G6PD Assessment Before Primaquine for Radical Treatment of Vivax Malaria

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02876549
• Date of registration: 28/07/2016
• Prospective Registration: Yes
• Primary sponsor: University of Oxford
• Public title: G6PD Assessment Before Primaquine for Radical Treatment of Vivax Malaria GAP
• Scientific title: G6PD Assessment Before Primaquine for Radical Treatment of Vivax Malaria
• Date of first enrolment: September 1, 2016
• Target sample size: 1000
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02876549
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Afghanistan

Key inclusion & exclusion 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



Age minimum: 6 Months
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Vivax Malaria

Intervention(s)

Drug: Chloroquine

Drug: Primaquine 0.25 mg/kg/day

Drug: Primaquine 0.75 mg/kg weekly

Primary Outcome(s)

Specificity of CareStart™ G6PD rapid test compared to a genotyping result as gold-standard [Time Frame: 3 years]

Sensitivity of CareStart™ G6PD rapid test compared to a genotyping result as gold-standard [Time Frame: 3 years]

Secondary Outcome(s)

Percentage of P. vivax patients receiving a correct primaquine prescription after G6PD testing compared to using phenotype as gold standard [Time Frame: 3 years]

The degree to which healthcare workers act appropriately on the results of G6PD testing in terms of primaquine prescription [Time Frame: 3 years]

Level of whole blood carboxyprimaquine at day 7 [Time Frame: 7 days]

Level of primaquine metabolite in dried blood spots collected after treatment [Time Frame: 2, 7 and 14 days]

Level of whole blood carboxyprimaquine at day 14 [Time Frame: 14 days]

Barriers to long-term use of the approach based on a qualitative questionnaire-based survey [Time Frame: 3 years]

Secondary ID(s)

BAKMAL1601

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mahidol Oxford Tropical Medicine Research Unit

Nangarhar University