Complicated Intra-Abdominal InfectionsBakkiNCT00860587
Antibiotic Resistant Bacteria Among Patients With Severe Intraabdominal Infections
An observational study of Complicated Intra-Abdominal Infections, run by University Hospital, Linkoeping.
Trial summary
The objectives of the study were: 1. To study risk factors for colonization and infection with antibiotic resistant bacteria among patients with severe IAI before and after antibiotic treatment and surgical intervention. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complicated Intra-Abdominal Infections
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to Oct 2009
- 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: Patients with evidence of severe intra-abdominal infections.
Who may be able to join
- Patients with evidence of intra-abdominal infections that require surgical intervention will be eligible.
- In addition will patients with intra-abdominal abscess confirmed with CT/ultrasound be eligible, but not treated with surgical intervention if estimated to require at least 5 days antibiotic treatment, with a severity needing initial intravenous administration of antibiotics.
Who cannot join
- Age under 18 years
About this study
Official title: Risk Factors for Colonization and Infection With Antibiotic Resistant Bacteria Among Patients With Severe Intraabdominal Infections (IAI). An Open Observational Study
The objectives of the study were:
- To study risk factors for colonization and infection with antibiotic resistant bacteria among patients with severe IAI before and after antibiotic treatment and surgical intervention.
- To study species changes in the rectal flora among patients with severe IAI before and after antibiotic treatment and surgical intervention.
- To review guidelines for antibiotic use in participating units.
- To evaluate surgical antibiotic prophylaxis and treatment in relation to risk for colonization and infection with antibiotic resistant bacteria among patients with severe IAI
- To use the results from the study in the process of a more appropriate use of antibiotics in participating units and care of patients with severe IAI.
- To study the dynamics of extended-spectrum beta-lactamase producing and wild-type Enterobacteriaceae in patients with suspected severe intra abdominal infections before, during and after antibiotic treatment.
Read the detailed description
In order to evaluate if standard empirical treatment was adequate in relation to resistance pattern among most prevalent species at admission we need another 70 patients to be included with at least data and cultures from admission.
- Conditions
- Complicated Intra-Abdominal Infections
- Keywords
- Antibiotic resistance, Antibiotic treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary End points for detection of AB-R Colonising index: (a) Proportion of patients colonised with AB-R strains per bacteria species.(b)Proportion of colonising cultures containing AB-R strains per bacteria species.
Measured: 48 hours - 2 weeks after end of antibiotic treatment
Secondary outcomes (1)
Proportion of patients with SSI other postoperative infections caused by AB-R strains, per infection type and per bacteria species.
Measured: 48 hours - 2 weeks after end of antibiotic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startFeb 2006
- Primary completionOct 2009 (estimated)
- Study completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complicated Intra-Abdominal InfectionsStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- Håkan SI Hanberger, Professor, Principal investigator, Division of Infectious Diseases, University Hospital, Linköping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860587
- Sponsor's protocol ID
- Bakki
- Acronym
- Bakki
- Status last verified
- Mar 2009
- First submitted
- 11 Mar 2009
- Last updated
- 12 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Colonization and Infection With Antibiotic Resistant Bacteria Among Patients With Severe Intraabdominal Infections (IAI). An Open Observational Study
- ClinicalTrials.gov ID
- NCT00860587
- Acronym / sponsor ID
- Bakki / Bakki
- Conditions
- Complicated Intra-Abdominal Infections
- Keywords
- Antibiotic resistance, Antibiotic treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Feb 2006
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Oct 2009 (estimated)
- First posted
- 12 Mar 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 objectives of the study were:
- To study risk factors for colonization and infection with antibiotic resistant bacteria among patients with severe IAI before and after antibiotic treatment and surgical intervention.
- To study species changes in the rectal flora among patients with severe IAI before and after antibiotic treatment and surgical intervention.
- To review guidelines for antibiotic use in participating units.
- To evaluate surgical antibiotic prophylaxis and treatment in relation to risk for colonization and infection with antibiotic resistant bacteria among patients with severe IAI
- To use the results from the study in the process of a more appropriate use of antibiotics in participating units and care of patients with severe IAI.
- To study the dynamics of extended-spectrum beta-lactamase producing and wild-type Enterobacteriaceae in patients with suspected severe intra abdominal infections before, during and after antibiotic treatment.
Detailed description
In order to evaluate if standard empirical treatment was adequate in relation to resistance pattern among most prevalent species at admission we need another 70 patients to be included with at least data and cultures from admission.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with evidence of severe intra-abdominal infections.
Key inclusion criteria (2 listed)
- Patients with evidence of intra-abdominal infections that require surgical intervention will be eligible.
- In addition will patients with intra-abdominal abscess confirmed with CT/ultrasound be eligible, but not treated with surgical intervention if estimated to require at least 5 days antibiotic treatment, with a severity needing initial intravenous administration of antibiotics.
Key exclusion criteria (1 listed)
- Age under 18 years
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
Primary End points for detection of AB-R Colonising index: (a) Proportion of patients colonised with AB-R strains per bacteria species.(b)Proportion of colonising cultures containing AB-R strains per bacteria species.
Time frame: 48 hours - 2 weeks after end of antibiotic treatment
1 secondary outcome
Proportion of patients with SSI other postoperative infections caused by AB-R strains, per infection type and per bacteria species.
Time frame: 48 hours - 2 weeks after end of antibiotic treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 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.
Håkan SI Hanberger, Professor principal investigator
Division of Infectious Diseases, University Hospital, Linköping
Questions about this trial
What is this clinical trial studying?
An observational study of Complicated Intra-Abdominal Infections, run by University Hospital, Linkoeping.
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: status not confirmed, as of the sponsor's last update on 12 Mar 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?
Results are not available in the source record.
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?
Primary End points for detection of AB-R Colonising index: (a) Proportion of patients colonised with AB-R strains per bacteria species.(b)Proportion of colonising cultures containing AB-R strains per bacteria species. (time frame: 48 hours - 2 weeks after end of antibiotic treatment). 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 12 Mar 2009.