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Non-Interventional Open Label Prospective Observational Comparative Study On Evaluation Of Compliance Of The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Mild To Moderate Community Acquired Pneumonia

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NCT01032694

Last updated on December 5, 2019
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Study Location
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Community-Acquired Pneumonia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Males or not pregnant or lactating females, 18 years of age or older, for whom oral
antibacterial therapy is indicated with clinically evidence of Diagnosis of
pneumonia, based on usual clinical practice:

1. Physical examination and auscultatory findings (dullness on percussion,
bronchial breath sounds, egophony, dry or fine most rales).

2. Body temperature >38 degrees C.

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

- Known or suspected hypersensitivity or intolerance or contraindications to
Azithromycin.

- Amoxiclav according to LPDs, pregnant or lactating women.

NCT01032694
Pfizer
Terminated
Non-Interventional Open Label Prospective Observational Comparative Study On Evaluation Of Compliance Of The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Mild To Moderate Community Acquired Pneumonia

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Descriptive Information
Brief TitleNon-Interventional Open Label Prospective Observational Comparative Study On Evaluation Of Compliance Of The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Mild To Moderate Community Acquired Pneumonia
Official TitleNon-Interventional Open Label Prospective Observational Comparative Study On Evaluation Of Compliance Of The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Mild To Moderate Community Acquired Pneumonia
Brief SummaryTo compare compliance between patients with CAP treated with Azithromycin SR 2.0 g single dose orally and those treated with Amoxiclav - 1000 mg twice daily 10 days for the empiric treatment of CAP in outpatient clinic practice.
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case Control
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationPatients with Community-Acquired Pneumonia.
ConditionCommunity-Acquired Pneumonia
Intervention
  • Drug: Azithromycin SR
    Azithromycin SR, 2.0 g PO x 1 dose for treatment period
  • Drug: Amoxiclav
    Amoxiclav 1000 x twice daily, 10 days duration
Study Groups/Cohorts
  • Z-max treated group
    Patients with Community-Acquired Pneumonia
    Intervention: Drug: Azithromycin SR
  • Amoxiclav treated group
    Patients with Community-Acquired Pneumonia
    Intervention: Drug: Amoxiclav
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 StatusTerminated
Actual Enrollment
 (submitted: October 3, 2011)		30
Original Estimated Enrollment
 (submitted: December 14, 2009)		120
Actual Study Completion DateDecember 2010
Actual Primary Completion DateDecember 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Males or not pregnant or lactating females, 18 years of age or older, for whom oral antibacterial therapy is indicated with clinically evidence of Diagnosis of pneumonia, based on usual clinical practice:

    1. Physical examination and auscultatory findings (dullness on percussion, bronchial breath sounds, egophony, dry or fine most rales).
    2. Body temperature >38 degrees C.

Exclusion Criteria:

  • Known or suspected hypersensitivity or intolerance or contraindications to Azithromycin.
  • Amoxiclav according to LPDs, pregnant or lactating women.
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years to 80 Years   (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 NumberNCT01032694
Other Study ID NumbersA0661200
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 DateNovember 2011

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