Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections (COMPAS)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00939185
First received: July 13, 2009
Last updated: March 25, 2010
Last verified: March 2010
Results First Received: December 17, 2009  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Respiratory Tract Infections
Intervention: Drug: Azithromycin

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Azithromycin The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.

Participant Flow:   Overall Study
    Azithromycin  
STARTED     400  
Received Treatment     390  
COMPLETED     375  
NOT COMPLETED     25  
Adverse Event                 3  
Lack of Efficacy                 1  
Lost to Follow-up                 6  
Unspecified                 3  
Withdrawal by Subject                 2  
Randomized But Did Not Receive Treatment                 10  



  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.
No text entered.

Reporting Groups
  Description
Azithromycin The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.

Baseline Measures
    Azithromycin  
Number of Participants  
[units: participants]
  390  
Age, Customized  
[units: participants]
 
Birth to 1 month     2  
> 1 month to 2 years     82  
> 2 years to 12 years     292  
> 12 years to 18 years     10  
> 18 years     0  
Unspecified     4  
Gender  
[units: participants]
 
Female     167  
Male     223  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients With Adverse Events (AEs)   [ Time Frame: 3 to 7 days after receiving treatment ]

2.  Secondary:   Number of Subjects Who Withdrew From the Study   [ Time Frame: 3 to 7 days after receiving treatment ]

3.  Secondary:   Compliance   [ Time Frame: 3 to 7 days after receiving treatment ]

4.  Secondary:   Time Reported for a Patient Being Consulted and Diagnosed From the Moment He/She Entered the Hospital   [ Time Frame: Day 1 ]


  Serious Adverse Events


  Other Adverse Events


  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
Only 1 subject received tablet; therefore, no suspension versus tablet efficacy data is displayed as initially planned.


  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


No publications provided


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00939185     History of Changes
Other Study ID Numbers: A0661182
Study First Received: July 13, 2009
Results First Received: December 17, 2009
Last Updated: March 25, 2010
Health Authority: Greece: National Organization of Medicines