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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
History of Changes
Results First Received: March 30, 2010  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Upper Respiratory Tract Infections

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Azithromycin The use and dosage recommendations for Azithromycin took place on the basis of the approved local product document (LPD) and were adjusted solely according to medical and therapeutic necessities. According to the approved LPD, in general a total dose of 30 mg/kg was given as a single daily dose(10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on day 1, and then reduced to 5 mg/kg on days 2 to 5). For children with acute otitis media a single dose of 30 mg/kg was recommended. Children with streptococcal pharyngitis were given a single dose of 10 mg/kg or 20 mg/kg for 3 days and did not exceed a daily dose of 500mg. The maximum recommended total dose of Azithromycin in children for any treatment was 1500 mg. Azithromycin tablets were administered only to children weighing more than 45 kg.

Participant Flow:   Overall Study
    Azithromycin  
STARTED     421  
Received Treatment (Number Treated)     410  
COMPLETED     400  
NOT COMPLETED     21  
randomized but not treated                 11  
Adverse Event                 1  
Lost to Follow-up                 4  
Withdrawal by Subject                 5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Azithromycin No text entered.

Baseline Measures
    Azithromycin  
Number of Participants  
[units: participants]
 		  410  
Age, Customized  
[units: participants]
 		 
<18 years     51  
18-44 years     270  
45-64 years     73  
>= 65 years     9  
Unspecified     2  
Demographic information not collected     5  
Gender, Customized  
[units: participants]
 		 
Female     155  
Male     245  
Unspecified     5  
Demographic information not collected     5  



  Outcome Measures
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1.  Primary:   Number of Subjects With an Investigator Assessment of Clinical Outcome (Success/Failure) at End of Study   [ Time Frame: Baseline to 2 weeks ]
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2.  Primary:   Number of Subjects With an Investigator Assessment of Clinical Outcome (Cure/Improvement/Failure) at End of Study   [ Time Frame: Baseline to 2 weeks ]
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3.  Secondary:   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 ]
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  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com



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