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

This study has been completed.
Sponsor:
Collaborators:
Pfizer
Hoffmann-La Roche
Information provided by (Responsible Party):
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT01114165
First received: April 23, 2010
Last updated: December 4, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Hematologic Diseases
Neutropenia
Febrile Neutropenia
Sepsis
 Other: Detection of microbial DNA in blood by SeptiFast Test
Other: Pathogen detection by blood culture
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Value of the LightCycler® SeptiFast Test MGRADE for the Pathogen Detection in Neutropenic Hematological Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • The number of changes in empirical antimicrobial therapy [ Time Frame: up to the end of study participation ] [ Designated as safety issue: No ]
  • Time to the change to the targeted antimicrobial therapy [ Time Frame: at time point of change to the targeted antimicrobial therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: at day 1 and 72h after study inclusion ] [ Designated as safety issue: No ]
  • Number of patients having a change to a more appropriate antimicrobial (evaluated retrospectively by susceptibility) [ Time Frame: up to the end of study participation ] [ Designated as safety issue: No ]
  • Time to identification of a potential pathogen [ Time Frame: at time point of identification of a potential pathogen ] [ Designated as safety issue: No ]
  • Time to change antimicrobial to a more appropriate antimicrobial [ Time Frame: at time point of change to a more appropriate antimicrobial ] [ Designated as safety issue: No ]
  • Duration (in days) of antimicrobials [ Time Frame: up to the end of study participation ] [ Designated as safety issue: No ]
  • Change in condition severity (clinical parameters) [ Time Frame: daily ] [ Designated as safety issue: No ]
  • Days in intensive care unit (ICU) [ Time Frame: at the end of study participation ] [ Designated as safety issue: No ]
  • Ventilation duration in ICU (hours) [ Time Frame: at the end of study participation ] [ Designated as safety issue: No ]
  • Days in hospital (from study inclusion) [ Time Frame: at the end of study participation ] [ Designated as safety issue: No ]
  • All-cause death [ Time Frame: at the end of study participation ] [ Designated as safety issue: No ]
  • Treatment costs [ Time Frame: up to the end of study participation ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: May 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SeptiFast Test
Pathogen detection by SeptiFast Test as an adjunct to traditional microbiological assessments including blood culture
 Other: Detection of microbial DNA in blood by SeptiFast Test
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
Active Comparator: Only Conventional Diagnostics
Pathogen detection only by conventional microbiological assessments, e.g. blood culture
 Other: Pathogen detection by blood culture
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient with hematological disease and neutropenia < 500/µl (or < 1000/µl, if criterion 5A is fulfilled)
  2. Known or acute infection, or suspected infection, or sepsis, which clinically indicates investigation by blood culture
  3. Time-frame after diagnosis or suspicion of infection or sepsis: < 72 hours
  4. Species causing infection not known before inclusion

  5. Patient fulfils criterion A or/and B

    A. Indication for an initiation of antimicrobial therapy in patients with febrile neutropenia

    • 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)

    B. 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
  6. Patient is able to provide written informed consent

Exclusion Criteria:

  1. Moribund patients with survival expectation < 24h
  2. Younger than 18 years
  3. Patient is not able to provide informed consent
  4. Patients not suitable for study participation in the opinion of investigator
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01114165

Locations
Germany
University Hospital Muenster
Muenster, North Rhine-Westphalia, Germany, 48149
Sponsors and Collaborators
University Hospital Muenster
Pfizer
Hoffmann-La Roche
Investigators
Principal Investigator: Karsten Becker, MD, Professor Institute of Medical Microbiology, University Hospital Muenster
  More Information

No publications provided

Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT01114165     History of Changes
Other Study ID Numbers: UKM-SF-042010
Study First Received: April 23, 2010
Last Updated: December 4, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Muenster:
Neutropenia
Febrile Neutropenia
Sepsis
Polymerase Chain Reaction

Additional relevant MeSH terms:
Fever
Hematologic Diseases
Neutropenia
Sepsis
Body Temperature Changes
Signs and Symptoms
Agranulocytosis
 Leukopenia
Leukocyte Disorders
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013