ClinicalTrials.gg
RecruitingNCT03299608RAISEUpdated Jul 3, 2024

Rapid Analysis of Infections by Spectrometry of Exhaled Breath

An observational study in Respiratory Tract Infections and Hematologic Diseases, sponsored by Universitaire Ziekenhuizen KU Leuven. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Started Jun 2019; still recruiting 7 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
246
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 26 studies in Respiratory Tract Infections with a site in Belgium — 5 open to participants now, 6 under way, 4 of them phase 3. Respiratory Tract Infections · Belgium.

Started
2019
the only one that year
Observational
9 of 26
1 open now
Registered
13th of 26
by date

Among the 26 studies in Respiratory Tract Infections with a site in Belgium, this one is the only one that started in 2019, is one of 9 observational ones, and was the 13th registered.

Respiratory Tract Infections

751 studies on the registry are indexed under Respiratory Tract Infections; 114 are open to participants now.

Browse Respiratory Tract Infections studies →

Open to participants now

5 of the 26 studies in Respiratory Tract Infections with a site in Belgium are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in Belgium have not opened yet or have stopped. Only those recruiting at a site in Belgium →

Who these studies take

Of the 73 Respiratory Tract Infections studies recruiting now, 34 (47%) set no upper age limit and 31 (42%) stop at 75 or younger; 34 take children under 18; 25 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 26 studies in Respiratory Tract Infections with a site in Belgium, or all of them as a file.
02

Study summary

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

03

Conditions studied

  • Respiratory Tract Infections
  • Hematologic Diseases
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study 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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 18y at start of study
  • One of the following diagnoses:

    • De novo, or relapsed AML/MDS receiving intensive chemotherapy
    • De novo, refractory or relapsed ALL/T-lymphoblastic lymphoma receiving intensive chemotherapy
    • Aplastic anemia requiring ATG therapy
    • Any patient admitted for either hematopoietic stem cell transplantation. Transplantation may not have been performed at time of enrolment.
    • Any patient admitted with allogeneic hematopoietic stem cell transplantation within the last year, or planned during this admission.
  • Written obtained from the patient

Exclusion criteria

Exclusion Criteria:

  • 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).
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
246 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testBreath analysis

    Spectrometric analysis of exhaled breath as screening for opportunistic respiratory infections

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2019 (actual). Primary completion is estimated for Jun 2025, 72 months after the start.

Of 66 non-industry observational studies under Respiratory Tract Infections, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 72 months is above that.

Counting every sponsor, half of 85 studies reached it within 18 months; a quarter within 8 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 15, 2017
First posted
Oct 3, 2017
StartActual
Jun 21, 2019
Primary completionEst.
Jun 2025
CompletionEst.
Sep 2025
Last update
Jul 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03299608
Responsible party
Sponsor
First posted
Oct 3, 2017
Start date
Jun 21, 2019
Primary completion
Jun 2025 (estimated)
Completion
Sep 2025 (estimated)
Last update
Jul 3, 2024

Study contacts

Toine Mercier, MD
Contact
toine.mercier@uzleuven.be
+32 16 34 00 04

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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