Venous blood sampling (2 timepoints) (Phase A and B)
Other8.5ml at Day 1 + 8.5ml at Day 5
NCT Number: NCT02668406
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
HOPE Community Medical Center, Phnom Penh, Cambodia
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
8.5ml at Day 1 + 8.5ml at Day 5
8.5ml at Day 1
At least 20ml upon confirmation of being part of one of the 3 study groups
At least 20ml during routine hospital stay or routine follow-up visit
Time frame: 15 months
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.
Time frame: 15 months
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.
Institute of Tropical Medicine, Belgium
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06089668
Bacterial Infections, Bacterial Infections and Mycoses
Vientiane, Laos
View Trial DetailsNCT05105035
Bacterial Infections, Bacterial Infections and Mycoses
Nai Muang, Thailand
View Trial DetailsNCT04299412
Acute Febrile Illness, Bacterial Infections
Darwin, Australia
View Trial DetailsNCT02089152
Bacterial Infections, Bacterial Infections and Mycoses
Ubon Ratchathani, Thailand
View Trial Details