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)
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Chronic Myeloproliferative Disorders, Infection, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms, Unspecified Adult Solid Tumor, Protocol Specific
Both
Chronic Myeloproliferative Disorders, Infection, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
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)
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of a malignancy
- Indwelling catheter (central or peripheral) with external lumen(s) that has been in
place for ≤ 7 days
- Inpatients must have each lumen of the catheter able to be locked with the study
solution uninterruptedly for a minimum of one hour per day
- Outpatients must agree to flush and relock the catheter each day
PATIENT CHARACTERISTICS:
- Willing and able to follow the instructions required to complete the study
- No local or systemic infection as defined by the evidence of fever (e.g., body
temperature ≥ 38.0 degrees C) within 24 hours including any of the following:
- White Blood Count (WBC) ≥ 12,000/mm³ or ≤ 4,000/mm³ OR with a differential count
showing ≥ 10% bands
- Tachycardia defined as pulse rate ≥ 100 bpm
- Tachypnea defined as respiratory rate > 20 breaths/minute
- Hypotension defined as systolic blood pressure (BP) ≤ 90 mm Hg
- Signs and symptoms of localized catheter-related infection (e.g., tenderness
and/or pain, erythema, swelling, or purulent exudate within 2 cm of entry site)
- No occluded (partially or totally) catheter defined as inability to either withdraw
blood or instill 3 cc of fluid without resistance through any catheter lumen
- No known alcohol dehydrogenase deficiency
- No known history of allergic reaction to ethanol, trimethoprim (including
trimethoprim/sulfamethoxazole), or any other components within the lock solution
formulation
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No renal failure or creatinine level ≥ 2.0 mg/dL
- No known heart failure or ejection fraction ≤ 25%
- No alcohol dependency
PRIOR CONCURRENT THERAPY:
- Concurrent investigational chemotherapy agents allowed
- No concurrent non-chemotherapy investigational protocols
- Not requiring multiple central venous catheters
- Multiple lumens in a single catheter allowed
- No catheter coated or impregnated with heparin or antimicrobial or antiseptic agent
- No concurrent routine treatment of the underlying disease that will interfere with
the lock solution
- No concurrent disulfiram or metronidazole
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Outcome Measure:
Incidence of occlusion as defined by the inability to infuse or withdraw 3 cc of saline from the catheter
Outcome Time Frame:
60 days
Safety Issue:
No
Principal Investigator
Patrick Chaftari, MD
Investigator Role:
Study Chair
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2009-0237
NCT ID:
NCT01101412
Start Date:
Completion Date:
Related Keywords:
- Chronic Myeloproliferative Disorders
- Infection
- Leukemia
- Lymphoma
- Lymphoproliferative Disorder
- Multiple Myeloma and Plasma Cell Neoplasm
- Myelodysplastic Syndromes
- Myelodysplastic/Myeloproliferative Neoplasms
- Unspecified Adult Solid Tumor, Protocol Specific
- infection
- unspecified adult solid tumor, protocol specific
- accelerated phase chronic myelogenous leukemia
- acute undifferentiated leukemia
- adult acute lymphoblastic leukemia in remission
- adult acute myeloid leukemia in remission
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities
- adult acute myeloid leukemia with inv(16)(p13;q22)
- adult acute myeloid leukemia with t(15;17)(q22;q12)
- adult acute myeloid leukemia with t(16;16)(p13;q22)
- adult acute myeloid leukemia with t(8;21)(q22;q22)
- atypical chronic myeloid leukemia, BCR-ABL negative
- blastic phase chronic myelogenous leukemia
- chronic myelomonocytic leukemia
- chronic phase chronic myelogenous leukemia
- mast cell leukemia
- meningeal chronic myelogenous leukemia
- progressive hairy cell leukemia, initial treatment
- prolymphocytic leukemia
- recurrent adult acute lymphoblastic leukemia
- recurrent adult acute myeloid leukemia
- recurrent adult T-cell leukemia/lymphoma
- refractory chronic lymphocytic leukemia
- refractory hairy cell leukemia
- relapsing chronic myelogenous leukemia
- secondary acute myeloid leukemia
- stage 0 chronic lymphocytic leukemia
- stage I adult T-cell leukemia/lymphoma
- stage I chronic lymphocytic leukemia
- stage II adult T-cell leukemia/lymphoma
- stage II chronic lymphocytic leukemia
- stage III adult T-cell leukemia/lymphoma
- stage III chronic lymphocytic leukemia
- stage IV adult T-cell leukemia/lymphoma
- stage IV chronic lymphocytic leukemia
- T-cell large granular lymphocyte leukemia
- untreated adult acute lymphoblastic leukemia
- untreated adult acute myeloid leukemia
- untreated hairy cell leukemia
- recurrent adult Hodgkin lymphoma
- stage I adult Hodgkin lymphoma
- stage II adult Hodgkin lymphoma
- stage III adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- anaplastic large cell lymphoma
- angioimmunoblastic T-cell lymphoma
- cutaneous B-cell non-Hodgkin lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- stage I cutaneous T-cell non-Hodgkin lymphoma
- stage II cutaneous T-cell non-Hodgkin lymphoma
- stage III cutaneous T-cell non-Hodgkin lymphoma
- stage IV cutaneous T-cell non-Hodgkin lymphoma
- recurrent mycosis fungoides/Sezary syndrome
- stage I mycosis fungoides/Sezary syndrome
- stage II mycosis fungoides/Sezary syndrome
- stage III mycosis fungoides/Sezary syndrome
- stage IV mycosis fungoides/Sezary syndrome
- adult grade III lymphomatoid granulomatosis
- adult nasal type extranodal NK/T-cell lymphoma
- Waldenstrom macroglobulinemia
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- contiguous stage II adult Burkitt lymphoma
- contiguous stage II adult diffuse large cell lymphoma
- contiguous stage II adult diffuse mixed cell lymphoma
- contiguous stage II adult diffuse small cleaved cell lymphoma
- contiguous stage II adult immunoblastic large cell lymphoma
- contiguous stage II adult lymphoblastic lymphoma
- contiguous stage II grade 1 follicular lymphoma
- contiguous stage II grade 2 follicular lymphoma
- contiguous stage II grade 3 follicular lymphoma
- contiguous stage II mantle cell lymphoma
- contiguous stage II marginal zone lymphoma
- contiguous stage II small lymphocytic lymphoma
- stage I adult Burkitt lymphoma
- stage I adult diffuse large cell lymphoma
- stage I adult diffuse mixed cell lymphoma
- stage I adult diffuse small cleaved cell lymphoma
- stage I adult immunoblastic large cell lymphoma
- stage I adult lymphoblastic lymphoma
- stage I grade 1 follicular lymphoma
- stage I grade 2 follicular lymphoma
- stage I grade 3 follicular lymphoma
- stage I mantle cell lymphoma
- stage I marginal zone lymphoma
- stage I small lymphocytic lymphoma
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- noncontiguous stage II mantle cell lymphoma
- noncontiguous stage II marginal zone lymphoma
- noncontiguous stage II small lymphocytic lymphoma
- stage III adult Burkitt lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult lymphoblastic lymphoma
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III mantle cell lymphoma
- stage III marginal zone lymphoma
- stage III small lymphocytic lymphoma
- stage IV adult Burkitt lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV mantle cell lymphoma
- stage IV marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- recurrent adult Burkitt lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult grade III lymphomatoid granulomatosis
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent mantle cell lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- intraocular lymphoma
- post-transplant lymphoproliferative disorder
- chronic eosinophilic leukemia
- chronic neutrophilic leukemia
- primary myelofibrosis
- essential thrombocythemia
- polycythemia vera
- extramedullary plasmacytoma
- isolated plasmacytoma of bone
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- primary systemic amyloidosis
- refractory multiple myeloma
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- myelodysplastic/myeloproliferative neoplasm, unclassifiable
- Neoplasms
- Leukemia
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoproliferative Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
- Myelodysplastic Syndromes
- Preleukemia
- Myeloproliferative Disorders
- Lymphoma, Large-Cell, Immunoblastic
- Myelodysplastic-Myeloproliferative Diseases
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