Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03140826
Recruitment Status : Recruiting
First Posted : May 4, 2017
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
University Hospital of Cologne
Information provided by (Responsible Party):
Dr. Matthias Willmann, 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.

Condition or disease Intervention/treatment
Antibiotic Selection Pressure Drug: meropenem

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Amplification and Selection of Antimicrobial Resistance in the Intestine II
Actual Study Start Date : January 30, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Group/Cohort Intervention/treatment
Meropenem arm
Patients receiving meropenem to treat an infection.
Drug: meropenem
Antibiotics to treat infections.
Other Name: piperacillin-tazobactam

Pip-Tazo arm
Patients receiving piperacillin-meropenem to treat an infection.



Primary Outcome Measures :
  1. Antibiotic Selection Pressure [ Time Frame: under treatment, max. 10 days ]
    Degree of the change of the intestinal resistome.


Biospecimen Retention:   Samples With DNA
Stool Samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with hemato-oncological disease in neutropenia or with expected neutropenia
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03140826


Contacts
Layout table for location contacts
Contact: Matthias Willmann, Prof. Dr. +49 70712981527 matthias.willmann@med.uni-tuebingen.de

Locations
Layout table for location information
Germany
University Hospital Cologne Recruiting
Cologne, Germany, 50935
Contact: Maria Vehreschild, Dr         
Institute of Medical Microbiology and Hygiene, University Hospital of Tuebingen Recruiting
Tuebingen, Germany, 72076
Contact: Matthias Willmann, MD    +49 7071 29-81527    matthias.willmann@med.uni-tuebingen.de   
Sponsors and Collaborators
University Hospital Tuebingen
University Hospital of Cologne
Investigators
Layout table for investigator information
Principal Investigator: Matthias Willmann, Prof. Dr. University Tuebingen

Layout table for additonal information
Responsible Party: Dr. Matthias Willmann, Prof. Dr. med., University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03140826     History of Changes
Other Study ID Numbers: ASARI-II
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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

Additional relevant MeSH terms:
Layout table for MeSH terms
Meropenem
Piperacillin
Piperacillin, Tazobactam Drug Combination
Anti-Infective Agents
Anti-Bacterial Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action