Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000554066
Ethics application status
Approved
Date submitted
8/07/2010
Date registered
9/07/2010
Date last updated
12/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and safety of chloroquine for the treatment of uncomplicated Plasmodium vivax malaria in Mae Hong Son and Kanchanaburi provinces in Thailand
Scientific title
Efficacy and safety of chloroquine for the treatment of uncomplicated Plasmodium vivax malaria in Mae Hong Son and Kanchanaburi provinces in Thailand
Secondary ID [1] 252181 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uncomplicated vivax malaria patients 257720 0
Condition category
Condition code
Infection 257887 257887 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral chloroquine tablet (25 mg base/kg divided to be given over 3 days; day 0, 5 mg base/kg per/meal for 3 meals; day 1, 5 mg/kg; day 2, 5 mg/kg). In this trial, we study the efficacy of chloroquine alone for the treatment of uncomplicated vivax malaria. So we give Primaquine after study finished. The standard treatment of vivax malaria patient in Thailand is 25 mg base/kg divided to be given over 3 days plus primaquine 20 mg base taken daily for 14 days.
Intervention code [1] 256772 0
Treatment: Drugs
Comparator / control treatment
The study will be done in 2 sentinel sites for Chloroquine treatment of uncomplicated vivax malaria patients.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258754 0
Treatment outcomes will be classified on the basis of an assessment of the parasitological and clinical outcome of antimalarial treatment according to the latest World Health Organization (WHO) guidelines. Thus, all patients will be classified as having early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response.
Timepoint [1] 258754 0
Day 1, 2, 3, 7, 14, 21, and 28
Secondary outcome [1] 264805 0
The incidence of any adverse event such as nausea, vomiting, diarrhea, etc. will be documented. All patients will be asked routinely about the previous symptoms and about symptoms that have emerged since the previous follow-up visit. When clinically indicated, patients will be evaluated and treated appropriately. All adverse events will be recorded on the case report form. Serious adverse events must be reported to the sponsor.
Timepoint [1] 264805 0
Day 1, 2, 3, 7, 14, 21, and 28

Eligibility
Key inclusion criteria
-Age 6 months and above;
-Mono-infection with Plasmodium vivax for vivax malaria patients detected by microscopy
-P. vivax paraasitemia of >250/ul asexual forms
-presence of axillary or tympanic temperature equal or more than 37.5C or history of fever during the past 24 h
-Ability to swallow oral medication
-Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule and
-Informed consent from the patient or from a parent or guardian in the case of children
Minimum age
6 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO -mixed or mono-infection with another Plasmodium species detected by microscopy -presence of severe malnutrition (defined as a child whose growth standard is below -3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference <110 mm) -presence of febrile conditions due to diseases other than malaria or other known underlying chronic or severe diseases -Regular medication, which may interfere with antimalarial pharmacokinetics -history of hypersensitivity reactions or contraindications to any of the medicine being tested or used as alternative treatment -Female of child-bearing potential with ages 12-17 years old inclusive -A positive pregnancy test or breastfeeding -Unable to or unwilling to take contraceptives for pregnancy negative married women of child-bearing age

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 2754 0
Thailand
State/province [1] 2754 0

Funding & Sponsors
Funding source category [1] 257264 0
Other
Name [1] 257264 0
World Health Organization
Country [1] 257264 0
Thailand
Primary sponsor type
Government body
Name
Bureau of Vector-borne Disease
Address
Department of Disease Control, Ministry of Public Health, Tiwanon Road, Muang District, Nonthaburi 11000
Country
Thailand
Secondary sponsor category [1] 256508 0
None
Name [1] 256508 0
Address [1] 256508 0
Country [1] 256508 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259283 0
The Ethical Committee for Research in Human Subjects
Ethics committee address [1] 259283 0
Department of Disease Control, Ministry of Public Health, Tiwanon Road, Muang District, Nonthaburi 11000
Ethics committee country [1] 259283 0
Thailand
Date submitted for ethics approval [1] 259283 0
Approval date [1] 259283 0
01/06/2010
Ethics approval number [1] 259283 0

Summary
Brief summary
Title: Efficacy and safety of chloroquine for the treatment of uncomplicated Plasmodium vivax malaria in Mae Hong Son and Kanchanaburi provinces in Thailand
Background: Current first-line treatment for P. vivax in Thailand is chloroquine. Study conducted in 2009 in 2 sentinel sites revealed high efficacy of the chloroquine (100%). The monitoring the efficacy of the first line treatment to generate valuable information for updating the national treatment policy is critical.
Objective: To assess the efficacy and safety of chloroquine for the treatment of uncomplicated Plasmodium vivax malaria in Mae Hong Son and Kanchanaburi provinces in Thailand
Methods: Antimalarial drug efficacy trials will be conducted in 2 sites. The participants will be febrile patients aged 6 months and above with confirmed uncomplicated P. vivax infection. Vivax malaria patients will be treated with Chloroquine 25 mg base/kg divided over 3 days; day 0, 5 mg base/kg per/meal for 3 meals; day 1, 5 mg/kg; day 2, 5 mg/kg. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy for vivax malaria. The study will be conducted from July to December, 2010. The results of this study will be used to assist the Ministry of Public Health of Thailand in assessing the current national treatment guidelines for uncomplicated P. vivax malaria.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31376 0
Address 31376 0
Country 31376 0
Phone 31376 0
Fax 31376 0
Email 31376 0
Contact person for public queries
Name 14623 0
Dr. Kanungnit Congpuong
Address 14623 0
Bureau of Vector-borne Disease,
Department of Disease Control,
Ministry of Public Health,
Tiwanon Road, Muang District,
Nonthaburi, 11000
Country 14623 0
Thailand
Phone 14623 0
662 965 9608
Fax 14623 0
662 591 8422
Email 14623 0
[email protected]
Contact person for scientific queries
Name 5551 0
Dr. Kanungnit Congpuong
Address 5551 0
Bureau of Vector-borne Disease,
Department of Disease Control,
Ministry of Public Health,
Tiwanon Road, Muang District,
Nonthaburi, 11000
Country 5551 0
Thailand
Phone 5551 0
662 965 9608
Fax 5551 0
662 591 8422
Email 5551 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.