Monitoring the efficacy of mefloquine-artesunate combination

• Register: TCTR
• Last refreshed on: 29 April 2024
• Main ID: TCTR20150623001
• Date of registration: 23/06/2015
• Prospective Registration: No
• Primary sponsor: Not available
• Public title: Monitoring the efficacy of mefloquine-artesunate combination
• Scientific title: Evaluating the efficacy of artesunate-mefloquine on the Thai-Myanmar border and the relative roles of resistance genetic markers: A retrospective cohort study
• Date of first enrolment: 09/10/2003
• Recruitment status: Completed
• URL: https://www.thaiclinicaltrials.org/show/TCTR20150623001
• Study type: Observational
• Study design: Non-randomized
• Phase: Phase 4

Countries of recruitment

Thailand

Contacts

• Name: Aung Pyae Phyo
• Affiliation: Shoklo Malaria Research Unit

• Name: Aung Pyae Phyo
• Affiliation: hoklo Malaria Research Unit

Key inclusion & exclusion criteria

Inclusion criteria: • Non pregnant patients of any age and sex who received treatment for uncomplicated malaria between January 2003 to December 2013
• Symptomatic of malaria infection, i.e. history of fever or tympanic temperature ≥37.5°c
• Microscopically confirmed asexual stages of P. falciparum ≥ 5/500 WBC (alone or mixed with non- P. falciparum species)
• Received fully supervised treatment of mefloquine-artesunate

Exclusion criteria: • Pregnant woman
• P. falciparum asexual stage parasitaemia greater than or equal to 4% red blood cells (175 000/µL).
• Signs or symptoms indicative of severe malaria:
• Mefloquine treatment within 60 days of current episode of malaria
• Splenectomy


Age minimum: 0 Years
Age maximum: 99 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Drug resistant Plasmodium falciparum malaria Artemisinin resistance K-13 mutation in Plasmodium falciparum malaria Pfmdr1(Plasmodium falciparum multi drug resistant gene 1) copy number variation
Mefloquine and artesunate combination
Thai Myanmar border
Drug resistant Plasmodium falciparum malaria
Artemisinin resistance
K-13 mutation in Plasmodium falciparum malaria
Pfmdr1

Mefloquine and artesunate combination
Thai Myanmar border
Drug resistant Plasmodium falciparum malaria
Artemisinin resistance
K-13 mutation in Plasmodium falciparum malaria
Pfmdr1

Intervention(s)

Retrospective cohort of patients with uncomplicated Plasmodium falciparum

Patients with uncomplicated Plasmodium falciparum malaria treated with supervised mefloquine-artesunate for 3 days and followed up for 42 days between the years 2003-2013.

Treatment

Primary Outcome(s)

Day-42 PCR adjusted cure rate 42 days Asexual parasitaemia by microscopy

Secondary Outcome(s)

Day-3 positivite for asexual parasitaemia day-3 Asexual parasitaemia by microscopy

Secondary ID(s)

OXTREC 562-15

Source(s) of Monetary Support

Not available

Secondary Sponsor(s)

Not available

Ethics review

Status: Submitted, approved
Approval date:
Contact:

and Faculty of Tropical Medicine, Mahidol University

[phone] Ext.

Results

• Date Completed: 27/12/2013