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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00827502
First received: January 21, 2009
Last updated: April 25, 2011
Last verified: April 2011
  Purpose

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


Condition
Upper Respiratory Tract Infections

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Subjects With an Investigator Assessment of Clinical Outcome (Success/Failure) at End of Study [ Time Frame: Baseline to 2 weeks ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects With an Investigator Assessment of Clinical Outcome (Cure/Improvement/Failure) at End of Study [ Time Frame: Baseline to 2 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]
    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).


Enrollment: 421
Study Start Date: February 2009
Study Completion Date: July 2009
Primary Completion Date: July 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
India
Pfizer Investigational Site
Jn Vishakhapatnam, Andhra Pradesh, India, 530001
Pfizer Investigational Site
Visakhapatnam, Andhra Pradesh, India, 530 020
Pfizer Investigational Site
Guwhati, Assam, India, 781 011
Pfizer Investigational Site
New delhi, Delhi, India, 110060
Pfizer Investigational Site
New Delhi, Delhi, India, 110 057
Pfizer Investigational Site
Nagpur, Maharashtra, India, 440 009
Pfizer Investigational Site
Vashi, Maharashtra, India, 400 075
Pfizer Investigational Site
Delhi, New Delhi, India, 110085
Pfizer Investigational Site
Chennai, Tamil Nadu, India, 600 084
Pfizer Investigational Site
Chennai, Tamil Nadu, India, 602 001
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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00827502     History of Changes
Other Study ID Numbers: A0661198
Study First Received: January 21, 2009
Results First Received: March 30, 2010
Last Updated: April 25, 2011
Health Authority: India: Institutional Review Board

Keywords provided by Pfizer:
TRULIMAX (AZITHROMYCIN ) NON-INTERVENTIONAL STUDY

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014