MelioidosisNCT02668406
Study to Obtain Blood and Voided Urine Samples to Improve the Diagnosis of Melioidosis
An observational study of Melioidosis and Systemic Inflammatory Response Syndrome, run by Institute of Tropical Medicine, Belgium at 2 sites in Cambodia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melioidosis, Systemic Inflammatory Response Syndrome, Suspected or Confirmed Bloodstream Infections
- What is being tested?
- Venous blood sampling (2 timepoints) (Phase A and B), Venous blood sampling (1 timepoint) (Phase A and B) and Voided urine sampling (first sample) (Phase A)
- How many people
- 4,203 participants
- Where
- 2 sitesCambodia
- Study dates
- Feb 2016to 30 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients presenting with systemic inflammatory response syndrome.
Who may be able to join
- Adult (>18 years old)
- Blood culture request by treating physician as part of standard care
- Willing to give informed consent
Who cannot join
- Refusal to give informed consent
Trial locations and contacts
2 sites in 1 country.
Cambodia2 sites
HOPE Community Medical Center
Phnom Penh
Sihanouk Hospital Center of HOPE (SHCH), Cambodia
Phnom Penh
About this study
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
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.
Read the 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:
- Patients for whom blood cultures grew Burkholderia pseudomallei
- Patients for whom blood cultures did not grow a pathogen, but have other body site grown with Burkholderia pseudomallei, or are suspected of melioidosis
- 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
- Melioidosis, Systemic Inflammatory Response Syndrome, Suspected or Confirmed Bloodstream Infections
- Being tested
- Venous blood sampling (2 timepoints) (Phase A and B), Venous blood sampling (1 timepoint) (Phase A and B), Voided urine sampling (first sample) (Phase A), Voided urine sampling (second sample) (Phase A)
- Keywords
- Blood infection, melioidosis, rapid diagnostic test
- Medical subject headings
- Melioidosis, Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous blood sampling (2 timepoints) (Phase A and B)Other
8.5ml at Day 1 + 8.5ml at Day 5
Venous blood sampling (1 timepoint) (Phase A and B)Other
8.5ml at Day 1
Voided urine sampling (first sample) (Phase A)Other
At least 20ml upon confirmation of being part of one of the 3 study groups
Voided urine sampling (second sample) (Phase A)Other
At least 20ml during routine hospital stay or routine follow-up visit
| Study group | Role | What they receive |
|---|---|---|
| Burkholderia pseudomallei | Patients for whom blood cultures grew Burkholderia pseudomallei Receives: 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 Receives: 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 Receives: Other: Venous blood sampling (1 timepoint) (Phase A and B); Other: Voided urine sampling (first sample) (Phase A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelioidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 4,203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- Sihanouk Hospital Center of HOPE, SRI International
- Responsible party
- Sponsor
- Investigators
- Jan Jacobs, MD, Study director, Institute of Tropical Medicine, Antwerp, BelgiumThong Phe, MD, Principal investigator, Sihanouk Hospital Center of HOPE (SHCH), Cambodia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668406
- Sponsor's protocol ID
- Melioidosis
- Status last verified
- Oct 2018
- First submitted
- 26 Jan 2016
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02668406
- Acronym / sponsor ID
- Melioidosis
- Conditions
- Melioidosis, Systemic Inflammatory Response Syndrome, Suspected or Confirmed Bloodstream Infections
- Keywords
- Blood infection, melioidosis, rapid diagnostic test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,203 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- Sihanouk Hospital Center of HOPE, SRI International
- Study start
- Feb 2016 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Patients for whom blood cultures grew Burkholderia pseudomallei
- Patients for whom blood cultures did not grow a pathogen, but have other body site grown with Burkholderia pseudomallei, or are suspected of melioidosis
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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)Patients for whom blood cultures grew Burkholderia pseudomallei |
| No pathogen | – | 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)Patients for whom blood cultures did not grow a pathogen, but have other body site grown with Burkholderia pseudomallei, or are suspected of melioidosis |
| Another pathogen | – | Other: Venous blood sampling (1 timepoint) (Phase A and B), Other: Voided urine sampling (first sample) (Phase A)Patients for whom blood cultures grew another pathogen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting with systemic inflammatory response syndrome.
Key inclusion criteria (3 listed)
- Adult (>18 years old)
- Blood culture request by treating physician as part of standard care
- Willing to give informed consent
Key exclusion criteria (1 listed)
- Refusal to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venous blood sampling (2 timepoints) (Phase A and B)8.5ml at Day 1 + 8.5ml at Day 5 | Other | Burkholderia pseudomallei, No pathogen |
| Venous blood sampling (1 timepoint) (Phase A and B)8.5ml at Day 1 | Other | Another pathogen |
| Voided urine sampling (first sample) (Phase A)At least 20ml upon confirmation of being part of one of the 3 study groups | Other | Another pathogen, Burkholderia pseudomallei, No pathogen |
| Voided urine sampling (second sample) (Phase A)At least 20ml during routine hospital stay or routine follow-up visit | Other | Burkholderia pseudomallei, No pathogen |
Primary outcome
Clinical reference panel (blood)
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.
Clinical reference panel (urine)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
Related trials for Melioidosis
RecruitingObservational study
Environment, Pathogens, and Host Interactions in Melioidosis
Melioidosis
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Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Jacobs, MD study director
Institute of Tropical Medicine, Antwerp, Belgium
Thong Phe, MD principal investigator
Sihanouk Hospital Center of HOPE (SHCH), Cambodia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melioidosis and Systemic Inflammatory Response Syndrome, run by Institute of Tropical Medicine, Belgium at 2 sites in Cambodia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Cambodia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical reference panel (blood) (time frame: 15 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.