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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 April 2016 |
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Main ID: |
NCT02610686 |
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Date of registration:
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23/10/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluating the Efficacy of Chloroquine for the Treatment of Plasmodium Vivax Infections in Central Vietnam
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Scientific title:
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Evaluating the Efficacy of Chloroquine for the Treatment of Plasmodium Vivax Infections in Central Vietnam |
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Date of first enrolment:
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March 2015 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02610686 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Vietnam
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Contacts
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Name:
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Phuc Bui, MD, PhD |
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Address:
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Telephone:
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+84 913522874 |
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Email:
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phucnimpe@yahoo.com |
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Affiliation:
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Name:
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Duong Tran, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Institute of Malariology Parasitology Entomology, Hanoi, Vietnam |
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Name:
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Phuc Bui, PhD, MD |
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Address:
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Telephone:
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+84 913522874 |
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Email:
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phucnimpe@yahoo.com |
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Affiliation:
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Name:
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Anna Rosanas-Urgell, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institute of Tropical Medicine, Antwerp, Belgium |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Mono-infection of P. vivax by light microscopy (LM) with asexual parasite density
>250/µl
- Age =1year
- Axillary temperature = 37.5º C and/or history of fever during the previous 48 hours;
- Patient or caregiver consent to enrolment and agree to sampling and return visits;
Exclusion Criteria:
- General danger signs or symptoms of severe malaria (as per WHO definitions; Annex I);
- Signs or symptoms of severe malnutrition, defined as weight-for-age = 3 standard
deviations below the mean (NCHS/WHO normalized reference values, Annex II);
- Slide confirmed infection with any other Plasmodium species (including mixed
infections);
- Severe anaemia, defined as haemoglobin (Hb) <7g/dl in adults and <5g/dl in children;
- Known hypersensitivity to any of the drugs being evaluated;
- Presence of fever due to illness other than malaria;
- History of serious and/or chronic medical condition (cardiac, renal, hepatic
diseases, sickle cell disease, HIV/AIDS);
- Pregnancy (confirmed by rapid test) or breastfeeding;
- Regular use of medication that may interfere with antimalarial pharmacokinetics;
Age minimum:
1 Year
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Plasmodium Vivax
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Intervention(s)
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Drug: Chloroquine
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Primary Outcome(s)
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Number of patients with Adequate Clinical and Parasitological Response (ACPR) at day 42 after treatment with Chloroquine.
[Time Frame: day 42]
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Secondary Outcome(s)
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Ex vivo susceptibility of P. vivax isolates to QN, DHA , PPQ and CQ (Mean IC50 and IC90)
[Time Frame: At day0 and day of recurrence of P.vivax parasitemia after initial parasite clearance assessed up to day 42]
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Secondary ID(s)
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ITM- NIMPE
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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