Antimicrobial Solution or Saline Solution in Maintaining Catheter Patency and Preventing Catheter-Related Blood Infections in Patients With Malignancies

Lymphoma Clinical Trial

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Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Chronic Myeloproliferative Disorders
Communicable Diseases
Disease
Infection
Leukemia
Lymphoma
Lymphoproliferative Disorder
Lymphoproliferative Disorders
Multiple Myeloma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic-Myeloproliferative Diseases
Myelodysplastic/Myeloproliferative Neoplasms
Myeloproliferative Disorders
Neoplasms
Neoplasms, Plasma Cell
Plasmacytoma
Preleukemia
Unspecified Adult Solid Tumor, Protocol Specific

Clinical Trial Details

NCT number	NCT01101412
Study type	Interventional
Source	M.D. Anderson Cancer Center
Contact
Status	Withdrawn
Phase	Phase 1/Phase 2

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05540340` - A Study of Melphalan in People With Lymphoma Getting an Autologous Hematopoietic Cell Transplant	Phase 1
Completed	`NCT01947140` - Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies	Phase 1/Phase 2
Completed	`NCT00001512` - Active Specific Immunotherapy for Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines	Phase 1
Recruiting	`NCT05618041` - The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies	N/A
Completed	`NCT01410630` - FLT-PET/CT vs FDG-PET/CT for Therapy Monitoring of Diffuse Large B-cell Lymphoma
Active, not recruiting	`NCT04270266` - Mind-Body Medicine for the Improvement of Quality of Life in Adolescents and Young Adults Coping With Lymphoma	N/A
Terminated	`NCT00801931` - Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders	Phase 1/Phase 2
Completed	`NCT01949883` - A Phase 1 Study Evaluating CPI-0610 in Patients With Progressive Lymphoma	Phase 1
Completed	`NCT01682226` - Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies	Phase 2
Completed	`NCT00003270` - Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer	Phase 2
Recruiting	`NCT05019976` - Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma	N/A
Recruiting	`NCT04904588` - HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide	Phase 2
Completed	`NCT04434937` - Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)	Phase 2
Completed	`NCT01855750` - A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma	Phase 3
Terminated	`NCT00788125` - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors	Phase 1/Phase 2
Terminated	`NCT00775268` - 18F- Fluorothymidine to Evaluate Treatment Response in Lymphoma	Phase 1/Phase 2
Active, not recruiting	`NCT04188678` - Resiliency in Older Adults Undergoing Bone Marrow Transplant	N/A
Terminated	`NCT00014560` - Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia	Phase 1
Recruiting	`NCT04977024` - SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer	Phase 2
Active, not recruiting	`NCT03936465` - Study of the Bromodomain (BRD) and Extra-Terminal Domain (BET) Inhibitors BMS-986158 and BMS-986378 in Pediatric Cancer	Phase 1