A Pharmacovigilance Evaluation and Assessment of the Prescribing Practice for Tygacil in Usual Health Care Setting - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00488488

Purpose

To assess the efficacy and safety of Tygacil in the usual German hospital setting. The main goals are: • to assess the efficacy of Tygacil under usual care conditions (cure rate) • to assess the main side effects observed in daily medical practice (Safety of Tygacil) • to determine whether patients are optimally dosed with Tygacil (according to the label) and the proportion of patients receiving a monotherapy versus combination therapy. • to observe the potential resistance development against Tygacil in Germany • to determine which antibiotic agents are chosen for a combination therapy with Tygacil • to determine to which antibiotic substance non-responders to Tygacil are switched • to assess the duration of the intravenous therapy with Tygacil and to determine whether and which patients receive an oral antibiotic substance after the therapy with Tygacil • to collect information on profile, comorbidities and characteristics of patients treated with Tygacil

Condition	Intervention	Phase
Infection	Drug: Tygacil	Phase IV

MedlinePlus related topics: Antibiotics

Drug Information available for: Tigecycline

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	A Pharmacovigilance Evaluation and Assessment of the Prescribing Practice for Tygacil in Usual Health Care Setting

Further study details as provided by Wyeth:

Study Start Date:	November 2006
Study Completion Date:	December 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

At least 18 years old,
No hypersensibility to Antibiotics or Tigecycline

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488488

Locations

Germany

Multiple Cities, Germany

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For Germany, medinfoDEU@wyeth.com

More Information

Study ID Numbers:	102045
Study First Received:	June 18, 2007
Last Updated:	December 9, 2007
ClinicalTrials.gov Identifier:	NCT00488488
Health Authority:	Germany: Ethics Commission; Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Tigecycline

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009