Secondary PeritonitisNCT01096511
Moxifloxacin i.v. in the Treatment of Complicated Intra-Abdominal Infection (cIAI)
An observational study of Secondary Peritonitis and Abscess, Intra-Abdominal, run by Bayer at 1 site in China.
Trial summary
This study is a local, prospective, open-label, company-sponsored, non interventional, multi-center study. Patients documented must suffer from a cIAI and take at least one dose of Moxifloxacin infusion.The primary objective is to define the types of cIAI infections that require Moxifloxacin i.v. therapy in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Peritonitis, Abscess, Intra-Abdominal
- What is being tested?
- Moxifloxacin (Avelox, BAY12-8039)
- Type of treatment
- Injection or infusion
- How many people
- 1,001 participants
- Where
- 1 siteChina
- Study dates
- Dec 2009to Jan 2011
- 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: Adult female and male patients with cIAI, who are at least 18 years of age and are scheduled to be treated with Moxifloxacin infusion, can be documented after the therapy decision has been made.
Who may be able to join
- Patients at least 18 years of age with a diagnosis of cIAI treated with Moxifloxacin infusion with/without sequential tablet treatment can be included into the study. The local Moxifloxacin product information must be considered.
Who cannot join
- Contraindications stated in the local Moxifloxacin product information. Warnings and precautions, stated in the local Moxifloxacin product information must be considered as potential exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Effectiveness and Safety Study of Moxifloxacin i.v. in the Treatment of Complicated Intra-Abdominal Infection (cIAI)
This study is a local, prospective, open-label, company-sponsored, non interventional, multi-center study. Patients documented must suffer from a cIAI and take at least one dose of Moxifloxacin infusion.The primary objective is to define the types of cIAI infections that require Moxifloxacin i.v. therapy in China.
- Conditions
- Secondary Peritonitis, Abscess, Intra-Abdominal
- Being tested
- Moxifloxacin (Avelox, BAY12-8039)
- Keywords
- Moxifloxacin,, cIAI, non-interventional
- Medical subject headings
- Peritonitis, Abdominal Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin (Avelox, BAY12-8039)Drug
The treatment with Moxifloxacin 400 mg infusion should comply with the recommendations written in the local product information. The decision about the treatment with Moxifloxacin as well as the duration of treatment is solely up to the attending physician.
| 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.
Types of cIAI infections
Measured: Day 1
Secondary outcomes (4)
Cure rate
Measured: 5-14 days
Clinical signs and symptoms
Measured: 5-14 days
Duration until improvement and cure
Measured: 5-14 days
Adverse event collection
Measured: 5-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startDec 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary PeritonitisStudies 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
- 1,001 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096511
- Sponsor's protocol ID
- 14537
- Other IDs
- AX0910CN
- Status last verified
- Jun 2013
- First submitted
- 11 Mar 2010
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness and Safety Study of Moxifloxacin i.v. in the Treatment of Complicated Intra-Abdominal Infection (cIAI)
- ClinicalTrials.gov ID
- NCT01096511
- Acronym / sponsor ID
- 14537
- Conditions
- Secondary Peritonitis, Abscess, Intra-Abdominal
- Keywords
- Moxifloxacin,, cIAI, non-interventional
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,001 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 31 Mar 2010 (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.
This study is a local, prospective, open-label, company-sponsored, non interventional, multi-center study. Patients documented must suffer from a cIAI and take at least one dose of Moxifloxacin infusion.The primary objective is to define the types of cIAI infections that require Moxifloxacin i.v. therapy in China.
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
- Adult female and male patients with cIAI, who are at least 18 years of age and are scheduled to be treated with Moxifloxacin infusion, can be documented after the therapy decision has been made.
Key inclusion criteria (1 listed)
- Patients at least 18 years of age with a diagnosis of cIAI treated with Moxifloxacin infusion with/without sequential tablet treatment can be included into the study. The local Moxifloxacin product information must be considered.
Key exclusion criteria (1 listed)
- Contraindications stated in the local Moxifloxacin product information. Warnings and precautions, stated in the local Moxifloxacin product information must be considered as potential exclusion criteria.
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)The treatment with Moxifloxacin 400 mg infusion should comply with the recommendations written in the local product information. The decision about the treatment with Moxifloxacin as well as the duration of treatment is solely up to the attending physician. | Drug | Group 1 |
Primary outcome
Types of cIAI infections
Time frame: Day 1
4 secondary outcomes
Cure rate
Time frame: 5-14 days
Clinical signs and symptoms
Time frame: 5-14 days
Duration until improvement and cure
Time frame: 5-14 days
Adverse event collection
Time frame: 5-14 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 21 Jun 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 Secondary Peritonitis and Abscess, Intra-Abdominal, 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 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 21 Jun 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?
Types of cIAI infections (time frame: Day 1). 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 Jun 2013.