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Hematologic DiseasesPhase 4NCT01114165

Value of the LightCycler® SeptiFast Test MGRADE for the Pathogen Detection in Neutropenic Hematological Patients

A Phase 4 study testing Detection of microbial DNA in blood by SeptiFast Test and Pathogen detection by blood culture in people with Hematologic Diseases and Neutropenia, run by University Hospital Muenster at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The overall objective of this study is to assess the clinical value of the SeptiFast Test as an adjunct to traditional microbiological, clinical, and other laboratory assessments in early detection and identification of a potential pathogen and therefore early targeted antimicrobial management of neutropenic… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Detection of microbial DNA in blood by SeptiFast Test and Pathogen detection by blood culture
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteGermany
Study dates
May 2010to Sep 2012
Phase
Phase 4
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

Who may be able to join

  • Patient with hematological disease and neutropenia < 500/µl (or < 1000/µl, if criterion 5A is fulfilled)
  • Known or acute infection, or suspected infection, or sepsis, which clinically indicates investigation by blood culture
  • Time-frame after diagnosis or suspicion of infection or sepsis: < 72 hours
  • Species causing infection not known before inclusion
  • Patient fulfils criterion A or/and B
  • Indication for an initiation of antimicrobial therapy in patients with febrile neutropenia
Show all 14Show fewer
  • Neutropenia <500/µl or <1000/µl if decline to <500/µl is expected in the next 48h.
  • Single (oral) temperature of ≥ 38.3°C, or temperature ≥ 38.0°C lasting for at least 1h or measured twice within 12h.
  • No evidence of non-infectious cause of fever (blood products, drugs reactions, etc)
  • At least two of the following criteria:
  • Temperature >38°C or <36°C
  • Heart rate >90 beats/minute
  • Respiratory rate >20 breaths/minute or PaCO2 <32 mmHg / 4,3 kPa
  • Patient is able to provide written informed consent

Who cannot join

  • Moribund patients with survival expectation < 24h
  • Younger than 18 years
  • Patient is not able to provide informed consent
  • Patients not suitable for study participation in the opinion of investigator

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital Muenster

    Münster, North Rhine-Westphalia, 48149

Other trials in Germany

About this study

The overall objective of this study is to assess the clinical value of the SeptiFast Test as an adjunct to traditional microbiological, clinical, and other laboratory assessments in early detection and identification of a potential pathogen and therefore early targeted antimicrobial management of neutropenic hematological patients with suspected infection or sepsis.

Read the detailed description

Infections, including sepsis, continue to be a major cause of morbidity and mortality in patients with hematologic diseases. Early diagnosis of infection, rapid identification of the causative pathogen(s), and prompt initiation of appropriate antimicrobial treatment (the first 24 hours are most critical) all have a major impact on mortality.

The LightCycler® SeptiFast Test MGRADE (SeptiFast Test) is an in vitro nucleic acid amplification test for the direct detection and identification of DNA from bacterial and fungal microorganisms in human EDTA whole blood. The SeptiFast test can detect nucleic acids from the most common pathogens (approximately 90%) responsible for hospital-associated bacteremia. The test is used in conjunction with the patient's clinical presentation and established microbiological assays and other laboratory markers as an aid in antimicrobial treatment decision making for patients with suspected sepsis and other bloodstream infections.

This is a randomized prospective study of the use of the SeptiFast Test as an adjunct to traditional management of neutropenic haematological patients suspected of having infection or sepsis. The study will be performed in a two-armed manner. The blood sample for the SeptiFast Test will be collected from all included patients. However, analysis of the SeptiFast Test in the control group will only be performed at a later point in time; thus, in the control group results will not become available until the end of the study and, therefore, cannot be used for guiding clinical decisions.

Patients complete the study when the episode of infection or sepsis resolves, or the patient is discharged from a hospital, or the patient died.

Being tested
Detection of microbial DNA in blood by SeptiFast Test, Pathogen detection by blood culture
Keywords
Neutropenia, Febrile Neutropenia, Sepsis, Polymerase Chain Reaction
Medical subject headings
Hematologic Diseases, Neutropenia, Febrile Neutropenia, Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Detection of microbial DNA in blood by SeptiFast TestOther

    The SeptiFast Test is a multiplex polymerase chain reaction (PCR) test that can detect nucleic acids from the most common pathogens (approximately 90%) responsible for hospital-associated bacteremia and takes approx. 6 hours to perform

  • Pathogen detection by blood cultureOther

    Blood culture is a conventional microbiological method of pathogen detection. Results from blood cultures are usually not available until 24 to 72 hours after sampling

Study groups in NCT01114165
Study groupRoleWhat they receive
SeptiFast TestExperimentalPathogen detection by SeptiFast Test as an adjunct to traditional microbiological assessments including blood culture
Receives: Other: Detection of microbial DNA in blood by SeptiFast Test
Only Conventional DiagnosticsActive comparatorPathogen detection only by conventional microbiological assessments, e.g. blood culture
Receives: Other: Pathogen detection by blood culture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of changes in empirical antimicrobial therapy

    Measured: up to the end of study participation

  2. Time to the change to the targeted antimicrobial therapy

    Measured: at time point of change to the targeted antimicrobial therapy

Secondary outcomes (11)

  1. The number of patients with a potential pathogen identified by the SeptiFast Test, compared with the number of patients likely to have bloodstream infection or sepsis, as determined by a constructed clinical comparator

    Measured: at day 1 and 72h after study inclusion

  2. Number of patients having a change to a more appropriate antimicrobial (evaluated retrospectively by susceptibility)

    Measured: up to the end of study participation

  3. Time to identification of a potential pathogen

    Measured: at time point of identification of a potential pathogen

  4. Time to change antimicrobial to a more appropriate antimicrobial

    Measured: at time point of change to a more appropriate antimicrobial

  5. Duration (in days) of antimicrobials

    Measured: up to the end of study participation

  6. Change in condition severity (clinical parameters)

    Measured: daily

  7. Days in intensive care unit (ICU)

    Measured: at the end of study participation

  8. Ventilation duration in ICU (hours)

    Measured: at the end of study participation

  9. Days in hospital (from study inclusion)

    Measured: at the end of study participation

  10. All-cause death

    Measured: at the end of study participation

  11. Treatment costs

    Measured: up to the end of study participation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionSep 2012
  4. Study completionSep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01114165
Sponsor's protocol ID
UKM-SF-042010
Status last verified
Nov 2012
First submitted
23 Apr 2010
Last updated
5 Dec 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Detection of microbial DNA in blood by SeptiFast Test and Pathogen detection by blood culture in people with Hematologic Diseases and Neutropenia, run by University Hospital Muenster at 1 site in Germany.

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 14 inclusion and 4 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 5 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The number of changes in empirical antimicrobial therapy (time frame: up to the end of study participation). 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?

On the ClinicalTrials.gov record for NCT01114165.

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 5 Dec 2012.

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