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

Last updated on February 23, 2020

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bacterial Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients not administered Azithromycin SR.

NCT00998309
Pfizer
Completed
Zithromax-SR 2g, Special Investigation (Regulatory Post Marketing Commitment Plan)

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Descriptive Information
Brief Title 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)
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The patients whom an involving A0661202 prescribes the Azithromycin SR.
Condition Bacterial Infections
Intervention Drug: Azithromycin SR
Zithromax SR 2g, taking once for treatment.
Other Name: Zithromax SR, Azithromycin SR
Study Groups/Cohorts Azithromycin SR
Patients taking Azithromycin.
Intervention: Drug: Azithromycin SR
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 24, 2011)
502
Original Estimated Enrollment
 (submitted: October 19, 2009)
360
Actual Study Completion Date January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00998309
Other Study ID Numbers A0661202
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2012

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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