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

Systemic Inflammatory Response Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02668406
• Other study ID #: Melioidosis
• Status: Completed
• Start date: February 2016
• Est. completion date: September 30, 2018

Study information

• Verified date: October 2018
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4203
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melioidosis
• Suspected or Confirmed Bloodstream Infections
• Systemic Inflammatory Response Syndrome

Intervention

Other:
• Venous blood sampling (2 timepoints) (Phase A and B)
8.5ml at Day 1 + 8.5ml at Day 5
• Venous blood sampling (1 timepoint) (Phase A and B)
8.5ml at Day 1
• Voided urine sampling (first sample) (Phase A)
At least 20ml upon confirmation of being part of one of the 3 study groups
• Voided urine sampling (second sample) (Phase A)
At least 20ml during routine hospital stay or routine follow-up visit

Locations

Country	Name	City	State
Cambodia	HOPE Community Medical Center	Phnom Penh
Cambodia	Sihanouk Hospital Center of HOPE (SHCH), Cambodia	Phnom Penh

Sponsors (3)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium	Sihanouk Hospital Center of HOPE, SRI International

Country where clinical trial is conducted

Cambodia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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