Parasitic Clearance and Recurrence Rates Among Patients With Vivax Malaria
BCAPES
PARASITIC CLEARANCE AND RECURRENCE RATES AMONG PATIENTS WITH VIVAX MALARIA ON CHLOROQUINE AND PRIMAQUINE THERAPY
1 other identifier
observational
50
1 country
3
Brief Summary
This research is intended to study the efficacy of CQ alone for P.vivax infection and also to study the recurrence rate among patients with P.vivax on standard dose of CQ and PQ. For this study, PQ will be withheld for 28 days so as to study the efficacy of CQ alone since masking effect over one another was found when CQ is given with PQ. So the investigators are not sure whether the recurrence is due to resistance to CQ or CQ concentration in blood is below therapeutic level or it is due to PQ is in inadequate dose. From this study the investigators will get findings like may be CQ is still working for P.vivax or no longer working for P.vivax due to resistance developed by P.vivax parasites. So for P.vivax which is not responding to CQ therapy, the investigators will go for second line treatment with ACT in a similar fashion as it is given for P. falciparum infection in Bhutan. And if the investigators find CQ is still working for P.vivax infection, the next level of study will be to compare higher dose of PQ with standard dose of PQ ( as practiced now) in lieu of bringing down the relapse rates in P. vivax infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2013
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2012
CompletedFirst Posted
Study publicly available on registry
February 5, 2013
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedNovember 25, 2013
November 1, 2013
1.8 years
September 1, 2012
November 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To measure recurrence rates among patients with vivax malarial infection put on standard dose of Chloroquine and Primaquine
Patients with P.vivax mono-infection will be recruited for the study with a follow up for a period of 12 months. These patients will be put on standard dose of Chloroquine(10mg/Kg on day 0 and 5mg/kg on day 1, and 2) and Primaquine(0.25mg/kg)and any recurrence rates will be measured.
12 months
Secondary Outcomes (1)
Genotyping of P.vivax strains in Bhutan.
12 months.
Other Outcomes (1)
To measure Haemoglobin variations during the malarial infection with treatment.
12 months.
Study Arms (1)
Chloroquine, primaquine and ACT
Standard dose of Chloroquine( 10mg/kg on day 0 and 5mg/kg on day1 and day2) and Primaquine(0.25mg/kg for 14 days). Artemisinin combination therapies (ACT) of 4 tablets on 0,8,24,36,48 and 60 hours will be used for Chloroquine resistant P.vivax infection
Interventions
4 tablets of ACT on 0,8,24,36,48 and 60 hours will be given for Chloroquine resistant P.vivax infection.
Chloroquine:10mg/kg for day1,2 and 5mg/kg for day 3 Primaquine: 0.25mg/kg daily for 14 days.
Eligibility Criteria
Patients with P.vivax infections from 6 sentinel sites reported to health facility will be recruited for the study after getting the consent signed.
You may qualify if:
- age above 12months
- infection with P.vivax
- presence of axillary temperature \>37.5 or history of fever during the past 24h
- ability to swallow oral medication
- ability and willingness to comply with the study protocol for the duration of the study ie 12 months follow up
- informed consent from the patient/parent/guardian in the case of children
You may not qualify if:
- signs and symptoms of severe or complicated malaria requiring parenteral treatment according to WHO criteria
- severe malnutrition
- febrile conditions caused by disease other than malaria or other known underlying chronic or severe diseases
- regular medication which interferes with antimalarial pharmacokinetics
- history of hypersensitivity reactions or contraindications to the medicine tested
- positive pregnancy test or breastfeeding
- unable to or unwilling to take contraceptives
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ministry of Health, Bhutanlead
- Asia Pacific Malaria Elimination Networkcollaborator
- Menzies School of Health Researchcollaborator
Study Sites (3)
Vector Diseases Control Program, Gelephu
Geylegphug, Gelephu, 00975, Bhutan
Vector Diseases Control Program, Gelephu
Geylegphug, Gelephu, 00975, Bhutan
Mr. Thinly
Sarpang, Sarpang District, 00975, Bhutan
Related Links
Biospecimen
Filter blot paper will be retained to study the whole genome of P.vivax malaria in Bhutan.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr.Yeshey Dorjey
Ministry of Health, Bhutan
Central Study Contacts
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 1, 2012
First Posted
February 5, 2013
Study Start
March 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
November 25, 2013
Record last verified: 2013-11