P. Falciparum Malaria Clinical Trial
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
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.
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).
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