NCT00827060

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
702

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
Last Updated

January 28, 2009

Status Verified

January 1, 2009

Enrollment Period

6 months

First QC Date

January 21, 2009

Last Update Submit

January 27, 2009

Conditions

Respiratory Tract Infections

Keywords

primary careprocalcitoninacute respiratory tract infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

primary care patients in 45 practices in greater Hannover

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical School Hannover, Department Pneumology

Hanover, 30625, Germany

Location

Related Publications (1)

  • 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.

    PMID: 20185423DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • Olaf Burkhardt, PD Dr. med.

    Medical School Hannover

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 21, 2009

First Posted

January 22, 2009

Study Start

December 1, 2006

Primary Completion

June 1, 2007

Study Completion

September 1, 2007

Last Updated

January 28, 2009

Record last verified: 2009-01

Locations

DE(1)