PneumoniaPhase 4NCT00137007
Zithromax EV in Community-Acquired Pneumonia (CAP)
A Phase 4 study testing Azithromycin and Ampicillin/sulbactam in people with Pneumonia, run by Pfizer.
Trial summary
The intravenous (IV) regimen containing azithromycin (Zithromax) plus ampicillin-sulbactam is consistent with current guidelines for the treatment of CAP. In fact the International guidelines for the treatment of CAP in hospitalised patients suggests the use of a combination between a b-lactam and a macrolide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- Azithromycin and Ampicillin/sulbactam
- How many people
- 151 participants
- Where
- No sites listed yet
- Study dates
- Nov 2003to Sep 2005
- 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
- Subjects must require hospitalization and intravenous therapy.
- Subjects must have a Fine pneumonia score > 70 (Fine Class > II).
- Subjects must have a medical history and clinical and radiological findings consistent with a community-acquired bronchopneumonia or lobar pneumonia. The following criteria must be met:
- new infiltrate(s) on chest X-ray; AND
- at least two of the CAP signs or symptoms.
Who cannot join
- Treatment with any systemic antibiotic for 24 hours or longer within 72 hours of the baseline visit, or treatment for more than 7 days within 15 days.
- Specific systemic diseases or other medical conditions that would interfere with the evaluation of the therapeutic response or safety of the study drug, including:
- Known acquired immunodeficiency syndrome (AIDS) or suspected Pneumocystis carinii pneumonia;
- Neutropenia;
- Cavitary lung disease by chest X-ray;
- Primary lung cancer or other malignancy metastatic to the lung;
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- Aspiration pneumonia;
- Empyema;
- Known or suspected tuberculosis;
- Neoplastic disease;
- Cystic fibrosis;
- A history of any form of epilepsy or seizure;
- DDM;
- Bronchiectasis, bronchial obstruction or history of post-obstructive pneumonia (this does not exclude patients with chronic obstructive pulmonary disease);
- Significant gastrointestinal or other conditions which may affect study drug absorption; and
- Significant cardiovascular disorders.
- Immunosuppressive therapy, defined as chronic treatment with known immunosuppressant medications
- Impaired hepatic function, as shown by, but not limited to, AST, (SGOT), or ALT (SGPT) greater than three times the laboratory upper limit of normal, or total bilirubin greater than two times the upper limit of normal.
- Subjects already hospitalized or who resided in a long-term-care facility for greater than 14 days before the onset of symptoms.
About this study
Official title: A Multicenter, Open Label Trial Evaluating Intravenous Azithromycin Plus Intravenous Ampicillin/Sulbactam Followed by Oral Azithromycin Plus Intravenous Ampicillin/Sulbactam for the Treatment of Hospitalized Subjects With Community-Acquired Pneumonia (CAP)
The intravenous (IV) regimen containing azithromycin (Zithromax) plus ampicillin-sulbactam is consistent with current guidelines for the treatment of CAP. In fact the International guidelines for the treatment of CAP in hospitalised patients suggests the use of a combination between a b-lactam and a macrolide.
This trial will allow investigators to evaluate the efficacy of azithromycin plus ampicillin-sulbactam in the treatment of hospitalized subjects with community acquired pneumonia. In addition, this trial will allow investigators to evaluate the safety and toleration of combination therapy.
- Conditions
- Pneumonia
- Being tested
- Azithromycin, Ampicillin/sulbactam
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Ampicillin/sulbactamDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the clinical efficacy of intravenous (IV) azithromycin 500 mg once daily plus IV ampicillin/sulbactam 3 grams twice a day (BID) for 2 to 5 days
followed by oral azithromycin 500 mg once daily plus IV ampicillin/sulbactam 3 grams.
Secondary outcomes (1)
To evaluate the eradication of baseline pathogens of IV azithromycin plus IV ampicillin/sulbactam followed by oral azithromycin plus IV ampicillin/sulbactam at Visit 3 and Visit 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startNov 2003
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 151 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
- NCT00137007
- Sponsor's protocol ID
- A0661082
- Status last verified
- Apr 2011
- First submitted
- 25 Aug 2005
- Last updated
- 22 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label Trial Evaluating Intravenous Azithromycin Plus Intravenous Ampicillin/Sulbactam Followed by Oral Azithromycin Plus Intravenous Ampicillin/Sulbactam for the Treatment of Hospitalized Subjects With Community-Acquired Pneumonia (CAP)
- ClinicalTrials.gov ID
- NCT00137007
- Acronym / sponsor ID
- A0661082
- Conditions
- Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Study completion
- Sep 2005 (actual)
- First posted
- 29 Aug 2005 (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.
The intravenous (IV) regimen containing azithromycin (Zithromax) plus ampicillin-sulbactam is consistent with current guidelines for the treatment of CAP. In fact the International guidelines for the treatment of CAP in hospitalised patients suggests the use of a combination between a b-lactam and a macrolide.
This trial will allow investigators to evaluate the efficacy of azithromycin plus ampicillin-sulbactam in the treatment of hospitalized subjects with community acquired pneumonia. In addition, this trial will allow investigators to evaluate the safety and toleration of combination therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must require hospitalization and intravenous therapy.
- Subjects must have a Fine pneumonia score > 70 (Fine Class > II).
- Subjects must have a medical history and clinical and radiological findings consistent with a community-acquired bronchopneumonia or lobar pneumonia. The following criteria must be met:
Key exclusion criteria (19 listed)
- Treatment with any systemic antibiotic for 24 hours or longer within 72 hours of the baseline visit, or treatment for more than 7 days within 15 days.
- Specific systemic diseases or other medical conditions that would interfere with the evaluation of the therapeutic response or safety of the study drug, including:
- Immunosuppressive therapy, defined as chronic treatment with known immunosuppressant medications
- Impaired hepatic function, as shown by, but not limited to, AST, (SGOT), or ALT (SGPT) greater than three times the laboratory upper limit of normal, or total bilirubin greater than two times the upper limit of normal.
- Subjects already hospitalized or who resided in a long-term-care facility for greater than 14 days before the onset of symptoms.
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 |
|---|---|---|
| Azithromycin | Drug | – |
| Ampicillin/sulbactam | Drug | – |
Primary outcome
To evaluate the clinical efficacy of intravenous (IV) azithromycin 500 mg once daily plus IV ampicillin/sulbactam 3 grams twice a day (BID) for 2 to 5 days
followed by oral azithromycin 500 mg once daily plus IV ampicillin/sulbactam 3 grams.
1 secondary outcome
To evaluate the eradication of baseline pathogens of IV azithromycin plus IV ampicillin/sulbactam followed by oral azithromycin plus IV ampicillin/sulbactam at Visit 3 and Visit 4
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 22 Apr 2011.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azithromycin and Ampicillin/sulbactam in people with Pneumonia, run by Pfizer.
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 5 inclusion and 19 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 22 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
To evaluate the clinical efficacy of intravenous (IV) azithromycin 500 mg once daily plus IV ampicillin/sulbactam 3 grams twice a day (BID) for 2 to 5 days. The study lists 2 primary outcomes in all. 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 22 Apr 2011.