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

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

Study Overview

• Status: Completed
• Conditions: Upper Respiratory Tract Infections

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 421

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: January 21, 2009
• First Submitted That Met QC Criteria: January 21, 2009
• First Posted (Estimate): January 22, 2009

Study Record Updates

• Last Update Posted (Estimate): April 28, 2011
• Last Update Submitted That Met QC Criteria: April 25, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: TRULIMAX (AZITHROMYCIN ) NON-INTERVENTIONAL STUDY
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: A0661198