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

NCT01659281 | Completed

• 1 other identifier: WRAIR-1327
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Plasmodium Falciparum Malaria

Keywords

Artesunate; Mefloquine; Plasmodium Falciparum; Thailand; Uncomplicated Plasmodium Falciparum malaria

Outcome Measures

Primary Outcomes (1)

• Determination of parasitological cure rate of directly observed antimalarial therapy

  63 days from initiation of treatment

Secondary Outcomes (4)

• Parasitological cure rates

  Weekly to Day 56

• Occurence of treatment-emergent adverse events

  3 days

• In vitro drug sensitivity profile for individual parasite isolates

  Baseline

• Mefloquine whole blood concentrations

  28 days

Study Arms (2)

1

ACTIVE COMPARATOR

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; Drug: Mefloquine

2

ACTIVE COMPARATOR

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; Drug: Mefloquine

Interventions

Artesunate DRUG

6 mg/kg/day for 2 days (total dose 12 mg/kg)

1

Mefloquine DRUG

15mg/kg at T=0 and 10 mg/kg 6-24 hours later

1

Eligibility Criteria

• Age: 5 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Armed Forces Research Institute of Medical Sciences, Thailand: lead

Study Sites (1)

Vector Borne Diseases Control Units (VBDC, malaria clinics)

Borai, Khaosaming and Muang Districts, Changwat Trat, 23000, Thailand

Location

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

Artesunate; Mefloquine

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Sesquiterpenes; Terpenes; Hydrocarbons; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dept Chief

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: August 7, 2012
• Study Start: September 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2012
• Last Updated: August 7, 2012

Record last verified: 2012-08

Locations

TH (1)