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

Plasmodium Falciparum Malaria Clinical Trial

Official title:

Efficacy of Artesunate-Mefloquine Combination Therapy for the Treatment of Uncomplicated Falciparum Malaria in Trat Province, Thailand

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01659281
• Other study ID #: WRAIR-1327
• Status: Completed
• Phase: N/A
• First received: January 26, 2011
• Last updated: August 6, 2012
• Start date: September 2007
• Est. completion date: May 2012

Study information

• Verified date: August 2012
• Source: Armed Forces Research Institute of Medical Sciences, Thailand
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentThailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 2012
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum
• Plasmodium Falciparum Malaria

Intervention

Drug:
• Artesunate
6 mg/kg/day for 2 days (total dose 12 mg/kg)
• Artesunate
4 mg/kg/day for 3 days
• Mefloquine
15mg/kg at T=0 and 10 mg/kg 6-24 hours later
• Mefloquine
8 mg/kg daily for 3 days

Locations

Country	Name	City	State
Thailand	Vector Borne Diseases Control Units (VBDC, malaria clinics)	Borai, Khaosaming and Muang districts	Trat

Sponsors (1)

Lead Sponsor	Collaborator
Armed Forces Research Institute of Medical Sciences, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of parasitological cure rate of directly observed antimalarial therapy		63 days from initiation of treatment	No
Secondary	Parasitological cure rates		Weekly to Day 56	No
Secondary	Occurence of treatment-emergent adverse events		3 days	No
Secondary	In vitro drug sensitivity profile for individual parasite isolates		Baseline	No
Secondary	Mefloquine whole blood concentrations		28 days	No