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Amplification and Selection of Antimicrobial Resistance in the Intestine II

Amplification and Selection of Antimicrobial Resistance in the Intestine II

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03140826
Acronym
ASARI II
Enrollment
60
Registered
2017-05-04
Start date
2018-01-30
Completion date
2020-07-31
Last updated
2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Selection Pressure

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.

Interventions

DRUGmeropenem

Antibiotics to treat infections.

Sponsors

University Hospital of Cologne
CollaboratorOTHER
University Hospital Tuebingen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Antibiotic Selection Pressureunder treatment, max. 10 daysDegree of the change of the intestinal resistome.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026