Uncomplicated MalariaPhase 3NCT00406146
Amodiaquine+Artesunate vs. Artemether-Lumefantrine for Uncomplicated Malaria in Ghanaian Children
A Phase 3 study testing amodiaquine+artesunate/artemether-lumefantrine in people with Uncomplicated Malaria, run by University of Ghana Medical School at 1 site in Ghana.
Trial summary
Artemisinin combination therapies (ACT) are currently recommended for malaria treatment. Artemether-lumefantrine(A-L) and Artesunate+amodiaquine (A+A) have been the most commonly adopted of the recommended ACT regimens. Read more about this study
- Who is it for?
- Ages 6 months to 14 years
- Conditions the study is for
- Uncomplicated Malaria
- What is being tested?
- amodiaquine+artesunate/artemether-lumefantrine
- How many people
- Not given
- Where
- 1 siteGhana
- Study dates
- Oct 2004to Dec 2006
- 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 6 months to 14 years
- All sexes
- Child
Who may be able to join
- microscopically confirmed acute uncomplicated falciparum malaria;
- temperature at screening 37.50C or more or history of fever 24 preceding enrollment;
- willingness to comply with follow up schedule;
- written informed consent by accompanying parent or guardian
Who cannot join
- features of severe malaria or danger signs of malaria
- known intolerance or allergy to any of the study medications
- known treatment with any of the study medications in the month preceding enrollment
- serious underlying disease that may mask outcome assessment
Trial locations and contacts
1 site in 1 country.
About this study
Artemisinin combination therapies (ACT) are currently recommended for malaria treatment. Artemether-lumefantrine(A-L) and Artesunate+amodiaquine (A+A) have been the most commonly adopted of the recommended ACT regimens. In Ghana, A+A is the current first-line antimalarial treatment in Ghana, but there has been 1 efficacy report of this regimen in Ghana till date. Moreover, the safety of repeated treatments with ACT has been little studied. This study aims to evaluate the efficacy of A+A vs. A-L, as well as the safety of repeated treatments of these regimens in a longitudinal trial in which recruited children will be followed up for 1 year.
- Conditions
- Uncomplicated Malaria
- Being tested
- amodiaquine+artesunate/artemether-lumefantrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amodiaquine+artesunate/artemether-lumefantrineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startOct 2004
- Study completionDec 2006
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 Uncomplicated 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- University of Ghana Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Investigators
- George O. Adjei, MD, Principal investigator, Dept. of Child Health, Korle Bu Teaching Hospital, Accra, GhanaBamenla Q. Goka, MBchB, Principal investigator, Dept of Child Health, Korle Bu Teaching Hospital, Accra, GhanaJorgen A.L. Kurtzhals, MD, Ph.D, Principal investigator, Dept. of Clinical Microbiology, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00406146
- Sponsor's protocol ID
- 91199 / 104. DAN.8-864
- Other IDs
- GHN-202-M03-M-00
- Status last verified
- Nov 2006
- First submitted
- 13 Nov 2006
- Last updated
- 4 Dec 2006
- Results posted
- No
Publications
Adjei GO, Kurtzhals JA, Rodrigues OP, Alifrangis M, Hoegberg LC, Kitcher ED, Badoe EV, Lamptey R, Goka BQ. Amodiaquine-artesunate vs artemether-lumefantrine for uncomplicated malaria in Ghanaian children: a randomized efficacy and safety trial with one year follow-up. Malar J. 2008 Jul 11;7:127. doi: 10.1186/1475-2875-7-127.
PubMed 18620577
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amodiaquine+Artesunate vs. Artemether-Lumefantrine for Uncomplicated Malaria in Ghanaian Children
- ClinicalTrials.gov ID
- NCT00406146
- Acronym / sponsor ID
- 91199 / 104. DAN.8-864
- Conditions
- Uncomplicated Malaria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- University of Ghana Medical SchoolUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Oct 2004
- Study completion
- Dec 2006
- First posted
- 4 Dec 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.
Artemisinin combination therapies (ACT) are currently recommended for malaria treatment. Artemether-lumefantrine(A-L) and Artesunate+amodiaquine (A+A) have been the most commonly adopted of the recommended ACT regimens. In Ghana, A+A is the current first-line antimalarial treatment in Ghana, but there has been 1 efficacy report of this regimen in Ghana till date. Moreover, the safety of repeated treatments with ACT has been little studied. This study aims to evaluate the efficacy of A+A vs. A-L, as well as the safety of repeated treatments of these regimens in a longitudinal trial in which recruited children will be followed up for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 6 months to 14 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (4 listed)
- microscopically confirmed acute uncomplicated falciparum malaria;
- temperature at screening 37.50C or more or history of fever 24 preceding enrollment;
- willingness to comply with follow up schedule;
- written informed consent by accompanying parent or guardian
Key exclusion criteria (4 listed)
- features of severe malaria or danger signs of malaria
- known intolerance or allergy to any of the study medications
- known treatment with any of the study medications in the month preceding enrollment
- serious underlying disease that may mask outcome assessment
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 |
|---|---|---|
| amodiaquine+artesunate/artemether-lumefantrine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2006.
- Derived from this study: PubMed 18620577Adjei GO, Kurtzhals JA, Rodrigues OP, Alifrangis M, Hoegberg LC, Kitcher ED, Badoe EV, Lamptey R, Goka BQ. Amodiaquine-artesunate vs artemether-lumefantrine for uncomplicated malaria in Ghanaian children: a randomized efficacy and safety trial with one year follow-up. Malar J. 2008 Jul 11;7:127. doi: 10.1186/1475-2875-7-127.
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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.
George O. Adjei, MD principal investigator
Dept. of Child Health, Korle Bu Teaching Hospital, Accra, Ghana
Bamenla Q. Goka, MBchB principal investigator
Dept of Child Health, Korle Bu Teaching Hospital, Accra, Ghana
Jorgen A.L. Kurtzhals, MD, Ph.D principal investigator
Dept. of Clinical Microbiology, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark
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 amodiaquine+artesunate/artemether-lumefantrine in people with Uncomplicated Malaria, run by University of Ghana Medical School at 1 site in Ghana.
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 4 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 4 Dec 2006. 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 Ghana. 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?
Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00406146, 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 4 Dec 2006.