Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04565184 |
| Other study ID # |
MARCAD/UYI/NPTN/12/16 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
May 9, 2019 |
| Est. completion date |
November 30, 2020 |
Study information
| Verified date |
March 2021 |
| Source |
University of Yaounde 1 |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Artesunate-amodiaquine and artemether-lumfantrine are currently being used for the treatment
of uncomplicated Plasmodium falciparum in Cameroon. Globally, many studies have reported high
efficacy and safety of artemisinin-based combination therapies (ACTs) mostly under strict
supervision of drug intake and limited to children less than 5 years of age. Patients over 5
years of age are usually not involved in such studies. The main objective of this study is to
assess the genetic markers of antimalarial drug resistance and drug metabolism subsequent to
the efficacy and safety of artesunate-amodiaquine and artemether-lumefantrine during a 28-day
follow-up period in children with acute uncomplicated P. falciparum malaria in Yaounde,
Cameroon. A randomized, open-labelled, controlled clinical trial comparing
artesunate-amodiaquine (ASAQ) and artemether-lumefantrine (AL) will be carried out from 9th
May 2019 to 30th November 2020 at two secondary health centres (Cité Verte and Minkoameyos)
in Yaounde. The study participants shall include febrile patients aged 6 months to 10 years,
with confirmed uncomplicated P. falciparum infection. Eligible children for whom
parent/guardian informed consents are obtained will be randomized to receive either
artesunate-amodiaquine (group A) or artemether-lumefantrine (group B) in the ratio 1:1. A
minimum sample of 76 patients will be required for the study. With a 20 % increase to allow
loss to follow-up and withdrawals during the 28-day follow-up period, 92 patients will be
enrolled for each of the two study arms. The study will recruit a total of 184 patients. Drug
intake will be partially supervised only for the first dose and subsequent doses administered
unsupervised as pertains in routine practice in the field. Patients or their
parents/guardians will be advised on the time and mode of administration for the 3 days (D0,
D1 and D2) treatment unobserved at home. Follow-up visits will be performed on days 3, 7, 14,
21, and 28 to evaluate clinical and parasitological resolution of their malaria episode as
well as adverse events. Polymerase chain reaction (PCR) genotyping of merozoite surface
proteins 1 and 2 (msp-1, msp-2) as well as glutamate rich protein (GLURP) will be used to
differentiate between recrudescence and new infection.
Description:
Background: Artesunate-amodiaquine and artemether-lumfantrine are currently being used for
the treatment of uncomplicated Plasmodium falciparum in Cameroon. Globally, many studies have
reported high efficacy and safety of artemisinin-based combination therapies (ACTs) mostly
under strict supervision of drug intake and limited to children less than 5 years of age.
Patients over 5 years of age are usually not involved in such studies.
Objective: To assess the genetic markers of antimalarial drug resistance and drug metabolism
subsequent to the efficacy and safety of artesunate-amodiaquine and artemether-lumefantrine
during a 28-day follow-up period in children with acute uncomplicated P. falciparum malaria
in Yaounde, Cameroon.
Study sites: District Hospital Cité Verte and District Medical Centre Minkoa Meyos in
Yaounde, Cameroon. The two drugs, artesunate-amodiaquine and artemether-lumefantrine will be
tested in each site.
Study period: 9th May 2019 to 30th November 2020.
Study design: This surveillance study is a two-arm, open-label, randomized controlled
clinical trial.
Patient population: Febrile patients aged 6 months to 10 years, with confirmed uncomplicated
P. falciparum infection. Eligible children for whom parent/guardian informed consents are
obtained will be randomized to receive either artesunate-amodiaquine (group A) or
artemether-lumefantrine (group B) in the ratio 1:1.
Sample size: A minimum sample of 76 patients will be required for the study. With a 20 %
increase to allow loss to follow-up and withdrawals during the 28-day follow-up period, 92
patients will be enrolled for each of the two study arms. The study will recruit a total of
184 patients.
Treatment (s) and follow-up: Drug intake will be partially supervised only for the first dose
and subsequent doses administered unsupervised as pertains in routine practice in the field.
Patients or their parents/guardians will be advised on the time and mode of administration
for the 3 days (D0, D1 and D2) treatment unobserved at home. Follow-up visits will be
performed on days 3, 7, 14, 21, and 28 to evaluate clinical and parasitological resolution of
their malaria episode as well as adverse events. Polymerase chain reaction (PCR) genotyping
of merozoite surface proteins 1 and 2 (msp-1, msp-2) as well as glutamate rich protein
(GLURP) will be used to differentiate between recrudescence and new infection.
Classification of treatment outcomes Classification of treatment outcomes will be done based
on the WHO 2009 guidelines: treatment failure (Early Treatment Failure-ETF, Late Clinical
failure-LCF and Late Parasitological Failure-LPF) and treatment success (Adequate Clinical
and Parasitological Response-ACPR).
