P. Falciparum Malaria Clinical Trial
— MMAOfficial title:
Evaluating the Efficacy of Artesunate-mefloquine on the Thai-Myanmar Border and the Relative Roles of Resistance Genetic Markers: A Retrospective Cohort Study
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 |
Verified date | November 2018 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Thailand | Shoklo Malaria Research Unit | Mae Sot | Tak |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | Nanyang Technological University, Texas Biomedical Research Institute |
Thailand,
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 |
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