As an infrastructure at the German Center for Infection Research (DZIF), the Clinical Trial Unit tracks DZIF's study activities in the “Healex Site Management System (SMS)”. Studies are sorted by indication and are continuously updated.

The study register has recently been expanded to include the category “COVID-19”. For the first time, not only DZIF study activities are presented here: In order to provide a comprehensive overview in the current pandemic situation of planned and already active COVID-19 studies in Germany, the Clinical Trial Unit is cooperating with researchers from various German Centers for Health Research and other networks.

For researchers: If your study is not yet included in our portal, please contact the project management of the Clinical Trial Unit (angela.steinbach@uk-koeln.de or vassiliki.dimitriou@uk-koeln.de).

ISI - Improving Diagnosis of Severe Infections in Immunocompromised Patients

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS
ISI

Improving Diagnosis of Severe Infections in Immunocompromised Patients (ISI)

Status: Active

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

Patient attributes

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

Trial design

  • Single center

Intervention

none

Documents (password protected)

Responsibilities in overall trial

Infektiologie II

National Coordinating Investigator

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