Trulimax (Azithromycin ) Non-Interventional Study In Acute Bacterial Upper Respiratory Tract Infections

This study is not yet open for participant recruitment.

Verified by Pfizer, January 2009

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00827502

Purpose

To assess effectiveness of Trulimax (Azithromycin) in Acute Bacterial Upper Respiratory Tract Infections (URTIs)

Condition
Upper Respiratory Tract Infections

Drug Information available for: Azithromycin

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Trulimax (Azithromycin ) Non-Interventional Study In Acute Bacterial Upper Respiratory Tract Infections

Further study details as provided by Pfizer:

Primary Outcome Measures:

Investigator assessment of clinical outcome (success/failure) at end of study. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine safety and tolerability of Trulimax (azithromycin) treatment in patients suffering from URTIs. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Pharmacoeconomic analysis of management of URTIs shall be attempted [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	400
Study Start Date:	February 2009
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Detailed Description:

Prospective, Open-label, Non-interventional and Multi-center Study NA

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Only patients with acute URTI, presumed to be of bacterial origin as per the clinical judgment of the investigator will be enrolled in the study.

Criteria

Inclusion Criteria:

Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Patients with acute URTI, presumed to be of bacterial origin as per the clinical judgment of the investigator.

Exclusion Criteria:

N/A

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827502

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0661198
Study First Received:	January 21, 2009
Last Updated:	January 28, 2009
ClinicalTrials.gov Identifier:	NCT00827502
Health Authority:	India: Institutional Review Board

Keywords provided by Pfizer:

TRULIMAX (AZITHROMYCIN ) NON-INTERVENTIONAL STUDY

Study placed in the following topic categories:

Respiratory Tract Diseases
Respiratory Tract Infections
Azithromycin

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases

Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 30, 2009