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

Evaluating the Efficacy of Artesunate-mefloquine on the Thai-Myanmar Border and the Relative Roles of Resistance Genetic Markers: A Retrospective Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: P. Falciparum Malaria; P. Falciparum Malaria Mixed Infection

Detailed Description

The objective of this study is to evaluate the Day 42 PCR adjusted cure rate of mefloquine-artesunate (MAS3) in patients with P. falciparum

Study procedure

Clinic and patient records and log books will be reviewed and the following clinical information will be extracted: vital signs especially the temperature, clinical signs and symptoms, blood slide and haematocrit result and findings of physical examination (anaemia, jaundice, liver, spleen etc). As a routine, these data were recorded on the clinic patient record and malaria smear microscopy logbook accordingly (which will be regarded as the source documents in this analysis). These source documents will be reviewed and stored specimen will be analysed after getting the permission from the Director of Shoklo Malaria Research Unit, the University of Oxford Tropical Research Ethical Committee (OxTREC)and the Faculty of Tropical Medicine Ethics Committee (FTMEC). These data will be extracted and transcribed into the case record forms and entered into Microsoft access. During the data extraction, the unique ID will be assigned to each patient whereas the patients' name will neither be entered into database nor disclosed in the analysis process (ie: the data will be anonymised).

• Study Type: Observational
• Enrollment (Actual): 1022

Contacts and Locations

Study Locations

• Thailand
  • Tak
    • Mae Sot, Tak, Thailand
      • Shoklo Malaria Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
proportion of patients with clearance of asexual parasitaemia within 7 days of initiation of trial treatment	42 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of aparasitaemic patients		day 3
gametocytaemia	gametocytaemia will be measured on pre and post treatment	42 days
haematocrit change	Haematocrit changes will be measured on pre and post treatment	42 days
Prevalence and temporal trend of resistance molecular markers	the following molecular markers will be measured; SNP on Kelch/K13 gene and Pfmdr1 copy number	42 days

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: Nanyang Technological University; Texas Biomedical Research Institute

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: April 22, 2015
• First Submitted That Met QC Criteria: April 27, 2015
• First Posted (Estimate): April 28, 2015

Study Record Updates

• Last Update Posted (Actual): November 26, 2018
• Last Update Submitted That Met QC Criteria: November 22, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Retrospective Studies; Clinical Efficacy
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria; Malaria, Falciparum; Coinfection
• Other Study ID Numbers: SMRU1409