Status Acronym ISRCTN EudraCT NCT (clinicaltrials.gov) DRKS
Active ISI

Improving Diagnosis of Severe Infections in Immunocompromised Patients (ISI)

Purpose / Objectives

Primary Outcome

  • Creation of a tissue bank containing samples of patients with severe infections and appropriate controls
  • Development of new methods for the diagnosis of severe infections
  • Development of methods to assess the risk for infections
  • Development of methods to predict and evaluate the course and outcome of a disease
  • Identification of unknown pathogens or pathogens of unknown pathogenicity

Secondary Outcomes

none

Diagnosis

  • COVID-19 infection
  • Infectiology
  • Infectious diseases in Hematology and Oncology
  • Infectious diseases: Others

Target population

Disease stage

na

Age

18-99

Inclusion criteria

Patients with infections

At least one of the following conditions

  • Inpatient on intensive care unit
  • Immunosuppression, e.g. due to
  • Continuous steroid treatment
  • Inherited immune defect
  • Malignancy
  • HIV / AIDS
  • Previous chemotherapy
  • Transplantation
  • Probable or proven invasive fungal infection
  • Probable or proven disseminated viral infection or reactivation


Patients and healthy volunteers in the control group

  • Diagnosis of an infection which is not subject to the study
    OR
    Patients without acute infection, but colonization with an pathogen which is subject to the study
    OR
    Exclusion of an infection (healthy volunteers)

Exclusion criteria

Patients with infections

  • Patients with a documented infection of multiple concurrent pathogens
  • Patients with fever due to an uncontrolled underlying disease or drug intolerance

Study design

  • Single center

Intervention

none

Documents (password protected)

Networks

Responsibilities in overall study

Sponsor

Infektiologie II

(National) Coordinating Investigator

Univ.-Prof. Dr. med. Oliver A. Cornely