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

NCT00827502 | Completed Results

• 1 other identifier: A0661198
• Study Type: observational
• Target: 421
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Upper Respiratory Tract Infections

Keywords

TRULIMAX (AZITHROMYCIN ) NON-INTERVENTIONAL STUDY

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate

  Baseline to 3 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• Pfizer: lead

Study Sites (11)

Pfizer Investigational Site

Jn Vishakhapatnam, Andhra Pradesh, 530001, India

Location

Pfizer Investigational Site

Visakhapatnam, Andhra Pradesh, 530 020, India

Location

Pfizer Investigational Site

Guwhati, Assam, 781 011, India

Location

Pfizer Investigational Site

Nagpur, Maharashtra, 440 009, India

Location

Pfizer Investigational Site

Vāshi, Maharashtra, 400 075, India

Location

Pfizer Investigational Site

New Delhi, National Capital Territory of Delhi, 110 057, India

Location

Pfizer Investigational Site

New Delhi, National Capital Territory of Delhi, 110060, India

Location

Pfizer Investigational Site

Delhi, New Delhi, 110085, India

Location

Pfizer Investigational Site

Chennai, Tamil Nadu, 600 084, India

Location

Pfizer Investigational Site

Chennai, Tamil Nadu, 602 001, India

Location

Pfizer Investigational Site

Lucknow, Uttar Pradesh, 226020, India

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 21, 2009
• First Posted: January 22, 2009
• Study Start: February 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 28, 2011
• Results First Posted: June 9, 2010

Record last verified: 2011-04

Locations

IN (11)