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Efficacy of Artesunate-amodiaquine and Artemether-lumefantrine for Uncomplicated Malaria in South Kivu, DR Congo

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ClinicalTrials.gov Identifier: NCT02741024
Recruitment Status : Completed
First Posted : April 18, 2016
Last Update Posted : April 18, 2016
Sponsor:
Information provided by (Responsible Party):
Marit de Wit, Medecins Sans Frontieres, Netherlands

Brief Summary:

This will be an open-randomised non-inferiority study to test the hypothesis that the risk of recurrent parasitaemia after 42 days is not worse in the group receiving the Artesunate-Amodiaquine (ASAQ) regimen than in the group receiving the Artemether-Lumefantrine (Coartem®) regimen. Children with uncomplicated malaria meeting the inclusion criteria will be enrolled (after their parent/caretaker has given informed consent), treated on site with the drugs under evaluation and followed-up for a period of 42 days. Drugs will be given under direct supervision, either at the clinic or at home. Follow-up shall consist of a fixed schedule of clinical and laboratory examinations. Based on clinical and laboratory findings, children will be classified as therapeutic failures (early or late) or adequate responders.

The proportion of cases experiencing an in vivo therapeutic failure during the follow-up period will provide an estimate of the efficacy of the drug regimens. A Polymerase Chain Reaction (PCR) analysis will be carried out to differentiate true recrudescence due to treatment failure from episodes of re-infection. This proposal is compliant with the latest WHO recommendations for anti-malarial efficacy monitoring in high, medium or low transmission zones11.


Condition or disease Intervention/treatment Phase
Malaria Drug: Amodiaquine-Artesunate (ASAQ) Drug: Artemether-Lumefantrine (AL) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: In Vivo Efficacy of Artesunate-amodiaquine and Artemether-lumefantrine for the Treatment of Uncomplicated Falciparum Malaria: an Open-randomised, Non-inferiority Clinical Trial in South Kivu, DR Congo
Study Start Date : October 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Active Comparator: Amodiaquine-Artesunate (ASAQ)
Treatment regimen consisted of Amodiaquine-Artesunate (ASAQ) fixed dose (FD) (Winthrop Sanofi Aventis), given as 1 tablet/day 3 days (5-8 kg 1 tab of 25mg artesunate/67.5 mg amodiaquine base, 9-17 kg 50 mg artesunate/135 mg amodiaquine base)
Drug: Amodiaquine-Artesunate (ASAQ)
Treatment on site with Amodiaquine-Artesunate according to the manufacturer's dose and instruction and follow-up for a period of 42 days. Drugs will be given under direct supervision, either at the clinic or at home
Other Name: coarsucam

Active Comparator: Artemether-Lumefantrine (AL)
Treatment consisted of Artemether-Lumefantrine (AL) (Coartem, Novartis) given as six twice/daily doses over three days (5-14 kg 1tab of 20mg artemether/120mg lumefantrine BD, 15-24 kg 2tabs of 20mg artemether/120mg lumefantrine BD with fatty food).
Drug: Artemether-Lumefantrine (AL)
Treatment on site with Artemether-lumefantrine combination according to the manufacturer's dose and instruction and follow-up for a period of 42 days.
Other Name: coartem




Primary Outcome Measures :
  1. Percentage of children with adequate parasitological clearance after treatment of artesunate-amodiaquine (ASAQ) and artemether-lumefantrine (AL) [ Time Frame: 42 days ]
    In a Kaplan Meyer survival curve it will be shown what the parasitological free period is for children treated with ASAQ or AL, uncorrected for PCR (reinfection and recrudescence) and PCR corrected (recrudescence only).


Secondary Outcome Measures :
  1. The proportion of early therapeutic failures, late clinical failures and late parasitological failures in a period of 42 days after treatment initiation [ Time Frame: 42 days ]
  2. Recommendations to MoH on choice of antimalarial first line drugs [ Time Frame: 42 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 6 and 59 months
  • Weight ≥ 5 Kg
  • Slide-confirmed infection with Plasmodium falciparum only (no mixed infections)
  • Asexual parasite density between 2000 and 200000/µl of blood
  • Measured axillary temperature ≥ 37.5°C
  • Ability to swallow oral medication
  • High probability of respecting the follow-up visits (residence within 1 hour walking distance from the OPD, no upcoming travel plans, etc.)
  • Informed consent from a parent or caretaker aged at least 18 years.

Exclusion Criteria:

  • • General danger signs according to the WHO definition (Appendix 5.1.1)

    • Signs of severe/complicated malaria according to the WHO definition (Appendix 5.1.2)
    • Severe anaemia (haemoglobin < 5 g/dL)
    • Known history of hypersensitivity to any of the study drugs
    • Severe acute malnutrition (as defined by a weight-for-height below -3 Z-score and/or symmetrical oedemas involving at least the feet)
    • Concomitant febrile illness due to causes other than malaria with the potential to confound study outcome (measles, acute lower tract respiratory infection, otitis media, tonsillitis, abscesses, severe diarrhoea with dehydration).
    • Having received already a full course of the treatment (or one of the treatments) under study in the previous 28 days (as indicated by the parent/caretaker). Note that previous incomplete anti-malarial intake of treatments under study, or previous intake of anti-malarials not under study, are not exclusion criteria, but details of any such intake should be recorded carefully.
    • History of hypersensitivity reactions or contra-indications to any medicines being tested.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02741024


Sponsors and Collaborators
Medecins Sans Frontieres, Netherlands
Investigators
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Principal Investigator: Marit de Wit, MD, MIH Medecins sans Frontieres, Operational Centre Amsterdam
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marit de Wit, Health Advisor, Medecins Sans Frontieres, Netherlands
ClinicalTrials.gov Identifier: NCT02741024    
Other Study ID Numbers: MSansFrontieres
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: April 18, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data are available on request in accordance with MSF's data sharing policy: http://fieldresearch.msf.org/msf/handle/10144/306488
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Artesunate
Lumefantrine
Artemether
Artemether, Lumefantrine Drug Combination
Amodiaquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics