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Study to Obtain Blood and Voided Urine Samples to Improve the Diagnosis of Melioidosis

NCT02668406 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4203

Last updated 2018-10-23

No results posted yet for this study

Summary

Clinical samples \[blood and voided urine (only for phase A)\] from patient recruited at Sihanouk Hospital Centre of HOPE (SHCH) and HOPE Community Medical Center (CMC) will be processed (decontamination) and shipped to SRI International with the purpose of design and validation (proof of concept) and (case/control series) of in-vitro diagnostics for melioidosis.

Conditions

  • Melioidosis
  • Systemic Inflammatory Response Syndrome
  • Suspected or Confirmed Bloodstream Infections

Interventions

OTHER

Venous blood sampling (2 timepoints) (Phase A and B)

8.5ml at Day 1 + 8.5ml at Day 5

OTHER

Venous blood sampling (1 timepoint) (Phase A and B)

8.5ml at Day 1

OTHER

Voided urine sampling (first sample) (Phase A)

At least 20ml upon confirmation of being part of one of the 3 study groups

OTHER

Voided urine sampling (second sample) (Phase A)

At least 20ml during routine hospital stay or routine follow-up visit

Sponsors & Collaborators

  • Sihanouk Hospital Center of HOPE

    collaborator OTHER

  • SRI International

    collaborator INDUSTRY

  • Institute of Tropical Medicine, Belgium

    lead OTHER

Principal Investigators

  • Jan Jacobs, MD · Institute of Tropical Medicine, Antwerp, Belgium

  • Thong Phe, MD · Sihanouk Hospital Center of HOPE (SHCH), Cambodia

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • Cambodia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02668406 on ClinicalTrials.gov