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

Armed Forces Research Institute of Medical Sciences, Thailand

Status: Completed

Conditions: Plasmodium Falciparum Malaria

Treatments: Drug: Artesunate; Drug: Mefloquine

Study type: Interventional

Funder types: Other

Identifiers

NCT01659281

WRAIR-1327

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 5 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

1

Active Comparator group

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

Treatment:

Drug: Artesunate

Drug: Mefloquine

Drug: Mefloquine

Drug: Artesunate

2

Active Comparator group

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

Treatment:

Drug: Artesunate

Drug: Mefloquine

Drug: Mefloquine

Drug: Artesunate