Evaluating the Efficacy of Artesunate-mefloquine and the Relative Roles of Resistance Genetic Markers

NCT02427360 | Completed

• 1 other identifier: SMRU1409
• Study Type: observational
• Target: 1,022
• Locations: 1 country
• Sites: 1

Brief Summary

This is a retrospective non randomized cohort to evaluate efficacy of MAS3 on patients with uncomplicated P. falciparum malaria or mixed infection (P. falciparum + a non-falciparum species). The review of patients' records and blood samples will be performed for patients treated at the clinics of Shoklo Malaria Research Unit from the period of January 2003 to December 2013.

Conditions

P. Falciparum Malaria; P. Falciparum Malaria Mixed Infection

Keywords

Retrospective Studies; Clinical Efficacy

Outcome Measures

Primary Outcomes (1)

• proportion of patients with clearance of asexual parasitaemia within 7 days of initiation of trial treatment

  42 days

Secondary Outcomes (4)

• Proportion of aparasitaemic patients

  day 3

• gametocytaemia

  42 days

• haematocrit change

  42 days

• Prevalence and temporal trend of resistance molecular markers

  42 days

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with uncomplicated P.falciparum malaria or mixed infection (P.falciparum + a non-falciparum species) treated at the clinics of Shoklo Malaria Research Unit between 2003-2013. Medical records and stored/left-over samples from these patients will be reviewed/extracted and used for this study.

You may qualify if:

• Patients of any age and sex who received treatment for uncomplicated malaria and followed up 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

You may not qualify if:

• Pregnant woman
• P. falciparum asexual stage parasitaemia greater than or equal to 4% red blood cells Signs or symptoms indicative of severe malaria29
• Mefloquine treatment within the 60 days preceding the current episode of malaria
• Splenectomy
• Patients will be excluded from the efficacy analysis if they didn't finish the 3 days treatment of mefloquine artesunate but still kept in intention-to-treat population.

Sponsors & Collaborators

• University of Oxford: lead
• Texas Biomedical Research Institute: collaborator
• Nanyang Technological University: collaborator

Study Sites (1)

Shoklo Malaria Research Unit

Mae Sot, Changwat Tak, Thailand

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: April 28, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 26, 2018

Record last verified: 2018-11

Locations

TH (1)