Efficacy study of artemether-lumefantrine for the treatment of malaria in Solomon Islands.

Phase 4

Completed

• Conditions: Malaria infection; Infection - Other infectious diseases; Public Health - Epidemiology

• Registration Number: ACTRN12615000748516
• Lead Sponsor: Ministry of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

(i)Sex: male or female
(ii)Age: between 1 year and 65 years old
(iii)Falciparum or vivax infection with parasitemia between 500 and 100,000 parasites/ul of blood
(iv)History of fever during 48 hours prior to time of recruitment
(v)Ability to swallow oral medication
(vi)Is willing to give small amounts of blood via finger prick
(vii)Written informed consent from the patient or parent/guardian (in the case of young children), assent from child (ages 8-17 years inclusive).
(viii)Written informed consent and agreed to treatment follow-up for a total of 28 days
(ix)Willingness on the part of the patient to return to the clinic for scheduled check-ups during the 28-day follow-up period

Exclusion Criteria

(i)Severe/cerebral malaria or history of another serious medical disease
(ii)Prior treatment with an artemisinin or another antimalarial drug within the previous 7 days
(iii)Pregnancy and lactating
(iv)Inability to communicate well with the investigator (poor mental development or evidence of psychiatric disorder)
(v)Are likely to be absent from the household during the study period.
(vi)Chronic infectious diseases other than malaria (e.g. tuberculosis)
(vii)Known allergy and/or intolerance to drug(s) being tested

Study & Design

• Study Type: Interventional
• Study Design: Not specified