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Amodiaquine+Artesunate vs. Artemether-Lumefantrine for Uncomplicated Malaria in Ghanaian Children

U

University of Ghana Medical School

Status and phase

Unknown
Phase 3

Conditions

Uncomplicated Malaria

Treatments

Drug: amodiaquine+artesunate/artemether-lumefantrine

Study type

Interventional

Funder types

Other

Identifiers

NCT00406146
91199 / 104. DAN.8-864
GHN-202-M03-M-00

Details and patient eligibility

About

Artemisinin combination therapies (ACT) are currently recommended for malaria treatment. Artemether-lumefantrine(A-L) and Artesunate+amodiaquine (A+A) have been the most commonly adopted of the recommended ACT regimens. In Ghana, A+A is the current first-line antimalarial treatment in Ghana, but there has been 1 efficacy report of this regimen in Ghana till date. Moreover, the safety of repeated treatments with ACT has been little studied. This study aims to evaluate the efficacy of A+A vs. A-L, as well as the safety of repeated treatments of these regimens in a longitudinal trial in which recruited children will be followed up for 1 year.

Sex

All

Ages

6 months to 14 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • microscopically confirmed acute uncomplicated falciparum malaria;
  • temperature at screening 37.50C or more or history of fever 24 preceding enrollment;
  • willingness to comply with follow up schedule;
  • written informed consent by accompanying parent or guardian

Exclusion criteria

  • features of severe malaria or danger signs of malaria
  • known intolerance or allergy to any of the study medications
  • known treatment with any of the study medications in the month preceding enrollment
  • serious underlying disease that may mask outcome assessment

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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