunate
MH  - Child
MH  - Child, Preschool
MH  - Drug Combinations
MH  - Drug Resistance, Multiple/drug effects
MH  - Ecuador
MH  - Female
MH  - Humans
MH  - Malaria, Falciparum/*drug therapy
MH  - Male
MH  - Mefloquine/*therapeutic use
MH  - Plasmodium falciparum/*drug effects
MH  - Sesquiterpenes/administration & dosage/*therapeutic use
MH  - Treatment Outcome
EDAT- 2003/11/26 05:00
MHDA- 2004/01/21 05:00
CRDT- 2003/11/26 05:00
PHST- 2003/11/26 05:00 [pubmed]
PHST- 2004/01/21 05:00 [medline]
PHST- 2003/11/26 05:00 [entrez]
AID - S0001706X03002420 [pii]
AID - 10.1016/j.actatropica.2003.09.003 [doi]
PST - ppublish
SO  - Acta Trop. 2003 Dec;89(1):47-53. doi: 10.1016/j.actatropica.2003.09.003.