Amplification and Selection of Antimicrobial Resistance in the Intestine

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02058888

Acronym

ASARI

Enrollment

Registered

2014-02-10

Start date

2015-01-31

Completion date

2017-05-31

Last updated

2017-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Leukaemia

Keywords

metagenomics, antimicrobial resistance, multidrug resistance

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).

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Germany

Outcome results