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

NCT01114165

Last updated date
Study Location
University Hospital Muenster
Muenster, North Rhine-Westphalia, 48149, Germany
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hematologic Diseases, Neutropenia, Febrile Neutropenia, Sepsis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Hematologic Diseases, Neutropenia, Febrile Neutropenia, SepsisValue of the LightCycler® SeptiFast Test MGRADE for the Pathogen Detection in Neutropenic Hematological Patients
NCT01114165
  1. Muenster, North Rhine-Westphalia
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Value of the LightCycler® SeptiFast Test MGRADE for the Pathogen Detection in Neutropenic Hematological Patients
Official Title  ICMJE Value of the LightCycler® SeptiFast Test MGRADE for the Pathogen Detection in Neutropenic Hematological Patients
Brief 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 hematological patients with suspected infection or sepsis.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Hematologic Diseases
  • Neutropenia
  • Febrile Neutropenia
  • Sepsis
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: SeptiFast Test
    Pathogen detection by SeptiFast Test as an adjunct to traditional microbiological assessments including blood culture
    Intervention: Other: Detection of microbial DNA in blood by SeptiFast Test
  • Active Comparator: Only Conventional Diagnostics
    Pathogen detection only by conventional microbiological assessments, e.g. blood culture
    Intervention: Other: Pathogen detection by blood culture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 30, 2010)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01114165
Other Study ID Numbers  ICMJE UKM-SF-042010
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital Muenster
Study Sponsor  ICMJE University Hospital Muenster
Collaborators  ICMJE
  • Pfizer
  • Hoffmann-La Roche
Investigators  ICMJE
Principal Investigator:Karsten Becker, MD, ProfessorInstitute of Medical Microbiology, University Hospital Muenster
PRS Account University Hospital Muenster
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP