Acute LeukaemiaASARINCT02058888
Amplification and Selection of Antimicrobial Resistance in the Intestine
An observational study of Acute Leukaemia, run by University Hospital Tuebingen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Leukaemia
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2015to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be selected from patients admitted to the University Hospital Tuebingen or to the University Hospital Cologne.
Who may be able to join
- male or female patients ≥ 18 years
- patients with acute leukaemia
- admission to one of the 2 study centres
- obtained written consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Medical Microbiology and Hygiene, University Hospital of Tuebingen
Tübingen, 72076
About this study
Official title: Self-controlled Cohort Study of the Amplification and Selection of Antimicrobial Resistance in the Human Intestine
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: day 0, day 1, day 3, end of antimicrobial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study startJan 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute LeukaemiaStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Cologne
- Responsible party
- Principal investigator, Dr. Matthias Willmann, University Hospital Tuebingen
- Investigators
- Matthias Willmann, MD, Principal investigator, Institute of Medical Microbiology and Hygiene, Elfriede-Aulhorn-Str.6, 72076 Tuebingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058888
- Sponsor's protocol ID
- TTU 08.808
- Acronym
- ASARI
- Status last verified
- May 2017
- First submitted
- 5 Feb 2014
- Last updated
- 3 May 2017
- Results posted
- No
Publications
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.
PubMed 31533707
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-controlled Cohort Study of the Amplification and Selection of Antimicrobial Resistance in the Human Intestine
- ClinicalTrials.gov ID
- NCT02058888
- Acronym / sponsor ID
- ASARI / TTU 08.808
- Conditions
- Acute Leukaemia
- Keywords
- metagenomics, antimicrobial resistance, multidrug resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- University Hospital of Cologne
- Study start
- Jan 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 10 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be selected from patients admitted to the University Hospital Tuebingen or to the University Hospital Cologne.
Key inclusion criteria (4 listed)
- male or female patients ≥ 18 years
- patients with acute leukaemia
- admission to one of the 2 study centres
- obtained written consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Derived from this study: PubMed 31533707Willmann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Willmann, MD principal investigator
Institute of Medical Microbiology and Hygiene, Elfriede-Aulhorn-Str.6, 72076 Tuebingen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Leukaemia, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02058888, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.