Amplification and Selection of Antimicrobial Resistance in the Intestine II

NCT ID: NCT03140826

Last Updated: 2020-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-30

Study Completion Date

2020-07-31

Brief Summary

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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

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Conditions

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Antibiotic Selection Pressure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Meropenem arm

Patients receiving meropenem to treat an infection.

meropenem

Intervention Type DRUG

Antibiotics to treat infections.

Pip-Tazo arm

Patients receiving piperacillin-meropenem to treat an infection.

No interventions assigned to this group

Interventions

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meropenem

Antibiotics to treat infections.

Intervention Type DRUG

Other Intervention Names

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piperacillin-tazobactam

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital of Cologne

OTHER

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Dr. Matthias Willmann

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthias Willmann, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Tuebingen

Locations

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University Hospital Cologne

Cologne, , Germany

Site Status

Institute of Medical Microbiology and Hygiene, University Hospital of Tuebingen

Tübingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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ASARI-II

Identifier Type: -

Identifier Source: org_study_id

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