Observation of Initial Procalcitonin and the Clinical Cou... | NCT00827060

Studies
Observation of Initial Procalcitonin and the Clinical Course of Patients With Acute Respiratory Tract Infections

NCT00827060

Sponsor

Hannover Medical School

Status

Completed

Last Update Posted

Jan 28, 2009Estimated

Enrollment

702Actual

Phase

Not provided

Conditions

Respiratory Tract Infections

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

Jan 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

Dec 2006

Primary Completion Date

Jun 2007Actual

Completion Date

Sep 2007Actual

First Submitted Date

Jan 21, 2009

First Submission Date that Met QC Criteria

Jan 21, 2009

First Posted Date

Jan 22, 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

Jan 27, 2009

Last Update Posted Date

Jan 28, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Observation of the initial Procalcitonin values and the clinical course of consecutively included patients with Acute Respiratory Tract Infections at general medical practices in greater Hannover.

Detailed Description

Primary endpoint:

initial Procalcitonin values of patients with Acute Respiratory Tract Infections

Secondary endpoints:

correlation of initial Procalcitonin values to classify Acute Respiratory Tract Infections
correlation of initial Procalcitonin values to subjective severity of Acute Respiratory Tract Infections
correlation of initial Procalcitonin values to antibiotic- prescriptions
correlation of initial Procalcitonin values to frequency of admission to hospital
correlation of initial Procalcitonin values to frequency of referrals (radiology, pneumology)

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

702Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

written informed consent
all types of respiratory tract infection according to investigator´s diagnosis

Exclusion Criteria:

pretreatment with antibiotics in the past 2 weeks
portal hypertension
Major surgeries or multiple trauma which require hospitalization, in previous 4 weeks
Autoimmune disease and systemic diseases (lupus erythematodes, wegener´s disease)
Peritoneal dialysis
Acute treated or recently operated medullary c-cell-carcinoma, SCLC, carcinoid
Other inflammatory diseases (e.g. urinary tract infection, pyelonephritis, pancreatitis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

primary care patients in 45 practices in greater Hannover

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olaf Burkhardt, PD Dr. med.	Medical School Hannover	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical School Hannover, Department Pneumology		Hanover		30625	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20185423	Derived	Burkhardt O, Ewig S, Haagen U, Giersdorf S, Hartmann O, Wegscheider K, Hummers-Pradier E, Welte T. Procalcitonin guidance and reduction of antibiotic use in acute respiratory tract infection. Eur Respir J. 2010 Sep;36(3):601-7. doi: 10.1183/09031936.00163309. Epub 2010 Feb 25.

ID	Term
D007239	Infections
D012140	Respiratory Tract Diseases