Ignite Creation Date:
2024-05-06 @ 8:04 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02668406
Status:
COMPLETED
Last Update Posted:
2018-10-23
First Post:
2016-01-26
Brief Title:
Study to Obtain Blood and Voided Urine Samples to Improve the Diagnosis of Melioidosis
Sponsor:
Institute of Tropical Medicine Belgium
Organization:
Institute of Tropical Medicine Belgium
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 casecontrol series of in-vitro diagnostics for melioidosis
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None