Incidence of Vivax Along the Thai Burma Border (VHC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Oxford
Sponsor:
Collaborator:
Mahidol University
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01076868
First received: February 24, 2010
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

This is a continuous cohort study consisting of 200 participants (one third 6 months old to 5 years, one third 6 to 15 years old, one third ≥ 15 years old) i.e. a new patient will be recruited (from the same age group) for any patient who develops a Pv infection so that the cohort will always have 200 patients for 3 years. Each patient will be actively followed-up every 8 weeks until Plasmodium vivax infection occurs but the duration of follow up and the number of follow up visits for each patient will vary depending on when or if a vivax infection occurs and when the patient is recruited. Therefore, the minimum follow up period for each patient will be 6 months or time to vivax infection and the maximum will be 3 years if a patient does not get vivax infection and is recruited at the beginning of the study.


Condition Intervention
Vivax Malaria
Drug: Primaquine

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Determining the Incidence of New Plasmodium Vivax Infections After Radical Treatment Following Vivax Malaria Along the Thai Burma Border

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Incidence [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Incidence of primary infections with vivax malaria


Secondary Outcome Measures:
  • Adverse events [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Adverse event profile of primaquine


Estimated Enrollment: 200
Study Start Date: February 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Primaquine
Primaquine 14 days
Drug: Primaquine
Primaquine x 14 days
Other Name: primaquine 0.5 mg/kg/day

Detailed Description:

This study will evaluate the most likely approach to malaria elimination; the administration of a radical curative dose of primaquine to the entire potentially infected population. In this study we will focus on patients who have had vivax malaria in the past year and so are very likely to harbour liver hypnozoites. Radical treatment is not given on the Thai-Burmese border because risks are considered to outweigh benefits, but it is recommended in Thailand. We believe that this policy could be changed if there was sufficient information.

Patients who have received chloroquine only treatment could be considered as incompletely treated. We plan to conduct a carefully documented evaluation of radical treatment in such patients. Through this we aim to determine the incidence of vivax malaria in patients living in a vivax endemic area following radical treatment. This will provide information on the safety and tolerability of primaquine, used in the context most likely during an elimination programme, and also will provide information on the incidence of vivax malaria. Adults and children > 6 months old with a documented P.vivax infection in the last 12 months will be recruited. In conjunction with a parallel study evaluating epidemiology in treated vivax malaria, we will be able to characterize the relapse history of P vivax. This will provide the foundation for further studies evaluating the efficacy of primaquine regimens.

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Asymptomatic adults and children ≥ 6 months
  • Documented P.vivax infection in the last 12 months who have not received radical treatment with primaquine
  • Weight≥ 7 kg for children
  • Participant (or parent/guardian if <18 years old) is willing and able to give written informed consent
  • Ability (in the investigators opinion) and willingness of patient or parent/guardian to comply with all study requirements

Exclusion Criteria:

  • History of allergy to primaquine
  • Medical conditions such as known chronic diseases (TB, HIV, cardio vascular diseases), allergies, mental illnesses and similar conditions that could make the interpretation of symptoms or the follow up difficult.
  • Other conditions such as drug addiction, known poor compliance with treatment or follow up.
  • Inability to tolerate oral medication
  • Pregnancy
  • G6PD deficiency
  • Blood transfusion in the last 3 months
  • Microscopic evidence of Plasmodium vivax, P.falciparum, P. malariae or ovale
  • Fever ≥37.5C
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01076868

Contacts
Contact: Phaik Yeong Cheah, PhD phaikyeong@tropmedres.ac

Locations
Thailand
Shoklo Malaria Research Unit Recruiting
Mae Sot, Tak, Thailand
Contact: Cindy Chu, MD       cindy@shoko-unit.com   
Principal Investigator: Francois Nosten, MD         
Sponsors and Collaborators
University of Oxford
Mahidol University
Investigators
Principal Investigator: Francois Nosten, MD Shoklo Malaria Research Unit
  More Information

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01076868     History of Changes
Other Study ID Numbers: SMRU0909
Study First Received: February 24, 2010
Last Updated: August 28, 2013
Health Authority: Thailand: Ethical Committee

Keywords provided by University of Oxford:
vivax
malaria
relapse

Additional relevant MeSH terms:
Malaria
Malaria, Vivax
Protozoan Infections
Parasitic Diseases
Primaquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014