ACTRN12615000106538
Not yet recruiting
未知
Efficacy and safety of artemisinin-based combination therapy: artesunate-amodiaquine (ASAQ) and artemether-lumefantrine (AL) in the treatment of uncomplicated falciparum malaria in 4 provinces of Burundi
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- ncomplicated falciparum malaria
- Sponsor
- Ministry of Public Health
- Enrollment
- 528
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •children aged 6 months to 10 years
- •monoinfection with P falciparum confirmed by microscopy
- •parasitemia between 1000\-200000 parasites (asexual) per microliter
- •fever (equal or greater than 37\.5 celsius) or history of fever within past 24 hours
- •able to swallow oral medication
- •ability and willingness to follow protocol procedures and schedule of assessments
- •written informed consent from parent or guardian
Exclusion Criteria
- •presence of danger and signs of severe malaria
- •mixed infection or infection of than P. falciparum detected by microscopy
- •severely malnourished
- •fever due to other diseases (measles, acute lower respiratory tract infection, severa diarrhea); chronic or severe hepatic, renal or cardiac diseases; HIV/AIDS
- •clinical signs of acute jaundice
- •abnormal level of granulocytes or liver transaminases
- •regular medication that could interfere with antimalarial pharmacokinetics;
- •history of hypersensitivity reactions or contraindications to any medicines being used
Outcomes
Primary Outcomes
Not specified
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