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Therapeutic efficacy study of artemether-lumefantrine and artesunate-amodiaquine in the treatment of uncomplicated Plasmodium falciparum malaria at two sentinel sites in Togo

Therapeutic efficacy study of artemether-lumefantrine and artesunate-amodiaquine in the treatment of uncomplicated Plasmodium falciparum malaria at two sentinel sites in Togo

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12612001039875
Acronym
none
Enrollment
450
Registered
2012-09-28
Start date
2012-09-24
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

To monitor the efficacy and safety of artemether-lumefantrine and artesunate amodiaquine in the treatment of uncomplicated falciparum malaria in two sentinel sites in Togo

Interventions

Artemether-lumefantrine tablets, each containing 20 mg of artemether and 120 mg of lumefantrine, will be administered twice daily for 3 consecutive days. Children with body weight of 5-14 kg will receive one tablet morning and evening and chidren from 15 kg up to 24 kg will received 2 tablets morning and evening. Patients treated with artesunate plus amodiaquine will be administered oral tablets of artesunate at a dose of 4 mg/kg/day up to a maximum of 250 mg per day and oral tablets of amodiaqu

Artemether-lumefantrine tablets, each containing 20 mg of artemether and 120 mg of lumefantrine, will be administered twice daily for 3 consecutive days. Children with body weight of 5-14 kg will receive one tablet morning and evening and chidren from 15 kg up to 24 kg will received 2 tablets morning and evening. Patients treated with artesunate plus amodiaquine will be administered oral tablets of artesunate at a dose of 4 mg/kg/day up to a maximum of 250 mg per day and oral tablets of amodiaquine at a dose of 10/kg/day up to a maximum of 600 mg per day for three consecutive days. Patients will be observed for 28 days follwoing initiation of treatment. Artemether-lumefantrine and artesunate plus amodiaquine treatments correspond to the first and second line antimalarial treament policy (standard of care) in Togo, respectivlely.

Sponsors

Ministere de la Sante du Togo
Lead SponsorGovernment body

Eligibility

Sex/Gender
All
Age
6 Months to 59 Months
Healthy volunteers
No

Inclusion criteria

age between 6 and 59 months microscopically confirmed monoinfection with P falciparum parasitemia (asexual forms) between 2000 and 200 000 per microliter fever (body temperature of 37.5 C or greater) able to swallow medication able to comply with protocol assessment schedule

Exclusion criteria

clinical signs and symptoms of severe malaria infection with another Plasmodium species or co-infection severe malnutrition fever due to other diseases

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026