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

Not Applicable

• Conditions: ncomplicated falciparum malaria; Uncomplicated falciparum malaria; Infection - Other infectious diseases

• Registration Number: ACTRN12615000106538
• Lead Sponsor: Ministry of Public Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 528

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
proportion of patients with PCR-corrected adequate clinical and parasitological response according to WHO criteria [Day 28]

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events. Known or possible adverse events associated with ASAQ include anorexia, abdominal pain, nausea, fatique, drowziness, dizziness, insomnia and cough. Known or possible adverse events associated to AL include fever, cough, vomiting, anorexia and headache[Day 28]