Clinical trial NCT00998309: Zithromax-SR 2g, Special Investigation (Regulatory Post Marketing Commitment Plan)
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Infections
Keywords: skin infection
soft tissue infection
sexually-transmitted infection
infection oral
Regulatory Post Marketing Commitment Plan
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-10-20
Enrollment: 502
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients whom an involving A0661202 prescribes the Azithromycin SR.

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

Detailed description: All the patients whom an investigator prescribes the first Azithromycin SR should be registered within 14 days.

Eligibility 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:

* Patients not administered Azithromycin SR.

Primary outcomes:
measure: Number of Participants With an Investigator's Assessment of Clinical Outcome (Effective (Cured)/ Not Effective (Not Cured)) at End of the Study.
timeFrame: Baseline to 29 days
measure: Number of Participants With Treatment Related Adverse Events (TRAEs)
timeFrame: Baseline to 29 days
measure: Number of Unlisted Treatment Related Adverse Events (TRAEs)
timeFrame: Baseline to 29 days
Secondary outcomes:
measure: Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Gender
timeFrame: Baseline to 29 days
measure: Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Age
timeFrame: Baseline to 29 days
measure: Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Type of Infection
timeFrame: Baseline to 29 days
measure: Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Infection Severity
timeFrame: Baseline to 29 days
measure: Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Hepatic Dysfunction(HD)
timeFrame: Baseline to 29 days
measure: Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Renal Dysfunction(RD)
timeFrame: Baseline to 29 days
measure: Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Past Medical History (PMH)
timeFrame: Baseline to 29 days
measure: Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Complications
timeFrame: Baseline to 29 days
measure: Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Previous Antibiotic Treatment History (PATH)
timeFrame: Baseline to 29 days
measure: Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Comcomittant Drugs(CD)
timeFrame: Baseline to 29 days
measure: Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Non-Drug Therapy
timeFrame: Baseline to 29 days
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Gender
timeFrame: Baseline to 29 days
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Age
timeFrame: Baseline to 29 days
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Type of Infection
timeFrame: Baseline to 29 days
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Infection Severity
timeFrame: Baseline to 29 days
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Hepatic Dysfunction
timeFrame: Baseline to 29 days
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Renal Dysfunction
timeFrame: Baseline to 29 days
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Past Medical History
timeFrame: Baseline to 29 days
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Complications
timeFrame: Baseline to 29 days
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Previous Antibiotic Treatment History (PATH)
timeFrame: Baseline to 29 days
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Comcomittant Drugs
timeFrame: Baseline to 29 days
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Non-Drug Therapy
timeFrame: Baseline to 29 days
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Pregnancy in Female
timeFrame: Baseline to 29 days
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: