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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official 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

Conditions
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Melioidosis, Systemic Inflammatory Response Syndrome, Suspected or Confirmed Bloodstream Infections

Intervention / Treatment
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* Other: Venous blood sampling (2 timepoints) (Phase A and B)
* Other: Venous blood sampling (1 timepoint) (Phase A and B)
* Other: Voided urine sampling (first sample) (Phase A)
* Other: Voided urine sampling (second sample) (Phase A)


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Burkholderia pseudomallei<br>Patients for whom blood cultures grew Burkholderia pseudomallei | Other: Venous blood sampling (2 timepoints) (Phase A and B)<br>* 8.5ml at Day 1 + 8.5ml at Day 5<br>Other: Voided urine sampling (first sample) (Phase A)<br>* At least 20ml upon confirmation of being part of one of the 3 study groups<br>Other: Voided urine sampling (second sample) (Phase A)<br>* At least 20ml during routine hospital stay or routine follow-up visit<br>|
| No pathogen<br>Patients for whom blood cultures did not grow a pathogen, but have other body site grown with Burkholderia pseudomallei, or are suspected of melioidosis | Other: Venous blood sampling (2 timepoints) (Phase A and B)<br>* 8.5ml at Day 1 + 8.5ml at Day 5<br>Other: Voided urine sampling (first sample) (Phase A)<br>* At least 20ml upon confirmation of being part of one of the 3 study groups<br>Other: Voided urine sampling (second sample) (Phase A)<br>* At least 20ml during routine hospital stay or routine follow-up visit<br>|
| Another pathogen<br>Patients for whom blood cultures grew another pathogen | Other: Venous blood sampling (1 timepoint) (Phase A and B)<br>* 8.5ml at Day 1<br>Other: Voided urine sampling (first sample) (Phase A)<br>* At least 20ml upon confirmation of being part of one of the 3 study groups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical reference panel (blood) | 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. | 15 months | 
| Clinical reference panel (urine) | 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. | 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood infection, melioidosis, rapid diagnostic test