Health TrialsbyHealthPanel

Rapid Analysis of Infections by Spectrometry of Exhaled Breath

ConditionsRespiratory Tract InfectionsHematologic Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

To quantify the diagnostic, prognostic and therapeutic value of spectrometric analysis of exhaled breath from hematological patients with respiratory infection.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18y at start of study

De novo, refractory or relapsed AML/MDS receiving intensive chemotherapy

De novo, refractory or relapsed ALL/T-lymphoblastic lymphoma receiving intensive chemotherapy

Aplastic anemia requiring ATG therapy

Disqualifiers

Hematological disease beyond the specified inclusion criteria

Signs of active respiratory infection

If previously enrolled: incomplete clearance of all signs of respiratory infection (both clinically, microbiologically and radiologically).

Trial population

Patients at high risk for opportunistic respiratory infections due to acute myeloid or lymphatic leukemia (undergoing intensive treatment), patients who underwent allogeneic stem cell transplantation, and patients receiving autologous stem cell transplantation

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Breath analysis

    Diagnostic test

    Spectrometric analysis of exhaled breath as screening for opportunistic respiratory infections

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Diagnostic accuracy

Accuracy (expressed as specificity/sensitivity/NPV/PPV) will be assessed as compared to the revised EORTC-MSG criteria, at moment of diagnosis by high-resolution CT and bronchoscopy

Time frame
Through study completion (i.e. 6 weeks after diagnosis)

Secondary outcomes

1

Diagnostic accuracy at 2 weeks as compared to the revised EORTC-MSG response criteria using high-resolution CT

Time frame
2 weeks after diagnosis
2

Diagnostic accuracy at 2 weeks as compared to the revised EORTC-MSG response criteria using high-resolution CT

Time frame
6 weeks after diagnosis

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

Source ClinicalTrials.gov
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