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

NCT ID: NCT01659281

Last Updated: 2012-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2012-05-31

Brief Summary

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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

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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.

Conditions

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Plasmodium Falciparum Malaria

Keywords

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Artesunate Mefloquine Plasmodium Falciparum Thailand Uncomplicated Plasmodium Falciparum malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Artesunate

Intervention Type DRUG

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

Mefloquine

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Artesunate

Intervention Type DRUG

4 mg/kg/day for 3 days

Mefloquine

Intervention Type DRUG

8 mg/kg daily for 3 days

Interventions

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Artesunate

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

Intervention Type DRUG

Artesunate

4 mg/kg/day for 3 days

Intervention Type DRUG

Mefloquine

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

Intervention Type DRUG

Mefloquine

8 mg/kg daily for 3 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Armed Forces Research Institute of Medical Sciences, Thailand

OTHER_GOV

Sponsor Role lead

Responsible Party

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Douglas Walsh

Dept Chief

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wichai - Satimai, M.D., D.T.M. & H.

Role: PRINCIPAL_INVESTIGATOR

Bureau of Vector-Borne Disease, Department of Disease Control, Ministry of Public Health

Mark M. Fukuda, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dept. of Immunology and Medicine, AFRIMS

Locations

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Vector Borne Diseases Control Units (VBDC, malaria clinics)

Borai, Khaosaming and Muang Districts, Changwat Trat, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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WRAIR-1327

Identifier Type: -

Identifier Source: org_study_id