In Vivo Efficacy of Artemether-Lumefantrine and Artesunate-Amodiaquine for Uncomplicated P. Falciparum Malaria

• Register: ClinicalTrials.gov
• Last refreshed on: 28 December 2015
• Main ID: NCT02637128
• Date of registration: 17/12/2015
• Prospective Registration: No
• Primary sponsor: Centers for Disease Control and Prevention
• Public title: In Vivo Efficacy of Artemether-Lumefantrine and Artesunate-Amodiaquine for Uncomplicated P. Falciparum Malaria
• Scientific title: In Vivo Efficacy of Artemether-Lumefantrine and Artesunate-Amodiaquine for Uncomplicated Plasmodium Falciparum Malaria in Malawi, 2014
• Date of first enrolment: March 2014
• Target sample size: 452
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02637128
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Malawi

Contacts

• Name: Don P Mathanga, MBBS, PhD
• Affiliation: 1. Malaria Alert Centre (MAC), University of Malawi College of Medicine, Blantyre, Malawi

Key inclusion & exclusion criteria

Inclusion Criteria:

- age between 6 to 59 months

- mono-infection with P. falciparum detected by microscopy

- parasitaemia of 1,000-200,000/µl asexual forms

- presence of axillary temperature = 37.5 °C or history of fever during the past 24 h

- ability to swallow oral medication

- ability and willingness to comply with the study protocol for the duration of the
study and to comply with the study visit schedule

- informed consent from the parent or guardian of the child

Exclusion Criteria:

- presence of general danger signs in children aged 6-59 months or signs of severe
falciparum malaria according to the definitions of World Health Organization

- mixed or mono-infection with another Plasmodium species detected by microscopy

- presence of severe malnutrition (defined as a child whose growth standard is below -3
z-score)

- presence of febrile conditions due to diseases other than malaria (e.g. measles,
acute lower respiratory tract infection, severe diarrhoea with dehydration) or other
known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic
diseases, HIV/AIDS)

- regular medication that may interfere with antimalarial pharmacokinetics

- history of hypersensitivity reactions or contraindications to any of the medicines
being tested or used as alternative treatments



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

Health Condition(s) or Problem(s) studied

MALARIA, FALCIPARUM

Intervention(s)

Drug: artemether-lumefantrine (AL)

Drug: artesunate-amodiaquine (ASAQ)

Primary Outcome(s)

Adequate clinical and parasitological response (ACPR) [Time Frame: 28 days]

Secondary ID(s)

Malawi TES 2014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Malawi College of Medicine