Skip to main content
OpenTrials
Completed

NCT Number: NCT03140826

Amplification and Selection of Antimicrobial Resistance in the Intestine 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Antibiotic Selection Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Cologne, Cologne, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meropenem

Drug

Antibiotics to treat infections.

Other names: piperacillin-tazobactam

Primary outcomes

  1. Antibiotic Selection Pressure

    Time frame: under treatment, max. 10 days

    Degree of the change of the intestinal resistome.

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • University Hospital of Cologne

Registry information

Acronym: ASARI II

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 4, 2017
Registry last updated
Aug 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.