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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02668406 |
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Date of registration:
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26/01/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study to Obtain Blood and Voided Urine Samples to Improve the Diagnosis of Melioidosis
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Scientific title:
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Establishment of a Reference Clinical Sample Panel Allowing for the Development and Proof-of-concept Validation of an In-vitro Diagnostic Test for the Diagnosis of Melioidosis |
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Date of first enrolment:
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February 2016 |
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Target sample size:
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4203 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02668406 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Cambodia
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Contacts
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Name:
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Jan Jacobs, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institute of Tropical Medicine, Antwerp, Belgium |
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Name:
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Thong Phe, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sihanouk Hospital Center of HOPE (SHCH), Cambodia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult (>18 years old)
- Blood culture request by treating physician as part of standard care
- Willing to give informed consent
Exclusion Criteria:
- Refusal to give informed consent
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Melioidosis
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Suspected or Confirmed Bloodstream Infections
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Systemic Inflammatory Response Syndrome
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Intervention(s)
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Other: Voided urine sampling (second sample) (Phase A)
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Other: Venous blood sampling (1 timepoint) (Phase A and B)
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Other: Voided urine sampling (first sample) (Phase A)
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Other: Venous blood sampling (2 timepoints) (Phase A and B)
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Primary Outcome(s)
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Clinical reference panel (urine)
[Time Frame: 15 months]
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Clinical reference panel (blood)
[Time Frame: 15 months]
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Secondary ID(s)
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Melioidosis
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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