Azithromycin SR
DrugZithromax SR 2g, taking once for treatment.
Other names: Zithromax SR, Azithromycin SR
NCT Number: NCT00998309
To collect the efficacy and safety information of Zithromax-SR related to their appropriate use in daily practice.
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Observational
All the patients whom an investigator prescribes the first Azithromycin SR should be registered within 14 days.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Zithromax SR 2g, taking once for treatment.
Other names: Zithromax SR, Azithromycin SR
Time frame: Baseline to 29 days
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.
Time frame: Baseline to 29 days
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.
Time frame: Baseline to 29 days
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.
Time frame: Baseline to 29 days
Number of participants with responders of azithromycin to determine whether male or female is significant risk factor.
Time frame: Baseline to 29 days
Number of participants with responders of azithromycin to determine whether <65 years or >=65 years is significant risk factor.
Time frame: Baseline to 29 days
Number of participants with responders of azithromycin to determine whether type of infection, "Skin and Soft Tissue Infection, Sexual Transmitted Infection, or Dental and Oral Surgery Infection", is significant risk factor.
Time frame: Baseline to 29 days
Number of participants with responders of azithromycin to determine whether Infection severity, "mild infection, moderate infection, or severe infection", is significant risk factor.
Time frame: Baseline to 29 days
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
Number of participants with responders of azithromycin to determine whether with or without renal dysfunction is significant risk factor.
Time frame: Baseline to 29 days
Number of participants with responders of azithromycin to determine whether with or without past medical history is significant risk factor.
Time frame: Baseline to 29 days
Number of participants with responders of azithromycin to determine whether with or without complications is significant risk factor.
Time frame: Baseline to 29 days
Number of participants with responders of azithromycin to determine whether with or without previous antibiotic treatment history is significant risk factor.
Time frame: Baseline to 29 days
Number of participants with responders of azithromycin to determine whether with or without comcomittant drugs is significant risk factor.
Time frame: Baseline to 29 days
Number of participants with responders of azithromycin to determine whether with or without non-drug therapy is significant risk factor.
Time frame: Baseline to 29 days
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether male or female is significant risk factor.
Time frame: Baseline to 29 days
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether <65 years or >=65 years is significant risk factor.
Time frame: Baseline to 29 days
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether Type of Infection, "Skin and Soft Tissue Infection, Sexual Transmitted Infection, or Dental, or Oral Surgery Infection", is significant risk factor.
Time frame: Baseline to 29 days
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether mild infection, moderate infection, or severe infection is significant risk factor.
Time frame: Baseline to 29 days
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Hepatic Dysfunction is significant risk factor.
Time frame: Baseline to 29 days
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Renal Dysfunction is significant risk factor.
Time frame: Baseline to 29 days
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Past Medical History is significant risk factor.
Time frame: Baseline to 29 days
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without complications is significant risk factor.
Time frame: Baseline to 29 days
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without previous antibioutic treatment history (PATH) is significant risk factor.
Time frame: Baseline to 29 days
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without comcomittant drugs is significant risk factor.
Time frame: Baseline to 29 days
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without non-drug therapy is significant risk factor.
Time frame: Baseline to 29 days
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Pregnancy in Female is significant risk factor.
Pfizer
Industry
Zithromax-SR 2g, Special Investigation For Skin And Soft Tissue Infection, Sexually-Transmitted Infection, And Infection Of The Oral (Regulatory Post Marketing Commitment Plan)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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