Amplification and Selection of Antimicrobial Resistance in the Intestine

Acute Leukaemia Clinical Trial

— ASARI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02058888
• Other study ID #: TTU 08.808
• Status: Completed
• Phase: N/A
• First received: February 5, 2014
• Last updated: May 2, 2017
• Start date: January 2015
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Leukaemia

Locations

Country	Name	City	State
Germany	Institute of Medical Microbiology and Hygiene, University Hospital of Tuebingen	Tuebingen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	University Hospital of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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