Intra-abdominal InfectionNCT00244088
Study Evaluating the Etiology of Intra-Abdominal Infections
An observational study of Intra-abdominal Infection, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
The aim of this study is to define the etiology of intra-abdominal infections, to study the role of Enterococcus spp and Pseudomonas aeruginosa in these infections and to clarify the need for specific enterococcal antimicrobial coverage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra-abdominal Infection
- How many people
- 340 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Dec 2004
- 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: Surgery units
Who may be able to join
- A case will be defined as an intra-abdominal abscess or peritoneal fluid culture that will be positive for enterococcus or an enterococcal bacteriemia in association with an intra-abdominal source of infection.
- A control will be defined as a culture-positive intra-abdominal infection or bacteriemia due to an intraabdominal focus where enterococci have not been isolated.
Who cannot join
- -
About this study
Official title: Study of the Etiology of Intra-Abdominal Infections
The aim of this study is to define the etiology of intra-abdominal infections, to study the role of Enterococcus spp and Pseudomonas aeruginosa in these infections and to clarify the need for specific enterococcal antimicrobial coverage.
- Conditions
- Intra-abdominal Infection
- Keywords
- Abdominal infection
- Medical subject headings
- Intraabdominal Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2005 (estimated)
- Study startApr 2004
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-abdominal InfectionStudies of the same condition, open and under way.
- 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
- 340 participants
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Principal investigator, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00244088
- Sponsor's protocol ID
- 101316
- Status last verified
- Aug 2009
- First submitted
- 21 Oct 2005
- Last updated
- 1 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Etiology of Intra-Abdominal Infections
- ClinicalTrials.gov ID
- NCT00244088
- Acronym / sponsor ID
- 101316
- Conditions
- Intra-abdominal Infection
- Keywords
- Abdominal infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 25 Oct 2005 (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 define the etiology of intra-abdominal infections, to study the role of Enterococcus spp and Pseudomonas aeruginosa in these infections and to clarify the need for specific enterococcal antimicrobial coverage.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgery units
Key inclusion criteria (2 listed)
- A case will be defined as an intra-abdominal abscess or peritoneal fluid culture that will be positive for enterococcus or an enterococcal bacteriemia in association with an intra-abdominal source of infection.
- A control will be defined as a culture-positive intra-abdominal infection or bacteriemia due to an intraabdominal focus where enterococci have not been isolated.
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.
Primary outcome
Not reported in the source record.
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 1 Sep 2009.
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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.
Medical Monitor principal investigator
Wyeth is now a wholly owned subsidiary of Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Intra-abdominal Infection, run by Wyeth is now a wholly owned subsidiary of 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 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 1 Sep 2009. 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?
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.
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 1 Sep 2009.