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Status unknownNCT00860587BakkiUpdated Mar 12, 2009

Antibiotic Resistant Bacteria Among Patients With Severe Intraabdominal Infections

An observational study in Complicated Intra-Abdominal Infections, sponsored by University Hospital, Linkoeping. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-03-12.

Sponsored by University Hospital, Linkoeping · Observational

The sponsor has not verified this record recently (last verified Mar 2009), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
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Study 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. To study species changes in the rectal flora among patients with severe IAI before and after antibiotic treatment and surgical intervention.
  3. To review guidelines for antibiotic use in participating units.
  4. To evaluate surgical antibiotic prophylaxis and treatment in relation to risk for colonization and infection with antibiotic resistant bacteria among patients with severe IAI
  5. 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.
  6. 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.

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Conditions studied

  • Complicated Intra-Abdominal Infections

Keywords

  • Antibiotic resistance
  • Antibiotic treatment
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In context

Infections

6,688 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 200 is below the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

University Hospital, Linkoeping is the lead sponsor of 118 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with evidence of severe intra-abdominal infections.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Age under 18 years
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
200 participants (estimated)
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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

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Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00860587
Lead sponsor
University Hospital, Linkoeping
Collaborators
Merck Sharp & Dohme LLC
First posted
Mar 12, 2009
Start date
Feb 2006
Primary completion
Oct 2009 (estimated)
Completion
Oct 2009 (estimated)
Last update
Mar 12, 2009

Study contacts

Håkan SI Hanberger, Professor
principal investigator · Division of Infectious Diseases, University Hospital, Linköping

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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