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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00998309

First received: October 16, 2009

Last updated: April 2, 2012

Last verified: April 2012

History of Changes

Results First Received: January 12, 2012

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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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
Number of Participants [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	12

[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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Measure Type	Secondary
Measure Title	Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Hepatic Dysfunction(HD)
Measure Description	Number of participants with responders of azithromycin to determine whether with or without hepatic dysfunction is significant risk factor.
Time Frame	Baseline to 29 days
Safety Issue	No

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.
The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).

Reporting Groups

	Description
Azithromycin -Without Hepatic Dysfunction	Participants without Hepatic Dysfunction (HD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Azithromycin-with Hepatic Dysfunction	Participants with Hepatic Dysfunction (HD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.

Measured Values

	Azithromycin -Without Hepatic Dysfunction	Azithromycin-with Hepatic Dysfunction
Number of Participants Analyzed [units: participants]	395	2
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Hepatic Dysfunction(HD) [units: participants]
Number of Participants	395	2
Participatns of Responders	381	1

Statistical Analysis 1 for Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Hepatic Dysfunction(HD)

Groups ^[1]	All groups
Method ^[2]	Fisher Exact
P Value ^[3]	=0.074

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The risk factor tested was "hepatic dysfunction". The null hypothesis is there is no difference between "with and without hepatic dysfunction" in the participatns of responders.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

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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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.

Limitations and Caveats

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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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

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00998309 History of Changes
Other Study ID Numbers:	A0661202
Study First Received:	October 16, 2009
Results First Received:	January 12, 2012
Last Updated:	April 2, 2012
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

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