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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00998309

Purpose

To collect the efficacy and safety information of Zithromax-SR related to their appropriate use in daily practice.

Condition	Intervention	Phase
Bacterial Infections	Drug: Azithromycin SR	Phase IV

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Zithromax-SR 2g, Special Investigation For Skin And Soft Tissue Infection, Sexually-Transmitted Infection, And Infection Of The Oral (Regulatory Post Marketing Commitment Plan)

Resource links provided by NLM:

Drug Information available for: Azithromycin

Further study details as provided by Pfizer:

Primary Outcome Measures:

The frequency of treatment related adverse events. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Risk factors likely to affect the frequency of treatment related adverse events. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Unlisted treatment related adverse events. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The proportion of responders to azithromycin-SR treatment. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Risk factors likely to affect the proportion of responders. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	360
Study Start Date:	October 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Azithromycin SR Patients taking Azithromycin.	Drug: Azithromycin SR Zithromax SR 2g, taking once for treatment.

Eligibility

Study Population

The patients whom an involving A0661202 prescribes the Azithromycin SR.

Criteria

Inclusion Criteria:

Male or female subjects diagnosed with skin and soft tissue infection, sexually-transmitted infection, and infection of the oral.
Subjects must have no prior experience with Azithromycin SR.

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998309

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0661202
Study First Received:	October 16, 2009
Last Updated:	January 14, 2010
ClinicalTrials.gov Identifier:	NCT00998309 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

Keywords provided by Pfizer:

Skin and soft tissue infection Sexually-transmitted infection Infection of the oral Regulatory Post Marketing Commitment Plan

Additional relevant MeSH terms:

Bacterial Infections
Communicable Diseases
Anti-Infective Agents
Soft Tissue Infections
Infection
Genital Diseases, Male
Pharmacologic Actions

Virus Diseases
Genital Diseases, Female
Anti-Bacterial Agents
Azithromycin
Therapeutic Uses
Sexually Transmitted Diseases

ClinicalTrials.gov processed this record on February 08, 2010