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Amplification and Selection of Antimicrobial Resistance in the Intestine II

Completed
Conditions
Antibiotic Selection Pressure
Interventions
Registration Number
NCT03140826
Lead Sponsor
University Hospital Tuebingen
Brief Summary

Stool samples will be collected from two groups of neutropenic patients in the case that a therapy with either meropenem or piperacillin/tazobactam is needed due to a suspected infection. The intestinal resistome will be determined and quantified using shotgun metagenomics. Based on this, regression models will be used to determine the actual selection pressure caused by these drugs, and both selective forces will be compared. The results will reveal if there is a drug that causes a lower selection pressure compared to the other. The study aims to generate knowledge that is required to design effective antibiotic stewardship programs.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
Inclusion Criteria
  • Patients with hemato-oncological disease in neutropenia or with expected neutropenia
  • Need for treatment with meropenem or piperacillin-tazobactam
Exclusion Criteria
  • pregnancy
  • HIV, HBV, HCV

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Meropenem armmeropenemPatients receiving meropenem to treat an infection.
Primary Outcome Measures
NameTimeMethod
Antibiotic Selection Pressureunder treatment, max. 10 days

Degree of the change of the intestinal resistome.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Institute of Medical Microbiology and Hygiene, University Hospital of Tuebingen

🇩🇪

Tuebingen, Germany

University Hospital Cologne

🇩🇪

Cologne, Germany

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