Clinical trial NCT02058888: Amplification and Selection of Antimicrobial Resistance in the Intestine
Official title: Self-controlled Cohort Study of the Amplification and Selection of Antimicrobial Resistance in the Human Intestine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Leukaemia
Keywords: metagenomics
antimicrobial resistance
multidrug resistance
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: University Hospital of Cologne
First posted: 2014-02-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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).


Eligibility 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

Primary outcomes:
measure: Changes from Baseline of Antimicrobial Resistance Gene Content in the human Intestine at three Time Points with respect to different Antibiotic Treatment Regimes.
timeFrame: day 0, day 1, day 3, end of antimicrobial treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Institute of Medical Microbiology and Hygiene, University Hospital of Tuebingen
Study officials:
affiliation: Institute of Medical Microbiology and Hygiene, Elfriede-Aulhorn-Str.6, 72076 Tuebingen, Germany
name: Matthias Willmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Willmann M, Vehreschild MJGT, Biehl LM, Vogel W, Dorfel D, Hamprecht A, Seifert H, Autenrieth IB, Peter S. Distinct impact of antibiotics on the gut microbiome and resistome: a longitudinal multicenter cohort study. BMC Biol. 2019 Sep 18;17(1):76. doi: 10.1186/s12915-019-0692-y.