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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02427360
Other study ID # SMRU1409
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2015
Est. completion date December 2015

Study information

Verified date November 2018
Source University of Oxford
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 1022
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Thailand Shoklo Malaria Research Unit Mae Sot Tak

Sponsors (3)

Lead Sponsor Collaborator
University of Oxford Nanyang Technological University, Texas Biomedical Research Institute

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary proportion of patients with clearance of asexual parasitaemia within 7 days of initiation of trial treatment 42 days
Secondary Proportion of aparasitaemic patients day 3
Secondary gametocytaemia gametocytaemia will be measured on pre and post treatment 42 days
Secondary haematocrit change Haematocrit changes will be measured on pre and post treatment 42 days
Secondary 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
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Completed NCT01082705 - Assessing the Efficacy of Artemisinin Combination Therapies for Treatment of Uncomplicated Malaria Infection in Children Phase 3