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Trial record 10 of 21 for:    ( Map: Papua New Guinea )

Artemether-Lumefantrine Clinical Effectiveness Study

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ClinicalTrials.gov Identifier: NCT01599000
Recruitment Status : Completed
First Posted : May 15, 2012
Last Update Posted : August 16, 2012
Sponsor:
Collaborators:
Australian Agency for International Development
National Department of Health, Papua New Guinea
Information provided by (Responsible Party):
Papua New Guinea Institute of Medical Research

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.


Condition or disease Intervention/treatment Phase
Parasitologically Confirmed; Malarial Drug: Artemether-lumefantrine combination Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Artemether-Lumefantrine Clinical Effectiveness Study
Study Start Date : March 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Efficacy arm
Supervised administration of six doses of fixed-dose artemether-lumefantrine (Coartem, Novartis)
Drug: Artemether-lumefantrine combination
fixed-dose tablet, six doses over three days, according to weight group
Other Name: Coartem, Novartis
Experimental: Effectiveness arm
Un-supervised administration of six doses of fixed-dose artemether-lumefantrine (Coartem, Novartis)
Drug: Artemether-lumefantrine combination
fixed-dose tablet, six doses over three days, according to weight group
Other Name: Coartem, Novartis



Primary Outcome Measures :
  1. Adequate Clinical and Parasitological Response (ACPR) [ Time Frame: 42 days ]
    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).



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Ages Eligible for Study:   6 Months to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01599000


Locations
Papua New Guinea
Gurney Health Centre
Alotau, Milne Bay, Papua New Guinea
Sponsors and Collaborators
Papua New Guinea Institute of Medical Research
Australian Agency for International Development
National Department of Health, Papua New Guinea
Investigators
Principal Investigator: 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

Responsible Party: Papua New Guinea Institute of Medical Research
ClinicalTrials.gov Identifier: NCT01599000     History of Changes
Other Study ID Numbers: MRAC.09.13
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: August 16, 2012
Last Verified: August 2012

Keywords provided by Papua New Guinea Institute of Medical Research:
malaria
Plasmodium
Papua New Guinea
artemether/lumefantrine

Additional relevant MeSH terms:
Lumefantrine
Artemether
Artemisinins
Artemether-lumefantrine combination
Lactitol
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics
Cathartics
Gastrointestinal Agents