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Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia

Last updated on November 14, 2019

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Study Location
Pfizer Investigational Site
Manila, Metro Manila, 1000 Philippines
Contact
1-800-718-1021
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 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female, 18 years age or older, for whom oral, outpatient therapy is
indicated.

- Diagnosis of CAP as manifested by at least 3 or more of the following:

- cough, pleuritic chest pain, fever (temperature of >37.8 C to findings on pulmonary examination of rales and/or evidence of pulmonary
consolidation, dyspnea, tachypnea, laboratory results of elevated total peripheral
white blood count (WBC> 10,000/mm3 or greater than 15% immature neutrophils (bands)

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

- Known or suspected hypersensitivity or intolerance to azithromycin or other
macrolides.

- Previously diagnosed disease(s) of immune function, including: subjects with baseline
absolute neutrophil count cells/mm3, any immunoglobin or neutrophil disorder.

NCT00140023
Pfizer
Completed
Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia

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Descriptive Information
Brief Title  ICMJE Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia
Official Title  ICMJE A Multi-center, Open Label Study to Evaluate the Efficacy and Safety of Azithromycin Microspheres in Subjects Identified as Having Low Risk Community Acquired Pneumonia (CAP)
Brief SummaryThe study will assess the clinical efficacy at Day 14-21 (Test of Cure), 14-21 days after starting the study drug; those subjects from whom a baseline pathogen is identified will also be assessed for bacteriologic response. All subjects who receive 1 dose of study medication will be assessed for safety.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Community-Acquired Pneumonia
Intervention  ICMJE Drug: Azithromycin microspheres 2.0 single dose
Study Arms  ICMJE Not Provided
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2011)
47
Original Enrollment  ICMJE
 (submitted: August 30, 2005)
50
Actual Study Completion Date  ICMJE June 2006
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female, 18 years age or older, for whom oral, outpatient therapy is indicated.
  • Diagnosis of CAP as manifested by at least 3 or more of the following:
  • cough, pleuritic chest pain, fever (temperature of >37.8 C to <40 C), auscultatory findings on pulmonary examination of rales and/or evidence of pulmonary consolidation, dyspnea, tachypnea, laboratory results of elevated total peripheral white blood count (WBC> 10,000/mm3 or greater than 15% immature neutrophils (bands)

Exclusion Criteria:

  • Known or suspected hypersensitivity or intolerance to azithromycin or other macrolides.
  • Previously diagnosed disease(s) of immune function, including: subjects with baseline absolute neutrophil count < 1,000/mm3, HIV positive subjects with CD4 count < 200 cells/mm3, any immunoglobin or neutrophil disorder.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Philippines
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00140023
Other Study ID Numbers  ICMJE A0661149
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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

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1-800-718-1021

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