Antimalaria Drugs Susceptibility Testing for an Effective Management of Infected Patients in Sub-Sahara Africa

• Register: ClinicalTrials.gov
• Last refreshed on: 5 December 2016
• Main ID: NCT02974348
• Date of registration: 18/11/2016
• Prospective Registration: No
• Primary sponsor: University of Bamenda
• Public title: Antimalaria Drugs Susceptibility Testing for an Effective Management of Infected Patients in Sub-Sahara Africa
• Scientific title: Assessment of Antimalaria Drugs Susceptibility Testing for an Effective Management of Infected Patients in Sub-Sahara Africa
• Date of first enrolment: January 2013
• Target sample size: 300
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02974348
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Cameroon

Contacts

• Name: Xiaonong Zhou, PhD
• Affiliation: National Institute for Parasitic Disease

Key inclusion & exclusion criteria

Inclusion Criteria:

- signs/symptoms of uncomplicated malaria with axillary temperature = 37.5;

- monoinfection with Plasmodium falciparum;

- parasite count between 2000 and 200 000 per µl;

- haemoglobin level> 5 g/dL;

- absence of signs/symptoms of severe malaria or other diseases requiring drugs with
antimalaria or antihistaminic activities;

- parent/guardian willingness to give their consent

Exclusion Criteria:

- Chronic disease (HIV, malnutrition etc.),

- severe anaemia (haemoglobin level< 5 g/dL),

- respiratory distress, inability to drink, convulsion etc.,

- history of intolerance to test drugs;

- co-infection requiring drug with antihistaminic or antimalaria activities such as
cotrimozaxole



Age minimum: 6 Months
Age maximum: 59 Months
Gender: Both

Health Condition(s) or Problem(s) studied

Drug Resistant Malaria Due to Plasmodium Falciparum

Intervention(s)

Drug: Arthemeter-lumefantrine

Drug: Dihydroartemisinin piperaquine

Drug: Paracetamol

Drug: Quinine

Drug: Amoxicillin

Drug: Artesunate mefloquine

Primary Outcome(s)

efficacy and safety assessment [Time Frame: 42 days]

Secondary Outcome(s)

PCR-correction [Time Frame: 42 days]

parasite clearance rate assessment [Time Frame: 42 days]

Hemoglobin level [Time Frame: 42 days follow-up]

Secondary ID(s)

CASTEP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ministry of Science and Technology of the People´s Republic of China

National Institute for Parasitic Disease, Chinese Center for Disease Control and Prevention