PneumoniaNCT01416506
Community-Acquired Pneumonia (CAP) Surveillance
An observational study of Pneumonia, run by Bayer at 1 site in China.
Trial summary
Prospective, non-interventional, multi-center study. 7 investigative centers will involved in China. Around 560 CAP outpatients or inpatients will be screened until 56 M. pneumoniae isolates collected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- No Drug
- How many people
- 560 participants
- Where
- 1 siteChina
- Study dates
- Sep 2010to Jan 2013
- Phase
- Observational
- 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
Study population: Chinese adult (male or female) >/= 18 years old
Who may be able to join
- Chinese adult (male or female) ≥18 years old
- Outpatients or inpatients who suffer from CAP
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community-Acquired Pneumonia (CAP) Mycoplasma Surveillance
Prospective, non-interventional, multi-center study. 7 investigative centers will involved in China. Around 560 CAP outpatients or inpatients will be screened until 56 M. pneumoniae isolates collected.
- Conditions
- Pneumonia
- Being tested
- No Drug
- Keywords
- Pneumonia, surveillance
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No DrugOther
It's a surveillance
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Other: No Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
In vitro Minimal Inhibitory Concentration Detection
Measured: Up to 27 months
Secondary outcomes (1)
In vitro Gene Mutation Detection
Measured: Up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study startSep 2010
- Primary completionAug 2012
- Study completionJan 2013
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 BayerThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416506
- Sponsor's protocol ID
- 15465
- Other IDs
- NN1010CN
- Status last verified
- Nov 2013
- First submitted
- 12 Aug 2011
- Last updated
- 5 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Acquired Pneumonia (CAP) Mycoplasma Surveillance
- ClinicalTrials.gov ID
- NCT01416506
- Acronym / sponsor ID
- 15465
- Conditions
- Pneumonia
- Keywords
- Pneumonia, surveillance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 15 Aug 2011 (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.
Prospective, non-interventional, multi-center study. 7 investigative centers will involved in China. Around 560 CAP outpatients or inpatients will be screened until 56 M. pneumoniae isolates collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: No Drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese adult (male or female) >/= 18 years old
Key inclusion criteria (2 listed)
- Chinese adult (male or female) ≥18 years old
- Outpatients or inpatients who suffer from CAP
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| No DrugIt's a surveillance | Other | Group 1 |
Primary outcome
In vitro Minimal Inhibitory Concentration Detection
Time frame: Up to 27 months
1 secondary outcome
In vitro Gene Mutation Detection
Time frame: Up to 15 months
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 5 Nov 2013.
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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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, run by Bayer at 1 site in China.
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 1 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 5 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
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?
In vitro Minimal Inhibitory Concentration Detection (time frame: Up to 27 months). 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 5 Nov 2013.