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

NCT ID: NCT01114165

Last Updated: 2012-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2012-09-30

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.

Conditions

Hematologic Diseases; Neutropenia; Febrile Neutropenia; Sepsis

Keywords

Neutropenia; Febrile Neutropenia; Sepsis; Polymerase Chain Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

SeptiFast Test

Pathogen detection by SeptiFast Test as an adjunct to traditional microbiological assessments including blood culture

Group Type: EXPERIMENTAL

Detection of microbial DNA in blood by SeptiFast Test

Intervention Type: OTHER

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

Only Conventional Diagnostics

Pathogen detection only by conventional microbiological assessments, e.g. blood culture

Group Type: ACTIVE_COMPARATOR

Pathogen detection by blood culture

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

University Hospital Muenster

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karsten Becker, MD, Professor

Role: PRINCIPAL_INVESTIGATOR

Institute of Medical Microbiology, University Hospital Muenster

Locations

University Hospital Muenster

Münster, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

UKM-SF-042010

Identifier Type: -

Identifier Source: org_study_id