Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-29 @ 2:13 AM
Study NCT ID:
NCT01101412
Status:
WITHDRAWN
Last Update Posted:
2013-02-15
First Post:
2010-04-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antimicrobial Solution or Saline Solution in Maintaining Catheter Patency and Preventing Catheter-Related Blood Infections in Patients With Malignancies
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Multi-Center, Prospective, Randomized, Double-Blinded, Controlled Clinical Trial to Evaluate the Safety and Effectiveness of an Antimicrobial Catheter Lock Solution in Maintaining Catheter Patency and Preventing Catheter Related Blood Stream Infections (CRBSI)
Status:
WITHDRAWN
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was not opened.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: Antimicrobial solution comprising trimethoprim-sulfamethoxazole, edetate calcium disodium, and ethanol may help prevent blockages and infections from forming in patients with central venous access catheters or peripheral venous catheters.
PURPOSE: This randomized trial is studying an antimicrobial solution or saline solution in maintaining catheter patency and preventing catheter-related blood infections in patients with malignancies.
PURPOSE: This randomized trial is studying an antimicrobial solution or saline solution in maintaining catheter patency and preventing catheter-related blood infections in patients with malignancies.
Detailed Description:
OBJECTIVES:
* To evaluate the safety of antimicrobial catheter lock solution comprising trimethoprim-sulfamethoxazole, edetate calcium disodium (EDTA), and ethanol versus saline solution in patients with malignancies.
* To compare the efficacy of this lock solution versus saline solution in maintaining catheter patency in these patients.
* To demonstrate the superiority of this lock solution in preventing or reducing the incidence of catheter-related bloodstream infections in patients with long-term indwelling catheters.
OUTLINE: This is a multicenter study. Patients are stratified according to clinical site and randomized to 1 of 2 intervention arms.
* Arm I: Patients receive antimicrobial solution into the central or peripheral venous catheter (CVC or PVC) once daily for 90 days. Catheter dwell time is 1-24 hours. The catheter is then flushed through before any drug infusion or blood aspiration.
* Arm II: Patients receive saline solution into the CVC or PVC once daily for 90 days. Catheter dwell time is 1-24 hours. The catheter is then flushed through before any drug infusion or blood aspiration.
After completion of study, patients are followed up at 10 days.
* To evaluate the safety of antimicrobial catheter lock solution comprising trimethoprim-sulfamethoxazole, edetate calcium disodium (EDTA), and ethanol versus saline solution in patients with malignancies.
* To compare the efficacy of this lock solution versus saline solution in maintaining catheter patency in these patients.
* To demonstrate the superiority of this lock solution in preventing or reducing the incidence of catheter-related bloodstream infections in patients with long-term indwelling catheters.
OUTLINE: This is a multicenter study. Patients are stratified according to clinical site and randomized to 1 of 2 intervention arms.
* Arm I: Patients receive antimicrobial solution into the central or peripheral venous catheter (CVC or PVC) once daily for 90 days. Catheter dwell time is 1-24 hours. The catheter is then flushed through before any drug infusion or blood aspiration.
* Arm II: Patients receive saline solution into the CVC or PVC once daily for 90 days. Catheter dwell time is 1-24 hours. The catheter is then flushed through before any drug infusion or blood aspiration.
After completion of study, patients are followed up at 10 days.
Study Oversight
Has Oversight DMC:
True
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?: