Community Acquired Pneumonia (CAP)Phase 3NCT00809328
The Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP)
A Phase 3 study testing Azithromycin in people with Community Acquired Pneumonia (CAP), run by Pfizer at 34 sites in Japan.
Trial summary
Azithromycin has high rates of clinical response and eradication, wide spectrum of activity, so we suppose the development of the azithromycin injectable formulation in Japan would deliver benefit to patients of community acquired pneumonia. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Community Acquired Pneumonia (CAP)
- What is being tested?
- 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
- 102 participants
- Where
- 34 sitesJapan
- Study dates
- Feb 2009to Mar 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 16 years of age or older patients with CAP.
- Patients who were diagnosed as moderate in severity.
Who cannot join
- Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides, or ketolides.
- Hepatic dysfunction (AST, ALT, total bilirubin > 3 times institutional normal).
- Severe renal dysfunction (creatinine clearance < 30 ml/min).
- Patients who have a history of severe heart diseases (4th -degree of NYHA). Patients who have a congenital or sporadic long QT syndrome, or who are received the drugs with reported QT prolongation.
- Severe underlying disease.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
Japan34 sites
Pfizer Investigational Site
Asahikawa, Hokkaido
Pfizer Investigational Site
Chikushino-shi, Fukuoka
Pfizer Investigational Site
Emukae, Kitamatsuura, Nagasaki
Pfizer Investigational Site
Fukuoka, Fukuoka
Pfizer Investigational Site
Hamamatsu, Shizuoka
Pfizer Investigational Site
Higashihiroshima, Hiroshima
Pfizer Investigational Site
Himejishi, Hyōgo
Pfizer Investigational Site
Hiroshima, Hiroshima
Pfizer Investigational Site
Isahaya, Nagasaki
Pfizer Investigational Site
Kanazawa, Ishikawa-ken
Pfizer Investigational Site
Kawasaki, Kanagawa
Pfizer Investigational Site
Kochi, Kochi
Pfizer Investigational Site
Koga, Fukuoka
Pfizer Investigational Site
Kurashiki, Okayama-ken
Pfizer Investigational Site
Matsumoto, Nagano
Pfizer Investigational Site
Meguro-Ku, Tokyo
Pfizer Investigational Site
Moriya, Ibaraki
Pfizer Investigational Site
Nagasaki, Nagasaki
Pfizer Investigational Site
Niigata, Niigata
Pfizer Investigational Site
Ōita, Oita Prefecture
Pfizer Investigational Site
Okinawa, Okinawa
Pfizer Investigational Site
Sakai, Osaka
Pfizer Investigational Site
Sasebo, Nagasaki
Pfizer Investigational Site
Sendai, Miyagi
Pfizer Investigational Site
Seto-shi, Aichi-ken
Pfizer Investigational Site
Shiogama
Pfizer Investigational Site
Takamatsu, Kagawa-ken
Pfizer Investigational Site
Toshima-ku, Tokyo
Pfizer Investigational Site
Touon, Ehime
Pfizer Investigational Site
Tsu, Mie-ken
Pfizer Investigational Site
Ureshinoshi, Saga-ken
Pfizer Investigational Site
Yanagawa, Fukuoka
Pfizer Investigational Site
Yonezawa, Yamagata
Pfizer Investigational Site
Yufu, Oita Prefecture
About this study
Official title: A Multicenter, Non-Randomized, Open Label Study Of Azithromycin Intravenous Followed By Oral Administration In Japanese Adult Subjects With Community Acquired Pneumonia (CAP) Requiring Initial Intravenous Therapy
Azithromycin has high rates of clinical response and eradication, wide spectrum of activity, so we suppose the development of the azithromycin injectable formulation in Japan would deliver benefit to patients of community acquired pneumonia.
- Conditions
- Community Acquired Pneumonia (CAP)
- Being tested
- Azithromycin
- 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.
AzithromycinDrug
The intravenous formulation 500 mg is administered once daily for 2-5 days; followed by the oral formulation 500 mg will be given once daily to complete a 7 to 10-day course of therapy.
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin | Experimental | Azithromycin switch therapy (switch from intravenous to oral) Receives: Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate (Clinical Response, Data Review Committee Assessment)
Response rate was calculated from the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100.
Measured: End of Treatment, Day 15 and Day 29
Secondary outcomes (4)
Response Rate (Clinical Response, Investigator Assessment)
Response rate was calculated from the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100
Measured: End of Treatment, Day 15 and Day 29
The Tendency Toward Clinical Improvement (Investigator Assessment)
The number of participants who showed tendency toward clinical improvement based on the assessment of temperature, white blood cell count, C-reactive protein, clinical symptoms on Day 3, and was determined to continue the treatment.
Measured: Day 3
Eradication Rate (Bacteriological Response, Data Review Committee Assessment)
Eradication Rate was calculated from the following formula, "the number of participants assessed as eradication , presumed eradication or microbial substitution" over "total participants excluding ones assessed as indeterminate" multiplied by 100
Measured: Day 3, End of Treatment, Day 15 and Day 29
Eradication Rate (Bacteriological Response, Investigator Assessment)
Eradication Rate was calculated from the following formula, "the number of participants assessed as eradication , presumed eradication or microbial substitution" over "total participants excluding ones assessed as indeterminate" multiplied by 100
Measured: Day 3, End of Treatment, Day 15 and Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 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
- NCT00809328
- Sponsor's protocol ID
- A0661191
- Status last verified
- May 2011
- First submitted
- 16 Dec 2008
- Last updated
- 19 May 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kohno S, Tateda K, Kadota J, Fujita J, Niki Y, Watanabe A, Nagashima M. Contradiction between in vitro and clinical outcome: intravenous followed by oral azithromycin therapy demonstrated clinical efficacy in macrolide-resistant pneumococcal pneumonia. J Infect Chemother. 2014 Mar;20(3):199-207. doi: 10.1016/j.jiac.2013.10.010. Epub 2013 Dec 11.
PubMed 24477328
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Non-Randomized, Open Label Study Of Azithromycin Intravenous Followed By Oral Administration In Japanese Adult Subjects With Community Acquired Pneumonia (CAP) Requiring Initial Intravenous Therapy
- ClinicalTrials.gov ID
- NCT00809328
- Acronym / sponsor ID
- A0661191
- Conditions
- Community Acquired Pneumonia (CAP)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 17 Dec 2008 (estimated)
- Results
- Posted 13 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Azithromycin has high rates of clinical response and eradication, wide spectrum of activity, so we suppose the development of the azithromycin injectable formulation in Japan would deliver benefit to patients of community acquired pneumonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Azithromycin | Experimental | Drug: AzithromycinAzithromycin switch therapy (switch from intravenous to oral) |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 16 years of age or older patients with CAP.
- Patients who were diagnosed as moderate in severity.
Key exclusion criteria (5 listed)
- Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides, or ketolides.
- Hepatic dysfunction (AST, ALT, total bilirubin > 3 times institutional normal).
- Severe renal dysfunction (creatinine clearance < 30 ml/min).
- Patients who have a history of severe heart diseases (4th -degree of NYHA). Patients who have a congenital or sporadic long QT syndrome, or who are received the drugs with reported QT prolongation.
- Severe underlying disease.
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 |
|---|---|---|
| AzithromycinThe intravenous formulation 500 mg is administered once daily for 2-5 days; followed by the oral formulation 500 mg will be given once daily to complete a 7 to 10-day course of therapy. | Drug | Azithromycin |
Primary outcome
Response Rate (Clinical Response, Data Review Committee Assessment)
Time frame: End of Treatment, Day 15 and Day 29
Response rate was calculated from the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100.
4 secondary outcomes
Response Rate (Clinical Response, Investigator Assessment)
Time frame: End of Treatment, Day 15 and Day 29
The Tendency Toward Clinical Improvement (Investigator Assessment)
Time frame: Day 3
Eradication Rate (Bacteriological Response, Data Review Committee Assessment)
Time frame: Day 3, End of Treatment, Day 15 and Day 29
Eradication Rate (Bacteriological Response, Investigator Assessment)
Time frame: Day 3, End of Treatment, Day 15 and Day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24477328Kohno S, Tateda K, Kadota J, Fujita J, Niki Y, Watanabe A, Nagashima M. Contradiction between in vitro and clinical outcome: intravenous followed by oral azithromycin therapy demonstrated clinical efficacy in macrolide-resistant pneumococcal pneumonia. J Infect Chemother. 2014 Mar;20(3):199-207. doi: 10.1016/j.jiac.2013.10.010. Epub 2013 Dec 11.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azithromycin in people with Community Acquired Pneumonia (CAP), run by Pfizer at 34 sites in Japan.
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 2 inclusion and 5 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 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Response Rate (Clinical Response, Data Review Committee Assessment) (time frame: End of Treatment, Day 15 and Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00809328, which also lists 1 linked publication.
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 19 May 2011.