Community-Acquired PneumoniaPROSTONCT01032694
Non-Interventional Open Label Prospective Observational Comparative Study On Evaluation Of Compliance Of The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Mild To Moderate Community Acquired Pneumonia
An observational study of Community-Acquired Pneumonia, run by Pfizer.
Trial summary
To compare compliance between patients with CAP treated with Azithromycin SR 2.0 g single dose orally and those treated with Amoxiclav - 1000 mg twice daily 10 days for the empiric treatment of CAP in outpatient clinic practice. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Community-Acquired Pneumonia
- What is being tested?
- Azithromycin SR and Amoxiclav
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Dec 2010
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Community-Acquired Pneumonia.
Who may be able to join
- Males or not pregnant or lactating females, 18 years of age or older, for whom oral antibacterial therapy is indicated with clinically evidence of Diagnosis of pneumonia, based on usual clinical practice:
- Physical examination and auscultatory findings (dullness on percussion, bronchial breath sounds, egophony, dry or fine most rales).
- Body temperature >38 degrees C.
Who cannot join
- Known or suspected hypersensitivity or intolerance or contraindications to Azithromycin.
- Amoxiclav according to LPDs, pregnant or lactating women.
About this study
To compare compliance between patients with CAP treated with Azithromycin SR 2.0 g single dose orally and those treated with Amoxiclav - 1000 mg twice daily 10 days for the empiric treatment of CAP in outpatient clinic practice.
- Conditions
- Community-Acquired Pneumonia
- Being tested
- Azithromycin SR, Amoxiclav
- Keywords
- Community-Acquired Pneumonia, Azithromycin SR, Amoxiclav
- 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.
Azithromycin SRDrug
Azithromycin SR, 2.0 g PO x 1 dose for treatment period
AmoxiclavDrug
Amoxiclav 1000 x twice daily, 10 days duration
| Study group | Role | What they receive |
|---|---|---|
| Z-max treated group | Patients with Community-Acquired Pneumonia Receives: Drug: Azithromycin SR | |
| Amoxiclav treated group | Patients with Community-Acquired Pneumonia Receives: Drug: Amoxiclav |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Response of Very Convenient or Somewhat Convenient
Participant reported outcome questionnaire was the assessment of participant's convenience with drug treatment based on following categories: very convenient or somewhat convenient and not convenient or not at all convenient. Value of 1 was reported if participant answered 'very convenient' or 'somewhat convenient' and 0 if participant answered 'not convenient' or 'not at all convenient'.
Measured: Days 11-12
Secondary outcomes (2)
Percent Compliance With the Prescribed Treatment Regimen
Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed).
Measured: Days 11-12
Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen
Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed). Value of 1 was reported if percent compliance equals to 100, and 0 if percent compliance was non-missing and less than 100.
Measured: Days 11-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startApr 2010
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: This study was terminated January 11, 2011 due to low enrollment. This study is not being terminated because of safety or efficacy concerns.
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.
- Other trials for Community-Acquired 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032694
- Sponsor's protocol ID
- A0661200
- Acronym
- PROSTO
- Status last verified
- Nov 2011
- First submitted
- 14 Dec 2009
- Last updated
- 21 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional Open Label Prospective Observational Comparative Study On Evaluation Of Compliance Of The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Mild To Moderate Community Acquired Pneumonia
- ClinicalTrials.gov ID
- NCT01032694
- Acronym / sponsor ID
- PROSTO / A0661200
- Conditions
- Community-Acquired Pneumonia
- Keywords
- Community-Acquired Pneumonia, Azithromycin SR, Amoxiclav
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This study was terminated January 11, 2011 due to low enrollment. This study is not being terminated because of safety or efficacy concerns.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 15 Dec 2009 (estimated)
- Results
- Posted 21 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare compliance between patients with CAP treated with Azithromycin SR 2.0 g single dose orally and those treated with Amoxiclav - 1000 mg twice daily 10 days for the empiric treatment of CAP in outpatient clinic practice.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Z-max treated group | – | Drug: Azithromycin SRPatients with Community-Acquired Pneumonia |
| Amoxiclav treated group | – | Drug: AmoxiclavPatients with Community-Acquired Pneumonia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Community-Acquired Pneumonia.
Key inclusion criteria (3 listed)
- Males or not pregnant or lactating females, 18 years of age or older, for whom oral antibacterial therapy is indicated with clinically evidence of Diagnosis of pneumonia, based on usual clinical practice:
Key exclusion criteria (2 listed)
- Known or suspected hypersensitivity or intolerance or contraindications to Azithromycin.
- Amoxiclav according to LPDs, pregnant or lactating women.
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 SRAzithromycin SR, 2.0 g PO x 1 dose for treatment period | Drug | Z-max treated group |
| AmoxiclavAmoxiclav 1000 x twice daily, 10 days duration | Drug | Amoxiclav treated group |
Primary outcome
Percentage of Participants With Response of Very Convenient or Somewhat Convenient
Time frame: Days 11-12
Participant reported outcome questionnaire was the assessment of participant's convenience with drug treatment based on following categories: very convenient or somewhat convenient and not convenient or not at all convenient. Value of 1 was reported if participant answered 'very convenient' or 'somewhat convenient' and 0 if participant answered 'not convenient' or 'not at all convenient'.
2 secondary outcomes
Percent Compliance With the Prescribed Treatment Regimen
Time frame: Days 11-12
Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen
Time frame: Days 11-12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
Questions about this trial
What is this clinical trial studying?
An observational study of Community-Acquired 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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 21 Dec 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 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?
Percentage of Participants With Response of Very Convenient or Somewhat Convenient (time frame: Days 11-12). 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 21 Dec 2011.