Parasitic Clearance and Recurrence Rates Among Patients With Vivax Malaria (BCAPES)

November 21, 2013 updated by: Dr.Yeshey Dorjey, Ministry of Health, Bhutan

PARASITIC CLEARANCE AND RECURRENCE RATES AMONG PATIENTS WITH VIVAX MALARIA ON CHLOROQUINE AND PRIMAQUINE THERAPY

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In recent time in Bhutan P.vivax infection is on rise compared to other types of malaria like P.falciparum which used to be the most common infections. May be this is mainly due to intensive measures taken place in controlling the diseases especially vector control measures. So that way P.falciparum has gone now. But on other hand P.vivax has peaked the infection. The main reason could be due to resistant to Chloroquine or may be Chloroquine dose is inadequate, and it could also mean it could be due to relapses from the hypnozoites stage where Primaquine dose could be inadequate. Therefore this study is developed to study the efficacy of Chloroquine alone withholding Primaquine for day 28 slightly deviating from the current treatment protocol of Bhutan. That parasitic clearance and recurrence rates will be recorded while on Chloroquine and Primaquine separately. For those patients whose blood stage of parasites doesnt get cleared with standard dose of Chloroquine or for any recurrences occurring before day 28, will be treated with second line treatment with ACT, and the blood level of Chloroquine(drug concentration) will be determined to say whether that could be due to resistance or due to low level of Chloroquine in the blood. And for any recurrences occurring after day 28 while of Primaquine or after completion of Primaquine dosage for a total of 14 days (from day 29 to day 42) those patients will be treated in a similar fashion as initial treatment with Chloroquine and Primaquine and the recurrence rates will be recorded so as to develop next level of study where two different doses of Primaquine (high dose vs low dose) will be compared to study the efficacy of Primaquine.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Bhutan
      • Gelephu, Bhutan, 00975
        • Not yet recruiting
        • Vector Diseases Control Program, Gelephu
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tobgyel Drukpa
        • Sub-Investigator:
          • Dr.Tashi Peldon
        • Sub-Investigator:
          • Dr.Kinley Penjor
      • Gelephu, Bhutan, 00975
        • Recruiting
        • Vector Diseases Control Program, Gelephu
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Dr.Tashi Peldon
        • Sub-Investigator:
          • Dr.Kinley Penjor
        • Sub-Investigator:
          • Tobgay Drukpa
      • Sarpang, Bhutan, 00975
        • Recruiting
        • Mr. Thinly
        • Contact:
        • Sub-Investigator:
          • Dr. Kinly Penjor, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with P.vivax infections from 6 sentinel sites reported to health facility will be recruited for the study after getting the consent signed.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Drug: Artemisinin combination therapies (ACT)will be used for Chloroquine resistant P.vivax
4 tablets of ACT on 0,8,24,36,48 and 60 hours will be given for Chloroquine resistant P.vivax infection.
Other Names:
  • ACT
Drug: Chloroquine and Primaquine
Chloroquine:10mg/kg for day1,2 and 5mg/kg for day 3 Primaquine: 0.25mg/kg daily for 14 days.
Other Names:
  • Chloroquine(CQ)
  • Primaquine (PQ)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To measure recurrence rates among patients with vivax malarial infection put on standard dose of Chloroquine and Primaquine
Time Frame: 12 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Genotyping of P.vivax strains in Bhutan.
Time Frame: 12 months.
One time venous blood samples will be collected from patients infected with mixed or mono-infection of P.vivax malaria. And the genotyping will be conducted to study the strains of P.vivax malaria that exist in Bhutan.
12 months.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To measure Haemoglobin variations during the malarial infection with treatment.
Time Frame: 12 months.
Finger prick blood will be taken to check Haemoglobin levels on day 0,3, 7, 14, 28, 35, 42 and at the end of study(ie at the end of 12months).
12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ministry of Health, Bhutan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Menzies School of Health Research
Asia Pacific Malaria Elimination Network

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dr.Yeshey Dorjey, Ministry of Health, Bhutan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BCAPES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings