Amplification and Selection of Antimicrobial Resistance in the Intestine

NCT02058888 | Completed

• 1 other identifier: TTU 08.808
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Leukaemia

Keywords

metagenomics; antimicrobial resistance; multidrug resistance

Outcome Measures

Primary Outcomes (1)

• Changes from Baseline of Antimicrobial Resistance Gene Content in the human Intestine at three Time Points with respect to different Antibiotic Treatment Regimes.

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• University Hospital of Cologne: collaborator

Study Sites (1)

Institute of Medical Microbiology and Hygiene, University Hospital of Tuebingen

Tübingen, 72076, Germany

Location

Related Publications (1)

• 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.

  PMID: 31533707 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Bacterial DNA from human stool samples.

Study Officials

• Matthias Willmann, MD

  Institute of Medical Microbiology and Hygiene, Elfriede-Aulhorn-Str.6, 72076 Tuebingen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, DTM&H

Study Record Dates

• First Submitted: February 5, 2014
• First Posted: February 10, 2014
• Study Start: January 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 3, 2017

Record last verified: 2017-05

Locations

DE (1)