PneumoniaNCT00987792
CAPRIVI: Community Acquired Pneumonia: Treatment With Avelox® in Hospitalized Patients
An observational study of Pneumonia, run by Bayer at 11 sites in 11 countries.
Trial summary
The aim of this study is to obtain data from hospitalized Community Acquired Pneumonia (CAP) patients on the disease including disease severity, clinical signs and symptoms and measures used for diagnosis in daily routine practice as well as data on Avelox® including information on the use, effectiveness, treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- Moxifloxacin (Avelox, BAY12-8039)
- How many people
- 2,595 participants
- Where
- 11 sitesin 11 countries
- Study dates
- Sep 2009to Oct 2012
- 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: Female and male hospitalized adult patients scheduled to be treated with moxifloxacin for their CAP and starting treatment with intravenous administration will be documented after the attending physician made the therapeutic decision at his/her discretion.
Who may be able to join
- Adult hospitalized patients with a diagnosis of CAP (based on local medical practice) and decision taken by the investigator to treat with moxifloxacin and to start treatment with intravenous administration. The local moxifloxacin product information must be considered.
Who cannot join
- Contraindications stated in the local moxifloxacin product information; warnings and precautions must be considered.
Trial locations and contacts
11 sites in 11 countries.
11 sites in 11 countries
About this study
The aim of this study is to obtain data from hospitalized Community Acquired Pneumonia (CAP) patients on the disease including disease severity, clinical signs and symptoms and measures used for diagnosis in daily routine practice as well as data on Avelox® including information on the use, effectiveness, treatment outcome, safety and tolerability.
As this is a non-interventional observational study, routine clinical practice is observed. The application of medications follows the normal routines and is decided by the treating physician under recognition of the package insert.
- Conditions
- Pneumonia
- Being tested
- Moxifloxacin (Avelox, BAY12-8039)
- Keywords
- Community Acquired Pneumonia
- Medical subject headings
- Pneumonia, Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin (Avelox, BAY12-8039)Drug
Hospitalized patients receiving Avelox according to local drug information
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Moxifloxacin (Avelox, BAY12-8039) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to evaluate the distribution of the CRB-65 severity index at baseline in hospitalized patients suffering from CAP and to whom moxifloxacin (starting with intravenous administration) was prescribed, in countries from South Eastern
Measured: At baseline only
Secondary outcomes (5)
Assessment of use of different diagnostic measures in daily routine practice, especially chest radiography and microbiology
Measured: 7-14 days
Determination of the proportion of patients treated with moxifloxacin as antibiotic second-line therapy
Measured: 7-14 days
Assessment of clinical signs and symptoms before and after therapy with moxifloxacin
Measured: 7-14 days
Measurement of moxifloxacin treatment success in terms of effectiveness and outcome
Measured: 7-14 days
Evaluation of safety and tolerability of moxifloxacin in hospitalized CAP patients
Measured: 7-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2011
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 2,595 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
- NCT00987792
- Sponsor's protocol ID
- 14522
- Other IDs
- AX0801
- Status last verified
- Aug 2015
- First submitted
- 30 Sep 2009
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kuzman I, Bezlepko A, Kondova Topuzovska I, Rokusz L, Iudina L, Marschall HP, Petri T. Efficacy and safety of moxifloxacin in community acquired pneumonia: a prospective, multicenter, observational study (CAPRIVI). BMC Pulm Med. 2014 Jun 30;14:105. doi: 10.1186/1471-2466-14-105.
PubMed 24975809
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAPRIVI: Community Acquired Pneumonia: Treatment With Avelox® in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT00987792
- Acronym / sponsor ID
- 14522
- Conditions
- Pneumonia
- Keywords
- Community Acquired Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,595 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 1 Oct 2009 (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 aim of this study is to obtain data from hospitalized Community Acquired Pneumonia (CAP) patients on the disease including disease severity, clinical signs and symptoms and measures used for diagnosis in daily routine practice as well as data on Avelox® including information on the use, effectiveness, treatment outcome, safety and tolerability.
As this is a non-interventional observational study, routine clinical practice is observed. The application of medications follows the normal routines and is decided by the treating physician under recognition of the package insert.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Moxifloxacin (Avelox, BAY12-8039) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female and male hospitalized adult patients scheduled to be treated with moxifloxacin for their CAP and starting treatment with intravenous administration will be documented after the attending physician made the therapeutic decision at his/her discretion.
Key inclusion criteria (1 listed)
- Adult hospitalized patients with a diagnosis of CAP (based on local medical practice) and decision taken by the investigator to treat with moxifloxacin and to start treatment with intravenous administration. The local moxifloxacin product information must be considered.
Key exclusion criteria (1 listed)
- Contraindications stated in the local moxifloxacin product information; warnings and precautions must be considered.
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 |
|---|---|---|
| Moxifloxacin (Avelox, BAY12-8039)Hospitalized patients receiving Avelox according to local drug information | Drug | Group 1 |
Primary outcome
The primary objective is to evaluate the distribution of the CRB-65 severity index at baseline in hospitalized patients suffering from CAP and to whom moxifloxacin (starting with intravenous administration) was prescribed, in countries from South Eastern
Time frame: At baseline only
5 secondary outcomes
Assessment of use of different diagnostic measures in daily routine practice, especially chest radiography and microbiology
Time frame: 7-14 days
Determination of the proportion of patients treated with moxifloxacin as antibiotic second-line therapy
Time frame: 7-14 days
Assessment of clinical signs and symptoms before and after therapy with moxifloxacin
Time frame: 7-14 days
Measurement of moxifloxacin treatment success in terms of effectiveness and outcome
Time frame: 7-14 days
Evaluation of safety and tolerability of moxifloxacin in hospitalized CAP patients
Time frame: 7-14 days
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 7 Aug 2015.
- Results publication: PubMed 24975809Kuzman I, Bezlepko A, Kondova Topuzovska I, Rokusz L, Iudina L, Marschall HP, Petri T. Efficacy and safety of moxifloxacin in community acquired pneumonia: a prospective, multicenter, observational study (CAPRIVI). BMC Pulm Med. 2014 Jun 30;14:105. doi: 10.1186/1471-2466-14-105.
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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
11 sites in 11 countries: 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 11 sites in 11 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 1 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 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Croatia, France, Hungary, Jordan, Kazakhstan and 6 more countries. 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?
The primary objective is to evaluate the distribution of the CRB-65 severity index at baseline in hospitalized patients suffering from CAP and to whom moxifloxacin (starting with intravenous administration) was prescribed, in countries from South Eastern (time frame: At baseline only). 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 NCT00987792, 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 7 Aug 2015.