Malaria, Vivax Clinical Trial
Official title:
Developing a Methodology to Assess 8-aminoquinoline Associated Haemolytic Risk in Females Heterozygous for G6PD in Endemic Populations
Verified date | May 2019 |
Source | PATH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A clinical study designed to develop and inform an individual risk of hemolysis model based on individual red blood cell G6PD levels. Volunteers who are eligible to treatment with primaquine as per national guidelines and with confirmed normal G6PD levels as per the fluorescent spot test will be exposed to treatment regimens of either primaquine alone for 14 days or 3 day chloroquine with concomitant primaquine for 14 days. The volunteers will be followed intensively during treatment and for 14 days after treatment for haematologic measures, G6PD quantification, and drug level assays.
Status | Terminated |
Enrollment | 54 |
Est. completion date | October 21, 2018 |
Est. primary completion date | August 21, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Previous G6PD test at Shoklo Malaria Research Unit (SMRU) clinic with one of following results: 1) G6PD homozygous wildtype females (G6PD genotype normal) 2) G6PD heterozygous females with a normal FST (G6PD genotype abnormal with G6PD activity =40% and =80% of normal ) 3) G6PD hemizygous wildtype males (G6PD genotype normal) - Willing to participate and sign informed consent form - Willing to allow donated samples to be used in future research - Aged =18 years - Ability (in the investigators' opinion) and willing to comply with all study requirements Exclusion Criteria: All participants: - Malaria or other illness - Recent history (within 20 days) of anti-malarial treatment - History of allergy or adverse reaction to chloroquine or primaquine - Blood transfusion in the past 3 months - G6PD activity less than 40% normal activity or 3.00 IU/gHb by the quantitative G6PD spectrophotometric assay - Haemoglobin =10 g/dL - Presence of any condition which in the judgment of the investigator would place the subject at undue risk or interfere with the results of the study Female participants only: - Pregnancy at the time of screening - Breastfeeding |
Country | Name | City | State |
---|---|---|---|
Thailand | Shoklo Malaria Research Unit (SMRU) | Mae Sot |
Lead Sponsor | Collaborator |
---|---|
PATH | Mahidol Oxford Tropical Medicine Research Unit |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Haemoglobin | The change in haemoglobin from baseline on exposure to primaquine for P.vivax treatment over treatment course to hemoglobin level at day 28. | 28 days after enrollment | |
Primary | Change in G6PD Concentration | The haemoglobin-related change in G6PD concentration, as determined by spectrometer, over treatment course.
Change is determined from baseline to day 28 |
28 days after enrollment | |
Secondary | Significance of CYP2D6 | relevance of Dextromethorphan assay results to risk of haemolysis models | 28 days after enrollment | |
Secondary | Association of Drug Levels | Association of chloroquine and primaquine drug levels at the time of sampling for haematological and G6PD profiles. | Days 1,2,3,5,7,9,11,14,17,21 | |
Secondary | Serious Adverse Events | frequency of serious adverse events in women heterozygous for G6PD | 28 days after enrollment | |
Secondary | Significance of Reticulocyte Count | relevance of reticulocyte count to risk of haemolysis models | Days 1,2,3,5,7,9,11,14,17,21 | |
Secondary | Significance of Urobilinogen Levels | relevance of urobilinogen tests to risk of haemolysis models | Days 1,2,3,5,7,9,11,14,17,21 |
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