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

Upper Respiratory Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00827502
• Other study ID #: A0661198
• Status: Completed
• Phase: N/A
• First received: January 21, 2009
• Last updated: April 25, 2011
• Start date: February 2009
• Est. completion date: July 2009

Study information

• Verified date: April 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 421
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Infection
• Respiratory Tract Infections
• Upper Respiratory Tract Infections

Locations

Country	Name	City	State
India	Pfizer Investigational Site	Chennai	Tamil Nadu
India	Pfizer Investigational Site	Chennai	Tamil Nadu
India	Pfizer Investigational Site	Delhi	New Delhi
India	Pfizer Investigational Site	Guwhati	Assam
India	Pfizer Investigational Site	Jn Vishakhapatnam	Andhra Pradesh
India	Pfizer Investigational Site	Lucknow	Uttar Pradesh
India	Pfizer Investigational Site	Nagpur	Maharashtra
India	Pfizer Investigational Site	New Delhi	Delhi
India	Pfizer Investigational Site	New delhi	Delhi
India	Pfizer Investigational Site	Vashi	Maharashtra
India	Pfizer Investigational Site	Visakhapatnam	Andhra Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With an Investigator Assessment of Clinical Outcome (Success/Failure) at End of Study	Success: Cure (disappearance of all pre-treatment signs and symptoms of infection) or improvement in or partial disappearance of signs and symptoms not requiring further treatment at end of study; Failure: No change in, or worsening of baseline signs and symptoms requiring modification of treatment, ie, addition of or switch to another systemic antibacterial therapy. Unknown or missing values were considered as failure.	Baseline to 2 weeks	No
Primary	Number of Subjects With an Investigator Assessment of Clinical Outcome (Cure/Improvement/Failure) at End of Study	Cure: Disappearance of all pre-treatment signs and symptoms of infection; Improvement: Improvement in, or partial disappearance of signs and symptoms without requiring further antibacterial therapy. Subjects who discontinued study drug for reasons other than lack of clinical response, i.e., despite clinical improvement, were included in this category; and Failure: No change in, or worsening of baseline signs and symptoms requiring modification of treatment, ie, addition of or switch to another systemic antibacterial therapy. An unknown response or missing value was considered clinical failure.	Baseline to 2 weeks	No
Secondary	Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate	Cost (in Indian Rupees) per participant of utilizations including general consultations over the study; each medication over the study (study drug, analgesics, antipyretics, anti-inflammatory drugs, vitamins, other study medication), radiological tests over the study (chest X-ray); and clinical laboratory tests over the study (complete blood count and erythrocyte sedimentation rate).	Baseline to 3 months	No

External Links

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