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Completed

NCT Number: NCT02668406

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

HOPE Community Medical Center, Phnom Penh, Cambodia

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About this study

Study will be proposed to all patients at Sihanouk Hospital Centre of HOPE (SHCH) and HOPE Community Medical Center (CMC) presenting with systemic inflammatory response syndrome (SIRS).

Blood samples will be collected upon admission for patients with blood culture request as part of routine patient care and agreement on informed consent. A second sample will be collected in patients with blood culture proven melioidosis or suspicion of melioidosis (only for phase B), at day 5 after initiation of appropriate antibiotic treatment. Depending on the final diagnosis, a subset of patients will be assigned to 3 groups:

  • Patients for whom blood cultures grew Burkholderia pseudomallei
  • Patients for whom blood cultures did not grow a pathogen, but have other body site grown with Burkholderia pseudomallei, or are suspected of melioidosis
  • Patients for whom blood cultures grew with another pathogen

In phase A only, at least 20 ml of voided urine will be collected when a patient is hospitalized and identified as belonging to study group 1, 2 or 3. A second collection of voided urine will be collected for group 1 and 2 patients during routine further hospital stay or a routine follow-up visit.

The clinical samples from these patients will be processed and shipped to SRI International with the purpose of design (=phase A) and validation (=phase B) of in-vitro diagnostics for melioidosis.

A coded database will be completed with basic demographic, clinical and microbiological data and final diagnosis. This coded information will be provided to SRI International.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

8.5ml at Day 1 + 8.5ml at Day 5

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

Other

8.5ml at Day 1

Voided urine sampling (first sample) (Phase A)

Other

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

Voided urine sampling (second sample) (Phase A)

Other

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

Primary outcomes

  1. Clinical reference panel (blood)

    Time frame: 15 months

    Establishment of a quality-assured and well-documented clinical reference panel (cases/control) of human blood samples allowing for the design, development and proof-of-concept validation of an in-vitro diagnostic assay for the diagnosis of melioidosis.

  2. Clinical reference panel (urine)

    Time frame: 15 months

    Establishment of a quality-assured and well-documented clinical reference panel (cases/control) of human voided urine samples allowing for the design, development and proof-of-concept validation of an in-vitro diagnostic assay for the diagnosis of melioidosis.

Sponsors and collaborators

Lead sponsor

Institute of Tropical Medicine, Belgium

Other

Collaborators

  • SRI International
  • Sihanouk Hospital Center of HOPE

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 29, 2016
Registry last updated
Oct 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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