NCT02668406

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,203

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

October 23, 2018

Status Verified

October 1, 2018

Enrollment Period

2.7 years

First QC Date

January 26, 2016

Last Update Submit

October 22, 2018

Conditions

MelioidosisSystemic Inflammatory Response SyndromeSuspected or Confirmed Bloodstream Infections

Keywords

Blood infection, melioidosis, rapid diagnostic test

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

Burkholderia pseudomallei

Patients for whom blood cultures grew Burkholderia pseudomallei

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)

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

Another pathogen

Patients for whom blood cultures grew another pathogen

Other: Venous blood sampling (1 timepoint) (Phase A and B)Other: Voided urine sampling (first sample) (Phase A)

Interventions

Venous blood sampling (2 timepoints) (Phase A and B)OTHER

8.5ml at Day 1 + 8.5ml at Day 5

Burkholderia pseudomalleiNo pathogen
Venous blood sampling (1 timepoint) (Phase A and B)OTHER

8.5ml at Day 1

Another pathogen
Voided urine sampling (first sample) (Phase A)OTHER

At least 20ml upon confirmation of being part of one of the 3 study groups

Another pathogenBurkholderia pseudomalleiNo pathogen
Voided urine sampling (second sample) (Phase A)OTHER

At least 20ml during routine hospital stay or routine follow-up visit

Burkholderia pseudomalleiNo pathogen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients presenting with systemic inflammatory response syndrome.

You may qualify if:

  • Adult (\>18 years old)
  • Blood culture request by treating physician as part of standard care
  • Willing to give informed consent

You may not qualify if:

  • Refusal to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

HOPE Community Medical Center

Phnom Penh, Cambodia

Location

Sihanouk Hospital Center of HOPE (SHCH), Cambodia

Phnom Penh, Cambodia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood (phase A and B) and voided urine samples (only phase A)

MeSH Terms

Conditions

MelioidosisSystemic Inflammatory Response Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Burkholderia InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jan Jacobs, MD

    Institute of Tropical Medicine, Antwerp, Belgium

    STUDY DIRECTOR

  • Thong Phe, MD

    Sihanouk Hospital Center of HOPE (SHCH), Cambodia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2016

First Posted

January 29, 2016

Study Start

February 1, 2016

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

October 23, 2018

Record last verified: 2018-10

Locations

CA(2)