Plasmodium Falciparum MalariaPhase 4ALENCT02089841
Efficacy of Artemether/Lumefantrine for the Treatment of Uncomplicated Malaria.
A Phase 4 study testing Artemether-lumefantrine in people with Plasmodium Falciparum Malaria, run by Richard Mwaiswelo at 1 site in Tanzania.
Trial summary
Artemether-lumefantrine has been used in Tanzania as first-line treatment for uncomplicated malaria since 2007. Nonetheless, a report of increased proportion of patients with parasitaemia on day 1 following treatment with artemisinin based combination therapies has emerged from Kenya. Read more about this study
- Who is it for?
- Ages 6 to 120 months
- Conditions the study is for
- Plasmodium Falciparum Malaria
- What is being tested?
- Artemether-lumefantrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTanzania
- Study dates
- May 2012to Aug 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 6 to 120 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Mono-infection with P. falciparum
- Parasitaemia level of 2000 - 200,000/μL
- Absence of danger signs or signs of severe malaria
- Axillary temperature ≥ 37.5°C or history of fever 24 hours prior to coming to the facility
- Absence of other concomitant infections like pneumonia which can cause fever
- No use of antimalarial drug two weeks prior to the study
- Consent to comply to the protocol.
Who cannot join
- Presence of general danger signs or signs of severe falciparum malaria
- Severe malnutrition
- Febrile condition due to diseases other than malaria, such as measles, acute lower respiratory infection or other known chronic diseases
- Regular medication which might interfere with antimalarial pharmacokinetics
- History of hypersensitivity reactions or contraindications to any medicine being used in the trial.
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Muhimbili University of Health and Allied Sciences
Dar es Salaam, P.O Box 65001
About this study
Official title: Efficacy of Artemether/Lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Five Years After Wide Scale Use of the Drug in Tanzania.
Artemether-lumefantrine has been used in Tanzania as first-line treatment for uncomplicated malaria since 2007. Nonetheless, a report of increased proportion of patients with parasitaemia on day 1 following treatment with artemisinin based combination therapies has emerged from Kenya. Similarly, resistance against artemisinins has been confirmed in South-East Asia and it can spread to Africa. Therefore, the purpose of this study was to assess the efficacy of Artemether-lumefantrine for the treatment of uncomplicated malaria among children after five years of wide scale use of the drug in Tanzania.
Read the detailed description
Artemisinin based combination therapies (ACTs) are currently recommended by the World Health Organization (WHO) as first-line treatment for uncomplicated malaria in all malaria endemic countries including Tanzania, that adopted the policy in 2007. ACTs have proven to be highly efficacious in different parts of the world with different malaria endemicity. Artemisinins clear asexual parasites rapidly and they are also potent against P. falciparum gametocytes, hence reducing disease transmission and spread of drug resistance. Nonetheless, a report in Kenya shows an increase in proportion of patients with parasitaemia on day 1. Most recently, resistance against artemisinins has been confirmed in four countries of South-East Asia, and it may spread to Africa.
In order to safeguard ACTs life span, WHO recommends all suspected malaria cases to be confirmed with parasitological diagnosis, followed by prompt treatment with effective antimalarials. It also emphasizes on the need to conduct efficacy studies for the first and second line antimalarial treatments after every two years so as to be able to detect resistance early on its course. Therefore, based on this notion, this study aimed to assess the therapeutic efficacy of Artemether/Lumefantrine among children with uncomplicated falciparum malaria in Bagamoyo district, five years after its wide scale use in Tanzania.
- Conditions
- Plasmodium Falciparum Malaria
- Being tested
- Artemether-lumefantrine
- Keywords
- Efficacy, Artemether/lumefantrine, Malaria, Children
- Medical subject headings
- Malaria, Falciparum, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemether-lumefantrineDrug
Also called Coartem
Blood samples will be collected on blood slides and filter papers for asexual parasites assessment both by microscope and molecular genotyping respectively following treatment with artemether-lumefantrine, to assess its efficacy.
| Study group | Role | What they receive |
|---|---|---|
| Artemether/lumefantrine | Experimental | In this single-arm study, patients will be treated with Artemether/lumefantrine, and the first, third and fifth doses of the drug will be given under the direct observation of the health workers. The patients will be followed-up for 42 days, on day 1, 2, 3, 7, 14, 21, 28 and 42 to assess the efficacy of the drug. Receives: Drug: Artemether-lumefantrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients without parasitaemia on day 42.
Proportion of patients without parasitaemia or with new infection as corrected by molecular genotyping on day 42 will be used to calculate the efficacy of the trial medicine.
Measured: 42 Days
Secondary outcomes (1)
Plasma lumefantrine concentration
Mean plasma lumefantrine concentration among patients on day 7 and day 14 following treatment with artemether/lumefantrine as a predictor of cure rate.
Measured: 7 days and 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startMay 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasmodium Falciparum 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Richard Mwaiswelo
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor-investigator, Richard Mwaiswelo, Muhimbili University of Health and Allied Sciences
- Investigators
- Andreas Martensson, PhD, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089841
- Sponsor's protocol ID
- 3.0.2011
- Acronym
- ALE
- Status last verified
- Mar 2014
- First submitted
- 15 Mar 2014
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Artemether/Lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Five Years After Wide Scale Use of the Drug in Tanzania.
- ClinicalTrials.gov ID
- NCT02089841
- Acronym / sponsor ID
- ALE / 3.0.2011
- Conditions
- Plasmodium Falciparum Malaria
- Keywords
- Efficacy, Artemether/lumefantrine, Malaria, Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Richard MwaisweloUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- May 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 18 Mar 2014 (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.
Artemether-lumefantrine has been used in Tanzania as first-line treatment for uncomplicated malaria since 2007. Nonetheless, a report of increased proportion of patients with parasitaemia on day 1 following treatment with artemisinin based combination therapies has emerged from Kenya. Similarly, resistance against artemisinins has been confirmed in South-East Asia and it can spread to Africa. Therefore, the purpose of this study was to assess the efficacy of Artemether-lumefantrine for the treatment of uncomplicated malaria among children after five years of wide scale use of the drug in Tanzania.
Detailed description
Artemisinin based combination therapies (ACTs) are currently recommended by the World Health Organization (WHO) as first-line treatment for uncomplicated malaria in all malaria endemic countries including Tanzania, that adopted the policy in 2007. ACTs have proven to be highly efficacious in different parts of the world with different malaria endemicity. Artemisinins clear asexual parasites rapidly and they are also potent against P. falciparum gametocytes, hence reducing disease transmission and spread of drug resistance. Nonetheless, a report in Kenya shows an increase in proportion of patients with parasitaemia on day 1. Most recently, resistance against artemisinins has been confirmed in four countries of South-East Asia, and it may spread to Africa.
In order to safeguard ACTs life span, WHO recommends all suspected malaria cases to be confirmed with parasitological diagnosis, followed by prompt treatment with effective antimalarials. It also emphasizes on the need to conduct efficacy studies for the first and second line antimalarial treatments after every two years so as to be able to detect resistance early on its course. Therefore, based on this notion, this study aimed to assess the therapeutic efficacy of Artemether/Lumefantrine among children with uncomplicated falciparum malaria in Bagamoyo district, five years after its wide scale use in Tanzania.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Artemether/lumefantrine | Experimental | Drug: Artemether-lumefantrineIn this single-arm study, patients will be treated with Artemether/lumefantrine, and the first, third and fifth doses of the drug will be given under the direct observation of the health workers. The patients will be followed-up for 42 days, on day 1, 2, 3, 7, 14, 21, 28 and 42 to assess the efficacy of the drug. |
Who may qualify
- Ages
- 6 to 120 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Mono-infection with P. falciparum
- Parasitaemia level of 2000 - 200,000/μL
- Absence of danger signs or signs of severe malaria
- Axillary temperature ≥ 37.5°C or history of fever 24 hours prior to coming to the facility
- Absence of other concomitant infections like pneumonia which can cause fever
Key exclusion criteria (5 listed)
- Presence of general danger signs or signs of severe falciparum malaria
- Severe malnutrition
- Febrile condition due to diseases other than malaria, such as measles, acute lower respiratory infection or other known chronic diseases
- Regular medication which might interfere with antimalarial pharmacokinetics
- History of hypersensitivity reactions or contraindications to any medicine being used in the trial.
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-lumefantrineAlso: CoartemBlood samples will be collected on blood slides and filter papers for asexual parasites assessment both by microscope and molecular genotyping respectively following treatment with artemether-lumefantrine, to assess its efficacy. | Drug | Artemether/lumefantrine |
Primary outcome
Proportion of patients without parasitaemia on day 42.
Time frame: 42 Days
Proportion of patients without parasitaemia or with new infection as corrected by molecular genotyping on day 42 will be used to calculate the efficacy of the trial medicine.
1 secondary outcome
Plasma lumefantrine concentration
Time frame: 7 days and 14 days
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 18 Mar 2014.
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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.
Andreas Martensson, PhD study director
Karolinska Institutet
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 in people with Plasmodium Falciparum Malaria, run by Richard Mwaiswelo at 1 site in Tanzania.
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 7 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 18 Mar 2014. 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 Tanzania. 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?
Proportion of patients without parasitaemia on day 42. (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 18 Mar 2014.