Harmonized AS/MQ Efficacy Study - Thailand

NCT02052323 | Completed Phase 4

• 1 other identifier: WRAIR2017
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this study is to determine parasitological clearance rates by microscopy for the 72-hour period after first artesunate dose in subjects with uncomplicated P. falciparum malaria.

Conditions

Malaria

Keywords

P.f Malaria, Artemisinin resistance, ACT treatment failure

Outcome Measures

Primary Outcomes (1)

• Parasite clearance rate

  Parasite clearance rate as defined by the slope of the linear portion of the logarithm parasite clearance curve using microscopy to determine parasitemia

  one year

Secondary Outcomes (1)

• Number of patients with prolonged parasite clearance times, adequate drug levels and positive molecular markers of parasite resistance.

  one year

Other Outcomes (1)

• Numbers of patients with features suggestive of antimalarial drug resistance in Thailand with partner sites in Kenya and Peru.

  One year

Study Arms (1)

artesunate/mefloquine (AS/MQ)

EXPERIMENTAL

The antimalarial drug regimen being evaluated is: artesunate (AS) 4mg/kg by mouth once daily at 0, 24 and 48 hours; plus mefloquine (MQ) 15mg/kg by mouth once at 72 hours, and 10mg/kg once by mouth at 84-96 hours; plus primaquine (PQ) 0.5mg/kg single dose by mouth at 84-96 hours

Drug: Artesunate/mefloquine (AS/MQ)

Interventions

Artesunate/mefloquine (AS/MQ) DRUG

* artesunate (AS) 4mg/kg by mouth once daily at 0, 24 and 48 hours * mefloquine (MQ) 15mg/kg by mouth once at 72 hours, and 10mg/kg once by mouth at 84-96 hours * primaquine (PQ) 0.5mg/kg single dose by mouth at 84-96 hours

Also known as: Mequin

artesunate/mefloquine (AS/MQ)

Eligibility Criteria

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

You may qualify if:

• Thai or non-Thai, otherwise healthy, male or female, aged from 5 years to 65 years inclusive
• Acute uncomplicated P. falciparum malaria monoinfection, confirmed by positive blood smear
• Asexual P. falciparum parasitaemia of 1,000 to 200,000 parasites/µL, confirmed on a thin or thick blood film
• Fever defined as ≥ 38.0°C tympanic temperature (or equivalent) or a history of fever within the last 24 hours
• Willingness to participate in the study as evidenced by written informed consent from the subject or parent/guardian (for children), and by assent (for children)

You may not qualify if:

• Severe malaria as defined by WHO criteria (reference WHO 2012)
• Inability to eat or drink, inability to tolerate oral antimalarial medication, recent history of seizures (one or more in the previous 24 hours), altered level of consciousness, inability to sit or stand
• Mixed species asexual stage malaria infection as determined by microscopy
• Recent antimalarial treatment, defined as a clear history of any antimalarial medication taken within the previous 7 days; or a clear history of mefloquine within previous 4 weeks
• History of splenectomy
• Pregnancy or nursing mother
• Known hypersensitivity to artesunate, mefloquine or primaquine
• PI determines that it is in the best interests of the subject not to participate in the trial

Sponsors & Collaborators

• Armed Forces Research Institute of Medical Sciences, Thailand: lead
• Walter Reed Army Institute of Research (WRAIR): collaborator
• Global Emerging Infections Surveillance and Response System: collaborator

Study Sites (1)

Kwai River Christian Hospital in Sangklaburi

Thong Pha Phum, Kanchanaburi, 71240, Thailand

Location

MeSH Terms

Conditions

Malaria

Interventions

Artesunate; Mefloquine; Methaqualone

Condition Hierarchy (Ancestors)

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; Quinazolinones; Quinazolines

Study Officials

• Krisada Jongsakul, MD

  Armed Forces Research Institute of Medical Sciences, Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: February 3, 2014
• Study Start: October 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 25, 2016

Record last verified: 2016-01

Locations

TH (1)