Trial document




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  DRKS00004159

Trial Description

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Title

Investigation and validation of the diagnostic performance of new biomarker candidates for (I) the early detection of an infectious origin of neutropenic fever and for the prediction of (II) an infection of patients after apoplectic stroke and the progression of (III) a nosocomial infection or (IV) a community acquired pneunomia to a severe sepsis/ septic shock

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Trial Acronym

Lab-ALERTS

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URL of the Trial

http://www.uniklinikum-jena.de/alerts/ALERTS/LAB_ALERTS.html

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Brief Summary in Lay Language

Sepsis is a complex inflammation reaction to an infection. After cardiologic diseases, severe sepsis and septic shock represent the major cause of death in intensive care units. Every year about 150.000 people in Germany develop a sepsis, roughly the half of them dies from severe complications. Early identification of patients at high risk is of great importance. This study inspects biomarker candidates found in previous investigations to answer the question if they allow a better estimation of risk for complications than commonly used markers do.

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Brief Summary in Scientific Language

There is no clinical index or biomarker available, that early indicates a progression of a nosocomial infection or community acquired pneumonia to a severe sepsis/ septic shock or an infection in patients after stroke or that discriminates an infectious from an non-infectious cause of a neutropenic fever. Moreover, commonly used biomarkers predictive for a bacterial infection such as procalcitonin, IL-6 and IL-8 show insufficient diagnostic power. We need therefore new diagnostic biomarkers for an early detection of an infection and sepsis.
In previous studies, we found biomarker candidates of peptidic and metabolic origin that could indicate an infectious origin of neutropenic fever (Lab-ALERTS pilot study) or a systemic inflammation (SIRS/sepsis study Kiehntopf et al. Shock 36, 560-9, 2011) more reliable than conventional biomarkers. The diagnostic performance of the new markers will now be studied in different patient cohorts and compared to conventional biomakers.

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Organizational Data

  •   DRKS00004159
  •   2012/07/17
  •   [---]*
  •   yes
  •   Approved
  •   3139-05/11, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

  •   Förderkennzeichen BMBF  (01 E0 1002)
  •   DRKS00003166  (Diese Studie ist ein Teilprojekt unter der EK-Nummer 3139-05/11. This study is subproject within the EC-ID 3139-05/11.)
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Health Condition or Problem studied

  •   A41.9 -  Septicaemia, unspecified
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Interventions/Observational Groups

  •   Asservation of blood plasma from remaining routine material after routine diagnositcs during hospital stay. Determination of new biomarker candidates and conventional biomarkers at different time points (onset of infection and two following days). Calculation and comparison of diagnostic performances.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

Improved receiver operating curve (ROC) values of novel molecular biomarkers
and their combinations compared to conventional biomarkers (PCT, CRP, IL-6)
for the prediction of:
I) Infectious fever origin in patients with neutropenic fever
II) Infections in patients after apoplectic stroke
III) Progression of a nosocomial infection to severe sepsis / septic shock
IV) Progression of a community acquired pneumonia to severe pneumonia / septic pneumonia

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Secondary Outcome

Identification of peptides/ proteins underlying discriminatory peaks from the Lab-ALERTS-Pilot study;
Development of robust assays suitable for routine procedures;
Build up a biobank by collecting plasma samples from patients with neutropenic fever or nosocomial infections

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/07/25
  •   4516
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

I) patients with hemato-malignancies who are expected to develop neutropenia during/ after chemotherapy, age ≥ 18 (297 patients, recruitment in this study);
II) Ischemic stroke in the territory of A. cerebri media (or beyond), age ≥ 18, NIH stroke score (NIHSS) > 8 (136 patients, recruitment in PRED-SEP study, DRKS00003392);
III) hospital stay of >48 hours and nosocomial infection (4219 patients, recruitment in this study);
IV) patienten with community acquired pneumonia (400 patients, recruitment in PROGRESS-CAP study)

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Exclusion Criteria

I) none;
II) infection present upon hospital atmittance; anamnesis of a previous stroke; cardiac arrhythmia;
III) none;
IV) none

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Addresses

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    • Institut für Klinische Chemie und Laboratoriumsdiagnostik / Integriertes Forschungs- und Behandlungszentrum Sepsis und Sepsisfolgen
    • Mr.  Dr. med. Dr. rer. nat.  Michael  Kiehntopf 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
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    • Institut für Klinische Chemie und Laboratoriumsdiagnostik / Integriertes Forschungs- und Behandlungszentrum Sepsis und Sepsisfolgen
    • Mr.  Dr. med. Dr. rer. nat.  Michael  Kiehntopf 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
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    • Institut für Klinische Chemie und Laboratoriumsdiagnostik / Integriertes Forschungs- und Behandlungszentrum Sepsis und Sepsisfolgen
    • Mr.  Dr. med. Dr. rer. nat.  Michael  Kiehntopf 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.