Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138112
Status:
COMPLETED
Last Update Posted:
2006-09-08
First Post:
2005-08-26
Brief Title:
Trial of Prophylactic Versus Empirical Vancomycin for the Prevention of Streptococcal Sepsis After Hematopoietic Cell Transplantation
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Randomized Trial of Prophylactic Versus Empirical Vancomycin for the Prevention of Early Viridans Streptococcal Sepsis After Hematopoietic Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized 2-arm study to compare two different times of giving the drug vancomycin Half of the patients will begin vancomycin two days before a bone marrow transplant The other half will get it as soon as they have the first fever
Streptococci are bacteria that live in ones mouth and gut These bacteria can escape into the blood when the lining of the mouth and gut weakens from cancer therapy This can make the person who is undergoing a bone marrow transplant very sick All patients who get this infection are treated with antibiotics Vancomycin is one drug that is used to treat this bloodstream infection once it is diagnosed Studies have shown that giving vancomycin before a bone marrow transplant seems to prevent this infection However giving vancomycin too soon may increase the chance that the kidneys will be irritated It may also increase the chance that other bacteria will become resistant to this drug We the investigators at Memorial Sloan-Kettering Cancer Center do not know if waiting to start vancomycin until the patient has a first fever can also prevent this infection
Streptococci are bacteria that live in ones mouth and gut These bacteria can escape into the blood when the lining of the mouth and gut weakens from cancer therapy This can make the person who is undergoing a bone marrow transplant very sick All patients who get this infection are treated with antibiotics Vancomycin is one drug that is used to treat this bloodstream infection once it is diagnosed Studies have shown that giving vancomycin before a bone marrow transplant seems to prevent this infection However giving vancomycin too soon may increase the chance that the kidneys will be irritated It may also increase the chance that other bacteria will become resistant to this drug We the investigators at Memorial Sloan-Kettering Cancer Center do not know if waiting to start vancomycin until the patient has a first fever can also prevent this infection
Detailed Description:
The primary objective of this study is as follows
To compare prophylactic with empirical vancomycin administration for reducing early viridans streptococcal bacteremia in allogeneic hematopoietic stem cell transplant HSCT patients
The secondary objectives of the study are
To examine the safety and tolerability for each vancomycin administration approach
To measure the incidence of vancomycin-resistant enterococcal VRE infections for patients managed with each of the two vancomycin administration approaches
To compare prophylactic with empirical vancomycin administration for reducing early viridans streptococcal bacteremia in allogeneic hematopoietic stem cell transplant HSCT patients
The secondary objectives of the study are
To examine the safety and tolerability for each vancomycin administration approach
To measure the incidence of vancomycin-resistant enterococcal VRE infections for patients managed with each of the two vancomycin administration approaches
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