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

May 2, 2017 updated by: Dr. Matthias Willmann, University Hospital Tuebingen

Self-controlled Cohort Study of the Amplification and Selection of Antimicrobial Resistance in the Human Intestine

The worldwide increase in the incidence of multidrug-resistant (MDR) pathogens is alarming. Antimicrobial treatment is a risk factor for the isolation of MDR pathogens and can therefore contribute to the observed trend. Differences in the degree of selection pressure caused by various antimicrobials have not been systematically investigated until today. The aim of the proposed project is the determination of the impact of antibiotic treatment on the copy number of resistance genes in the human intestinal microbiome using metagenome shotgun sequencing. The resistance gene count in the gastrointestinal tract will be determined in a clinical cohorts of patients treated with either ciprofloxacin or cotrimoxazol as monotherapy. The subsequent quantification and comparison of the selection pressure facilitates the application of antibiotics with a lower potential to select for resistance. To achieve this goal, a self-controlled, prospective observational epidemiological study will be performed at two centres of the German Centre for Infection Research (Tübingen, Cologne).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

The study population will be selected from patients admitted to the University Hospital Tuebingen or to the University Hospital Cologne.

Description

Inclusion Criteria:

  • male or female patients ≥ 18 years
  • patients with acute leukaemia
  • admission to one of the 2 study centres
  • obtained written consent

Exclusion Criteria:

  • treatment with antibiotics in the previous 30 days
  • pregnancy
  • patients currently treated for HIV and/or hepatitis b/c
  • patients who can not estimate scope and consequences of their participation in the study
  • patients who will most likely not be able to follow the study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from Baseline of Antimicrobial Resistance Gene Content in the human Intestine at three Time Points with respect to different Antibiotic Treatment Regimes.
Time Frame: day 0, day 1, day 3, end of antimicrobial treatment

Stool samples will be collected from patients at four time points:

t0 (baseline) The time point serves as a control. The stool sample will be obtained before treatment start.

t1 (early phase) The time point reflects the early phase at day 1 of treatment with either ciprofloxacin or cotrimoxazol.

t2 (early-late phase) The time point reflects the early-late phase at day 3 of treatment.

t3 (late phase) The time point reflects the end of treatment (max. day 7).
day 0, day 1, day 3, end of antimicrobial treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Collaborators

University Hospital of Cologne

Investigators

  • Principal Investigator: Matthias Willmann, MD, Institute of Medical Microbiology and Hygiene, Elfriede-Aulhorn-Str.6, 72076 Tuebingen, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

February 5, 2014

First Submitted That Met QC Criteria

February 6, 2014

First Posted (Estimate)

February 10, 2014

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TTU 08.808

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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