Safety and Efficacy of Chloroquine and Primaquine for Vivax Malaria in Bhutan

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Menzies School of Health Research
Sponsor:
Collaborator:
Ministry of Health, Bhutan
Information provided by (Responsible Party):
Menzies School of Health Research
ClinicalTrials.gov Identifier:
NCT01716260
First received: October 25, 2012
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

This research is intended to study the efficacy of chloroquine (CQ) and primaquine (PQ) for Plasmodium vivax (P.vivax) infection, and also to study the recurrence rate among patients with P.vivax malaria on standard doses of CQ and PQ. For this study, PQ will be withheld for 28 days so as to study the efficacy of CQ alone.

This study will assess whether CQ is still effective against P.vivax or whether there are resistant P.vivax strains in Bhutan.


Condition Intervention
Vivax Malaria
Drug: Chloroquine
Drug: Primaquine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Parasitic Clearance and Recurrence Rates Among Patients With Vivax Malaria on Chloroquine and Primaquine Therapy

Resource links provided by NLM:


Further study details as provided by Menzies School of Health Research:

Primary Outcome Measures:
  • Chloroquine efficacy for P.vivax infections in Bhutan. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    The purpose is to study the efficacy of Chloroquine alone by recording recrudescent rates and parasitic clearance in P.vivax patients who are given a standard dose of Chloroquine treatment.


Secondary Outcome Measures:
  • To study the efficacy of Primaquine. [ Time Frame: Patients with recurrence after day 28 will be recorded. ] [ Designated as safety issue: Yes ]
    In this study, Primaquine will be administered on day 28, and any relapse will be recorded to study relapse rates over a 12 month period.


Other Outcome Measures:
  • To assess the feasibility of a 12 month follow-up of patients with vivax malaria in Bhutan. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To assess the safety of the currently prescribed CQ and PQ regimens in Bhutan. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Chloroquine and Primaquine
Chloroquine (CQ)10mg/kg for day 1, 2 and 5mg/kg for day 3 Primaquine (PQ)0.25mg/kg/day for 14 days
Drug: Chloroquine Drug: Primaquine

Detailed Description:

This study aims to assess the efficacy of Chloroquine alone, withholding Primaquine until day 28. Parasitic clearance and recurrence rates will be recorded. Patients whose blood stage of parasites are not cleared with the standard dose of Chloroquine, or any recurrences before day 28, will be treated with second line treatment (ACT).

The patients blood level of Chloroquine (drug concentration) at the time of a recrudescent infection will de determined to assess whether that could be due to resistance, or due to low level of Chloroquine.

Any relapses occurring after day 28 when not receiving Primaquine, or after completion of Primaquine dosage for a total of 14 days (from day 29 to 42), will be treated with repeat doses of the initial treatment. The recurrence rates will be recorded so as to develop the next phase of the study where the two different doses of Primaquine (high dose vs. low dose) will be compared.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with P.vivax infections will be recruited from 6 sentinel sites and will be recruited for the study after informed consent is received.

Criteria

Inclusion Criteria:

  • >12 months of age
  • infection with P.vivax parasitaemia monoinfection
  • presence of axillary temperature >37.5 degrees or history of fever during the past 24 hours
  • ability to swallow oral medication
  • ability and willingness to comply with the study protocol for the duration of the study, including 12 months follow up
  • informed consent from the patient/parent/guardian in the case of children

Exclusion Criteria:

  • Presence of general danger signs in children aged under 5 years or signs of severe malaria according to the definitions of WHO
  • Presence of severe malnutrition (defined as a child whose growth standard is below -3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference < 110 mm);
  • History of haemolysis or severe anaemia
  • Acute anaemia <7 mg/dL
  • Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
  • Regular medication, which may interfere with antimalarial pharmacokinetics
  • History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s)
  • a positive pregnancy test or lactating
  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: NCT01716260

Contacts
Contact: Dr Lorenz von Seidlein, MD +61 8 8922 6998

Locations
Bhutan
Vector Diseases Control Program Recruiting
Gelephu, Bhutan
Contact: Dr Yeshey Dorjey, MD         
Contact: Dr Kinley Penjor, MD         
Sub-Investigator: Dr Yeshey Dorjey         
Sub-Investigator: Dr Kinley Penjor         
Sub-Investigator: Dr Tashi Peldon         
Principal Investigator: Mr Tobgay Tobgay         
Sub-Investigator: Dr Lorenz von Seidlein         
Sponsors and Collaborators
Menzies School of Health Research
Ministry of Health, Bhutan
  More Information

No publications provided

Responsible Party: Menzies School of Health Research
ClinicalTrials.gov Identifier: NCT01716260     History of Changes
Other Study ID Numbers: Bhutan_APMEN_CQ PQ_2013
Study First Received: October 25, 2012
Last Updated: September 25, 2013
Health Authority: Australia: Human Research Ethics Committee

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

ClinicalTrials.gov processed this record on September 22, 2014