P. Knowlesi Trial of Artesunate-mefloquine Versus Chloroquine (ACT KNOW)
Preliminary studies have supported the background efficacy of local standard anti-malarial medications in the treatment of uncomplicated knowlesi malaria, however this has not been tested systematically and there are no current WHO treatment guidelines for this infection. There are both health cost benefits to a more rapidly acting agent, and due to difficulties with microscopic identification there may be more effective treatment for all malaria species if an aligned treatment guideline could be supported.
The investigators aim to test whether the fixed combination of artesunate-mefloquine is superior to chloroquine in order to define the optimal treatment for uncomplicated P. knowlesi infection in both adults and children in this region.
Uncomplicated Plasmodium Knowlesi Malaria
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Artesunate-mefloquine vs Chloroquine in Patients With Acute Uncomplicated P. Knowlesi Malaria: a Randomized Open Label Trial in Sabah, Malaysia|
- Parasite clearance [ Time Frame: 24 hours ] [ Designated as safety issue: No ]The primary endpoint is the therapeutic efficacy of artesunate-mefloquine versus chloroquine, as defined by the assessment of microscopic P. knowlesi parasite clearance 24 hours after initiation of treatment.
- Rates of recurrent infection / treatment failure at day 42. [ Time Frame: 42 days ] [ Designated as safety issue: No ]
- Occurrence of anaemia at day 28 when using AS-MQ vs. CQ. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- P. knowlesi gametocyte carriage throughout follow up when using AS-MQ vs. CQ. [ Time Frame: 42 days ] [ Designated as safety issue: No ]
- Frequency of complications throughout follow up when using AS-MQ vs. CQ. [ Time Frame: 42 days ] [ Designated as safety issue: No ]
- Utility of malaria rapid diagnostic tests in diagnosis of P. knowlesi infection. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- Rates of P. knowlesi recurrence in a 1 year follow up period. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Artesunate-mefloquine
3 doses artesunate-mefloquine - daily over 3 days (dosage according to bodyweight - 4mg/kg and 8.3mg/kg respectively).
Active Comparator: Chloroquine
4 doses chloroquine over 3 days - total dose 25mg/kg. 10mg/kg at 0 hours, 5mg/kg at 6-8, 24, 48 hours.
Other Name: Chloroquine; 1 tablet = 155mg base
Show Detailed Description
|Contact: Timothy William, MBBSemail@example.com|
|Kota Marudu District Hospital||Not yet recruiting|
|Kota Marudu, Sabah, Malaysia, 89108|
|Kudat District Hospital||Recruiting|
|Kudat, Sabah, Malaysia, 89057|
|Study Director:||Jayaram Menon, MBBS||Sabah Ministry of Health|
|Study Director:||D Prabhakaran, MBBS||Sabah Ministry of Health|
|Study Director:||Matthew J Grigg, MBBS||Menzies School of Health Research|
|Study Director:||Tsin Yeo, MBBS||Menzies School of Health Research|
|Study Director:||Lorenz von Seidlein, MBBS||Menzies School of Health Research|
|Study Director:||Nicholas M Anstey, MBBS||Menzies School of Health Research|
|Study Director:||Ric Price, MBBS||Menzies School of Health Research|