Amplification and Selection of Antimicrobial Resistance in the Intestine II (ASARI II)

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.

Study Overview

• Status: Completed
• Conditions: Antibiotic Selection Pressure
• Intervention / Treatment: Drug: meropenem

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany, 50935
    • University Hospital Cologne
  • Tuebingen, Germany, 72076
    • Institute of Medical Microbiology and Hygiene, University Hospital of Tuebingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with hemato-oncological disease in neutropenia or with expected neutropenia

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Meropenem arm; Patients receiving meropenem to treat an infection.	Drug: meropenem; Antibiotics to treat infections.; Other Names: piperacillin-tazobactam
Pip-Tazo arm; Patients receiving piperacillin-meropenem to treat an infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibiotic Selection Pressure	Degree of the change of the intestinal resistome.	under treatment, max. 10 days

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Collaborators: University Hospital of Cologne
• Investigators: Principal Investigator: Matthias Willmann, Prof. Dr., University Tuebingen

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2018
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: May 2, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 4, 2017

Study Record Updates

• Last Update Posted (Actual): August 3, 2020
• Last Update Submitted That Met QC Criteria: July 30, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Meropenem; Piperacillin; Tazobactam; Piperacillin, Tazobactam Drug Combination
• Other Study ID Numbers: ASARI-II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No