MalariaPhase 4NCT01038063
Safety and Effectiveness of Artemisinin-based Combination Therapies (ACTs) With Repeated Treatments for Uncomplicated Falciparum Malaria Over a Three-year Period
A Phase 4 study testing Artemether-lumefantrine combination in people with Malaria, run by Liverpool School of Tropical Medicine at 1 site in Malawi.
Trial summary
A community-based, open-label, cluster-randomised longitudinal study in which children are randomized according to village health worker catchment areas comparing the safety and effectiveness of repeated treatments with artemether-lumefantrine (AL) over a 3-year period in children 4-48 months to that of repeated… Read more about this study
- Who is it for?
- Ages 4 to 48 months
- Conditions the study is for
- Malaria
- What is being tested?
- Artemether-lumefantrine combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteMalawi
- Study dates
- Oct 2010to Sep 2013
- 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 4 to 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged between 4 months and 11 months at the time of randomization
- Bodyweight ≥ 5 kg at the time of randomization
- Provision of informed consent by parent or guardian
- Intention to stay in the study area for the time of the study
Who cannot join
- Ongoing participation into another clinical study involving ongoing or scheduled treatment with medicinal products
- Intent to reside outside of catchment area during the course of the study
- Known hypersensitivity to the study drug randomized to
- Known pre-existing hearing problem or neurological impairment
- Known need at the time of randomization for concomitant prohibited medication
- Suspected non-compliance with the follow-up schedule
Trial locations and contacts
1 site in 1 country.
Malawi1 site, 1 recruiting
- Recruiting
Malawi-Liverpool-Wellcome Trust Research Programme, College of Medicine
Blantyre, 30096
Kamija Phiri, MD PhD, +265 999 957 048, kamijaphiri@gmail.com
Kamija Phiri, MD PhD
About this study
Official title: Programmatic Implementation of ACTs in Malawi: Safety and Effectiveness of Combination Therapies With Repeated Treatments for Uncomplicated P. Falciparum Malaria Over a Three-year Period
A community-based, open-label, cluster-randomised longitudinal study in which children are randomized according to village health worker catchment areas comparing the safety and effectiveness of repeated treatments with artemether-lumefantrine (AL) over a 3-year period in children 4-48 months to that of repeated treatment with dihydroartemisinin-piperaquine (DHA-PPQ).
- Conditions
- Malaria
- Being tested
- Artemether-lumefantrine combination
- 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
| Study group | Role | What they receive |
|---|---|---|
| Artemether-lumefantrine | Experimental | Children in this study arm will be treated with artemether-lumefantrine during a three year follow-up period each time a child develops uncomplicated malaria. Receives: Drug: Artemether-lumefantrine combination |
| Dihydroartemisinin-piperaquine | Active comparator | Children in this study arm will be treated with dihydroartemisinin-piperaquine during a three year follow-up period each time a child develops uncomplicated malaria. Receives: Drug: Artemether-lumefantrine combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of ototoxicity at 18 months and 36 months of enrolment.
Measured: At 18 mo and 36 month of follow up
Secondary outcomes (1)
Incidence of clinical malaria during 18 months and 36 months of follow-up
Measured: 18 and 36 months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startOct 2010
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies 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
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Malawi-Liverpool-Wellcome Trust Clinical Research Programme, National Malaria Control Programme, Malawi, Research for Equity and Community Health Trust
- Investigators
- David Lalloo, MD, Principal investigator, Liverpool School of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038063
- Sponsor's protocol ID
- 09.07
- Status last verified
- Dec 2010
- First submitted
- 21 Dec 2009
- Last updated
- 9 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roca-Feltrer A, Lalloo DG, Phiri K, Terlouw DJ. Rolling Malaria Indicator Surveys (rMIS): a potential district-level malaria monitoring and evaluation (M&E) tool for program managers. Am J Trop Med Hyg. 2012 Jan;86(1):96-8. doi: 10.4269/ajtmh.2012.11-0397.
PubMed 22232457
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Programmatic Implementation of ACTs in Malawi: Safety and Effectiveness of Combination Therapies With Repeated Treatments for Uncomplicated P. Falciparum Malaria Over a Three-year Period
- ClinicalTrials.gov ID
- NCT01038063
- Acronym / sponsor ID
- 09.07
- Conditions
- Malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Liverpool School of Tropical MedicineUniversity, hospital or other
- Collaborators
- Malawi-Liverpool-Wellcome Trust Clinical Research Programme, National Malaria Control Programme, Malawi, Research for Equity and Community Health Trust
- Study start
- Oct 2010
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 23 Dec 2009 (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.
A community-based, open-label, cluster-randomised longitudinal study in which children are randomized according to village health worker catchment areas comparing the safety and effectiveness of repeated treatments with artemether-lumefantrine (AL) over a 3-year period in children 4-48 months to that of repeated treatment with dihydroartemisinin-piperaquine (DHA-PPQ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artemether-lumefantrine | Experimental | Drug: Artemether-lumefantrine combinationChildren in this study arm will be treated with artemether-lumefantrine during a three year follow-up period each time a child develops uncomplicated malaria. |
| Dihydroartemisinin-piperaquine | Active comparator | Drug: Artemether-lumefantrine combinationChildren in this study arm will be treated with dihydroartemisinin-piperaquine during a three year follow-up period each time a child develops uncomplicated malaria. |
Who may qualify
- Ages
- 4 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged between 4 months and 11 months at the time of randomization
- Bodyweight ≥ 5 kg at the time of randomization
- Provision of informed consent by parent or guardian
- Intention to stay in the study area for the time of the study
Key exclusion criteria (6 listed)
- Ongoing participation into another clinical study involving ongoing or scheduled treatment with medicinal products
- Intent to reside outside of catchment area during the course of the study
- Known hypersensitivity to the study drug randomized to
- Known pre-existing hearing problem or neurological impairment
- Known need at the time of randomization for concomitant prohibited medication
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 combination | Drug | Artemether-lumefantrine, Dihydroartemisinin-piperaquine |
Primary outcome
Prevalence of ototoxicity at 18 months and 36 months of enrolment.
Time frame: At 18 mo and 36 month of follow up
1 secondary outcome
Incidence of clinical malaria during 18 months and 36 months of follow-up
Time frame: 18 and 36 months of follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2010.
- Derived from this study: PubMed 22232457Roca-Feltrer A, Lalloo DG, Phiri K, Terlouw DJ. Rolling Malaria Indicator Surveys (rMIS): a potential district-level malaria monitoring and evaluation (M&E) tool for program managers. Am J Trop Med Hyg. 2012 Jan;86(1):96-8. doi: 10.4269/ajtmh.2012.11-0397.
- The ACT Consortium is a global research partnership formed in November 2007 to answer key questions on malaria drug delivery in Africa and Asia.Link provided by the sponsor.
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
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.
David Lalloo, MD principal investigator
Liverpool School of Tropical Medicine
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 Malaria, run by Liverpool School of Tropical Medicine at 1 site in Malawi.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Dec 2010. 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 Malawi. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Lalloo, MD (+44 151 705 3179, dlalloo@liverpool.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of ototoxicity at 18 months and 36 months of enrolment. (time frame: At 18 mo and 36 month of follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01038063, which also lists 1 linked publication.
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 9 Dec 2010.