Systemic AspergillosisNCT01040156
Antimycotic Prophylaxis in Pediatric Patients Following Allogeneic Stem Cell Transplantation
An observational study of Systemic Aspergillosis and Systemic Candidiasis, run by University Children's Hospital Tuebingen at 1 site in Germany.
Trial summary
Pediatric patients are at high risk to acquire mycotic infections following allogeneic bone marrow transplantation. In the present retrospective analysis we assess the safety and efficacy of different regimens in antimycotic prophylaxis. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Systemic Aspergillosis, Systemic Candidiasis
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Aug 2008to Dec 2009
- 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 Up to 18 years
- All sexes
- Child, Adult
Study population: Pediatric patients undergoing allogeneic stem cell transplantation
Who may be able to join
- Pediatric patients under the age of 18 years
- Pediatric patients after HSCT treated with caspofungin
- Pediatric patients after HSCT treated with liposomal amphotericin
Who cannot join
- Pediatric patients with uncontrolled hematological malignancies
- Pediatric patients with IFI at start of HSCT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Feasibility and Efficacy of Caspofungin Versus Liposomal Amphotericin B as Antifungal Prophylaxis Following Allogeneic Hematopoietic Stem Cell Transplantation in Pediatric Patients - a Retrospective Phase I/II Study
Pediatric patients are at high risk to acquire mycotic infections following allogeneic bone marrow transplantation. In the present retrospective analysis we assess the safety and efficacy of different regimens in antimycotic prophylaxis.
- Conditions
- Systemic Aspergillosis, Systemic Candidiasis
- Medical subject headings
- Systemic candidiasis
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 |
|---|---|---|
| LAmb | Not described | |
| Cas | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2009 (estimated)
- Study startAug 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic 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
Sponsor and investigators
- Lead sponsor
- University Children's Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Investigators
- Ingo Mueller, M.D., Principal investigator, UCHT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040156
- Sponsor's protocol ID
- UCHT-1209
- Status last verified
- Dec 2009
- First submitted
- 28 Dec 2009
- Last updated
- 29 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Feasibility and Efficacy of Caspofungin Versus Liposomal Amphotericin B as Antifungal Prophylaxis Following Allogeneic Hematopoietic Stem Cell Transplantation in Pediatric Patients - a Retrospective Phase I/II Study
- ClinicalTrials.gov ID
- NCT01040156
- Acronym / sponsor ID
- UCHT-1209
- Conditions
- Systemic Aspergillosis, Systemic Candidiasis
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University Children's Hospital TuebingenUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 29 Dec 2009 (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.
Pediatric patients are at high risk to acquire mycotic infections following allogeneic bone marrow transplantation. In the present retrospective analysis we assess the safety and efficacy of different regimens in antimycotic prophylaxis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAmb | – | – |
| Cas | – | – |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Pediatric patients undergoing allogeneic stem cell transplantation
Key inclusion criteria (3 listed)
- Pediatric patients under the age of 18 years
- Pediatric patients after HSCT treated with caspofungin
- Pediatric patients after HSCT treated with liposomal amphotericin
Key exclusion criteria (2 listed)
- Pediatric patients with uncontrolled hematological malignancies
- Pediatric patients with IFI at start of HSCT
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2009.
Related trials for Systemic Aspergillosis
Recruiting
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Chronic Pulmonary Aspergillosis, Allergic Bronchopulmonary Aspergillosis
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.
Ingo Mueller, M.D. principal investigator
UCHT
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 Systemic Aspergillosis and Systemic Candidiasis, run by University Children's Hospital Tuebingen 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 29 Dec 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 29 Dec 2009.