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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12612001039875
• Date of registration: 28/09/2012
• Prospective Registration: No
• Primary sponsor: Ministere de la Sante du Togo
• Public title: Therapeutic efficacy study of artemether-lumefantrine and artesunate-amodiaquine in the treatment of uncomplicated Plasmodium falciparum malaria at two sentinel sites in Togo
• Scientific title: Therapeutic efficacy study of artemether-lumefantrine and artesunate-amodiaquine in the treatment of uncomplicated Plasmodium falciparum malaria at two sentinel sites in Togo
• Date of first enrolment: 24/09/2012
• Target sample size: 450
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12612001039875.aspx
• Study type: Observational
• Study design: Purpose: Natural history;Selection: Defined population;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

Togo

Contacts

• Name: Dr AM Dorkendoo

• Name: Dr AM Dorkendoo

Key inclusion & exclusion criteria

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

Age minimum: 6 Months
Age maximum: 59 Months
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Infection - Studies of infection and infectious agents

uncomplicated falciparum malaria;
uncomplicated falciparum malaria

Intervention(s)

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.

Primary Outcome(s)

PCR adjusted adequate clinical and parasitological response at Day 28 (percent of treatment failures (early + late clinical failure + late parasitological failureas defined in the latest WHO protocol for monitoring therapeutic efficacy of antimalarial drugs.[Day 28 following initiation of treatment]

Secondary Outcome(s)

Percent of adverse events will be documented. Possible adverse events, related or not to the medicines, include dizziness, itching, vomiting abdominal pain, flatulence, headache, bodyache, diarrhoea, tinnitus, increased hair loss, macular rash, reduction in neurophil counts, convulsions[Day 28 following initiation of treatment]

Secondary ID(s)

none

Source(s) of Monetary Support

World Health Organisation

Ethics review

Status: Approved
Approval date:
Contact:

WHO ERC