MalariaPhase 4NCT00336375
Treatment of Uncomplicated Childhood Malaria in Tanzania by Artemether+Lumefantrine - Efficacy and Genotyping
A Phase 4 study testing artemether-lumefantrine in people with Malaria, run by Karolinska University Hospital at 1 site in Tanzania.
Trial summary
The purpose of this explorative clinical trial is to study parasite population dynamics, diversity and clearance kinetics of Plasmodium falciparum as well as determination of the molecular mechanisms associated with drug resistance during the early phase of artemether-lumefantrine treatment when the drug intake is… Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Malaria
- What is being tested?
- artemether-lumefantrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTanzania
- Study dates
- Jun 2006to Jul 2006
- 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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 1-10 years
- Presence of asexual P. falciparum parasitaemia of 2000-200 000/μL
- No general danger signs or severe malaria present
- Haemoglobin ≥70 g/L
- History of fever within 24 hours OR axillary temperature ≥ 37.5Cº
- No other cause of fever is detectable
- No severe malnutrition
- Guardian/patient has understood the procedures of the study and willing to participate
Who cannot join
- Not able to drink or breastfeed
- Vomiting everything
- Recent history of convulsions
- Lethargic or unconscious
- Unable to sit or stand (as appropriate for age)
- History of allergy to test drugs
- History of intake of any drugs other than paracetamol and aspirin within 3 days
- Symptoms/signs of severe malaria
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Fukayosi Primary Health Care Center
Fukayosi, Bagamoyo District
About this study
Official title: Treatment of Uncomplicated Childhood Malaria by an Artemisinin Derivative in Combination With Lumefantrine. Efficacy, Safety and Genotyping.
The purpose of this explorative clinical trial is to study parasite population dynamics, diversity and clearance kinetics of Plasmodium falciparum as well as determination of the molecular mechanisms associated with drug resistance during the early phase of artemether-lumefantrine treatment when the drug intake is either accompanied with or without intake of fatty food. The hypothesis is that intake of fatty food together with artemether-lumefantrine will enhance parasite clearance and thereby decrease the risk of early selection of genetic markers related to drug resistance. The study population is children aged 1-10 years with uncomplicated malaria in Bagamoyo District, Tanzania. Enrolled children will be randomly allocated to either intake of a fatty meal or not together with the study drug. Artemether-lumefantrine will be given twice daily for 3 days in standard doses according to bodyweight. Study participants will be admitted during the study period (3 days)to allow close supervision and detailed blood sampling.
- Conditions
- Malaria
- Being tested
- 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-lumefantrineDrug
Also called All drug doses of artemether-lumefantrine is given either accompanied with or not-accompanied with intake of fatty food
All treatment doses given either accompanied or not-accompanied with intake of fatty food.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | All treatment doses accompanied with intake of fatty food Receives: Drug: artemether-lumefantrine |
| 2 | Active comparator | All treatment doses not-accompanied with intake of fatty food. Receives: Drug: artemether-lumefantrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of P.falciparum genotypes identified at baseline compared with accumulated number of genotypes in all blood samples
Measured: 72 hours
Secondary outcomes (1)
Clearance kinetics of P. falciparum measured with PCR genotyping compared with blood slide reading
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2006 (estimated)
- Study startJun 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Muhimbili University of Health and Allied Sciences
- Investigators
- Anders Bjorkman, Professor, Study director, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336375
- Sponsor's protocol ID
- 04/04/2006
- Status last verified
- Oct 2007
- First submitted
- 12 Jun 2006
- Last updated
- 1 Nov 2007
- Results posted
- No
Publications
Mwaiswelo R, Ngasala B, Jovel I, Xu W, Larsson E, Malmberg M, Gil JP, Premji Z, Mmbando BP, Martensson A. Prevalence of and Risk Factors Associated with Polymerase Chain Reaction-Determined Plasmodium falciparum Positivity on Day 3 after Initiation of Artemether-Lumefantrine Treatment for Uncomplicated Malaria in Bagamoyo District, Tanzania. Am J Trop Med Hyg. 2019 May;100(5):1179-1186. doi: 10.4269/ajtmh.18-0729.
PubMed 30860013Carlsson AM, Ngasala BE, Dahlstrom S, Membi C, Veiga IM, Rombo L, Abdulla S, Premji Z, Gil JP, Bjorkman A, Martensson A. Plasmodium falciparum population dynamics during the early phase of anti-malarial drug treatment in Tanzanian children with acute uncomplicated malaria. Malar J. 2011 Dec 20;10:380. doi: 10.1186/1475-2875-10-380.
PubMed 22185672
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Uncomplicated Childhood Malaria by an Artemisinin Derivative in Combination With Lumefantrine. Efficacy, Safety and Genotyping.
- ClinicalTrials.gov ID
- NCT00336375
- Acronym / sponsor ID
- 04/04/2006
- Conditions
- Malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Muhimbili University of Health and Allied Sciences
- Study start
- Jun 2006
- Study completion
- Jul 2006 (actual)
- First posted
- 13 Jun 2006 (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.
The purpose of this explorative clinical trial is to study parasite population dynamics, diversity and clearance kinetics of Plasmodium falciparum as well as determination of the molecular mechanisms associated with drug resistance during the early phase of artemether-lumefantrine treatment when the drug intake is either accompanied with or without intake of fatty food. The hypothesis is that intake of fatty food together with artemether-lumefantrine will enhance parasite clearance and thereby decrease the risk of early selection of genetic markers related to drug resistance. The study population is children aged 1-10 years with uncomplicated malaria in Bagamoyo District, Tanzania. Enrolled children will be randomly allocated to either intake of a fatty meal or not together with the study drug. Artemether-lumefantrine will be given twice daily for 3 days in standard doses according to bodyweight. Study participants will be admitted during the study period (3 days)to allow close supervision and detailed blood sampling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: artemether-lumefantrineAll treatment doses accompanied with intake of fatty food |
| 2 | Active comparator | Drug: artemether-lumefantrineAll treatment doses not-accompanied with intake of fatty food. |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age 1-10 years
- Presence of asexual P. falciparum parasitaemia of 2000-200 000/μL
- No general danger signs or severe malaria present
- Haemoglobin ≥70 g/L
- History of fever within 24 hours OR axillary temperature ≥ 37.5Cº
Key exclusion criteria (8 listed)
- Not able to drink or breastfeed
- Vomiting everything
- Recent history of convulsions
- Lethargic or unconscious
- Unable to sit or stand (as appropriate for age)
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: All drug doses of artemether-lumefantrine is given either accompanied with or not-accompanied with intake of fatty foodAll treatment doses given either accompanied or not-accompanied with intake of fatty food. | Drug | 1, 2 |
Primary outcome
Number of P.falciparum genotypes identified at baseline compared with accumulated number of genotypes in all blood samples
Time frame: 72 hours
1 secondary outcome
Clearance kinetics of P. falciparum measured with PCR genotyping compared with blood slide reading
Time frame: 72 hours
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 1 Nov 2007.
- Derived from this study: PubMed 30860013Mwaiswelo R, Ngasala B, Jovel I, Xu W, Larsson E, Malmberg M, Gil JP, Premji Z, Mmbando BP, Martensson A. Prevalence of and Risk Factors Associated with Polymerase Chain Reaction-Determined Plasmodium falciparum Positivity on Day 3 after Initiation of Artemether-Lumefantrine Treatment for Uncomplicated Malaria in Bagamoyo District, Tanzania. Am J Trop Med Hyg. 2019 May;100(5):1179-1186. doi: 10.4269/ajtmh.18-0729.
- Derived from this study: PubMed 22185672Carlsson AM, Ngasala BE, Dahlstrom S, Membi C, Veiga IM, Rombo L, Abdulla S, Premji Z, Gil JP, Bjorkman A, Martensson A. Plasmodium falciparum population dynamics during the early phase of anti-malarial drug treatment in Tanzanian children with acute uncomplicated malaria. Malar J. 2011 Dec 20;10:380. doi: 10.1186/1475-2875-10-380.
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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.
Anders Bjorkman, Professor study director
Karolinska University Hospital
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 Malaria, run by Karolinska University Hospital 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 8 inclusion and 8 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 1 Nov 2007. 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?
Number of P.falciparum genotypes identified at baseline compared with accumulated number of genotypes in all blood samples (time frame: 72 hours). 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 NCT00336375, which also lists 2 linked publications.
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 1 Nov 2007.