Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250133
Status:
TERMINATED
Last Update Posted:
2007-09-03
First Post:
2005-11-04
Brief Title:
Microbiologic Effect of Selective Decontamination of the Digestive Tract With Colistin Gentamicin and Nystatin
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Microbiologic Effect of Selective Decontamination of the Digestive Tract With Colistin Gentamicin and Nystatin
Status:
TERMINATED
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to obtain funding to complete study never started study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 millionU 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 subjects 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 participants condition laboratory results current medication use and any other prior medical problemshistory This information will be obtain from the medical record andor 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 ie 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 Patersons laboratory in Scaife Hall Room 812 3550 Terrace Street or in Donskeys laboratory at the Cleveland Veterans Affairs Medical Center East Avenue Cleveland OH
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 millionU 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 subjects 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 participants condition laboratory results current medication use and any other prior medical problemshistory This information will be obtain from the medical record andor 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 ie 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 Patersons laboratory in Scaife Hall Room 812 3550 Terrace Street or in Donskeys laboratory at the Cleveland Veterans Affairs Medical Center East Avenue Cleveland OH
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None