In-vivo Efficacy and Safety of Artemether/Lumefantrine Vs Dihydroartemisinin-piperaquine for Treatment of Uncomplicated Malaria and Assessment of Parasite Genetic Factors Associated With Parasite Clearance or Treatment Failure
WB-Malaria
1 other identifier
interventional
509
1 country
2
Brief Summary
Drug efficacy testing is one of the most important tasks that is routinely undertaken by the National Malaria Control Program (NMCP) in Tanzania and has been recommended by the World health Organisation to monitor the efficacy of artemisinin based combination therapy (ACT) and possibly detect evolution/emergency of tolerance/resistance to these drugs. Currently, Artemether-lumefantrine (ALu) is the only ACT recommended by the Ministry of Health and Social Welfare and therefore testing of new ACTs such as dihydroartemisinin-piperaquine (DHA-PQ) is important because alternative drugs are urgently required. Meanwhile, NMCP is revising the guidelines for treatment of malaria in Tanzania and DHA-PQ has been earmarked as an alternative ACT to be used together with ALu. However, efficacy and safety data of DHA-PQ is missing since no studies have been done in Tanzania. Thus, a study is proposed to assess the efficacy and safety of DHA-PQ Vs ALu and provide important data which will enable the NMCP to make informed decisions; and possibly recommend DHA-PQ in the new Malaria treatment guidelines as the second line drug for the treatment of uncomplicated malaria in the country.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 13, 2014
CompletedFirst Posted
Study publicly available on registry
October 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedDecember 26, 2017
December 1, 2017
1.6 years
July 13, 2014
December 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
parasitological cure on day 28 for ALu and 42 for DHA-PQ
non-adjusted and adjusted by PCR to account for new infections.
42 days
Secondary Outcomes (6)
parasite clearance after 72 hours.
72 hours
parasitological cure on day 14
14 days
extended parasitological cure on day 42 for ALu and 63 for DHA-PQ
63 days
improvement in haemoglobin level at day 28 from the day 0 baseline
28 days
reduction in gametocyte carriage at day 14 and day 28 from the day 0 baseline,
28 days
- +1 more secondary outcomes
Study Arms (2)
A
ACTIVE COMPARATORArtemether-lumefantrine
B
EXPERIMENTALDihydroartemisinin-piperaquine
Interventions
Eligibility Criteria
You may qualify if:
- Patients aged between 6 months - 10 years, without severe malnutrition and with a slide-confirmed mono-infection of P. falciparum, and asexual parasitemia between 250 - 200000 asexual parasites/µl will be included.
You may not qualify if:
- Patients shall not be excluded on the basis of reported prior treatment with other anti-malarial drugs other than DHA-PQ within the past 24 hours if they have fever (axillary temperature \> 37.50C) and parasitemia.
- Patients should have stable residence within the catchment area throughout the study period
- Others will include severe malnutrition (defined as a child whose growth standard is below -3 z-score or symmetrical oedema involving at least one of the feet or a mid-upper arm circumference \< 110 mm.
- Patients with febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases and HIV/AIDS) will be excluded.
- Furthermore, patients under regular medication, which may interfere with anti-malarial pharmacokinetics and those with a history of hypersensitivity reactions or contraindications to the artemisinin-based therapy, piperaquine or the alternative treatment, will not be included into the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Ujiji Health Centre
Ujiji, Kigoma Region, 255, Tanzania
Muheza Disignated District Hospital
Muheza, Tanga, 255, Tanzania
Related Publications (1)
Mandara CI, Kavishe RA, Gesase S, Mghamba J, Ngadaya E, Mmbuji P, Mkude S, Mandike R, Njau R, Mohamed A, Lemnge MM, Warsame M, Ishengoma DS. High efficacy of artemether-lumefantrine and dihydroartemisinin-piperaquine for the treatment of uncomplicated falciparum malaria in Muheza and Kigoma Districts, Tanzania. Malar J. 2018 Jul 11;17(1):261. doi: 10.1186/s12936-018-2409-z.
PMID: 29996849DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deus Ishengoma, PHD
National Institute for Medical Research
- STUDY DIRECTOR
Celine Mandara, MD, Msc
National Institute for Medical Research
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Scientist
Study Record Dates
First Submitted
July 13, 2014
First Posted
October 29, 2015
Study Start
May 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
December 26, 2017
Record last verified: 2017-12