Intravenous Azithromycin Plus Intravenous Ceftriaxone Followed by Oral Azithromycin With Intravenous Levofloxacin Followed by Oral Levofloxacin for the Treatment of Moderate to Severely Ill Hospitalized Patients With Community Acquired Pneumonia
NCT00035347
Last updated date
ABOUT THIS STUDY
A trial in which patients over 18 years of age who are hospitalized with community acquired
pneumonia and are otherwise eligible for entry into the study are randomly selected to
receive one of two treatment regimens. After written informed consent is obtained, patients
will receive one of the following two treatment regimens: 1) intravenous administration of
azithromycin and ceftriaxone followed by azithromycin tablets, or 2) intravenous
administration of levofloxacin followed by levofloxacin tablets. At least four study visits
are normally conducted up to approximately one month after starting therapy. The objective of
this study is to compare the safety and efficacy of the two treatment regimens.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Community-Acquired Pneumonia (CAP)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ 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
- Patient must be 18 years or older.
- Patient must be hospitalized and require intravenous therapy for treatment of pneumonia.
- Patient must have pneumonia as documented by relevant signs and symptoms and a positive chest X-ray.
- Patients cannot have certain underlying diseases or conditions as defined in the study protocol.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Pregnant women, nursing mothers, or women of childbearing potential not practicing
adequate contraception.
- Known or suspected hypersensitivity or intolerance to any quinolone, penicillin,
cephalosporin, or macrolide antibiotic.
- Treatment with any systemic antibiotic for 24 hours or longer within 72 hours prior to
the baseline visit.
- Subjects with clinically significant renal dysfunction.
- Subjects with clinically significant hepatic dysfunction.
- Subjects with clinically significant cardiovascular disorders.
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Community-Acquired Pneumonia (CAP)Intravenous Azithromycin Plus Intravenous Ceftriaxone Followed by Oral Azithromycin With Intravenous Levofloxacin Followed by Oral Levofloxacin for the Treatment of Moderate to Severely Ill Hospitalized Patients With Community Acquired Pneumonia
NCT00035347
- Birmingham, Alabama
- Long Beach, California
- Sylmar, California
- Sarasota, Florida
- Columbus, Georgia
- Columbus, Georgia
- Ft Gordon, Georgia
- Shawnee Mission, Kansas
- Louisville, Kentucky
- Detroit, Michigan
- Royal Oak, Michigan
- Kirkwood, Missouri
- St. Louis, Missouri
- Albuquerque, New Mexico
- Mineola, New York
- New York, New York
- Winston-salem, North Carolina
- Cleveland, Ohio
- Columbus, Ohio
- Philadelphia, Pennsylvania
- Sellersville, Pennsylvania
- San Antonio, Texas
- Winnipeg, Manitoba
- Halifax, Nova Scotia
- Hamilton, Ontario
- London, Ontario
- Ottawa, Ontario
- Montreal, Quebec
- Ste-foy, Quebec
- Regina, Saskatchewan
- Saskatoon, Saskatchewan
- Rotenburg (wuemme), Niedersachsen
- Berlin,
- Luedenscheid,
- Maroussi. Attikis, Athens
- Barcelona, Cataluna
- Tarrasa, Cataluna
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Intravenous Azithromycin Plus Intravenous Ceftriaxone Followed by Oral Azithromycin With Intravenous Levofloxacin Followed by Oral Levofloxacin for the Treatment of Moderate to Severely Ill Hospitalized Patients With Community Acquired Pneumonia | |||
| Official Title ICMJE | A Randomized, Multicenter, Open Label Trial Comparing Intravenous Zithromax® (Azithromycin) Plus Intravenous Rocephin® (Ceftriaxone) Followed By Oral Zithromax® (Azithromycin) With Intravenous Levaquin® (Levofloxacin) Followed By Oral Levaquin® (Levofloxacin) For The Treatment Of Moderate To Severely Ill Hospitalized Subjects With Community-Acquired Pneumonia | |||
| Brief Summary | A trial in which patients over 18 years of age who are hospitalized with community acquired pneumonia and are otherwise eligible for entry into the study are randomly selected to receive one of two treatment regimens. After written informed consent is obtained, patients will receive one of the following two treatment regimens: 1) intravenous administration of azithromycin and ceftriaxone followed by azithromycin tablets, or 2) intravenous administration of levofloxacin followed by levofloxacin tablets. At least four study visits are normally conducted up to approximately one month after starting therapy. The objective of this study is to compare the safety and efficacy of the two treatment regimens. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Community-Acquired Pneumonia (CAP) | |||
| Intervention ICMJE |
| |||
| Study Arms ICMJE |
| |||
| 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 | 219 | |||
| Original Enrollment ICMJE | 360 | |||
| Actual Study Completion Date ICMJE | June 2002 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 | Canada, Germany, Greece, Spain, United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00035347 | |||
| Other Study ID Numbers ICMJE | A0661035 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | March 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||