- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01680406
Ethiopia Antimalarial in Vivo Efficacy Study 2012
Ethiopia Antimalarial in Vivo Efficacy Study 2012: Evaluating the Efficacy of Artemether-lumefantrine Alone Compared to Artemether-lumefantrine Plus Primaquine and Chloroquine Alone Compared to Chloroquine Plus Primaquine for Plasmodium Vivax Infection
The investigators hypothesize that the addition of primaquine (PQ) to both artemether-lumefantrine (AL) and chloroquine (CQ) for the treatment of Plasmodium vivax infection will result in decreased chance of relapse by about 60%.
The investigators plan to assess the therapeutic efficacy of AL compared to combined AL + PQ and CQ compared to combined CQ + PQ against P. vivax infection. They also plan to determine the number of recurrent vivax episodes in patients receiving PQ compared to those who don't receive PQ. Patients aged above 1 year with symptomatic malaria presenting to health centers will be enrolled for treatment with AL, AL+PQ, CQ, or CQ+PQ for P. vivax infection.
Phase 1 of the study will monitor the clinical, parasitological, and hematological parameters for P. vivax infection over a 42-day follow-up period, which will be used to evaluate drug efficacy. Phase 2 will continue monthly follow-up of these patients for one year to assess frequency of recurring vivax infections. Results from this research study will be used to assist Ethiopia in assessing their current national malaria drug policies.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Debre Zeit, Ethiopia
- Bishoftu Malaria Center
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Zeway, Ethiopia
- Batu Health Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Slide-confirmed infection with P. vivax
- Age > 1 year
- Lives within 20 km of the enrolling health facility
- Weight ≥ 5.0 kg
- Axillary temperature ≥ 37.5º C or history of fever during the previous 48 hours
- Patient or caregiver agrees to all finger pricks and return visits.
Exclusion Criteria:
- General danger signs or symptoms of severe malaria (see Annex II)
- Signs or symptoms of severe malnutrition, defined as weight-for-age ≤ 3 standard deviations below the mean (NCHS/WHO normalized reference values)
- Slide confirmed infection with any other Plasmodium species. besides P. vivax mono-infection
- Acute anemia, defined as Hg < 8 g/dl
- Known hypersensitivity to any of the drugs being evaluated
- Presence of febrile conditions caused by diseases other than malaria
- Serious or chronic medical condition by history (cardiac, renal, hepatic diseases, sickle cell disease, HIV/AIDS)
- Pregnant or breastfeeding women.
- History or hemolysis or severe anemia
- Regular medication, which may interfere with antimalarial pharmacokinetics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Artemether-lumefantrine
Weight-based dose to be administered as fixed-dose combination twice daily for three days.
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Experimental: Artemether-lumefantrine and primaquine
Artemether-lumefantrine will be given in a weight-based dose to be administered as fixed-dose combination twice daily for three days. Primaquine will be given beginning on day 2 of artemether-lumefantrine to patients with a normal G6PD test; dose is weight-based to be administered once daily for 14 days. |
|
Active Comparator: Chloroquine
Chloroquine will be given in a weight-based dose to be administered once daily for three days.
|
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Experimental: Chloroquine and primaquine
Chloroquine will be given in a weight-based dose to be administered once daily for three days. Primaquine will be given beginning on day 2 of chloroquine to patients with a normal G6PD test; dose is weight-based to be administered once daily for 14 days. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
P. vivax treatment failures following treatment with AL compared to AL+PQ
Time Frame: day 28 and 42
|
day 28 and 42
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P. vivax treatment failures following treatment with CQ compared to CQ+PQ
Time Frame: day 28 and 42
|
day 28 and 42
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of episodes of P. vivax parasitemia over one year following initial effective therapy against P. vivax (i.e. parasite clearance)
Time Frame: 1 year after day 0 of enrollment
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1 year after day 0 of enrollment
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety endpoint
Time Frame: baseline (day 0) and day 28
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Change in hemoglobin concentration
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baseline (day 0) and day 28
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jimee Hwang, MD MPH, Centers for Disease Control and Prevention
- Principal Investigator: Tesfay Abreha, MSc, MPH, ICAP-Columbia University, Addis Ababa, Ethiopia
- Principal Investigator: David Hoos, MD MPH, ICAP-Columbia University, New York, USA
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDC-CGH-6338
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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