P. Knowlesi Trial of Artesunate-mefloquine Versus Chloroquine (ACT KNOW)
This study is currently recruiting participants.
Verified October 2012 by Menzies School of Health Research
Sponsor:
Menzies School of Health Research
Collaborator:
Ministry of Health, Malaysia
Information provided by (Responsible Party):
Menzies School of Health Research
ClinicalTrials.gov Identifier:
NCT01708876
First received: October 15, 2012
Last updated: October 16, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Uncomplicated Plasmodium Knowlesi Malaria |
Drug: Artesunate-mefloquine Drug: Chloroquine |
Phase 3 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Malaria
Drug Information available for:
Chloroquine phosphate
Chloroquine
Chloroquine sulfate
Chloroquine hydrochloride
Mefloquine hydrochloride
U.S. FDA Resources
Further study details as provided by Menzies School of Health Research:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 250 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Artesunate-mefloquine
3 doses artesunate-mefloquine - daily over 3 days (dosage according to bodyweight - 4mg/kg and 8.3mg/kg respectively).
|
Drug: Artesunate-mefloquine
Other Names:
|
|
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.
|
Drug: Chloroquine
Other Name: Chloroquine; 1 tablet = 155mg base
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 1 Year and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female patients at least 1 year of age and weighing more than 10kg
- Microscopic diagnosis P . knowlesi (including diagnosis as P. malariae) or P . falciparum infection (any parasitaemia)
- Negative P. falciparum malaria rapid diagnostic test (histidine rich protein 2)
- Fever (temperature !37.5°C) or history of fever in the last 48 hours
- Able to participate in the trial and comply with the clinical trial protocol
- Written informed consent to participate in trial; thumbprint is required for illiterate patients, and written consent from parents/guardian for children below age of consent
Exclusion Criteria:
- Clinical or laboratory criteria for severe malaria, including warning signs, requiring parenteral treatment according to modified WHO criteria (see Appendix 4)
- Parasitaemia > 20,000 /μL
- Inability to tolerate oral treatment
- Concomitant infection with any other malaria species
- Pregnancy or lactation
- Unable or unwilling to use contraception during study period
- Known hypersensitivity or allergy to artemisinin derivatives
- Serious underlying disease (cardiac, renal or hepatic)
- Received anti-malarials in previous 14 days or mefloquine in last 2 months
- Previous psychiatric illness or epilepsy
- Previous episode of cerebral malaria
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708876
Contacts
| Contact: Timothy William, MBBS | +60138657078 | tim7008@gmail.com |
Locations
| Malaysia | |
| Kota Marudu District Hospital | Not yet recruiting |
| Kota Marudu, Sabah, Malaysia, 89108 | |
| Kudat District Hospital | Recruiting |
| Kudat, Sabah, Malaysia, 89057 | |
Sponsors and Collaborators
Menzies School of Health Research
Ministry of Health, Malaysia
Investigators
| 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 |
More Information
Publications:
| Responsible Party: | Menzies School of Health Research |
| ClinicalTrials.gov Identifier: | NCT01708876 History of Changes |
| Other Study ID Numbers: | NMRR-12-89-11005 |
| Study First Received: | October 15, 2012 |
| Last Updated: | October 16, 2012 |
| Health Authority: | Malaysia: Institutional Review Board |
Keywords provided by Menzies School of Health Research:
|
uncomplicated plasmodium knowlesi malaria infection |
Additional relevant MeSH terms:
|
Malaria Protozoan Infections Parasitic Diseases Chloroquine Artesunate Chloroquine diphosphate Mefloquine Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
Antimalarials Antirheumatic Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Filaricides Antinematodal Agents Anthelmintics Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 17, 2013