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Trial record 4 of 158 for:    Chloroquine phosphate

Evaluating the Efficacy of Chloroquine for the Treatment of Plasmodium Vivax Infections in Central Vietnam

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ClinicalTrials.gov Identifier: NCT02610686
Recruitment Status : Unknown
Verified October 2015 by National Institute of Malariology, Parasitology and Entomology, Vietnam.
Recruitment status was:  Recruiting
First Posted : November 20, 2015
Last Update Posted : March 23, 2016
Sponsor:
Collaborator:
Institute of Tropical Medicine, Belgium
Information provided by (Responsible Party):
National Institute of Malariology, Parasitology and Entomology, Vietnam

Brief Summary:

Understanding the extent and regional distribution of CQR vivax malaria and detecting early signs of resistance is critical to prevent the spread of resistant strains, optimize treatment guidelines, and reduce the risk of recurrent and severe malaria. In Vietnam, CQR in P.vivax has been reported sporadically. One study carried out in Binh Thuan province (central-south Vietnam) at the end of the 1990s demonstrated early P.vivax recurrences (7%) by Day 16 after a 3-day CQ treatment. However, in a summary report to World Health Organization (WHO) including data from 11 sentinel sites, from studies conducted between 2006 and 2011 in central and southern Vietnam (total 350 patients), P.vivax is still considered sensitive to CQ. More recently in a cohort study conducted in Quang Nam province (Central Vietnam) in which P.vivax patients were treated radically with CQ and primaquine (10-day at 0.5mg/kg/day) following national guidelines, the 28-day failure rate was measured at 3.45% and CQ blood concentrations measured at day of recurrence (>100ng/ml) confirmed resistance in three patients. The current national guidelines for the radical cure regimen of P.vivax infections recommends 3 days of CQ (total 25 mg/kg body weight (bw)) together with 14 days of primaquine at 0.25 mg/kg bw/ day.

The current WHO protocol recommends a 28-day follow-up to assess the efficacy of CQ for the treatment of P.vivax infections. However, recurrence of early stage resistant parasites may occur after Day 28 in the presence of CQ blood levels above the minimum efficacy concentration (MEC, ≥100ng/ml) and relapses could occur as early as 36 days after standard CQ treatment. Therefore, in order to confirm CQR it is recommended to extend the follow-up period, to Day 42 or 63 and measure whole blood CQ level at Day 28 and at the time of recurrence. Moreover, it has been shown that emerging drug resistance in P.vivax is associated with delayed parasite clearance after treatment, i.e. some parasites are still detectable at Day 3. The aim of the present study is to assess the in vivo and ex vivo susceptibility of P.vivax to CQ in Central Vietnam following the currently recommended radical cure regimen and using GMP certified CQ.


Condition or disease Intervention/treatment Phase
Plasmodium Vivax Drug: Chloroquine Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Efficacy of Chloroquine for the Treatment of Plasmodium Vivax Infections in Central Vietnam
Study Start Date : March 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016


Arm Intervention/treatment
Chloroquine
Single treatment arm
Drug: Chloroquine
efficacy of chloroquine for the treatment of Plasmodium vivax infections
Other Name: Nivaquine




Primary Outcome Measures :
  1. Number of patients with Adequate Clinical and Parasitological Response (ACPR) at day 42 after treatment with Chloroquine. [ Time Frame: day 42 ]
    This outcome will be measured at day42 of follow-up. Treatment outcomes such as ACPR, early or late clinical failures are defined following WHO guidelines;


Secondary Outcome Measures :
  1. 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 ]
    Individual and mean IC50 and IC90 values will be computed for each drug using the IVART tool available online (http://www.wwarn.org/tools-resources/toolkit/analyse/ivart)


Other Outcome Measures:
  1. Number of patients carrying asexual parasites during 42 days follow up [ Time Frame: From day0 to day 42 ]
    asexual parasite forms will be detected by qPCR. This outcome will be measured for each sampling time point.

  2. Number of patients with parasites carrying molecular markers of Plasmodium vivax resistance to CHL at day 0 and among recurrent vivax infections [ Time Frame: From day 0 to day42 ]
    All parasites at day0 will be genotyped and processed by whole genome sequencing to identify molecular markers of CHL resistance. The same analysis will be done for any P. vivax recurrence occurring during the 42-day follow-up.

  3. The number of patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency measured by rapid test [ Time Frame: day 42 ]
    All patients will be tested for G6PD deficiency by a rapid test (CareStart) before given the radical cure treatment with primaquine.

  4. Number of patients carrying sexual parasites during 42 days follow up [ Time Frame: From day0 to day 42 ]
    sexual parasite forms will be detected by RT-qPCR. This outcome will be measured for each sampling time point.

  5. Number of patients with allelic variants of glucose-6-phosphate dehydrogenase (G6PD) deficiency [ Time Frame: Day 42 ]
    G6PD allelic variants will be assessed by allele-specific qPCR assay



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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02610686


Contacts
Contact: Phuc Bui, PhD, MD +84 913522874 phucnimpe@yahoo.com
Contact: Duong Tran, PhD, MD +8416895919 tranthanhduong@hotmail.com

Locations
Vietnam
Chu R Cam Recruiting
Pleiku, Gia Lai, Vietnam
Contact: Phuc Bui, MD, PhD    +84 913522874    phucnimpe@yahoo.com   
Contact: Hong Nguyen, MD    +84 01668188919    nvhong1982@yahoo.com   
Sub-Investigator: Annette Erhart, MD, PhD         
Sub-Investigator: Edu Rovira Vallbona, PhD         
Sponsors and Collaborators
National Institute of Malariology, Parasitology and Entomology, Vietnam
Institute of Tropical Medicine, Belgium
Investigators
Principal Investigator: Duong Tran, MD, PhD National Institute of Malariology Parasitology Entomology, Hanoi, Vietnam
Principal Investigator: Anna Rosanas-Urgell, MD, PhD Institute of Tropical Medicine, Antwerp, Belgium

Publications:

Responsible Party: National Institute of Malariology, Parasitology and Entomology, Vietnam
ClinicalTrials.gov Identifier: NCT02610686     History of Changes
Other Study ID Numbers: ITM- NIMPE
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: October 2015

Keywords provided by National Institute of Malariology, Parasitology and Entomology, Vietnam:
Plasmodium vivax
recurrence
drug resistance

Additional relevant MeSH terms:
Chloroquine
Chloroquine diphosphate
Malaria
Protozoan Infections
Parasitic Diseases
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics