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Artemether-lumefantrine versus artemisinin-naphthoquine in Papua New Guinean children with uncomplicated malaria: a six months post-treatment follow-up study.

Laman M, Benjamin JM, Moore BR, Salib M, Tawat S, Davis WA, Siba PM, Robinson LJ, Davis TM - Malar. J. (2015)

Bottom Line: Of 247 children who were followed to Day 42, 176 (71.3%) were included in the present sub-study, 87 allocated to AM-LM and 89 to artemisinin-NQ.Twenty children in the AM-LM group (32.8%) had a first episode of clinical malaria within six months compared with 10 (16.4%) in the artemisinin-NQ group (P = 0.033, log rank test).There were no between-group differences in the incidence of first presentation with non-malarial illness (P = 0.31).

View Article: PubMed Central - PubMed

Affiliation: School of Medicine and Pharmacology, University of Western Australia, Fremantle Hospital, PO Box 480, Fremantle, 6959, WA, Australia. drmlaman@yahoo.com.

ABSTRACT

Background: In a recent trial of artemisinin-naphthoquine (artemisinin-NQ) and artemether-lumefantrine (AM-LM) therapy in young children from Papua New Guinea (PNG), there were no treatment failures in artemisinin-NQ-treated children with Plasmodium falciparum or Plasmodium vivax compared with 2.2% and 30.0%, respectively, in AM-LM-treated children during 42 days of follow-up. To determine whether, consistent with the long elimination half-life of NQ, this difference in efficacy would be more durable, clinical episodes of malaria were assessed in a subset of trial patients followed for six months post-treatment.

Methods: For children completing trial procedures and who were assessable at six months, all within-trial and subsequent clinical malaria episodes were ascertained, the latter by clinic attendances and/or review of hand-held health records. Presentations with non-malarial illness were also recorded. Differences between allocated treatments for pre-specified endpoints were determined using Kaplan-Meier survival analysis.

Results: Of 247 children who were followed to Day 42, 176 (71.3%) were included in the present sub-study, 87 allocated to AM-LM and 89 to artemisinin-NQ. Twenty children in the AM-LM group (32.8%) had a first episode of clinical malaria within six months compared with 10 (16.4%) in the artemisinin-NQ group (P = 0.033, log rank test). The median (interquartile range) time to first episode of clinical malaria was 64 (50-146) vs 116 (77-130) days, respectively (P = 0.20). There were no between-group differences in the incidence of first presentation with non-malarial illness (P = 0.31).

Conclusions: The greater effectiveness of artemisinin-NQ over conventional AM-LM extends to at least six months post-treatment for clinical malaria but not non-malarial illness.

Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12610000913077 .

No MeSH data available.


Related in: MedlinePlus

Profile of patients followed from randomization to the end of the six-month follow-up period.
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Fig1: Profile of patients followed from randomization to the end of the six-month follow-up period.

Mentions: Of the 267 children randomized in the parent trial, 247 (92.5%) were followed to Day 42. Of this latter number, 176 (71.3%) were included in the six month analysis, comprising 87 allocated to AM-LM and 89 to artemisinin-NQ (see Figure 1). The 71 children who were excluded were those who had not attended the Mugil and Alexishafen Health Centres post-trial and were still within the six month follow-up period when the two clinics closed at the end of the parent trial. There were no deaths or non-infection-related clinic attendances amongst the 176 included children, and no differences in baseline characteristics by allocated treatment except that more artemisinin-NQ-treated children presented with vivax malaria (see Table 1).Figure 1


Artemether-lumefantrine versus artemisinin-naphthoquine in Papua New Guinean children with uncomplicated malaria: a six months post-treatment follow-up study.

Laman M, Benjamin JM, Moore BR, Salib M, Tawat S, Davis WA, Siba PM, Robinson LJ, Davis TM - Malar. J. (2015)

Profile of patients followed from randomization to the end of the six-month follow-up period.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4374335&req=5

Fig1: Profile of patients followed from randomization to the end of the six-month follow-up period.
Mentions: Of the 267 children randomized in the parent trial, 247 (92.5%) were followed to Day 42. Of this latter number, 176 (71.3%) were included in the six month analysis, comprising 87 allocated to AM-LM and 89 to artemisinin-NQ (see Figure 1). The 71 children who were excluded were those who had not attended the Mugil and Alexishafen Health Centres post-trial and were still within the six month follow-up period when the two clinics closed at the end of the parent trial. There were no deaths or non-infection-related clinic attendances amongst the 176 included children, and no differences in baseline characteristics by allocated treatment except that more artemisinin-NQ-treated children presented with vivax malaria (see Table 1).Figure 1

Bottom Line: Of 247 children who were followed to Day 42, 176 (71.3%) were included in the present sub-study, 87 allocated to AM-LM and 89 to artemisinin-NQ.Twenty children in the AM-LM group (32.8%) had a first episode of clinical malaria within six months compared with 10 (16.4%) in the artemisinin-NQ group (P = 0.033, log rank test).There were no between-group differences in the incidence of first presentation with non-malarial illness (P = 0.31).

View Article: PubMed Central - PubMed

Affiliation: School of Medicine and Pharmacology, University of Western Australia, Fremantle Hospital, PO Box 480, Fremantle, 6959, WA, Australia. drmlaman@yahoo.com.

ABSTRACT

Background: In a recent trial of artemisinin-naphthoquine (artemisinin-NQ) and artemether-lumefantrine (AM-LM) therapy in young children from Papua New Guinea (PNG), there were no treatment failures in artemisinin-NQ-treated children with Plasmodium falciparum or Plasmodium vivax compared with 2.2% and 30.0%, respectively, in AM-LM-treated children during 42 days of follow-up. To determine whether, consistent with the long elimination half-life of NQ, this difference in efficacy would be more durable, clinical episodes of malaria were assessed in a subset of trial patients followed for six months post-treatment.

Methods: For children completing trial procedures and who were assessable at six months, all within-trial and subsequent clinical malaria episodes were ascertained, the latter by clinic attendances and/or review of hand-held health records. Presentations with non-malarial illness were also recorded. Differences between allocated treatments for pre-specified endpoints were determined using Kaplan-Meier survival analysis.

Results: Of 247 children who were followed to Day 42, 176 (71.3%) were included in the present sub-study, 87 allocated to AM-LM and 89 to artemisinin-NQ. Twenty children in the AM-LM group (32.8%) had a first episode of clinical malaria within six months compared with 10 (16.4%) in the artemisinin-NQ group (P = 0.033, log rank test). The median (interquartile range) time to first episode of clinical malaria was 64 (50-146) vs 116 (77-130) days, respectively (P = 0.20). There were no between-group differences in the incidence of first presentation with non-malarial illness (P = 0.31).

Conclusions: The greater effectiveness of artemisinin-NQ over conventional AM-LM extends to at least six months post-treatment for clinical malaria but not non-malarial illness.

Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12610000913077 .

No MeSH data available.


Related in: MedlinePlus