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

Last updated on October 11, 2019

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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 TitleZithromax-SR 2g, Special Investigation (Regulatory Post Marketing Commitment Plan)
Official TitleZithromax-SR 2g, Special Investigation For Skin And Soft Tissue Infection, Sexually-Transmitted Infection, And Infection Of The Oral (Regulatory Post Marketing Commitment Plan)
Brief SummaryTo collect the efficacy and safety information of Zithromax-SR related to their appropriate use in daily practice.
Detailed DescriptionAll the patients whom an investigator prescribes the first Azithromycin SR should be registered within 14 days.
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationThe patients whom an involving A0661202 prescribes the Azithromycin SR.
ConditionBacterial Infections
InterventionDrug: Azithromycin SR
Zithromax SR 2g, taking once for treatment.
Other Name: Zithromax SR, Azithromycin SR
Study Groups/CohortsAzithromycin 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 StatusCompleted
Actual Enrollment
 (submitted: February 24, 2011)
502
Original Estimated Enrollment
 (submitted: October 19, 2009)
360
Actual Study Completion DateJanuary 2011
Actual Primary Completion DateJanuary 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
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00998309
Other Study ID NumbersA0661202
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2012

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

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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