Status:
UNKNOWN
Efficacy and Safety of Artemether-Lumefantrine and Dihydroartemisinin-Piperaquine 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:
Malaria
Eligibility:
All Genders
6-120 years
Phase:
PHASE4
Brief Summary
Malaria is an infectious disease transmitted by the bite of an infected female anopheles mosquito. The most vulnerable group that bears the highest disease burden includes children less than five year...
Detailed Description
Brief title: Efficacy and Safety of Artemether-Lumefantrine (AL) and Dihydroartemisinin-Piperaquine (DHA-PPQ) in Cameroon Official title: Efficacy and Safety of Artemether-Lumefantrine and Dihydroart...
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 of 1000 to 200000 parasites/μl.
- Presenting with fever (axillary temperature ≥ 37.5 ºC) 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, hypoglycemia, 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 edema involving at least the feet or has a mid-upper arm circumference \<115 mm).
- Regular medication, which may interfere with antimalarial 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 antimalarial drugs within the last one month.
Key Trial Info
Start Date :
April 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT05340153
Start Date
April 11 2022
End Date
December 31 2022
Last Update
April 22 2022
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