Amplification and Selection of Antimicrobial Resistance in the Intestine (ASARI)
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.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02058888
Recruitment Status :
First Posted : February 10, 2014
Last Update Posted : May 3, 2017
University Hospital Tuebingen
University Hospital of Cologne
Information provided by (Responsible Party):
Dr. Matthias Willmann, University Hospital Tuebingen
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).
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).
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.
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
The study population will be selected from patients admitted to the University Hospital Tuebingen or to the University Hospital Cologne.
male or female patients ≥ 18 years
patients with acute leukaemia
admission to one of the 2 study centres
obtained written consent
treatment with antibiotics in the previous 30 days
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