Efficacy study of artemether-lumefantrine for the treatment of malaria in Solomon Islands.
Efficacy study of artemether-lumefantrine for the treatment of Plasmodium falciparum (P. falciparum or Pf) and Plasmodium vivax (P. vivax or Pv) in Solomon Islands.
Ministry of Health
140 participants
Jun 30, 2008
Interventional
Conditions
Summary
PRIMARY PURPOSE To assess the efficacy of artemether- lumefantrine for the treatment of uncomplicated P. falciparum and P. vivax infections in Solomon Islands using the WHO 28-day protocol. The null hypothesis is that patients who take artemether-lumefantrine (CoArtem) for the treatment of uncomplicated P. falciparum and P. vivax infections have similar clinical and parasitological outcomes.
Eligibility
Inclusion Criteria9
- (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 Criteria7
- (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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Patients with a microscopically confirmed P. falciparum or P. vivax infection on day 0 will be administered a fixed dose combination of artemether (20 mg) and lumefantrine (120 mg) (CoartemTM, Novartis) as a six-dose regimen twice a day for three days according to body weight under direct supervision by the study team. The mode of administration is oral dosing as follows: 5 to <15 kg bodyweight: 1 tablet per dose; 15 to <25 kg: 2 tablets per dose; 25 to <35 kg: 3 tablets per dose; =35 kg: 4 tablets per dose. In addition, the Pv group will also receive oral primaquine once daily for 14 days (0.25 mg base/kg/day), starting on Day 28 after completion of the 28-day follow-up. The study patients will be observed for 30 min after drug administration for adverse reactions or vomiting. Any patient who vomited during this observation period will be re-treated with the same dose of AL and observed for an additional 30 min. Patients are requested to return to the clinic on days 1, 2, 3, 7, 14, 21 and 28 for clinical and parasitological assessment as per protocol follow up schedule, or whenever they did not feel well.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12615000748516