Community-Acquired Pneumonia (CAP)Phase 4NCT00035347
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
A Phase 4 study testing IV azithromycin, ceftriaxone and oral azithromycin in people with Community-Acquired Pneumonia (CAP), run by Pfizer at 37 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-Acquired Pneumonia (CAP)
- What is being tested?
- IV azithromycin, ceftriaxone and oral azithromycin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 37 sitesin 5 countries
- Study dates
- Jan 2001to Jun 2002
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
37 sites in 5 countries.
37 sites in 5 countries
United States22 sites
Pfizer Investigational Site
Albuquerque, New Mexico, 87108-5154
Pfizer Investigational Site
Birmingham, Alabama, 35233
Pfizer Investigational Site
Cleveland, Ohio, 44106
Pfizer Investigational Site
Columbus, Georgia, 31902
Pfizer Investigational Site
Columbus, Georgia, 31904
Pfizer Investigational Site
Columbus, Ohio, 43202
Pfizer Investigational Site
Detroit, Michigan, 48202
Pfizer Investigational Site
Fort Eisenhower, Georgia, 30905
Pfizer Investigational Site
Kirkwood, Missouri, 63122
Pfizer Investigational Site
Long Beach, California, 90822
Pfizer Investigational Site
Louisville, Kentucky, 40206
Pfizer Investigational Site
Mineola, New York, 11501
Pfizer Investigational Site
New York, New York, 10003
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19140
Pfizer Investigational Site
Royal Oak, Michigan, 48073-6769
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
Sarasota, Florida, 34339
Pfizer Investigational Site
Sellersville, Pennsylvania, 18960
Pfizer Investigational Site
Shawnee Mission, Kansas, 66204
Pfizer Investigational Site
St Louis, Missouri, 63110
Pfizer Investigational Site
Sylmar, California, 91342
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
Canada9 sites
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 3A7
Pfizer Investigational Site
Hamilton, Ontario, L8V 1C3
Pfizer Investigational Site
London, Ontario, N6A 4G5
Pfizer Investigational Site
Montreal, Quebec, H1T 2M4
Pfizer Investigational Site
Ottawa, Ontario, K1Y 4E9
Pfizer Investigational Site
Regina, Saskatchewan, S4P 1Z7
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7L 2W1
Pfizer Investigational Site
Ste-foy, Quebec, G1V 4G5
Pfizer Investigational Site
Winnipeg, Manitoba, R3A 1R9
Germany3 sites
Pfizer Investigational Site
Berlin, State of Berlin, D-14109
Pfizer Investigational Site
Lüdenscheid, D58515
Pfizer Investigational Site
Rotenburg (Wümme), Lower Saxony, D-27356
Spain2 sites
Pfizer Investigational Site
Barcelona, Catalonia, 08036
Pfizer Investigational Site
Tarrasa, Catalonia, 08221
About this study
Official title: 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
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.
- Conditions
- Community-Acquired Pneumonia (CAP)
- Being tested
- IV azithromycin, ceftriaxone, oral azithromycin, IV levofloxacin, oral levofloxacin
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV azithromycinDrug
Also called Zithromax®
500 mg once daily
ceftriaxoneDrug
Also called Rocephin®
1 gram once daily for 2 to 5 days
oral azithromycinDrug
Also called Zithromax®
2 x 250 mg once daily
IV levofloxacinDrug
Also called Levaquin®
500 mg once daily
oral levofloxacinDrug
Also called Levaquin®
500 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin plus ceftriaxone group (AZY+CEF group) | Experimental | IV azithromycin (500 mg once daily) plus ceftriaxone (1 gram once daily) for 2 to 5 days followed by oral azithromycin (2 x 250 mg once daily) to complete a total of 7 to 10 days of therapy Receives: Drug: IV azithromycin; Drug: ceftriaxone; Drug: oral azithromycin |
| Levofloxacin group (LEV group) | Experimental | IV levofloxacin (500 mg once daily) for a minimum of 2 days followed by oral levofloxacin (500 mg once daily) to complete a total of 7 to 14 days of therapy. Receives: Drug: IV levofloxacin; Drug: oral levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of sequential therapy with IV Zithromax® plus IV Rocephin® followed by oral Zithromax® to IV Levaquin® (levofloxacin) followed by oral Levaquin® in the treatment of moderate to severely ill subjects with community-acquired pneumonia.
Measured: Duration of trial
Secondary outcomes (1)
Safety and toleration of IV Zithromax® plus IV Rocephin® followed by oral Zithromax® to IV Levaquin® followed by oral Levaquin®, and to compare the bacteriological response rates in subjects with a baseline pathogen.
Measured: Duration of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2002 (estimated)
- Study startJan 2001
- Study completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-Acquired Pneumonia (CAP)Studies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00035347
- Sponsor's protocol ID
- A0661035
- Status last verified
- Mar 2017
- First submitted
- 2 May 2002
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00035347
- Acronym / sponsor ID
- A0661035
- Conditions
- Community-Acquired Pneumonia (CAP)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2001
- Study completion
- Jun 2002 (actual)
- First posted
- 6 May 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azithromycin plus ceftriaxone group (AZY+CEF group) | Experimental | Drug: IV azithromycin, Drug: ceftriaxone, Drug: oral azithromycinIV azithromycin (500 mg once daily) plus ceftriaxone (1 gram once daily) for 2 to 5 days followed by oral azithromycin (2 x 250 mg once daily) to complete a total of 7 to 10 days of therapy |
| Levofloxacin group (LEV group) | Experimental | Drug: IV levofloxacin, Drug: oral levofloxacinIV levofloxacin (500 mg once daily) for a minimum of 2 days followed by oral levofloxacin (500 mg once daily) to complete a total of 7 to 14 days of therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV azithromycinAlso: Zithromax®500 mg once daily | Drug | Azithromycin plus ceftriaxone group (AZY+CEF group) |
| ceftriaxoneAlso: Rocephin®1 gram once daily for 2 to 5 days | Drug | Azithromycin plus ceftriaxone group (AZY+CEF group) |
| oral azithromycinAlso: Zithromax®2 x 250 mg once daily | Drug | Azithromycin plus ceftriaxone group (AZY+CEF group) |
| IV levofloxacinAlso: Levaquin®500 mg once daily | Drug | Levofloxacin group (LEV group) |
| oral levofloxacinAlso: Levaquin®500 mg once daily | Drug | Levofloxacin group (LEV group) |
Primary outcome
Efficacy of sequential therapy with IV Zithromax® plus IV Rocephin® followed by oral Zithromax® to IV Levaquin® (levofloxacin) followed by oral Levaquin® in the treatment of moderate to severely ill subjects with community-acquired pneumonia.
Time frame: Duration of trial
1 secondary outcome
Safety and toleration of IV Zithromax® plus IV Rocephin® followed by oral Zithromax® to IV Levaquin® followed by oral Levaquin®, and to compare the bacteriological response rates in subjects with a baseline pathogen.
Time frame: Duration of trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
37 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IV azithromycin, ceftriaxone and oral azithromycin in people with Community-Acquired Pneumonia (CAP), run by Pfizer at 37 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Canada, Germany, Spain, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of sequential therapy with IV Zithromax® plus IV Rocephin® followed by oral Zithromax® to IV Levaquin® (levofloxacin) followed by oral Levaquin® in the treatment of moderate to severely ill subjects with community-acquired pneumonia. (time frame: Duration of trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2017.