In Vivo Efficacy of Artemether-lumefantrine and Amodiaquine-artesunate in Mozambican Children

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02168569
• Date of registration: 13/06/2014
• Prospective Registration: No
• Primary sponsor: Centro de Investigacao em Saude de Manhica
• Public title: In Vivo Efficacy of Artemether-lumefantrine and Amodiaquine-artesunate in Mozambican Children MEFI
• Scientific title: In Vivo Efficacy of Artemether-lumefantrine and Amodiaquine-artesunate for the Treatment of Uncomplicated Falciparum Malaria in Children: A Multisite, Open-label, Two-cohort Clinical Trial in Mozambique.
• Date of first enrolment: June 2011
• Target sample size: 700
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02168569
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Mozambique

Key inclusion & exclusion criteria

Inclusion Criteria:

- Ages 6 to 59 months

- Weight Greater than or equal to 5 kg

- Absence of severe malnutrition;

- Mono-infection with Plasmodium falciparum in blood, confirmed by microscopy;

- Parasite density between 2,000 and 200,000 asexual parasites per microliter of blood;

- Axillary temperature = 37.5 C° or history of fever in the last 24 hours;

- Lack of danger signs, or no signs of severe and / or complicated malaria according to
the WHO definition

- Ability to swallow the drugs

- Haemoglobin greater than 5.0 g / dl

- Residents within the study area and have the possibility of an adequate follow-up in
the days of monitoring for a period of 28 days;

- Absence of a history of hypersensitivity to study medications;

- Informed consent of parents, guardians or caregivers (legal guardian) after
explaining the purpose of the study.

Exclusion Criteria:

- Presence of any danger sign or severe or complicated Plasmodium falciparum malaria
according to WHO definitions

- Presence of fever due to diseases other than malaria (eg measles, acute respiratory
infection, severe diarrhea with dehydration) or other known diseases, with chronic or
serious illnesses (cardiac, renal, hepatic or known infection with HIV AIDS),

- Presence of severe malnutrition (defined as a child whose growth pattern is below the
3rd percentile, mid-upper-arm circumference <110mm, weight / height <70% according to
the WHO tables, or the presence of bilateral edema of the lower limbs)

- Multi or mono-infection by another Plasmodium species detected by microscopy;

- Regular medication that may interfere with the pharmacokinetics of antimalarials;

- History of hypersensitivity or contraindication to study drug;

- A history of taking antimalarial drugs or drugs with antimalarial activity in less
than 7 days.

- Continuous prophylaxis with cotrimoxazole in HIV positive children



Age minimum: 6 Months
Age maximum: 59 Months
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria

Intervention(s)

Drug: Coartem™ (Artemether-lumefantrine combination)

Drug: Coarsucam™ (Amodiaquine-artesunate combination)

Primary Outcome(s)

To measure the Day 28, PCR corrected cure rates of artemether-lumefantrine (Coartem) and Amodiaquine-artesunate (Coarsucam). [Time Frame: 28 days]

Secondary Outcome(s)

to evaluate the incidence of adverse events [Time Frame: 28 days]

PCR uncorrected Day 28 efficacy of AL and AQ-AS [Time Frame: 28 days]

Secondary ID(s)

134/CNBS/11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

FHI 360