Parasitologically Confirmed; Malarial Clinical Trial
Official title:
Artemether-Lumefantrine Clinical Effectiveness Study
In 2009, Papua New Guinea officially adopted artemether-lumefantrine (AL) as new national
first-line drug for uncomplicated malaria. The principal purpose of this study is to measure
the absolute effectiveness of AL when used under real-life clinical conditions, as compared
to optimized in-vivo trial conditions. This question was raised by the National Department
of Health in preparation for the country-wide roll-out of AL.
The study is designed as a randomized controlled trial comparing two study arms. Patients in
the "effectiveness arm" receive the first dose of AL under full supervision in the clinic;
the following doses will be taken at home, as in real-life clinical practice and according
to the new national treatment guidelines. Patients in the "efficacy arm" will receive all
doses of AL as directly observed treatment in the clinic in order to establish the efficacy
of the drug when used under ideal conditions.
The study will enroll outpatients aged 6 months to 10 years with a history of fever and a
positive rapid test for malaria. Patients meeting all enrollment criteria and providing full
written informed consent by a parent/caretaker will be randomized into either of the two
study arms. Patients in both arms will be followed up actively for 42 days. Patients in the
efficacy arm will be scheduled for visits on days 0, 1, 2, 3, 7, 14, 28 and 42; patients in
the effectiveness arm on days 0, 3, 7, 14, 28 and 42.
| Status | Completed |
| Enrollment | 159 |
| Est. completion date | July 2012 |
| Est. primary completion date | July 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 6 Months to 10 Years |
| Eligibility |
Inclusion Criteria: - Age 6 months to 10 years (+/- 1 month for children without known date of birth) - Permanent resident in the study area - Not enrolled in another study at the same time - No known history of hypersensitivity reactions to artemether or lumefantrine - History of fever in the previous 72 hours (approximate) - Rapid diagnostic test (RDT) positive for any species of Plasmodium Exclusion Criteria: - General danger signs: inability to drink or breastfeed, vomiting everything, recent history of convulsions, lethargy or unconsciousness, inability to sit or stand up - Signs of severe malaria (impaired consciousness, respiratory distress, circulatory collapse, abnormal bleeding, jaundice, or as determined by clinician) - Severe malnutrition: defined as a child whose weight-for-height is below -3 standard deviation or less than 70% of the median of the NCHS/WHO normalized reference values, or who has symmetrical oedema involving at least the feet; or middle upper arm circumference under 12 cm - Clinically significant concomitant disease requiring admission - Contraindications mentioned in the national treatment guidelines |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Papua New Guinea | Gurney Health Centre | Alotau | Milne Bay |
| Lead Sponsor | Collaborator |
|---|---|
| Papua New Guinea Institute of Medical Research | Australian Agency for International Development, National Department of Health, Papua New Guinea |
Papua New Guinea,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Adequate Clinical and Parasitological Response (ACPR) | ACPR = Absence of parasitemia on Day 42 irrespective of axillary temperature without previously meeting any of the criteria of Early Treatment Failure or Late Clinical Failure or Late Parasitological Failure (adapted from WHO 2003). | 42 days | No |