Malaria, UncomplicatedNCT00153491
Adherence to Lumefantrine-Artemether
An observational study of Malaria, Uncomplicated, run by Centers for Disease Control and Prevention at 1 site in Tanzania.
Trial summary
This is a study of how well caregivers of children with malaria adhere to the recommended regimen for lumefantrine-artemether (LA). Children were randomly assigned to either a group receiving directly observed treatment in hospital or to a group treated at home by the routine caregiver (typically, patient's mother). Read more about this study
- Who is it for?
- Ages 0 years to 59 months
- Conditions the study is for
- Malaria, Uncomplicated
- What is being tested?
- artemether-lumefantrine
- How many people
- 300 participants
- Where
- 1 siteTanzania
- Study dates
- Aug 2002to Aug 2006
- Phase
- Observational
- 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 0 years to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age < 5 years of age.
- axillary temperature >= 37.5oC
- unmixed infection with P. falciparum of between 1,000 and 250,000 asexual parasites/mm3 as determined by microscopic examination of thick, or thick and thin peripheral blood smears.
- parent/guardian's informed consent and willingness to participate in the study
Who cannot join
- any evidence of severe or complicated malaria that would require hospitalization for treatment.
- reported allergy to any antimalarial drugs, including artemisinin derivatives and sulfa drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Adherence to a 6-Dose Regimen of Coartem for Treatment of Uncomplicated Malaria in Children Under 5 Years in Tanzania
This is a study of how well caregivers of children with malaria adhere to the recommended regimen for lumefantrine-artemether (LA). Children were randomly assigned to either a group receiving directly observed treatment in hospital or to a group treated at home by the routine caregiver (typically, patient's mother). Clinical/parasitologic, hematologic, pharmacologic and qualitative parameters were monitored over a 28-day follow-up period and are used to evaluate drug adherence.
- Conditions
- Malaria, Uncomplicated
- Being tested
- artemether-lumefantrine
- Keywords
- malaria, artemether-lumefantrine, co-artem, Tanzania, adherence
- 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startAug 2002
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria, UncomplicatedStudies 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
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Ifakara Health Research and Development Centre
- Investigators
- Louise Causer, MBBS, MScPH, Study director, Centers for Disease Control and PreventionSalim Abdulla, MD, PhD, Study director, Ifakara Health Research and Development CentrePeter B Bloland, DVM, MPVM, Principal investigator, Centers for Disease Control and PreventionStephen P Kachur, MD, MPH, Study director, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153491
- Sponsor's protocol ID
- CDC-NCID-3602
- Status last verified
- Sep 2005
- First submitted
- 8 Sep 2005
- Last updated
- 12 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Adherence to a 6-Dose Regimen of Coartem for Treatment of Uncomplicated Malaria in Children Under 5 Years in Tanzania
- ClinicalTrials.gov ID
- NCT00153491
- Acronym / sponsor ID
- CDC-NCID-3602
- Conditions
- Malaria, Uncomplicated
- Keywords
- malaria, artemether-lumefantrine, co-artem, Tanzania, adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Ifakara Health Research and Development Centre
- Study start
- Aug 2002
- Study completion
- Aug 2006
- First posted
- 12 Sep 2005 (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.
This is a study of how well caregivers of children with malaria adhere to the recommended regimen for lumefantrine-artemether (LA). Children were randomly assigned to either a group receiving directly observed treatment in hospital or to a group treated at home by the routine caregiver (typically, patient's mother). Clinical/parasitologic, hematologic, pharmacologic and qualitative parameters were monitored over a 28-day follow-up period and are used to evaluate drug adherence.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 years to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- age < 5 years of age.
- axillary temperature >= 37.5oC
- unmixed infection with P. falciparum of between 1,000 and 250,000 asexual parasites/mm3 as determined by microscopic examination of thick, or thick and thin peripheral blood smears.
- parent/guardian's informed consent and willingness to participate in the study
Key exclusion criteria (2 listed)
- any evidence of severe or complicated malaria that would require hospitalization for treatment.
- reported allergy to any antimalarial drugs, including artemisinin derivatives and sulfa drugs.
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 | Drug | – |
Primary outcome
Not reported in the source record.
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 12 Sep 2005.
- Ifakara Health Research and Development CentreLink provided by the sponsor.
Related trials for Malaria, Uncomplicated
Not yet recruitingObservational study
Factors Influencing Adoption of a Novel Malaria Treatment in Côte d'Ivoire, Ghana, and Rwanda
Malaria
RecruitingPhase 2
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort C2)
Uncomplicated Plasmodium Falciparum Malaria
Not yet recruitingObservational study
Ethiopian Antimalarial Therapeutic Efficacy Study 2026
Plasmodium Vivax Malaria Without Complication, Plasmodium Falciparum Malaria (Uncomplicated)
Not yet recruitingPhase 4
Study to Assess Safety and Clinical Responses With Coartem® Baby Dispersible Tablets in Paediatric Patients Weighing 2 to <5 kg With Uncomplicated Malaria
Malaria
Not yet recruitingPhase 2
A Phase 2A Study of a Novel Antimalarial Pyrrolidinamide in Adult Patients With Uncomplicated P. Falciparum Malaria
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.
Louise Causer, MBBS, MScPH study director
Centers for Disease Control and Prevention
Salim Abdulla, MD, PhD study director
Ifakara Health Research and Development Centre
Peter B Bloland, DVM, MPVM principal investigator
Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, Uncomplicated, run by Centers for Disease Control and Prevention 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 4 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 12 Sep 2005. 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.
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.
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 12 Sep 2005.