An observational study in Melioidosis, Systemic Inflammatory Response Syndrome and Suspected or Confirmed Bloodstream Infections, sponsored by Institute of Tropical Medicine, Belgium. Completed at 2 sites in Cambodia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-23.
Sponsored by Institute of Tropical Medicine, Belgium · Observational
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.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 4,203 is above the median of 160 across 931 observational studies indexed under Sepsis.
Browse Sepsis studies →Institute of Tropical Medicine, Belgium is the lead sponsor of 103 studies on the registry; 22 are open to participants now.
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Adult patients presenting with systemic inflammatory response syndrome.
Exclusion Criteria:
Patients for whom blood cultures grew Burkholderia pseudomallei
Other: Venous blood sampling (2 timepoints) (Phase A and B) · Other: Voided urine sampling (first sample) (Phase A) · Other: Voided urine sampling (second sample) (Phase A)
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) · Other: Voided urine sampling (first sample) (Phase A) · Other: Voided urine sampling (second sample) (Phase A)
Patients for whom blood cultures grew another pathogen
Other: Venous blood sampling (1 timepoint) (Phase A and B) · Other: Voided urine sampling (first sample) (Phase A)
8.5ml at Day 1 + 8.5ml at Day 5
8.5ml at Day 1
At least 20ml upon confirmation of being part of one of the 3 study groups
At least 20ml during routine hospital stay or routine follow-up visit
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.
Time frame: 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.
Time frame: 15 months
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Institute of Tropical Medicine, Belgium