VRE ColonizationNCT00250133
Microbiologic Effect of Selective Decontamination of the Digestive Tract With Colistin, Gentamicin and Nystatin
An observational study of VRE Colonization, run by University of Pittsburgh at 1 site in United States.
Trial summary
Selective decontamination of the digestive tract (SDD) is a prophylactic measure aimed at reducing Gram negative flora in the gut with an aim to reduce nosocomial infections such as ventilator-associated pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- VRE Colonization
- What is being tested?
- Blood draws
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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
Who may be able to join
- Patients in ICU who are identified as having VRE colonization by Infection Control's surveillance swabs or by the presence of VRE in clinical specimens.
- Patients must be above >18 years of age.
- Patients in whom there is an expectation of at least 4 days of mechanical ventilation.
- Presence of a nasogastric or enteral feeding tube.
- Written informed consent from patient or a proxy.
Who cannot join
- Allergy to colistin, gentamicin or nystatin.
- Pregnancy.
- Intestinal transplant or multivisceral transplant.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Selective decontamination of the digestive tract (SDD) is a prophylactic measure aimed at reducing Gram negative flora in the gut with an aim to reduce nosocomial infections such as ventilator-associated pneumonia. A recent large randomized trial in the Netherlands showed that SDD use was associated with reduced mortality in the ICU. Theoretically, SDD may select for Gram positive organisms such as MRSA or VRE. This was not observed in the Dutch study, but the rates of MRSA and VRE are very low in hospitals in the Netherlands. Fears of selection of MRSA and VRE have limited application of SDD in the United States.
In this pilot study, 40 patients in the transplant intensive care unit (where SDD has been used intermittently for at least 10 years), will be randomized to SDD or no SDD. These patients will be known to be VRE positive at baseline. The effects of SDD on the density of VRE in the stool on day 7 compared to pre-SDD will be the primary endpoint. Secondary endpoints will be detection of MRSA and colistin resistant Pseudomonas in the stool.
Read the detailed description
Study Design We will enroll 40 consecutive patients with VRE colonization who are admitted to Transplant ICU of Montefiore Hospital.
Methods:
A total of 40 patients will be randomized to SDD or no SDD by the Investigational Drugs Service of the Pharmacy. No placebo will be used for those assigned not to receive SDD. Patients will either receive standard of care or standard of care + SDD. No treatment of any kind is being withheld from the participants. Enrolled patients will be those known to be colonized with VRE (after obtaining informed consent from patients or patients' proxy). SDD will be given enterally through the nasogastric tube which will then be clamped for 1 hour. SDD will be stopped when patients are extubated. Otherwise SDD will be given for 7 days.
Day 1 is when patients are started on SDD which consists of colistin 100 mg, gentamicin 80mg, and nystatin 2 million/U in 23mL. It is given every 6 hour via a nasogastric tube with the nasogastric tube then clamped for 1 hour. Stool will be collected once a day at baseline (pre administration of SDD), and then days 4, 7 and 14 for quantitative culture of resistant pathogens in the stool. VRE, MRSA and Pseudomonas aeruginosa will be sought. An endotracheal aspirate once a day will also be collected on these days (baseline, 1, 4, 7, and 14) for qualitative culture for the presence of MRSA and Pseudomonas aeruginosa. If there are no bowel movements on the days that stool is to be collected, no samples will be obtained. In addition, if the endotracheal tube is pulled, no further endotracheal aspirates will be obtained. Samples will only be obtained if available.
In addition, for women of child bearing potential (any female who is biologically capable of becoming pregnant), a small sample (about 1 teaspoonful) of blood will be taken from a vein in the subject's arm for a pregnancy test, prior to study drug administration. Pregnant women, or women who are currently breast-feeding an infant, will not be allowed to take part in this study.
The primary microbiologic endpoint will be measurement of fecal density of VRE on day 7, in comparison to measurements on day 1. Secondary endpoints are changes in VRE fecal density from baseline to day 14, changes in MRSA fecal density from baseline to day 14, and presence of colistin resistant Pseudomonas in stool or endotracheal aspirates at day 14.
The following information will also be collected: Demographic data (address, date of birth, etc.) which includes age, sex, height, weight, and state of birth, previous reports associated with the participant's condition, laboratory results, current medication use, and any other prior medical problems/history. This information will be obtain from the medical record and/or the subject and become part of the research record.
Sample storage of the organism
The biologic samples (organism) will be under the control of the principal investigator of this research project. To protect confidentiality, all personal identifiers (i.e., name, social security number, and birth date) will be removed (de-identified) and replaced with a specific code number. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location. The investigators on this study will keep the samples indefinitely. The biologic samples will be provided to Dr. Curtis Donskey, Case Western Reserve University, Cleveland, Ohio. Dr Donskey will perform colony counts on the samples in order to determine the density of organisms in the sample, using methods he described in work he published in the New England Journal of Medicine (11). All samples will be provided de-identified. Dr Paterson will perform pulsed field gel electrophoresis on the isolates to determine if isolates are genotypically identical between baseline and post-SDD. If a subject withdraws and provides the request in writing, samples collected and not already processed will be destroyed. All samples will be kept in Dr Paterson's laboratory in Scaife Hall, Room 812, 3550 Terrace Street or in Donskey's laboratory at the Cleveland Veterans Affairs Medical Center, East Avenue, Cleveland OH.
- Conditions
- VRE Colonization
- Being tested
- Blood draws
- Keywords
- selective decontamination of the digestive tract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawsProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
Why it stopped: Unable to obtain funding to complete study never started study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VRE ColonizationStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Defined population
- Time perspective
- Other
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Investigators
- David L Paterson, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00250133
- Sponsor's protocol ID
- IRB#0503005
- Status last verified
- Aug 2007
- First submitted
- 4 Nov 2005
- Last updated
- 3 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiologic Effect of Selective Decontamination of the Digestive Tract With Colistin, Gentamicin and Nystatin
- ClinicalTrials.gov ID
- NCT00250133
- Acronym / sponsor ID
- IRB#0503005
- Conditions
- VRE Colonization
- Keywords
- selective decontamination of the digestive tract
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to obtain funding to complete study never started study
- Enrolment
- 40 participants
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- First posted
- 7 Nov 2005 (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.
Selective decontamination of the digestive tract (SDD) is a prophylactic measure aimed at reducing Gram negative flora in the gut with an aim to reduce nosocomial infections such as ventilator-associated pneumonia. A recent large randomized trial in the Netherlands showed that SDD use was associated with reduced mortality in the ICU. Theoretically, SDD may select for Gram positive organisms such as MRSA or VRE. This was not observed in the Dutch study, but the rates of MRSA and VRE are very low in hospitals in the Netherlands. Fears of selection of MRSA and VRE have limited application of SDD in the United States.
In this pilot study, 40 patients in the transplant intensive care unit (where SDD has been used intermittently for at least 10 years), will be randomized to SDD or no SDD. These patients will be known to be VRE positive at baseline. The effects of SDD on the density of VRE in the stool on day 7 compared to pre-SDD will be the primary endpoint. Secondary endpoints will be detection of MRSA and colistin resistant Pseudomonas in the stool.
Detailed description
Study Design We will enroll 40 consecutive patients with VRE colonization who are admitted to Transplant ICU of Montefiore Hospital.
Methods:
A total of 40 patients will be randomized to SDD or no SDD by the Investigational Drugs Service of the Pharmacy. No placebo will be used for those assigned not to receive SDD. Patients will either receive standard of care or standard of care + SDD. No treatment of any kind is being withheld from the participants. Enrolled patients will be those known to be colonized with VRE (after obtaining informed consent from patients or patients' proxy). SDD will be given enterally through the nasogastric tube which will then be clamped for 1 hour. SDD will be stopped when patients are extubated. Otherwise SDD will be given for 7 days.
Day 1 is when patients are started on SDD which consists of colistin 100 mg, gentamicin 80mg, and nystatin 2 million/U in 23mL. It is given every 6 hour via a nasogastric tube with the nasogastric tube then clamped for 1 hour. Stool will be collected once a day at baseline (pre administration of SDD), and then days 4, 7 and 14 for quantitative culture of resistant pathogens in the stool. VRE, MRSA and Pseudomonas aeruginosa will be sought. An endotracheal aspirate once a day will also be collected on these days (baseline, 1, 4, 7, and 14) for qualitative culture for the presence of MRSA and Pseudomonas aeruginosa. If there are no bowel movements on the days that stool is to be collected, no samples will be obtained. In addition, if the endotracheal tube is pulled, no further endotracheal aspirates will be obtained. Samples will only be obtained if available.
In addition, for women of child bearing potential (any female who is biologically capable of becoming pregnant), a small sample (about 1 teaspoonful) of blood will be taken from a vein in the subject's arm for a pregnancy test, prior to study drug administration. Pregnant women, or women who are currently breast-feeding an infant, will not be allowed to take part in this study.
The primary microbiologic endpoint will be measurement of fecal density of VRE on day 7, in comparison to measurements on day 1. Secondary endpoints are changes in VRE fecal density from baseline to day 14, changes in MRSA fecal density from baseline to day 14, and presence of colistin resistant Pseudomonas in stool or endotracheal aspirates at day 14.
The following information will also be collected: Demographic data (address, date of birth, etc.) which includes age, sex, height, weight, and state of birth, previous reports associated with the participant's condition, laboratory results, current medication use, and any other prior medical problems/history. This information will be obtain from the medical record and/or the subject and become part of the research record.
Sample storage of the organism
The biologic samples (organism) will be under the control of the principal investigator of this research project. To protect confidentiality, all personal identifiers (i.e., name, social security number, and birth date) will be removed (de-identified) and replaced with a specific code number. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location. The investigators on this study will keep the samples indefinitely. The biologic samples will be provided to Dr. Curtis Donskey, Case Western Reserve University, Cleveland, Ohio. Dr Donskey will perform colony counts on the samples in order to determine the density of organisms in the sample, using methods he described in work he published in the New England Journal of Medicine (11). All samples will be provided de-identified. Dr Paterson will perform pulsed field gel electrophoresis on the isolates to determine if isolates are genotypically identical between baseline and post-SDD. If a subject withdraws and provides the request in writing, samples collected and not already processed will be destroyed. All samples will be kept in Dr Paterson's laboratory in Scaife Hall, Room 812, 3550 Terrace Street or in Donskey's laboratory at the Cleveland Veterans Affairs Medical Center, East Avenue, Cleveland OH.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients in ICU who are identified as having VRE colonization by Infection Control's surveillance swabs or by the presence of VRE in clinical specimens.
- Patients must be above >18 years of age.
- Patients in whom there is an expectation of at least 4 days of mechanical ventilation.
- Presence of a nasogastric or enteral feeding tube.
- Written informed consent from patient or a proxy.
Key exclusion criteria (3 listed)
- Allergy to colistin, gentamicin or nystatin.
- Pregnancy.
- Intestinal transplant or multivisceral transplant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood draws | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Unable to obtain funding to complete study never started study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2007.
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VRE Colonization, CRE Colonization
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.
David L Paterson, MD principal investigator
University of Pittsburgh
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 VRE Colonization, run by University of Pittsburgh at 1 site in United States.
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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 3 Sep 2007. 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 United States. 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 was stopped early (reason given: Unable to obtain funding to complete study never started study). Results are not available in the source record.
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.
Where can I read the original study information?
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 Sep 2007.