Efficacy and Safety of the Pediatric Formulation of Artemether- Lumefantrine in Children With Uncomplicated P. Falciparum Malaria.

Conditions

Falciparum, Malaria

Keywords

Marsh fever, Plasmodium infections, Remittent fever, Paludism, Artemether, Artemisinins, Malaria, Benflumetol, Lumefantrine

Brief summary

This study will evaluate the safety and efficacy of artemether-lumefantrine against uncomplicated malaria caused P. falciparum in children of 5-35 kg bodyweight.

Wounounou, Gildas, Tiono, Alfred B., Ogutu, Bernhards, Manyando, Christine, Sagara, Issaka et al. (23 authors)

2025-01-01

10.6084/m9.figshare.30561984

Additional file 2 of Pharmacokinetics, safety and efficacy of an optimized dose of artemether–lumefantrine in the treatment of acute uncomplicated Plasmodium falciparum malaria in neonates and infants of less than 5 kg body weight: a multicentre, open-label, single-arm phase 2/3 study (CALINA)

Wounounou, Gildas, Tiono, Alfred B., Ogutu, Bernhards, Manyando, Christine, Sagara, Issaka et al. (23 authors)

OPAL (Open@LaTrobe) (La Trobe University)2025-01-01

10.6084/m9.figshare.30561984.v1

Efficacy and safety of artemether-lumefantrine dispersible tablets compared with crushed commercial tablets in African infants and children with uncomplicated malaria: a randomised, single-blind, multicentre trial.

Abdulla S, Sagara I, Borrmann S, D'Alessandro U, González R, Hamel M, Ogutu B, Mårtensson A, Lyimo J, Maiga H, Sasi P, Nahum A, Bassat Q, Juma E, Otieno L, Björkman A, Beck HP, Andriano K, Cousin M, Lefèvre G, Ubben D, Premji Z.

2008-10-1495 citations

10.1016/s0140-6736(08)61492-0

Interventions

DRUGArtemether-lumefantrine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

No minimum to 12 Years

Healthy volunteers

No

Inclusion criteria

* male or female infants and children ≤12 years of age * body weight of ≥5 kg and \<35 kg, * with a confirmed diagnosis of uncomplicated malaria caused by the P. falciparum parasite

Exclusion criteria

* complicated malaria * persistent vomiting * malaria due to parasites other than P. falciparum * antimalarial treatment received in the past 2 weeks * known chronic disease e.g. positive HIV status, severe cardiac, renal, or hepatic disease

Design outcomes

Primary

Measure	Time frame
Proportion of patients free of parasites at day 28.	—

Secondary

Measure	Time frame
Proportion of patients free of parasites at 7 days and at 14 days	—
Time to clearance from parasites	—
Time to clearance of fever	—
Hematology and biochemistry parameters	—
Electrocardiogram	—

Countries

Benin, Kenya, Mali, Mozambique, Tanzania

Outcome results

None listed