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

NCT00998309 | Completed Results

• 1 other identifier: A0661202
• Study Type: observational
• Target: 502
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Bacterial Infections

Keywords

skin infection; soft tissue infection; sexually-transmitted infection; infection oral; Regulatory Post Marketing Commitment Plan

Outcome Measures

Primary Outcomes (3)

• Number of Participants With an Investigator's Assessment of Clinical Outcome (Effective (Cured)/ Not Effective (Not Cured)) at End of the Study.

  The physician in charge of the survey performed comprehensive clinical effect evaluation on result of clinical findings, bacteriological effect and others. Clinical effect (Effective (cured)/ Not effective (not cured)/ unable to evaluate effectiveness evaluation) was performed at visits during the observation period by comparing to the data before administration of this drug.Criteria of cured was disappearance or improvement of clinical findings with infections and/or causal bacterial disappearance.

  Baseline to 29 days

• Number of Participants With Treatment Related Adverse Events (TRAEs)

  All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Defenition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.

  Baseline to 29 days

• Number of Unlisted Treatment Related Adverse Events (TRAEs)

  All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Defenition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.

  Baseline to 29 days

Secondary Outcomes (23)

• Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Gender

  Baseline to 29 days

• Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Age

  Baseline to 29 days

• Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Type of Infection

  Baseline to 29 days

• Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Infection Severity

  Baseline to 29 days

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

  Baseline to 29 days

Study Arms (1)

Azithromycin SR

Patients taking Azithromycin.

Drug: Azithromycin SR

Interventions

Azithromycin SR DRUG

Zithromax SR 2g, taking once for treatment.

Also known as: Zithromax SR, Azithromycin SR

Azithromycin SR

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients whom an involving A0661202 prescribes the Azithromycin SR.

You may qualify if:

• 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.

You may not qualify if:

• Patients not administered Azithromycin SR.

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Bacterial Infections; Cellulitis; Soft Tissue Infections; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Communicable Diseases; Genital Diseases; Urogenital Diseases; Disease Attributes

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2009
• First Posted: October 20, 2009
• Study Start: October 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: May 1, 2012
• Results First Posted: May 1, 2012

Record last verified: 2012-04