Back to resultsEfficacy of Artesunate-Mefloquine Combination Therapy in Trat Province, Thailand
Primary Purpose
Plasmodium Falciparum Malaria
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Artesunate
Artesunate
Mefloquine
Mefloquine
Sponsored by
About this trial
This is an interventional treatment trial for Plasmodium Falciparum Malaria focused on measuring Artesunate, Mefloquine, Plasmodium Falciparum, Thailand, Uncomplicated Plasmodium Falciparum malaria
Eligibility Criteria
Inclusion Criteria:
- Age 5 to 70 years inclusive. If aged < 18 years the subject must have a parent or guardian in attendance.
- Asexual stages of P. falciparum parasites in a thick or thin blood film with no other visible plasmodial species.
- Willing to give informed consent. Parents or guardians of children and adolescents must agree to give informed consent. Assent is necessary in addition to parental informed consent.
- Able to tolerate oral therapy.
- Willing to attend follow-up appointments and undergo study procedures.
Exclusion Criteria:
- History of anti-malarial drug use within the past two weeks or mefloquine (MQ) use within 4 weeks.
- Bleeding tendency (by history or based on medical records).
- Severe/complicated malaria as determined by the investigator (coma or seizures, pulmonary edema, shock, renal failure, jaundice, severe anemia, spontaneous bleeding, hyperparasitemia (>5% RBCs infected), or prostration).
- History of allergy to or intolerance of study medications.
- Mixed malaria infection by Giemsa stain.
- Any other condition that in the opinion of the study investigator warrants parenteral antimalarial treatment.
- Pregnant woman or nursing mother
Sites / Locations
- Vector Borne Diseases Control Units (VBDC, malaria clinics)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
2-day oral treatment with: Artesunate 6mg/kg at 0 and 24 hours Mefloquine 25 mg/kg total dose split into 2 doses of 15 mg/kg at 0 hours and and 10 mg/kg given 6-24 hours later Primaquine 0.5 mg/kg single dose at 24 hours
3 days oral treatment with: Artesunate 4 mg/kg/day for 3 days Mefloquine 8 mg/kg/day for 3 days Primaquine 0.5 mg/kg single dose at 24 hours
Outcomes
Primary Outcome Measures
Determination of parasitological cure rate of directly observed antimalarial therapy
Secondary Outcome Measures
Parasitological cure rates
Occurence of treatment-emergent adverse events
In vitro drug sensitivity profile for individual parasite isolates
Mefloquine whole blood concentrations
Full Information
NCT ID
NCT01659281
First Posted
January 26, 2011
Last Updated
August 6, 2012
Sponsor
Armed Forces Research Institute of Medical Sciences, Thailand
1. Study Identification
Unique Protocol Identification Number
NCT01659281
Brief Title
Efficacy of Artesunate-Mefloquine Combination Therapy in Trat Province, Thailand
Official Title
Efficacy of Artesunate-Mefloquine Combination Therapy for the Treatment of Uncomplicated Falciparum Malaria in Trat Province, Thailand
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Armed Forces Research Institute of Medical Sciences, Thailand
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this study is to compare artesunate-mefloquine combination therapy given for 2 and 3 days at the same total dose for the treatment of uncomplicated falciparum malaria.
Detailed Description
This will be a randomized, open-label comparison of two versus three days artesunate-mefloquine treatment in patients with uncomplicated falciparum malaria. Primary endpoints will be 63-day parasitological cure rates in the 2 treatment groups. Secondary endpoints will be parasitological failure rates at each of the weekly follow-up visits to Day 56, occurence of treatment-emergent adverse events on days 0, 1 and 2, mefloquine blood concentrations on days 7, 14 and 28, and in vitro drug sensitivity profiles for parasite isolates as measured by inhibitory concentrations. Genotyping of parasites for known markers of drug resistence will be performed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plasmodium Falciparum Malaria
Keywords
Artesunate, Mefloquine, Plasmodium Falciparum, Thailand, Uncomplicated Plasmodium Falciparum malaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
2-day oral treatment with: Artesunate 6mg/kg at 0 and 24 hours Mefloquine 25 mg/kg total dose split into 2 doses of 15 mg/kg at 0 hours and and 10 mg/kg given 6-24 hours later Primaquine 0.5 mg/kg single dose at 24 hours
Arm Title
2
Arm Type
Active Comparator
Arm Description
3 days oral treatment with: Artesunate 4 mg/kg/day for 3 days Mefloquine 8 mg/kg/day for 3 days Primaquine 0.5 mg/kg single dose at 24 hours
Intervention Type
Drug
Intervention Name(s)
Artesunate
Intervention Description
6 mg/kg/day for 2 days (total dose 12 mg/kg)
Intervention Type
Drug
Intervention Name(s)
Artesunate
Intervention Description
4 mg/kg/day for 3 days
Intervention Type
Drug
Intervention Name(s)
Mefloquine
Intervention Description
15mg/kg at T=0 and 10 mg/kg 6-24 hours later
Intervention Type
Drug
Intervention Name(s)
Mefloquine
Intervention Description
8 mg/kg daily for 3 days
Primary Outcome Measure Information:
Title
Determination of parasitological cure rate of directly observed antimalarial therapy
Time Frame
63 days from initiation of treatment
Secondary Outcome Measure Information:
Title
Parasitological cure rates
Time Frame
Weekly to Day 56
Title
Occurence of treatment-emergent adverse events
Time Frame
3 days
Title
In vitro drug sensitivity profile for individual parasite isolates
Time Frame
Baseline
Title
Mefloquine whole blood concentrations
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 5 to 70 years inclusive. If aged < 18 years the subject must have a parent or guardian in attendance.
Asexual stages of P. falciparum parasites in a thick or thin blood film with no other visible plasmodial species.
Willing to give informed consent. Parents or guardians of children and adolescents must agree to give informed consent. Assent is necessary in addition to parental informed consent.
Able to tolerate oral therapy.
Willing to attend follow-up appointments and undergo study procedures.
Exclusion Criteria:
History of anti-malarial drug use within the past two weeks or mefloquine (MQ) use within 4 weeks.
Bleeding tendency (by history or based on medical records).
Severe/complicated malaria as determined by the investigator (coma or seizures, pulmonary edema, shock, renal failure, jaundice, severe anemia, spontaneous bleeding, hyperparasitemia (>5% RBCs infected), or prostration).
History of allergy to or intolerance of study medications.
Mixed malaria infection by Giemsa stain.
Any other condition that in the opinion of the study investigator warrants parenteral antimalarial treatment.
Pregnant woman or nursing mother
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wichai - Satimai, M.D., D.T.M. & H.
Organizational Affiliation
Bureau of Vector-Borne Disease, Department of Disease Control, Ministry of Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark M. Fukuda, M.D.
Organizational Affiliation
Dept. of Immunology and Medicine, AFRIMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vector Borne Diseases Control Units (VBDC, malaria clinics)
City
Borai, Khaosaming and Muang districts
State/Province
Trat
ZIP/Postal Code
23000
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Artesunate-Mefloquine Combination Therapy in Trat Province, Thailand
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