Antimycotic Prophylaxis in Pediatric Patients Following A... | NCT01040156

Studies
Antimycotic Prophylaxis in Pediatric Patients Following Allogeneic Stem Cell Transplantation

NCT01040156

Sponsor

University Children's Hospital Tuebingen

Status

Completed

Last Update Posted

Dec 29, 2009Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Systemic Aspergillosis
Systemic Candidiasis

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Dec 28, 2009

First Submission Date that Met QC Criteria

Dec 28, 2009

First Posted Date

Dec 29, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2009

Last Update Posted Date

Dec 29, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pediatric patients under the age of 18 years
Pediatric patients after HSCT treated with caspofungin
Pediatric patients after HSCT treated with liposomal amphotericin

Exclusion Criteria:

Pediatric patients with uncontrolled hematological malignancies
Pediatric patients with IFI at start of HSCT

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Pediatric patients undergoing allogeneic stem cell transplantation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ingo Mueller, M.D.	UCHT	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Children's Hospital		Tübingen		72076	Germany

Condition Browse Module

MeSH Terms

ID	Term
C536777	Systemic candidiasis

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
LAmb
Cas