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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00827502
Recruitment Status : Completed
First Posted : January 22, 2009
Results First Posted : June 9, 2010
Last Update Posted : April 28, 2011
Sponsor:
Information provided by:
Pfizer

Study Description
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Brief Summary:
To assess effectiveness of Trulimax (Azithromycin) in Acute Bacterial Upper Respiratory Tract Infections (URTIs).

Condition or disease
Upper Respiratory Tract Infections

Detailed Description:
Prospective, Open-label, Non-interventional and Multi-center Study NA
Study Design
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Study Type : Observational
Actual Enrollment : 421 participants
Time Perspective: Prospective
Official Title: Trulimax (Azithromycin ) Non-Interventional Study In Acute Bacterial Upper Respiratory Tract Infections
Study Start Date : February 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects With an Investigator Assessment of Clinical Outcome (Success/Failure) at End of Study [ Time Frame: Baseline to 2 weeks ]
    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.

  2. Number of Subjects With an Investigator Assessment of Clinical Outcome (Cure/Improvement/Failure) at End of Study [ Time Frame: Baseline to 2 weeks ]
    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 :
  1. 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 ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00827502


Locations
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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, 110 057
Pfizer Investigational Site
New delhi, Delhi, India, 110060
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
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00827502    
Other Study ID Numbers: A0661198
First Posted: January 22, 2009    Key Record Dates
Results First Posted: June 9, 2010
Last Update Posted: April 28, 2011
Last Verified: April 2011
Keywords provided by Pfizer:
TRULIMAX (AZITHROMYCIN ) NON-INTERVENTIONAL STUDY
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Respiratory Tract Infections
 Disease Attributes
Pathologic Processes
Respiratory Tract Diseases