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

This study has been completed.

First Received: January 21, 2009 Last Updated: August 11, 2009 History of Changes

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	Intervention
Upper Respiratory Tract Infections	Other: No Intervention

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

Resource links provided by NLM:

Drug Information available for: Azithromycin

U.S. FDA Resources

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:

Enrollment:	425
Study Start Date:	February 2009
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

Locations

India, Andhra Pradesh
Pfizer Investigational Site
Visakhapatnam, Andhra Pradesh, India, 530 020
Pfizer Investigational Site
Jn Vishakhapatnam, Andhra Pradesh, India, 530001
India, Assam
Pfizer Investigational Site
Guwhati, Assam, India, 781 011
India, Delhi
Pfizer Investigational Site
New delhi, Delhi, India, 110060
Pfizer Investigational Site
New Delhi, Delhi, India, 110 057
India, Maharashtra
Pfizer Investigational Site
Nagpur, Maharashtra, India, 440 009
Pfizer Investigational Site
Vashi, Maharashtra, India, 400 075
India, New Delhi
Pfizer Investigational Site
Delhi, New Delhi, India, 110085
India, Tamil Nadu
Pfizer Investigational Site
Chennai, Tamil Nadu, India, 600 084
Pfizer Investigational Site
Chennai, Tamil Nadu, India, 602 001
India, Uttar Pradesh
Pfizer Investigational Site
Lucknow, Uttar Pradesh, India, 226020

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

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

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0661198
Study First Received:	January 21, 2009
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00827502 History of Changes
Health Authority:	India: Institutional Review Board

Keywords provided by Pfizer:

TRULIMAX (AZITHROMYCIN ) NON-INTERVENTIONAL STUDY

Study placed in the following topic categories:

Anti-Infective Agents
Anti-Bacterial Agents
Respiratory Tract Diseases
Respiratory Tract Infections
Azithromycin

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Therapeutic Uses
Azithromycin
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009