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

NCT02637128 | Completed Phase 4

• 1 other identifier: Malawi TES 2014
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to determine the efficacy of both artemether-lumefantrine and artesunate-amodiaquine (but not to compare the efficacies of the two drugs) for the treatment of uncomplicated Plasmodium falciparum malaria at Machinga, Nkhotakota, and Karonga District Hospitals- Malawi.

Conditions

MALARIA, FALCIPARUM

Keywords

MALARIA, FALCIPARUM; MALAWI; ARTEMETHER-LUMEFANTRINE; ARTESUNATE-AMODIAQUINE

Outcome Measures

Primary Outcomes (1)

• Adequate clinical and parasitological response (ACPR)

  Absence of parasitaemia on day 28, assessed by microscopy, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure

  28 days

Study Arms (2)

artemether-lumefantrine (AL)

EXPERIMENTAL

20mg artemether/120 mg lumefantrine per tablet, Coartem-D™; Novartis, Basel, Switzerland administered following manufacturer's prescribed weight-based dosing, twice daily for 3 days. 5-14 kg: 1 tablet; 15-24: 2 tablets; 25-34 kg: 3 tablets; \>34 kg: 4 tablets per dose

Drug: artemether-lumefantrine (AL)

artesunate-amodiaquine (ASAQ)

EXPERIMENTAL

25mg artesunate/67.5 mg amodiaquine or 50 mg artesunate/135mg amodiaquine per tablet, Coarsucam™; Sanofi-Aventis, Paris, France administered following manufacturer's prescribed weight-based dosing, once daily for 3 days 4.5-8.9 kg: 1 25mg/67.5 mg tablet; 9-17.9 kg: 1 50mg/135 mg tablet; 18-35.9 kg 2 50mg/135 tablets; \>36 kg: 4 50mg/135mg tablets per dose

Drug: artesunate-amodiaquine (ASAQ)

Interventions

artemether-lumefantrine (AL) DRUG

Dispersible formulation of artemether-lumefantrine (Coartem-D™; 20mg artemether/120mg lumefantrine per tablet, Novartis, Switzerland) administered twice a day for 3 days according to manufacturer recommended dosing for weight

Also known as: Coartem

artemether-lumefantrine (AL)

artesunate-amodiaquine (ASAQ) DRUG

Co-formulated artesunate-amodiaquine (25mg artesunate/67.5mg amodiaquine and 50mg artesunate/135mg amodiaquine tablets) administered once a day for 3 days, according to manufacturer recommended dosing for weight

Also known as: Coarsucam

artesunate-amodiaquine (ASAQ)

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• Kamuzu University of Health Sciences: collaborator

Study Sites (1)

Malaria Alert Center, University of Malawi College of Medicine, Blantyre, Malawi

Blantyre, Malawi

Location

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

Artemether, Lumefantrine Drug Combination; amodiaquine, artesunate drug combination

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Artemether; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Lumefantrine; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sesquiterpenes; Terpenes; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Don P Mathanga, MBBS, PhD

  1. Malaria Alert Centre (MAC), University of Malawi College of Medicine, Blantyre, Malawi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2015
• First Posted: December 22, 2015
• Study Start: March 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 22, 2015

Record last verified: 2015-12

Locations

MA (1)