Clinical trial NCT02668406: Study to Obtain Blood and Voided Urine Samples to Improve the Diagnosis of Melioidosis
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melioidosis
Systemic Inflammatory Response Syndrome
Suspected or Confirmed Bloodstream Infections
Keywords: Blood infection, melioidosis, rapid diagnostic test
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: Sihanouk Hospital Center of HOPE
name: SRI International
First posted: 2016-01-29
Enrollment: 4203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients presenting with systemic inflammatory response syndrome.

Brief 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.

Detailed description: 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:

1. Patients for whom blood cultures grew Burkholderia pseudomallei
2. Patients for whom blood cultures did not grow a pathogen, but have other body site grown with Burkholderia pseudomallei, or are suspected of melioidosis
3. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical reference panel (blood)
timeFrame: 15 months
measure: Clinical reference panel (urine)
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phnom Penh
country: Cambodia
facility: HOPE Community Medical Center
city: Phnom Penh
country: Cambodia
facility: Sihanouk Hospital Center of HOPE (SHCH), Cambodia
Study officials:
affiliation: Institute of Tropical Medicine, Antwerp, Belgium
name: Jan Jacobs, MD
role: STUDY_DIRECTOR
affiliation: Sihanouk Hospital Center of HOPE (SHCH), Cambodia
name: Thong Phe, MD
role: PRINCIPAL_INVESTIGATOR
References: