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| Name | Class |
|---|---|
| Sihanouk Hospital Center of HOPE | OTHER |
| SRI International | INDUSTRY |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Burkholderia pseudomallei | Patients for whom blood cultures grew Burkholderia pseudomallei |
| |
| No pathogen | Patients for whom blood cultures did not grow a pathogen, but have other body site grown with Burkholderia pseudomallei, or are suspected of melioidosis |
| |
| Another pathogen | Patients for whom blood cultures grew another pathogen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venous blood sampling (2 timepoints) (Phase A and B) | Other | 8.5ml at Day 1 + 8.5ml at Day 5 |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients presenting with systemic inflammatory response syndrome.
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| Name | Affiliation | Role |
|---|---|---|
| Jan Jacobs, MD | Institute of Tropical Medicine, Antwerp, Belgium | Study Director |
| Thong Phe, MD | Sihanouk Hospital Center of HOPE (SHCH), Cambodia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HOPE Community Medical Center | Phnom Penh | Cambodia | ||||
| Sihanouk Hospital Center of HOPE (SHCH), Cambodia |
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Blood (phase A and B) and voided urine samples (only phase A)
| 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 |
|
| Phnom Penh |
| Cambodia |
| ID | Term |
|---|---|
| D008554 | Melioidosis |
| D018746 | Systemic Inflammatory Response Syndrome |
| ID | Term |
|---|---|
| D019121 | Burkholderia Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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