Evaluating the Efficacy of Artesunate-mefloquine and the Relative Roles of Resistance Genetic Markers
Information source: University of Oxford
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: P. Falciparum Malaria; P. Falciparum Malaria Mixed Infection
Phase: N/A
Status: Not yet recruiting
Sponsored by: University of Oxford Overall contact: Aung Pyae Phyo, MD, Phone: +66 55 545021, Email: aung.phyo@ndm.ox.ac.uk
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.
Clinical Details
Official title: Evaluating the Efficacy of Artesunate-mefloquine on the Thai-Myanmar Border and the Relative Roles of Resistance Genetic Markers: A Retrospective Cohort Study
Study design: Observational Model: Cohort, Time Perspective: Retrospective
Primary outcome: proportion of patients with clearance of asexual parasitaemia within 7 days of initiation of trial treatment
Secondary outcome: Proportion of aparasitaemic patientsgametocytaemia haematocrit change Prevalence and temporal trend of resistance molecular markers
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).
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Aung Pyae Phyo, MD, Phone: +66 55 545021, Email: aung.phyo@ndm.ox.ac.uk Additional Information
Starting date: May 2015
Last updated: April 27, 2015
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