NCT04829695

Efficacy and Safety of Artesunate-amodiaquine and Artemether-lumefantrine for the Treatment of Malaria in Cameroon

Efficacy and Safety of Artesunate-amodiaquine (ASAQ) and Artemether-lumefantrine (AL) for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Center Region of Cameroon

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 184 (estimated)
• Sponsor: University of Yaounde 1 · Academic / Other
• Sex: All
• Age: 6 Months – 120 Months
• Healthy volunteers: Not accepted

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.

Detailed description

Brief title: Efficacy and safety of artesunate-amodiaquine and artemether-lumefantrine for the treatment of malaria in Cameroon. Official title: Monitoring the efficacy and safety of artesunate-amodiaquine and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria among children in the Center Region of Cameroon. Purpose: To monitor the efficacy and safety of artesunate-amodiaquine and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria among children in the Center Region of Cameroon. Background: Malaria remains a major public health concern in Cameroon especially among vulnerable groups such as children less than 5 years and pregnant women. artesunate-amodiaquine (ASAQ) and artemether-lumefantrine (AL) are currently being used for the treatment of uncomplicated Plasmodium falciparum in Cameroon. 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. Objective: To assess the efficacy and safety of artesunate-amodiaquine and artemether-lumefantrine during a 28-day follow-up period among children with acute uncomplicated P. falciparum malaria in Center Region of Cameroon. Study sites: District Hospital Akonolinga, District Hospital Mfou, District Hospital Soa, District Hospital Mbalmayo, District Hospital Mbandjock, and District Hospital Ngog-Mapubi in the Center Region of Cameroon. Study period: 5th April to 31st December, 2021. 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. At least 30 participants shall be enrolled at each of the six study sites. Treatment (s) and follow-up: 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. 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).

Conditions

• Falciparum Malaria

Interventions

Type	Name	Description
DRUG	Artesunate-amodiaquine drug combination	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.
DRUG	Artemether-lumefantrine drug combination	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.

Timeline

• Start date: 2021-04-05
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2021-04-02
• Last updated: 2021-04-02