Parasitologically Confirmed; MalarialPhase 4NCT01599000
Artemether-Lumefantrine Clinical Effectiveness Study
A Phase 4 study testing Artemether-lumefantrine combination in people with Parasitologically Confirmed; Malarial, run by Papua New Guinea Institute of Medical Research at 1 site in Papua New Guinea.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 10 years
- Conditions the study is for
- Parasitologically Confirmed; Malarial
- What is being tested?
- Artemether-lumefantrine combination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 sitePapua New Guinea
- Study dates
- Mar 2011to Jul 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Papua New Guinea1 site
Gurney Health Centre
Alotau, Milne Bay Province
About this 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.
- Conditions
- Parasitologically Confirmed; Malarial
- Being tested
- Artemether-lumefantrine combination
- Keywords
- malaria, Plasmodium, Papua New Guinea, artemether/lumefantrine
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemether-lumefantrine combinationDrug
Also called Coartem, Novartis
fixed-dose tablet, six doses over three days, according to weight group
| Study group | Role | What they receive |
|---|---|---|
| Efficacy arm | Active comparator | Supervised administration of six doses of fixed-dose artemether-lumefantrine (Coartem, Novartis) Receives: Drug: Artemether-lumefantrine combination |
| Effectiveness arm | Experimental | Un-supervised administration of six doses of fixed-dose artemether-lumefantrine (Coartem, Novartis) Receives: Drug: Artemether-lumefantrine combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startMar 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parasitologically Confirmed; MalarialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papua New Guinea Institute of Medical Research
- Sponsor type
- Other government
- Collaborators
- Australian Agency for International Development, National Department of Health, Papua New Guinea
- Responsible party
- Sponsor
- Investigators
- Manuel W Hetzel, PhD, Principal investigator, Papua New Guinea Institute of Medical ResearchMueller Ivo, PhD, Principal investigator, Walter and Eliza Hall Institute of Medical ResearchPeter M Siba, PhD, Principal investigator, Papua New Guinea Institute of Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599000
- Sponsor's protocol ID
- MRAC.09.13
- Status last verified
- Aug 2012
- First submitted
- 1 Apr 2012
- Last updated
- 16 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artemether-Lumefantrine Clinical Effectiveness Study
- ClinicalTrials.gov ID
- NCT01599000
- Acronym / sponsor ID
- MRAC.09.13
- Conditions
- Parasitologically Confirmed; Malarial
- Keywords
- malaria, Plasmodium, Papua New Guinea, artemether/lumefantrine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Papua New Guinea Institute of Medical ResearchOther government
- Collaborators
- Australian Agency for International Development, National Department of Health, Papua New Guinea
- Study start
- Mar 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 15 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Efficacy arm | Active comparator | Drug: Artemether-lumefantrine combinationSupervised administration of six doses of fixed-dose artemether-lumefantrine (Coartem, Novartis) |
| Effectiveness arm | Experimental | Drug: Artemether-lumefantrine combinationUn-supervised administration of six doses of fixed-dose artemether-lumefantrine (Coartem, Novartis) |
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artemether-lumefantrine combinationAlso: Coartem, Novartisfixed-dose tablet, six doses over three days, according to weight group | Drug | Effectiveness arm, Efficacy arm |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel W Hetzel, PhD principal investigator
Papua New Guinea Institute of Medical Research
Mueller Ivo, PhD principal investigator
Walter and Eliza Hall Institute of Medical Research
Peter M Siba, PhD principal investigator
Papua New Guinea Institute of Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Artemether-lumefantrine combination in people with Parasitologically Confirmed; Malarial, run by Papua New Guinea Institute of Medical Research at 1 site in Papua New Guinea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Papua New Guinea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequate Clinical and Parasitological Response (ACPR) (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2012.