Amplification and Selection of Antimicrobial Resistance in the Intestine II

NCT03140826 | Completed FDA Drug

• 1 other identifier: ASARI-II
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Antibiotic Selection Pressure

Outcome Measures

Primary Outcomes (1)

• Antibiotic Selection Pressure

  Degree of the change of the intestinal resistome.

  under treatment, max. 10 days

Study Arms (2)

Meropenem arm

Patients receiving meropenem to treat an infection.

Drug: meropenem

Pip-Tazo arm

Patients receiving piperacillin-meropenem to treat an infection.

Interventions

meropenem DRUG

Antibiotics to treat infections.

Also known as: piperacillin-tazobactam

Meropenem arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Patients with hemato-oncological disease in neutropenia or with expected neutropenia
• Need for treatment with meropenem or piperacillin-tazobactam

You may not qualify if:

• pregnancy
• HIV, HBV, HCV

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• University Hospital of Cologne: collaborator

Study Sites (2)

University Hospital Cologne

Cologne, 50935, Germany

Location

Institute of Medical Microbiology and Hygiene, University Hospital of Tuebingen

Tübingen, 72076, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool Samples

MeSH Terms

Interventions

Meropenem; Piperacillin, Tazobactam Drug Combination

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tazobactam; Penicillanic Acid; Penicillins; Piperacillin; Ampicillin; Penicillin G; Sulfur Compounds; Sulfones; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Matthias Willmann, Prof. Dr.

  University Tuebingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 4, 2017
• Study Start: January 30, 2018
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: August 3, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)