Cologne Cohort of Neutropenic Patients (CoCoNut) | NCT01821456

Studies
Cologne Cohort of Neutropenic Patients (CoCoNut)

NCT01821456

Sponsor

University Hospital of Cologne

Status

Recruiting

Last Update Posted

Apr 1, 2013Estimated

Enrollment

100,000Estimated

Phase

Not provided

Conditions

Hematological Malignancies
Cancer
Chemotherapy
Neutropenia
Immunosuppression

Interventions

Antiinfectives

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

ID	Type	Description	Link
!!SZINF2	Other Identifier	University Hospital of Cologne

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1995

Primary Completion Date

Dec 2050Estimated

Completion Date

Dec 2050Estimated

First Submitted Date

Mar 19, 2013

First Submission Date that Met QC Criteria

Mar 26, 2013

First Posted Date

Apr 1, 2013Estimated

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

Mar 26, 2013

Last Update Posted Date

Apr 1, 2013Estimated

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

The Cologne Cohort of Neutropenic Patients (CoCoNut) is a non-interventional cohort study assessing risk factors, interventions, and outcome of immunosuppressed patients with or without opportunistic infections.

Detailed Description

This prospective cohort was established with the aim of a comprehensive data collection of all patients developing neutropenia after receiving chemotherapy for any kind of malignant disease, treated in the University Hospital of Cologne.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

100,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Antiinfectives		To analyze the efficacy of antiinfectives at high risk patients	Drug: Antiinfectives

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Antiinfectives	Drug	To analyze to efficacy of (novel) drug therapies	Antiinfectives

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Long-term survival of hematology and oncology patients following neutropenia		2 years following last follow-up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

immunosuppressed patients

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients developing neutropenia after receiving chemotherapy for any kind of malignant disease, treated in the University Hospital of Cologne

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Cologne	Recruiting	Cologne	North Rhine-Westphalia	50924	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20410061	Result	Vehreschild JJ, Ruping MJ, Wisplinghoff H, Farowski F, Steinbach A, Sims R, Stollorz A, Kreuzer KA, Hallek M, Bangard C, Cornely OA. Clinical effectiveness of posaconazole prophylaxis in patients with acute myelogenous leukaemia (AML): a 6 year experience of the Cologne AML cohort. J Antimicrob Chemother. 2010 Jul;65(7):1466-71. doi: 10.1093/jac/dkq121. Epub 2010 Apr 21.
24798021

ID	Term
D019337	Hematologic Neoplasms
D009369	Neoplasms
D009503	Neutropenia

ID	Term
D009371	Neoplasms by Site
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D000380	Agranulocytosis

ID	Term
D000890	Anti-Infective Agents
D000935	Antifungal Agents
D000998	Antiviral Agents

ID	Term
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses