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G6PD Assessment Before Primaquine for Radical Treatment of Vivax Malaria (GAP)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2016 by University of Oxford
Sponsor:
Collaborators:
Mahidol Oxford Tropical Medicine Research Unit
Nangarhar University, Afghanistan
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT02876549
First received: July 28, 2016
Last updated: August 22, 2016
Last verified: August 2016
  Purpose

This will be a single-arm observational cohort study. Malaria patients with Plasmodium vivax and meeting study inclusion criteria, who give consent to be enrolled in the study, will have their G6PD status measured by the CareStart™ G6DP rapid diagnostic test (G6PD RDT), and primaquine prescribed according to the result. According to the G6PD RDT result, primaquine will be prescribed at 0.25mg/kg/day for 14 days (normal patients) or 0.75mg/kg weekly for eight weeks (deficient patients). All will receive treatment with chloroquine to clear asexual stages of infection.

Patients will be reviewed at day 2, day 7 and day 14. At these visits patients will undergo a brief clinical assessment and a small blood sample will be taken for repeat haemoglobin measurement and dried blood spot for carboxyprimaquine measurement (day 7 and day 14 only).

In general, antimalarial treatment will be unsupervised to reflect field conditions. However a subset of 25 G6PD normal patients at a single site will have each day of their primaquine treatment administered and observed at the treatment centre. This is to determine a calibration curve for primaquine pharmacokinetic studies.

Dried blood spots will be stored appropriately. Day zero samples will be genotyped in Bangkok (MORU, Dr. Mallika Imwong) after DNA extraction. PCR-RFLP will be used to detect the allele associated with the Mediterranean variant of G6PD deficiency. In addition DNA extracts will be sent for more systematic genetic testing for known G6PD variants through existing collaborations with the Wellcome Trust Sanger Institute. The day 7 and 14 dried blood spot samples will be analysed in the MORU pharmacology laboratory for primaquine and carboxyprimaquine concentrations, from which adherence to primaquine can be determined retrospectively, using the subset of 25 patients receiving directly observed therapy to calibrate the results.


Condition Intervention Phase
Vivax Malaria
Drug: Chloroquine
Drug: Primaquine 0.25 mg/kg/day
Drug: Primaquine 0.75 mg/kg weekly
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: G6PD Assessment Before Primaquine for Radical Treatment of Vivax Malaria

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Sensitivity of CareStart™ G6PD rapid test compared to a genotyping result as gold-standard [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Specificity of CareStart™ G6PD rapid test compared to a genotyping result as gold-standard [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of P. vivax patients receiving a correct primaquine prescription after G6PD testing compared to using phenotype as gold standard [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Level of primaquine metabolite in dried blood spots collected after treatment [ Time Frame: 2, 7 and 14 days ] [ Designated as safety issue: No ]
    Day 2, 7, 14

  • Level of whole blood carboxyprimaquine at day 7 [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Level of whole blood carboxyprimaquine at day 14 [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • The degree to which healthcare workers act appropriately on the results of G6PD testing in terms of primaquine prescription [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Barriers to long-term use of the approach based on a qualitative questionnaire-based survey [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: August 2016
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: G6PD Normal Drug: Chloroquine
10 mg/kg on day 0 & 1 and 5mg/kg on day 2, (Afghanistan NMLCP guidelines)
Drug: Primaquine 0.25 mg/kg/day
0.25 mg/kg/day for 14 days
Experimental: G6PD Deficient Drug: Chloroquine
10 mg/kg on day 0 & 1 and 5mg/kg on day 2, (Afghanistan NMLCP guidelines)
Drug: Primaquine 0.75 mg/kg weekly
0.75 mg/kg weekly for eight weeks

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults and children >6 months
  • Confirmed diagnosis of Plasmodium vivax mono-infection
  • Ability to swallow oral medication
  • Participant (or parent/guardian if <15 years old) is willing and able to give documented informed consent and comply with study requirements

Exclusion Criteria:

  • Severe malaria (see World Health Organisation definition)
  • P. falciparum infection
  • Pregnancy or lactation
  • Hypersensitivity (allergy) to primaquine or chloroquine
  • Presence of any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study e.g. other acute febrile conditions or chronic disease
  • Ongoing involvement in another research study
  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: NCT02876549

Contacts
Contact: Dr. Ghulam Rahim Awab, MD 0093 (0)700044853 awabgr@yahoo.com

Locations
Afghanistan
Dr. Ghulam Rahim Awab MD Not yet recruiting
Jalalabad, Nangarha, Afghanistan
Contact: Dr. Ghulam Rahim Awab, MD    0093 (0)700044853    awabgr@yahoo.com   
Sponsors and Collaborators
University of Oxford
Mahidol Oxford Tropical Medicine Research Unit
Nangarhar University, Afghanistan
  More Information

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02876549     History of Changes
Other Study ID Numbers: BAKMAL1601 
Study First Received: July 28, 2016
Last Updated: August 22, 2016
Health Authority: Afghanistan: Ministry of Public Health
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Oxford:
G6PD
Primaquine

Additional relevant MeSH terms:
Malaria
Malaria, Vivax
Protozoan Infections
Parasitic Diseases
Chloroquine
Primaquine
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 22, 2016