Amplification and Selection of Antimicrobial Resistance in the 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).

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Key information

Conditions

Acute Leukaemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Medical Microbiology and Hygiene, University Hospital of Tuebingen

Tübingen, 72076, Germany

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

University Hospital of Cologne

Registry information

Official study title

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

Acronym: ASARI

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Feb 10, 2014
Registry last updated: May 3, 2017

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.

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