Efficacy and Safety of Artesunate-amodiaquine and Artemether-lumefantrine for the Treatment of Malaria in Cameroon
1 other identifier
interventional
184
0 countries
N/A
Brief Summary
Malaria remains a major public health concern in Cameroon especially among vulnerable groups such as children less than five years and pregnant women. Artesunate-amodiaquine (ASAQ) and artemether-lumefantrine (AL) have been used for the treatment of uncomplicated Plasmodium falciparum in Cameroon since 2004. Worldwide, several studies among children have reported high efficacy and safety of artemisinin-based combination therapies (ACTs). There is paucity of data to support the continuous use of ASAQ and AL in Cameroon. The main objective of this study is to assess 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 the Center Region of Cameroon. A randomized, open-labelled, controlled clinical trial comparing artesunate-amodiaquine (ASAQ) and artemether-lumefantrine (AL) will be carried out from 5th April to 31st December, 2021 at six hospitals in the Center Region of Cameroon. 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. However, since 6 sites will be involved, a minimum of 30 participants shall be enrolled per site. Drug intake will be done under strict supervision on days 0, 1 and 2. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2021
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2021
CompletedFirst Posted
Study publicly available on registry
April 2, 2021
CompletedStudy Start
First participant enrolled
April 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedApril 2, 2021
March 1, 2021
9 months
March 31, 2021
March 31, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with treatment success and adverse events following treatment with ASAQ and AL during 28 days follow-up period in children with uncomplicated P. falciparum malaria
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) and follow-up will be done for a duration of 28 days.
10 months
Secondary Outcomes (4)
Proportion of patients with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy according to the WHO 2009 guidelines
10 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
10 months
Number of children with single nucleotide polymorphisms of P. falciparum genes responsible for resistance to ASAQ and AL
10 months
Number of children with single nucleotide polymorphisms of P. falciparum histidine-rich protein 2 and 3 genes
10 months
Study Arms (2)
Artesunate-amodiaquine (Arm A)
EXPERIMENTALArtesunate-amodiaquine is co-packaged as artesunate 50 mg and amodiaquine hydrochloride USP equivalent to amodiaquine base of 153.1 mg. Each child shall be given one, two or three tablets depending on the weight.
Artemether-lumefantrine (Arm B)
ACTIVE COMPARATORArtemether-lumefantrine is formulated as tablets and will be provided in blister packs. Each tablet contains 20 mg artemether and 120 mg lumefantrine. Every pack has a picture showing how the drug should be given and contains two blisters for each day with one, two or three tablets depending on the weight of the child.
Interventions
Artesunate-amodiaquine is co-packaged as artesunate 50 mg and amodiaquine hydrochloride USP equivalent to amodiaquine base of 153.1 mg. Each child shall be given one, two or three tablets depending on the weight.
Artemether-lumefantrine is formulated as tablets and will be provided in blister packs. Each tablet contains 20 mg artemether and 120 mg lumefantrine. Every pack has a picture showing how the drug should be given and contains two blisters for each day with one, two or three tablets depending on the weight of the child.
Eligibility Criteria
You may qualify if:
- Children of either gender, aged 6 months to 10 years will be recruited.
- Uncomplicated P. falciparum malaria confirmed by microscopy using Giemsa-stained thick film with an asexual parasite density within the range 1000 to 200000 parasites/μl.
- Presenting with fever (axillary temperature ≥ 37.5oC) or having a history of fever in the preceding 24 hours.
- Able to ingest tablets orally (either suspended in water or uncrushed with food).
- Willing to participate in the study with written informed consent from parent/guardian.
- Willing and able to attend the clinic on stipulated regular follow-up visits.
You may not qualify if:
- Mixed or mono-infection with another Plasmodium species detected by microscopy.
- Children who are currently suffering or had the following within the last 2 months: tuberculosis, HIV, schistosomiasis, diabetes mellitus, cardiovascular disease, gout, rheumatoid arthritis, underlying chronic hepatic or renal disease, hypoglycaemia, jaundice, respiratory distress, and other inflammatory-related diseases.
- Signs/symptoms indicating severe/complicated malaria" according to WHO criteria (WHO definition) such as:
- Not able to drink or breastfeed.
- Persistent vomiting (\>2 episodes within the previous 24 hours).
- Convulsions (\>1 episode within the previous 24 hours).
- Lethargic/unconscious.
- Severe anemia (hemoglobin \< 5 g/dl).
- Serious gastrointestinal disease.
- Presence of severe malnutrition defined as a child aged between 6-60 months whose weight-for-height is below -3 z-score (W/H \< 70%) or has symmetrical oedema involving at least the feet or has a mid-upper arm circumference \< 115 mm).
- Regular medication, which may interfere with anti-malarial pharmacokinetics.
- History of hypersensitivity reactions or contraindications to any of the medicine (s) being tested or used as alternative treatment (s).
- Individuals who have taken part in anti-malarial efficacy and safety studies in the last 3 months.
- Participants who have taken anti-malarial drugs within the last one month.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wilfred Fon Mbacham, PhD
University of Yaounde I
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Wilfred Fon Mbacham
Study Record Dates
First Submitted
March 31, 2021
First Posted
April 2, 2021
Study Start
April 5, 2021
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
April 2, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- 31st December 2021 for at least 10 years
- Access Criteria
- Not available for now
Research findings will be communicated with the scientific community and policymakers. This will be done through public engagements and publications in peer-review journals.