Artemether-Lumefantrine Clinical Effectiveness Study

NCT01599000 | Completed Phase 4

• 1 other identifier: MRAC.09.13
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parasitologically Confirmed; Malarial

Keywords

malaria; Plasmodium; Papua New Guinea; artemether/lumefantrine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Efficacy arm

ACTIVE COMPARATOR

Supervised administration of six doses of fixed-dose artemether-lumefantrine (Coartem, Novartis)

Drug: Artemether-lumefantrine combination

Effectiveness arm

EXPERIMENTAL

Un-supervised administration of six doses of fixed-dose artemether-lumefantrine (Coartem, Novartis)

Drug: Artemether-lumefantrine combination

Interventions

Artemether-lumefantrine combination DRUG

fixed-dose tablet, six doses over three days, according to weight group

Also known as: Coartem, Novartis

Effectiveness arm; Efficacy arm

Eligibility Criteria

• Age: 6 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Papua New Guinea Institute of Medical Research: lead
• Australian Agency for International Development: collaborator
• National Department of Health, Papua New Guinea: collaborator

Study Sites (1)

Gurney Health Centre

Alotau, Milne Bay Province, Papua New Guinea

Location

MeSH Terms

Conditions

Malaria

Interventions

Artemether, Lumefantrine Drug Combination; lactitol

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Artemether; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Lumefantrine; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sesquiterpenes; Terpenes; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Manuel W Hetzel, PhD

  Papua New Guinea Institute of Medical Research

  PRINCIPAL INVESTIGATOR

• Mueller Ivo, PhD

  Walter and Eliza Hall Institute of Medical Research

  PRINCIPAL INVESTIGATOR

• Peter M Siba, PhD

  Papua New Guinea Institute of Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2012
• First Posted: May 15, 2012
• Study Start: March 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 16, 2012

Record last verified: 2012-08

Locations

PA (1)