Efficacy and Safety of the Pediatric Formulation of Artemether- Lumefantrine in Children With Uncomplicated P. Falciparum Malaria.
This study has been completed.

First Received on October 11, 2006. Last Updated on March 11, 2009 History of Changes
Sponsor: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00386763
Purpose
This study will evaluate the safety and efficacy of artemether-lumefantrine against uncomplicated malaria caused P. falciparum in children of 5-35 kg bodyweight.

Condition Intervention Phase
Malaria
Falciparum
Drug: Artemether-lumefantrine
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Randomized, Investigator-Blinded, Multicenter, Parallel-Group Study to Compare Efficacy, Safety and Tolerability of Arthemeter/ Lumefantrine Dispersible Tablet Formulation vs. Artemether/ Lumefantrine 6-Dose Crushed Tablet in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Infants and Children.

Resource links provided by NLM:

MedlinePlus related topics: Fever Malaria
Drug Information available for: Artemether Benflumetol Co-artemether
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
Proportion of patients free of parasites at day 28.

Secondary Outcome Measures:
Proportion of patients free of parasites at 7 days and at 14 days
Time to clearance from parasites
Time to clearance of fever
Hematology and biochemistry parameters
Electrocardiogram

Estimated Enrollment: 890
Study Start Date: August 2006
Estimated Study Completion Date: March 2007
Eligibility

Ages Eligible for Study: up to 12 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:

male or female infants and children ≤12 years of age
body weight of ≥5 kg and <35 kg,
with a confirmed diagnosis of uncomplicated malaria caused by the P. falciparum parasite
Exclusion Criteria:

complicated malaria
persistent vomiting
malaria due to parasites other than P. falciparum
antimalarial treatment received in the past 2 weeks
known chronic disease e.g. positive HIV status, severe cardiac, renal, or hepatic disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00386763

Locations
Benin
Novartis
Benin, Benin
Kenya
Novartis
Kenya, Kenya
Mali
Novartis
Mali, Mali
Mozambique
Novartis
Mozambique, Mozambique
Tanzania
Novartis
Tanzania, Tanzania
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Abdulla S, Sagara I, Borrmann S, D'Alessandro U, González R, Hamel M, Ogutu B, Mårtensson A, Lyimo J, Maiga H, Sasi P, Nahum A, Bassat Q, Juma E, Otieno L, Björkman A, Beck HP, Andriano K, Cousin M, Lefèvre G, Ubben D, Premji Z. Efficacy and safety of artemether-lumefantrine dispersible tablets compared with crushed commercial tablets in African infants and children with uncomplicated malaria: a randomised, single-blind, multicentre trial. Lancet. 2008 Nov 22;372(9652):1819-27. Epub 2008 Oct 14.

Responsible Party: Novartis ( Novartis )
ClinicalTrials.gov Identifier: NCT00386763 History of Changes
Other Study ID Numbers: CCOA566B2303
Study First Received: October 11, 2006
Last Updated: March 11, 2009
Health Authority: Kenya: Ministry of Health

Keywords provided by Novartis:
Marsh fever
Plasmodium infections
Remittent fever
Paludism
Artemether
Artemisinins
Malaria
Benflumetol
Lumefantrine

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Artemether
Artemisinins
Lumefantrine
Artemether-lumefantrine combination
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics

ClinicalTrials.gov processed this record on June 01, 2011

Reply

  • dbogecho dbogecho 19 Jul 2011

    Dear Zoumana,
    thank you very much! That's very useful to know. Many of our researchers are working on the issue of community consent and thinking about how to engage the community. Would you mind sharing your experiences in this study with us in a blog? For example, how did you go about obtaining community consent? How large was the community and how many community leaders did you speak to? Did you also have focus groups with general members of the community? Did you come across many community members who did not wish to consent? Any advice and experiences you can share with us would be so welcome. This is a topic we're all thinking about and wondering what is the 'best' way to engage with the community and get their consent.
    Thank you so much.
    Dina

  • zouisaac Zoumana Isaac TRAORE 7 Jul 2011

    Dear Dina,
    Well for Ethical Aspect, we have administer first a community consentement with community leader and before screening patient were been administered a consent/assent prior all research activities. The Protocol also receive the Ethic committee (IRB of the faculty of medicine pharmacy and Dentistry/university of Bamako) approval prior any field action

  • dbogecho dbogecho 7 Jul 2011

    Dear Zoumana,
    as this is a bioethics community, I was wondering if you could say something specific about the ethical aspects of this study? I am very curious. Thank you, Dina.

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