Status:
UNKNOWN
Efficacy and Safety of Artesunate-amodiaquine and Artemether-lumefantrine for the Treatment of Malaria in Cameroon
Lead Sponsor:
University of Yaounde 1
Collaborating Sponsors:
Biotechnology Center (BTC), University of Yaounde I, Cameroon
National Malaria Control Program (NMCP), Cameroon
Conditions:
Falciparum Malaria
Eligibility:
All Genders
6-120 years
Phase:
PHASE4
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-lume...
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-amodi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT04829695
Start Date
April 5 2021
End Date
December 31 2021
Last Update
April 2 2021
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