Vivax MalariaPhase 3NCT01625871
Artemether/Lumefantrine and Vivax Malaria
A Phase 3 study testing tablets artemether/lumefantrine in people with Vivax Malaria, run by University of Khartoum at 1 site in Sudan.
Trial summary
The cure rate of artemether/lumefantrine in the treatment of vivax malaria. Read more about this study
- Who is it for?
- Ages 5 to 80 years
- Conditions the study is for
- Vivax Malaria
- What is being tested?
- tablets artemether/lumefantrine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSudan
- Study dates
- Sep 2011to Sep 2012
- Phase
- Phase 3
- 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 5 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with vivax malaria
Who cannot join
- severe malaria
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Artemether/Lumefantrine in the Treatment of Plasmodium Vivax Malaria in Eastern Sudan
The cure rate of artemether/lumefantrine in the treatment of vivax malaria.
- Conditions
- Vivax Malaria
- Being tested
- tablets artemether/lumefantrine
- Keywords
- malaria, vivax, artemether/lumefantrine, Sudan
- Medical subject headings
- Malaria, Vivax, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tablets artemether/lumefantrineDrug
Also called Quartem
six doses of oral tablets of artemether/lumefantrine
| Study group | Role | What they receive |
|---|---|---|
| artemether-lumefantrine | Experimental | tablets (containing 20mg artemether and 120 mg lumefantrine) for three days Receives: Drug: tablets artemether/lumefantrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cure rate
The proportion of the cure patients
Measured: 28 days
Secondary outcomes (2)
Fever clearance time
The time for fever clearance
Measured: 28 days
Parasite clearance time
The time for the parasite to clear
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2012 (estimated)
- Study startSep 2011
- Primary completionSep 2012
- Study completionSep 2012
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 Vivax 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Khartoum
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kassala, Sudan
- Responsible party
- Principal investigator, Ishag Adam, University of Khartoum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625871
- Sponsor's protocol ID
- vivax
- Status last verified
- Jan 2013
- First submitted
- 17 Jun 2012
- Last updated
- 17 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Makanga M, Krudsood S. The clinical efficacy of artemether/lumefantrine (Coartem). Malar J. 2009 Oct 12;8 Suppl 1(Suppl 1):S5. doi: 10.1186/1475-2875-8-S1-S5.
PubMed 19818172Abdallah TM, Ali AA, Bakri M, Gasim GI, Musa IR, Adam I. Efficacy of artemether-lumefantrine as a treatment for uncomplicated Plasmodium vivax malaria in eastern Sudan. Malar J. 2012 Dec 5;11:404. doi: 10.1186/1475-2875-11-404.
PubMed 23217037
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artemether/Lumefantrine in the Treatment of Plasmodium Vivax Malaria in Eastern Sudan
- ClinicalTrials.gov ID
- NCT01625871
- Acronym / sponsor ID
- vivax
- Conditions
- Vivax Malaria
- Keywords
- malaria, vivax, artemether/lumefantrine, Sudan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of KhartoumUniversity, hospital or other
- Collaborators
- University of Kassala, Sudan
- Study start
- Sep 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 22 Jun 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.
The cure rate of artemether/lumefantrine in the treatment of vivax malaria.
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: tablets artemether/lumefantrinetablets (containing 20mg artemether and 120 mg lumefantrine) for three days |
Who may qualify
- Ages
- 5 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with vivax malaria
Key exclusion criteria (2 listed)
- severe malaria
- pregnancy
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 |
|---|---|---|
| tablets artemether/lumefantrineAlso: Quartemsix doses of oral tablets of artemether/lumefantrine | Drug | artemether-lumefantrine |
Primary outcome
The cure rate
Time frame: 28 days
The proportion of the cure patients
2 secondary outcomes
Fever clearance time
Time frame: 28 days
Parasite clearance time
Time frame: 28 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 17 Jan 2013.
- Background: PubMed 19818172Makanga M, Krudsood S. The clinical efficacy of artemether/lumefantrine (Coartem). Malar J. 2009 Oct 12;8 Suppl 1(Suppl 1):S5. doi: 10.1186/1475-2875-8-S1-S5.
- Derived from this study: PubMed 23217037Abdallah TM, Ali AA, Bakri M, Gasim GI, Musa IR, Adam I. Efficacy of artemether-lumefantrine as a treatment for uncomplicated Plasmodium vivax malaria in eastern Sudan. Malar J. 2012 Dec 5;11:404. doi: 10.1186/1475-2875-11-404.
- http://www.ncbi.nlm.nih.gov/pubmed?term=adam%20iLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tablets artemether/lumefantrine in people with Vivax Malaria, run by University of Khartoum at 1 site in Sudan.
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 1 inclusion and 2 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 17 Jan 2013. 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 Sudan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The cure rate (time frame: 28 days). 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 NCT01625871, 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 17 Jan 2013.