Efficacy of Artesunate-Mefloquine Combination Therapy in Trat Province, Thailand

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Douglas Walsh, Armed Forces Research Institute of Medical Sciences, Thailand
ClinicalTrials.gov Identifier:
NCT01659281
First received: January 26, 2011
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Plasmodium Falciparum Malaria
Drug: Artesunate
Drug: Mefloquine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Artesunate-Mefloquine Combination Therapy for the Treatment of Uncomplicated Falciparum Malaria in Trat Province, Thailand

Resource links provided by NLM:


Further study details as provided by Armed Forces Research Institute of Medical Sciences, Thailand:

Primary Outcome Measures:
  • Determination of parasitological cure rate of directly observed antimalarial therapy [ Time Frame: 63 days from initiation of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Parasitological cure rates [ Time Frame: Weekly to Day 56 ] [ Designated as safety issue: No ]
  • Occurence of treatment-emergent adverse events [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • In vitro drug sensitivity profile for individual parasite isolates [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Mefloquine whole blood concentrations [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: September 2007
Study Completion Date: May 2012
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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
Drug: Artesunate
6 mg/kg/day for 2 days (total dose 12 mg/kg)
Drug: Mefloquine
15mg/kg at T=0 and 10 mg/kg 6-24 hours later
Active Comparator: 2
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
Drug: Artesunate
4 mg/kg/day for 3 days
Drug: Mefloquine
8 mg/kg daily for 3 days

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.

  Eligibility

Ages Eligible for Study:   5 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 5 to 70 years inclusive. If aged < 18 years the subject must have a parent or guardian in attendance.
  2. Asexual stages of P. falciparum parasites in a thick or thin blood film with no other visible plasmodial species.
  3. 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.
  4. Able to tolerate oral therapy.
  5. Willing to attend follow-up appointments and undergo study procedures.

Exclusion Criteria:

  1. History of anti-malarial drug use within the past two weeks or mefloquine (MQ) use within 4 weeks.
  2. Bleeding tendency (by history or based on medical records).
  3. 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).
  4. History of allergy to or intolerance of study medications.
  5. Mixed malaria infection by Giemsa stain.
  6. Any other condition that in the opinion of the study investigator warrants parenteral antimalarial treatment.
  7. Pregnant woman or nursing mother
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01659281

Locations
Thailand
Vector Borne Diseases Control Units (VBDC, malaria clinics)
Borai, Khaosaming and Muang districts, Trat, Thailand, 23000
Sponsors and Collaborators
Armed Forces Research Institute of Medical Sciences, Thailand
Investigators
Principal Investigator: Wichai - Satimai, M.D., D.T.M. & H. Bureau of Vector-Borne Disease, Department of Disease Control, Ministry of Public Health
Principal Investigator: Mark M. Fukuda, M.D. Dept. of Immunology and Medicine, AFRIMS
  More Information

No publications provided

Responsible Party: Douglas Walsh, Dept Chief, Armed Forces Research Institute of Medical Sciences, Thailand
ClinicalTrials.gov Identifier: NCT01659281     History of Changes
Other Study ID Numbers: WRAIR-1327
Study First Received: January 26, 2011
Last Updated: August 6, 2012
Health Authority: United States: Federal Government
Thailand: Ministry of Public Health

Keywords provided by Armed Forces Research Institute of Medical Sciences, Thailand:
Artesunate
Mefloquine
Plasmodium Falciparum
Thailand
Uncomplicated Plasmodium Falciparum malaria

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Artesunate
Artemisinins
Mefloquine
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials

ClinicalTrials.gov processed this record on September 18, 2014