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Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia

Last updated on May 11, 2018

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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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Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia
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)
The 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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Community-Acquired Pneumonia
Drug: Azithromycin microspheres 2.0 single dose
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
June 2006
Not Provided

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Philippines
 
 
NCT00140023
A0661149
Not Provided
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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