Status:
COMPLETED
Estimating the Risk of Plasmodium Vivax Relapses in Afghanistan
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
National Malaria and Leishmaniasis Control Program, Afghanistan
Mahidol University
Conditions:
Vivax Malaria
Eligibility:
All Genders
6+ years
Phase:
PHASE4
Brief Summary
This is an open label two-arm randomized prospective study of two treatments for P. vivax malaria. Patients meeting study inclusion criteria will be enrolled and allocated either chloroquine alone or ...
Detailed Description
Globally more than 100 countries are endemic of malaria and about 60% of world population are at risk of getting the infection while around 10% are harboring malaria parasite in their blood stream. Of...
Eligibility Criteria
Inclusion
- Adults and children \>6 months
- Negative pregnancy test in women at risk of pregnancy
- Microscopic diagnosis of Plasmodium vivax mono-infection (\>200/µl asexual forms)
- Axillary temperature ≥37.5°C or oral/rectal temperature ≥38°C or history of fever within the last 24 hours
- Ability to swallow oral medication
- Participant (or parent/guardian if \<18 years old) is willing and able to give written informed consent
- Ability (in the investigator's opinion) and willingness of patient or parent/guardian to comply with all study requirements
Exclusion
- Severe malaria (see WHO definition)
- Patients with microscopic diagnosis of co-infection with Plasmodium falciparum
- Haemoglobin concentration \<8g/dl
- Presence of any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study e.g. other acute febrile conditions or chronic disease
- Pregnancy or lactation
- History or phenotypic test compatible with severe G6PD deficiency
- History of hypersensitivity to any of the drugs being tested
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
593 Patients enrolled
Trial Details
Trial ID
NCT01178021
Start Date
August 1 2009
End Date
February 1 2014
Last Update
January 15 2019
Active Locations (3)
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1
Provincial Malaria Control Centers (MRC)
Maymana, Faryab Province, Afghanistan
2
Provincial Malaria Control Centers (MRC)
Jalalabad, Afghanistan
3
Provincial Malaria Control Centers (MRC)
Kunduz, Afghanistan