|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
30 March 2015 |
|
Main ID: |
NCT02118090 |
|
Date of registration:
|
14/04/2014 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Assessment of Plasmodium Vivax Chloroquine Resistance in Cambodia:
CRePViCam |
|
Scientific title:
|
Assessing Chloroquine Resistance of Plasmodium Vivax in Malaria Endemic Area |
|
Date of first enrolment:
|
May 2014 |
|
Target sample size:
|
73 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT02118090 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Cambodia
| | | | | | | |
|
Contacts
|
|
Name:
|
Dysoley Lek, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
National Centre for Parasitology Entomology and Malaria Control |
|
|
Name:
|
Didier Ménard, PharmD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Institut Pasteur in Cambodia |
|
|
Name:
|
Jean Popovici, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Institut Pasteur in Cambodia |
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
(i) Being aged 15 years or more with competency to give informed consent, (ii) Being
positive for P. vivax and mono-infected
Exclusion Criteria:
(i) Being aged 14 years or less (ii) Individuals with illness that affected competency to
give informed consent, (iii) Pregnant or lactating women (iv) Having taken antimalarial
drugs in the past month
Age minimum:
15 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Vivax Malaria
|
|
Intervention(s)
|
|
Drug: DHA-PP
|
|
Drug: Chloroquine sulfate
|
|
Primary Outcome(s)
|
|
Number of patients with P. vivax CQ resistant parasite
[Time Frame: 6 months]
|
|
Secondary Outcome(s)
|
|
Number of isolates characterized by whole genome sequencing and multiple Single Nucleotide Polymorphisms Bar Code
[Time Frame: 1 year]
|
|
Secondary ID(s)
|
|
IPC_Pv_CQR_RTK
|
|
R01AI103228
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|