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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief Summary: Clinical samples (blood and voided urine) 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 Summary:

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). Expected number of cases is 3600.

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, 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 (n = 25)
  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 (n = 50)
  3. Patients for whom blood cultures grew with another pathogen ( n = 50)

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 and validation (proof of concept) and (case/control series) 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.


Sponsor: Institute of Tropical Medicine, Belgium

Current Primary Outcome:

  • 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.
  • 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.


Original Primary Outcome: Clinical reference panel [ 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.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Institute of Tropical Medicine, Belgium

Dates:
Date Received: January 26, 2016
Date Started: February 2016
Date Completion: May 2017
Last Updated: February 8, 2017
Last Verified: February 2017