Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in the provinces of Zivie/Atlantic, Kouande/Atacora and Zakpota /Zou in the Republic of Beni

Not Applicable

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

• Registration Number: ACTRN12613001258741
• Lead Sponsor: Ministere de la Sante Benin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Age between 6 months and 12 years
Minimum body weight of 5kg
Mono-infection with plasmodium falciparum confirmed by microscopy
Parasitemia between 1000-200000 asexual forms parasites per microliter
Axillary temperature equal or greater than 37.5 degrees Celsius or history of fever in the past 24 hours
Able to swallow oral medication
Capable and willing to follow protocol requirement, including schedule of assessments
Written consent from parent/guardian

Exclusion Criteria

Presence of signs in children aged under 5 years, or signs of severe falciparum malaria according to WHO definition
Mixed or mono infection with another Plasmodium species detected by microscopy
Presence of severe malnutrition (defined as a child whose growth standard is below minus 3z score, has symmetrical oedema involving at least the feet, or has mid-upper arm circumference less than 110 mm
Presence of febrile conditions due to diseases other than malaria (measles, acute lower respiratory tract infection, severe diarrhea with dehydration), or other known underlying chronic diseases (cardiac, renal and hepatic diseases, HIV/AIDS)
Regular medications, which may interfere with the antimalarial pharmacokinetics
History of hypersensitivity reaction or contraindications to any of the medicine(s) being tested or used as alternative treatments

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with adequate clinical and parasitological response adjusted by PCR (polymerase chain reaction)[Day 28]

Secondary Outcome Measures

Name	Time	Method
Incidence and nature of adverse events. Possible adverse events are those known to occur with antimalarials and include, headache, body ache, nausea, vomiting, abdominal discomfort, liver enzyme elelevation, and dizziness[Day 28];Hematocrit[Baseline and Day 28];In vitro susceptibility testing of Plasmodium isolates to artemether-lumefantrine[Day 0]