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

Institute of Tropical Medicine, Belgium

Status: Completed

Conditions: Melioidosis; Systemic Inflammatory Response Syndrome; Suspected or Confirmed Bloodstream Infections

Treatments: Other: Voided urine sampling (second sample) (Phase A); Other: Venous blood sampling (2 timepoints) (Phase A and B); Other: Venous blood sampling (1 timepoint) (Phase A and B); Other: Voided urine sampling (first sample) (Phase A)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02668406

Melioidosis

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,203 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

4,203 participants in 3 patient groups

Burkholderia pseudomallei

Description:

Patients for whom blood cultures grew Burkholderia pseudomallei

Treatment:

Other: Voided urine sampling (first sample) (Phase A)

Other: Venous blood sampling (2 timepoints) (Phase A and B)

Other: Voided urine sampling (second sample) (Phase A)

No pathogen

Description:

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

Treatment:

Other: Voided urine sampling (first sample) (Phase A)

Other: Venous blood sampling (2 timepoints) (Phase A and B)

Other: Voided urine sampling (second sample) (Phase A)

Another pathogen

Description:

Patients for whom blood cultures grew another pathogen

Treatment:

Other: Voided urine sampling (first sample) (Phase A)

Other: Venous blood sampling (1 timepoint) (Phase A and B)