Study to Obtain Blood and Voided Urine Samples to Improve the Diagnosis of Melioidosis
NCT ID: NCT02668406
Last Updated: 2018-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
4203 participants
OBSERVATIONAL
2016-02-29
2018-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Observational Study to Evaluate Clinical Characteristics of Adult Patients With Suspected or Confirmed Melioidosis
NCT06089668
Miltefosine/Paromomycin Phase III Trial for Treatment of Primary Visceral Leishmaniasis (VL) Patients in Eastern Africa
NCT03129646
Investigating Vector-Borne Determinants of Aedes Transmitted Arboviral Infections in Cambodia: An Observational Longitudinal Cohort Study in Children
NCT03534245
Prophylaxis of Visceral Leishmaniasis Relapses in HIV Co-infected Patients With Pentamidine: a Cohort Study
NCT01360762
Febrile Disease Landscape in Cambodia Via Metagenomic Pathogen Sequencing
NCT04034264
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Burkholderia pseudomallei
Patients for whom blood cultures grew Burkholderia pseudomallei
Venous blood sampling (2 timepoints) (Phase A and B)
8.5ml at Day 1 + 8.5ml at Day 5
Voided urine sampling (first sample) (Phase A)
At least 20ml upon confirmation of being part of one of the 3 study groups
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
Venous blood sampling (2 timepoints) (Phase A and B)
8.5ml at Day 1 + 8.5ml at Day 5
Voided urine sampling (first sample) (Phase A)
At least 20ml upon confirmation of being part of one of the 3 study groups
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
Venous blood sampling (1 timepoint) (Phase A and B)
8.5ml at Day 1
Voided urine sampling (first sample) (Phase A)
At least 20ml upon confirmation of being part of one of the 3 study groups
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Venous blood sampling (2 timepoints) (Phase A and B)
8.5ml at Day 1 + 8.5ml at Day 5
Venous blood sampling (1 timepoint) (Phase A and B)
8.5ml at Day 1
Voided urine sampling (first sample) (Phase A)
At least 20ml upon confirmation of being part of one of the 3 study groups
Voided urine sampling (second sample) (Phase A)
At least 20ml during routine hospital stay or routine follow-up visit
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Blood culture request by treating physician as part of standard care
* Willing to give informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sihanouk Hospital Center of HOPE
OTHER
SRI International
INDUSTRY
Institute of Tropical Medicine, Belgium
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jan Jacobs, MD
Role: STUDY_DIRECTOR
Institute of Tropical Medicine, Antwerp, Belgium
Thong Phe, MD
Role: PRINCIPAL_INVESTIGATOR
Sihanouk Hospital Center of HOPE (SHCH), Cambodia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
HOPE Community Medical Center
Phnom Penh, , Cambodia
Sihanouk Hospital Center of HOPE (SHCH), Cambodia
Phnom Penh, , Cambodia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Melioidosis
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.