NCT02427360

Completed

Evaluating the Efficacy of Artesunate-mefloquine and the Rel...

University of Oxford Source

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Other study identifiers

Sponsor study identifier

SMRU1409

Study Type

observational

Actual enrollment (reported)

1,022

Locations

1 country

Sites

1

Timeline

Study Start

May 2015

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2015

Actual (reported)

Study Completion

December 2015

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 1,022 participants
Study completion date: December 2015
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
April 22, 2015
Actual (reported)
First Posted
April 28, 2015
Actual (reported)
Study Start
May 2015
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
December 2015
Actual (reported)
Study Completion
December 2015
Actual (reported)

Last Updated: November 26, 2018
Status Verified: November 2018
Last Update Submitted: November 22, 2018

Conditions

P. Falciparum Malaria P. Falciparum Malaria Mixed Infection

Keywords

Retrospective StudiesClinical 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

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-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

Sponsors & Collaborators

Texas Biomedical Research Institute
Type not reportedcollaborator
University of Oxford
Otherlead
Nanyang Technological University

Study Sites (1)

Shoklo Malaria Research Unit

Mae Sot, Changwat Tak, Thailand

Enrollment

1,022 participants (actual enrollment reported by the registry).

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 2015

Date type not reported

This date has not been verified as actual or estimated.

Completed

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.

Contact the study team to confirm eligibility.

Othercollaborator

Primary Completion

December 2015

Actual (reported)

Study Completion

December 2015

Actual (reported)

Last Updated

November 26, 2018

Record last verified: 2018-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02427360
Data provider: ClinicalTrials.gov
Source updated: 2018-11-26
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:26 UTC

Locations

TH(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations