Zithromax-SR 2g, Special Investigation (Regulatory Post Marketing Commitment Plan)

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ClinicalTrials.gov Identifier: NCT00998309

Recruitment Status : Completed

First Posted : October 20, 2009

Results First Posted : May 1, 2012

Last Update Posted : May 1, 2012

Sponsor:

Information provided by (Responsible Party):

Pfizer

Study Type:	Observational
Study Design:	Observational Model: Case-Only; Time Perspective: Prospective
Condition:	Bacterial Infections
Intervention:	Drug: Azithromycin SR

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
This was a phase 4, observational, open-label study conducted in participants who were prescribed azithromycin by their treating physician per usual clinical practice. Study drug was not provided by the Sponsor.

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 SR	Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.

Participant Flow: Overall Study

	Azithromycin SR
STARTED	502
COMPLETED	498
NOT COMPLETED	4
Protocol Violation	4

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 SR	Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.

Baseline Measures

Azithromycin SR

Overall Participants Analyzed
[Units: Participants]

498

Age, Customized
[Units: Years]
Mean (Standard Deviation)

39.9 (15.6)

Gender
[Units: Participants]

Female

211

Male

287

Type of Infection ^[1]
[Units: Participants]

Skin and Soft Tissue Infection

104

Sexual Transmitted Infection

199

Dental and Oral Surgery Infection

183

Others

^[1]	The physician in charge of the survey made the diagnosis of type of infection based on symptoms.

Outcome Measures

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1. Primary:

Number of Participants With an Investigator’s Assessment of Clinical Outcome (Effective (Cured)/ Not Effective (Not Cured)) at End of the Study. [ Time Frame: Baseline to 29 days ]

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2. Primary:

Number of Participants With Treatment Related Adverse Events (TRAEs) [ Time Frame: Baseline to 29 days ]

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3. Primary:

Number of Unlisted Treatment Related Adverse Events (TRAEs) [ Time Frame: Baseline to 29 days ]

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4. Secondary:

Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Gender [ Time Frame: Baseline to 29 days ]

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5. Secondary:

Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Age [ Time Frame: Baseline to 29 days ]

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6. Secondary:

Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Type of Infection [ Time Frame: Baseline to 29 days ]

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7. Secondary:

Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Infection Severity [ Time Frame: Baseline to 29 days ]

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8. Secondary:

Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Hepatic Dysfunction(HD) [ Time Frame: Baseline to 29 days ]

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9. Secondary:

Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Renal Dysfunction(RD) [ Time Frame: Baseline to 29 days ]

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10. Secondary:

Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Past Medical History (PMH) [ Time Frame: Baseline to 29 days ]

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11. Secondary:

Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Complications [ Time Frame: Baseline to 29 days ]

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12. Secondary:

Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Previous Antibiotic Treatment History (PATH) [ Time Frame: Baseline to 29 days ]

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13. Secondary:

Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Comcomittant Drugs(CD) [ Time Frame: Baseline to 29 days ]

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14. Secondary:

Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Non-Drug Therapy [ Time Frame: Baseline to 29 days ]

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15. Secondary:

Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Gender [ Time Frame: Baseline to 29 days ]

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16. Secondary:

Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Age [ Time Frame: Baseline to 29 days ]

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17. Secondary:

Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Type of Infection [ Time Frame: Baseline to 29 days ]

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18. Secondary:

Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Infection Severity [ Time Frame: Baseline to 29 days ]

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19. Secondary:

Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Hepatic Dysfunction [ Time Frame: Baseline to 29 days ]

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20. Secondary:

Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Renal Dysfunction [ Time Frame: Baseline to 29 days ]

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21. Secondary:

Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Past Medical History [ Time Frame: Baseline to 29 days ]

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22. Secondary:

Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Complications [ Time Frame: Baseline to 29 days ]

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23. Secondary:

Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Previous Antibiotic Treatment History (PATH) [ Time Frame: Baseline to 29 days ]

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24. Secondary:

Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Comcomittant Drugs [ Time Frame: Baseline to 29 days ]

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25. Secondary:

Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Non-Drug Therapy [ Time Frame: Baseline to 29 days ]

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26. Secondary:

Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Pregnancy in Female [ Time Frame: Baseline to 29 days ]

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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 less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 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.gov_Inquiries@pfizer.com

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00998309 History of Changes
Other Study ID Numbers:	A0661202
First Submitted:	October 16, 2009
First Posted:	October 20, 2009
Results First Submitted:	January 12, 2012
Results First Posted:	May 1, 2012
Last Update Posted:	May 1, 2012

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