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

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 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 Overview

• Status: Completed
• Conditions: Systemic Inflammatory Response Syndrome; Melioidosis; Suspected or Confirmed Bloodstream Infections
• Intervention / Treatment: 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); Other: Venous blood sampling (1 timepoint) (Phase A and B)

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.

• Study Type: Observational
• Enrollment (Actual): 4203

Contacts and Locations

Study Locations

• Cambodia
  • Phnom Penh, Cambodia
    • Sihanouk Hospital Center of HOPE (SHCH), Cambodia
  • Phnom Penh, Cambodia
    • HOPE Community Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients presenting with systemic inflammatory response syndrome.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Burkholderia pseudomallei; Patients for whom blood cultures grew Burkholderia pseudomallei	Other: Venous blood sampling (2 timepoints) (Phase A and B); 8.5ml at Day 1 + 8.5ml at Day 5; Other: Voided urine sampling (first sample) (Phase A); At least 20ml upon confirmation of being part of one of the 3 study groups; Other: Voided urine sampling (second sample) (Phase A); At least 20ml during routine hospital stay or routine follow-up visit
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	Other: Venous blood sampling (2 timepoints) (Phase A and B); 8.5ml at Day 1 + 8.5ml at Day 5; Other: Voided urine sampling (first sample) (Phase A); At least 20ml upon confirmation of being part of one of the 3 study groups; Other: Voided urine sampling (second sample) (Phase A); At least 20ml during routine hospital stay or routine follow-up visit
Another pathogen; Patients for whom blood cultures grew another pathogen	Other: Voided urine sampling (first sample) (Phase A); At least 20ml upon confirmation of being part of one of the 3 study groups; Other: Venous blood sampling (1 timepoint) (Phase A and B); 8.5ml at Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Institute of Tropical Medicine, Belgium
• Collaborators: SRI International; Sihanouk Hospital Center of HOPE
• Investigators: Study Director: Jan Jacobs, MD, Institute of Tropical Medicine, Antwerp, Belgium; Principal Investigator: Thong Phe, MD, Sihanouk Hospital Center of HOPE (SHCH), Cambodia

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: January 26, 2016
• First Submitted That Met QC Criteria: January 26, 2016
• First Posted (Estimate): January 29, 2016

Study Record Updates

• Last Update Posted (Actual): October 23, 2018
• Last Update Submitted That Met QC Criteria: October 22, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Blood infection, melioidosis, rapid diagnostic test
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Shock; Burkholderia Infections; Sepsis; Systemic Inflammatory Response Syndrome; Melioidosis
• Other Study ID Numbers: Melioidosis