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

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
Overall Participants Analyzed; [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: 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. 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. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.; Restriction Description: Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

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
First Submitted:	January 21, 2009
First Posted:	January 22, 2009
Results First Submitted:	March 30, 2010
Results First Posted:	June 9, 2010
Last Update Posted:	April 28, 2011