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

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ClinicalTrials.gov Identifier: NCT02058888
Recruitment Status : Completed
First Posted : February 10, 2014
Last Update Posted : May 3, 2017
Sponsor:
Collaborator:
University Hospital of Cologne
Information provided by (Responsible Party):
Dr. Matthias Willmann, University Hospital Tuebingen

Brief Summary:
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).

Condition or disease
Acute Leukaemia

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Self-controlled Cohort Study of the Amplification and Selection of Antimicrobial Resistance in the Human Intestine
Actual Study Start Date : January 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics




Primary Outcome Measures :
  1. 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).



Biospecimen Retention:   Samples With DNA
Bacterial DNA from human stool samples.


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

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

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): NCT02058888


Locations
Germany
Institute of Medical Microbiology and Hygiene, University Hospital of Tuebingen
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
University Hospital of Cologne
Investigators
Principal Investigator: Matthias Willmann, MD Institute of Medical Microbiology and Hygiene, Elfriede-Aulhorn-Str.6, 72076 Tuebingen, Germany

Responsible Party: Dr. Matthias Willmann, MD, MSc, DTM&H, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02058888     History of Changes
Other Study ID Numbers: TTU 08.808
First Posted: February 10, 2014    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

Keywords provided by Dr. Matthias Willmann, University Hospital Tuebingen:
metagenomics
antimicrobial resistance
multidrug resistance

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents