Ethiopia Antimalarial in Vivo Efficacy Study 2012
1 other identifier
interventional
398
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2012
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2012
CompletedFirst Posted
Study publicly available on registry
September 7, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJanuary 19, 2017
January 1, 2015
2.2 years
August 30, 2012
January 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
P. vivax treatment failures following treatment with AL compared to AL+PQ
day 28 and 42
P. vivax treatment failures following treatment with CQ compared to CQ+PQ
day 28 and 42
Secondary Outcomes (1)
Number of episodes of P. vivax parasitemia over one year following initial effective therapy against P. vivax (i.e. parasite clearance)
1 year after day 0 of enrollment
Other Outcomes (1)
Safety endpoint
baseline (day 0) and day 28
Study Arms (4)
Artemether-lumefantrine
ACTIVE COMPARATORWeight-based dose to be administered as fixed-dose combination twice daily for three days.
Artemether-lumefantrine and primaquine
EXPERIMENTALArtemether-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.
Chloroquine
ACTIVE COMPARATORChloroquine will be given in a weight-based dose to be administered once daily for three days.
Chloroquine and primaquine
EXPERIMENTALChloroquine 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centers for Disease Control and Preventionlead
- Ethiopian Health and Nutrition Research Institutecollaborator
- Federal Minstry of Health of Ethiopiacollaborator
- Columbia Universitycollaborator
- Oromia Regional Health Bureau, Ethiopiacollaborator
- United States Agency for International Development (USAID)collaborator
- Menzies School of Health Researchcollaborator
Study Sites (2)
Bishoftu Malaria Center
Bishoftu, Ethiopia
Batu Health Center
Zeway, Ethiopia
Related Publications (2)
Kleinecke M, Sutanto E, Rumaseb A, Hoon KS, Trimarsanto H, Osborne A, Manrique P, Peters T, Hawkes D, Benavente ED, Whitton G, Siegel SV, Pearson RD, Amato R, Rai A, Nhien NTT, Nguyen HC, Assefa A, Degaga TS, Abate DT, Rahim AG, Pasaribu AP, Sutanto I, Alam MS, Pava Z, Lopera-Mesa T, Echeverry D, William T, Anstey NM, Grigg MJ, Day NP, White NJ, Kwiatkowski DP, Taylor AR, Noviyanti R, Neafsey D, Price RN, Auburn S. Microhaplotype deep sequencing assays to capture Plasmodium vivax infection lineages. Nat Commun. 2025 Aug 5;16(1):7192. doi: 10.1038/s41467-025-62357-x.
PMID: 40764298DERIVEDAbreha T, Hwang J, Thriemer K, Tadesse Y, Girma S, Melaku Z, Assef A, Kassa M, Chatfield MD, Landman KZ, Chenet SM, Lucchi NW, Udhayakumar V, Zhou Z, Shi YP, Kachur SP, Jima D, Kebede A, Solomon H, Mekasha A, Alemayehu BH, Malone JL, Dissanayake G, Teka H, Auburn S, von Seidlein L, Price RN. Comparison of artemether-lumefantrine and chloroquine with and without primaquine for the treatment of Plasmodium vivax infection in Ethiopia: A randomized controlled trial. PLoS Med. 2017 May 16;14(5):e1002299. doi: 10.1371/journal.pmed.1002299. eCollection 2017 May.
PMID: 28510573DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2012
First Posted
September 7, 2012
Study Start
October 1, 2012
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
January 19, 2017
Record last verified: 2015-01