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Study on the Treatment of Vivax Malaria (VHX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01074905
Recruitment Status : Completed
First Posted : February 24, 2010
Last Update Posted : August 28, 2013
Sponsor:
Collaborator:
Mahidol University
Information provided by (Responsible Party):
University of Oxford

Study Description
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Brief Summary:
This is a randomised open label trial with follow up for 1 year. 660 adults and children above 6 months diagnosed with acute Plasmodium vivax will be randomised into 3 groups, either chloroquine, artesunate, or chloroquine/primaquine therapy. Participants will be screened on the day of inclusion then followed weekly for 8 visits and every 4 weeks until week 52. The primary objective of the study is to compare the efficacy of the WHO and Thai Ministry of Public Health recommended radical curative regimen of chloroquine and primaquine with the currently used monotherapy regimens of chloroquine and artesunate along the Thai-Burmese border.

Condition or disease Intervention/treatment Phase
Vivax Malaria Drug: Artesunate Drug: Chloroquine Drug: Chloroquine/Primaquine Phase 3

Detailed Description:

Considerably less attention has been paid to Plasmodium vivax epidemiology than Plasmodium falciparum. In areas of relatively low unstable transmission, which comprise the majority of P.vivax affected areas, vivax malaria is predominantly a disease of children (Luxemburger et al 1999). Chloroquine has long been the standard treatment for vivax malaria. Primaquine is recommended for radical cure of vivax malaria, but is difficult to administer due to dosing duration and side effects.

This study aims to characterize the epidemiologic history comparing the efficacy of 3 antimalarial regimens (chloroquine, artesunate, and chloroquine/primaquine) for plasmodium vivax in western Thailand. Chloroquine is currently the standard of treatment for Plasmodium vivax. Due to the long half-life or chloroquine, the first relapse of vivax malaria may be delayed. In contrast, artesunate has a very short half-life, thus, having no impact on first relapse. It is not known whether chloroquine reduces the overall number of relapses, or only delays the first relapse. There are many important questions about the biology of vivax malaria of relevance to treatment that remain unanswered. For example is the number of relapses per infection (i.e. per successful inoculation) predetermined or adaptive? If it is predetermined then suppression of the first relapse (as with chloroquine, mefloquine or piperaquine) will reduce the total number of relapses and this is a clear benefit. If it is adaptive then these drugs will simply delay the relapses and there is less clear benefit. These various uncertainties illustrate the importance of detailed comparative longitudinal evaluations. In order to characterize the biology of vivax malaria, it will be necessary to compare regimens with and without primaquine. Because of the challenges that face primaquine prescription (side effects, toxicity in G6PD deficient patients and duration of treatment), it is not commonly deployed along the Thai Burma border. In effect, we will be comparing usual practice (non primaquine regimens) with the recommended WHO and Thai MOPH practice (use of primaquine for 14 days). The information we will gather is crucial to the understanding of chloroquine and its effect on the vivax parasite. This will lead to future studies and invariably change the way we treat vivax malaria.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 655 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Open Label Study Comparing the Efficacy of Chloroquine/Primaquine, Chloroquine and Artesunate in the Treatment of Vivax Malaria Along the Thai-Burmese Border
Study Start Date : May 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Artesunate
2 mg/kg/day as single daily dose given for 5 days; maximum dose range is 1.6 to 2.4 mg/kg/day or a total of 8 to 12 mg/kg.
 Drug: Artesunate
2 mg/kg/day as single daily dose given for 5 days; maximum dose range is 1.6 to 2.4 mg/kg/day or a total of 8 to 12 mg/kg.
Active Comparator: Chloroquine
25 mg base/kg given in divided doses (10,10,5) over 3 days; Absolute range 20-30 mg/kg.
 Drug: Chloroquine
25 mg base/kg given in divided doses (10,10,5) over 3 days; Absolute range 20-30 mg/kg.
Experimental: Chloroquine/Primaquine
Chloroquine 3 days and Primaquine 14 days
 Drug: Chloroquine/Primaquine
Chloroquine 3 days and Primaquine 14 days


Outcome Measures
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Primary Outcome Measures :
  1. The first recurrence of Plasmodium vivax malaria [ Time Frame: Day 28 ]
    The first recurrence of Plasmodium vivax malaria within 28 days


Secondary Outcome Measures :
  1. Any recurrence of Plasmodium vivax parasitemia [ Time Frame: 1 year ]
    Any recurrence of Plasmodium vivax parasitemia within the follow up period

  2. Time to first recurrence, median time between episodes of vivax infections and total number of episodes [ Time Frame: 1 year ]
    Time to first recurrence, median time between episodes of vivax infections and total number of episodes in the follow up period

  3. Overall number of days of illness and haematocrit below 30% [ Time Frame: 1 year ]
    Overall number of days of illness and haematocrit below 30% within the follow up period

  4. Chloroquine level [ Time Frame: Day 7 ]
    Whole blood chloroquine level at day 7 and any day of recurrence of Plasmodium vivax malaria

  5. Adverse events [ Time Frame: 1 year ]
    Adverse event profiles of artesunate, chloroquine and primaquine


Eligibility Criteria
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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults and children > 6 months
  • Weight > 7 kg for children
  • Have not had primaquine since last Pv episode
  • Participant (or parent/guardian if < 18 years old) is willing and able to give written informed consent
  • Microscopic diagnosis of Plasmodium vivax mono-infection
  • Ability (in the investigators opinion) and willingness of patient or parent/guardian to comply with all study requirements

Exclusion Criteria

  • Allergy to artesunate, chloroquine or primaquine
  • Severe malaria
  • Patients with microscopic diagnosis of co-infection with Plasmodium falciparum
  • Presence of any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study
  • Inability to tolerate oral medication
  • Pregnancy
  • Blood transfusion in the last 3 months
  • Antimalarial in last 2 months
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01074905


Locations
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Thailand
Shoklo Malaria Research Unit
Mae Sot, Thailand
Sponsors and Collaborators
University of Oxford
Mahidol University
Investigators
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Principal Investigator: Francois Nosten, MD Shoklo Malaria Research Unit
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01074905    
Other Study ID Numbers: SMRU0908
First Posted: February 24, 2010    Key Record Dates
Last Update Posted: August 28, 2013
Last Verified: August 2013
Keywords provided by University of Oxford:
vivax malaria
artesunate
chloroquine
primaquine
relapse
Additional relevant MeSH terms:
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Malaria
Malaria, Vivax
Protozoan Infections
Parasitic Diseases
Infections
Vector Borne Diseases
Artesunate
Chloroquine
Chloroquine diphosphate
Primaquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
 Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics
Amebicides
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