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NCT00140023 Clinical Trial

Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia

Community-Acquired Pneumonia Clinical Trial

Official title:
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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00140023
Other study ID # A0661149
Secondary ID
Status Completed
Phase Phase 3
First received August 29, 2005
Last updated May 9, 2011
Start date September 2005
Est. completion date June 2006

Study information
Verified date May 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Philippines: Bureau of Food and Drugs
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 47
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Azithromycin microspheres 2.0 single dose

Locations
Country Name City State
Philippines Pfizer Investigational Site Mandaluyong City
Philippines Pfizer Investigational Site Manila
Philippines Pfizer Investigational Site Manila Metro Manila
Philippines Pfizer Investigational Site Muntinlupa City
Philippines Pfizer Investigational Site Quezon City

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Philippines, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the clinical efficacy of 2.0 g single dose of azithromycin microspheres in Low Risk CAP.
Secondary To assess bacteriological efficacy of 2.0 g single dose of azithromycin microspheres. To assess the safety and tolerability of 2.0 g single dose of azithromycin microspheres.
See also
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Completed NCT05356494 - Postural Drainage and PEP Technique in Community Acquired Pneumonia N/A
Completed NCT05133752 - Oral Nemonoxacin in Treating Elderly Patients With CAP Phase 4
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Recruiting NCT05002192 - A Retrospective, Real-world Study of ELP Used in the Expectorant Treatment of Community-acquired Pneumonia
Completed NCT03452826 - Combined Use of a Respiratory Broad Panel mPCR and Procalcitonin to Reduce Duration of Antibiotics Exposure in Patients With Severe Community-Acquired Pneumonia N/A
Terminated NCT04071041 - Effect of Albumin Administration in Hypoalbuminemic Hospitalized Patients With Community-acquired Pneumonia. Phase 3
Completed NCT03474991 - KIDS-STEP_Betamethasone Therapy in Hospitalised Children With CAP Phase 3
Completed NCT01683487 - Delayed Antibiotic Treatment in Community-acquired Pneumococcal Pneumonia. Phase 4
Withdrawn NCT01662258 - Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For CAP N/A
Completed NCT01723644 - Clinical Reassessment Versus Procalcitonin in Order to Shorten Antibiotic Duration in Community-acquired Pneumonia N/A

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