Invasive AspergillosisNCT02773342
An Evaluation of Sequential Computed Tomography of the Chest in Management of Invasive Pulmonal Aspergillosis in Neutropenic Patients With Haematological Malignancies
An observational study of Invasive Aspergillosis, run by University Hospital of Cologne at 1 site in Germany.
Trial summary
The incidence of invasive pulmonary aspergillosis (IPA) is increasing in all parts of the world. Despite introduction of new antifungal agents for prophylaxis and treatment of IPA in the last decade, the outcome of patients with IPA is still unsatisfactory and needs improvement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Aspergillosis
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2013to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Immunocompromised patients with proven or probable invasive aspergillosis received caspofungin once daily as an intravenous infusion
Who may be able to join
- At least two subsequent, evaluable CT examinations of the chest performed while on study
Who cannot join
- Diagnosis of underlying disease other than haematological malignancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Cologne
Cologne, North Rhine-Westphalia, 50924
Jörg-Janne Vehreschild, MD, +0049 (0)221 478-6494, janne.vehreschild@ctuc.de
Oliver Cornely, MD, 0049 (0)221 478-6494, oliver.cornely@ctuc.de
About this study
The incidence of invasive pulmonary aspergillosis (IPA) is increasing in all parts of the world. Despite introduction of new antifungal agents for prophylaxis and treatment of IPA in the last decade, the outcome of patients with IPA is still unsatisfactory and needs improvement. Particularly, recent developments in diagnostic imaging, including introduction of high-resolution computed tomography (CT) into standard procedures, made a place for improvement of diagnosis of IPA.
Computed tomography of the chest is the optimal, recommended imaging procedure for diagnosis of pneumonia in febrile neutropenic patients and it is significantly superior to conventional chest X-ray. However, the method is associated with some difficulties mostly due to the broad spectrum of pathological findings in patients with IPA and their evolution over time. This has been described in retrospective studies on relatively small groups of patients. Prospective studies on larger populations are still missing, as well as studies on combination of different diagnostic modalities e.g. diagnostic imaging and microbiology.
Read more
We recently published the results of the clinical trial: "A Phase II Dose Escalation Study of Caspofungin in Patients with Invasive Aspergillosis" which used caspofungin doses of 70 to 200 mg daily for the first line treatment of IPA. The maximum tolerated dose was not reached, but response rates were impressive with complete plus partial responses accounting for 54.3% and overall mortality at 12-week follow-up as low as 28.3%. There was a tendency towards higher doses yielding higher response rates.
For the majority of these patients we obtained serial chest CT. So, for the first time a patient population is at hand, in which the kinetics of infiltrates over time can be described.
The main objective is to describe the pathological findings in chest CT performed sequentially in IPA patients while receiving effective antifungal therapy. The specific objectives are:
- Characteristics of pathological findings in sequential chest CTs
- To describe the pathological findings (e.g. halo sign, air crescent sign and air consolidation) in sequential high resolution computed tomogrphy (HRCT) examinations
- To calculate the incidence of individual pathological findings in sequential CT examinations
- To calculate a total volume of fungal infiltrates in sequential CT examinations
- Correlation of pathological findings in sequential CT with corresponding white blood count (WBC) and absolute neutrophil count (ANC)
- To correlate the appearance or disappearance of individual pathological findings with WBC and ANC
- To correlate the volume of fungal infiltrates in sequential CT examinations with WBC and absolute neutrophil count
- Correlation of pathological findings in sequential CT with the serum galactomannan index
- To correlate the appearance or disappearance of individual pathological findings with the serum galactomannan index
- To correlate the volume of fungal infiltrates in sequential HRCT examinations with the serum galactomannan index
- Correlation of pathological findings in sequential HRCT with outcome of IFI
- To correlate the appearance or disappearance of individual pathological findings with outcome of IFI
- To correlate the volume of fungal infiltrates in sequential HRCT examinations with outcome of IFI
- Conditions
- Invasive Aspergillosis
- Keywords
- Invasive Pulmonal Aspergillosis, Neutropenic Patients, Haematological Malignancies, Chest Computed Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pathological findings in chest CT | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (%)
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startJun 2013
- Primary completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive AspergillosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Oliver A. Cornely, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773342
- Sponsor's protocol ID
- CT_IPA_NEUT
- Status last verified
- May 2016
- First submitted
- 6 May 2013
- Last updated
- 16 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Sequential Computed Tomography of the Chest in Management of Invasive Pulmonal Aspergillosis in Neutropenic Patients With Haematological Malignancies
- ClinicalTrials.gov ID
- NCT02773342
- Acronym / sponsor ID
- CT_IPA_NEUT
- Conditions
- Invasive Aspergillosis
- Keywords
- Invasive Pulmonal Aspergillosis, Neutropenic Patients, Haematological Malignancies, Chest Computed Tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Apr 2016 (actual)
- First posted
- 16 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The incidence of invasive pulmonary aspergillosis (IPA) is increasing in all parts of the world. Despite introduction of new antifungal agents for prophylaxis and treatment of IPA in the last decade, the outcome of patients with IPA is still unsatisfactory and needs improvement. Particularly, recent developments in diagnostic imaging, including introduction of high-resolution computed tomography (CT) into standard procedures, made a place for improvement of diagnosis of IPA.
Computed tomography of the chest is the optimal, recommended imaging procedure for diagnosis of pneumonia in febrile neutropenic patients and it is significantly superior to conventional chest X-ray. However, the method is associated with some difficulties mostly due to the broad spectrum of pathological findings in patients with IPA and their evolution over time. This has been described in retrospective studies on relatively small groups of patients. Prospective studies on larger populations are still missing, as well as studies on combination of different diagnostic modalities e.g. diagnostic imaging and microbiology.
We recently published the results of the clinical trial: "A Phase II Dose Escalation Study of Caspofungin in Patients with Invasive Aspergillosis" which used caspofungin doses of 70 to 200 mg daily for the first line treatment of IPA. The maximum tolerated dose was not reached, but response rates were impressive with complete plus partial responses accounting for 54.3% and overall mortality at 12-week follow-up as low as 28.3%. There was a tendency towards higher doses yielding higher response rates.
For the majority of these patients we obtained serial chest CT. So, for the first time a patient population is at hand, in which the kinetics of infiltrates over time can be described.
The main objective is to describe the pathological findings in chest CT performed sequentially in IPA patients while receiving effective antifungal therapy. The specific objectives are:
- Characteristics of pathological findings in sequential chest CTs
- To describe the pathological findings (e.g. halo sign, air crescent sign and air consolidation) in sequential high resolution computed tomogrphy (HRCT) examinations
- To calculate the incidence of individual pathological findings in sequential CT examinations
- To calculate a total volume of fungal infiltrates in sequential CT examinations
- Correlation of pathological findings in sequential CT with corresponding white blood count (WBC) and absolute neutrophil count (ANC)
- To correlate the appearance or disappearance of individual pathological findings with WBC and ANC
- To correlate the volume of fungal infiltrates in sequential CT examinations with WBC and absolute neutrophil count
- Correlation of pathological findings in sequential CT with the serum galactomannan index
- To correlate the appearance or disappearance of individual pathological findings with the serum galactomannan index
- To correlate the volume of fungal infiltrates in sequential HRCT examinations with the serum galactomannan index
- Correlation of pathological findings in sequential HRCT with outcome of IFI
- To correlate the appearance or disappearance of individual pathological findings with outcome of IFI
- To correlate the volume of fungal infiltrates in sequential HRCT examinations with outcome of IFI
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pathological findings in chest CT | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Immunocompromised patients with proven or probable invasive aspergillosis received caspofungin once daily as an intravenous infusion
Key inclusion criteria (1 listed)
- At least two subsequent, evaluable CT examinations of the chest performed while on study
Key exclusion criteria (1 listed)
- Diagnosis of underlying disease other than haematological malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival (%)
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Aspergillosis, run by University Hospital of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jörg-Janne Vehreschild, MD (+0049 (0)221 478-6494, janne.vehreschild@ctuc.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (%) (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2016.