- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01101412
Antimicrobial Solution or Saline Solution in Maintaining Catheter Patency and Preventing Catheter-Related Blood Infections in Patients With Malignancies
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)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I: Antimicrobial Solution
Antimicrobial solution into 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.
|
Given through CVC or PVC.
Other Names:
Given through CVC or PVC
Other Names:
Given through CVC or PVC
Other Names:
|
Active Comparator: Arm II: Saline Solution
Saline solution into 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.
|
Given through CVC or PVC
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of occlusion as defined by the inability to infuse or withdraw 3 cc of saline from the catheter
Time Frame: 60 days
|
60 days
|
Time to development of a catheter-related bloodstream infections during the period of lock therapy administration
Time Frame: 60 days
|
60 days
|
Adverse events
Time Frame: 60 days
|
60 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Patrick Chaftari, MD, M.D. Anderson Cancer Center
Publications and helpful links
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- unspecified adult solid tumor, protocol specific
- primary myelofibrosis
- stage I cutaneous T-cell non-Hodgkin lymphoma
- stage I mycosis fungoides/Sezary syndrome
- stage 0 chronic lymphocytic leukemia
- stage I chronic lymphocytic leukemia
- infection
- stage III adult diffuse large cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult Burkitt lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult Burkitt lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult Burkitt lymphoma
- chronic myelomonocytic leukemia
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- 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)
- secondary acute myeloid leukemia
- chronic phase chronic myelogenous leukemia
- primary systemic amyloidosis
- recurrent adult acute myeloid leukemia
- untreated adult acute myeloid leukemia
- adult acute myeloid leukemia in remission
- recurrent adult Hodgkin lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- blastic phase chronic myelogenous leukemia
- relapsing chronic myelogenous leukemia
- Waldenstrom macroglobulinemia
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- stage II multiple myeloma
- stage III multiple myeloma
- stage I grade 1 follicular lymphoma
- stage I grade 2 follicular lymphoma
- stage I adult diffuse small cleaved cell lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- contiguous stage II grade 1 follicular lymphoma
- contiguous stage II grade 2 follicular lymphoma
- contiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II small lymphocytic lymphoma
- noncontiguous stage II marginal zone lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage I marginal zone lymphoma
- stage I small lymphocytic lymphoma
- stage III small lymphocytic lymphoma
- stage III marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- contiguous stage II marginal zone lymphoma
- contiguous stage II small lymphocytic lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- stage I multiple myeloma
- recurrent adult lymphoblastic lymphoma
- recurrent mantle cell lymphoma
- refractory chronic lymphocytic leukemia
- stage II chronic lymphocytic leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- stage III adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- stage III cutaneous T-cell non-Hodgkin lymphoma
- stage IV cutaneous T-cell non-Hodgkin lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- stage III adult lymphoblastic lymphoma
- stage IV adult lymphoblastic lymphoma
- stage III adult T-cell leukemia/lymphoma
- stage IV adult T-cell leukemia/lymphoma
- recurrent adult T-cell leukemia/lymphoma
- intraocular lymphoma
- angioimmunoblastic T-cell lymphoma
- anaplastic large cell lymphoma
- stage III mycosis fungoides/Sezary syndrome
- stage IV mycosis fungoides/Sezary syndrome
- recurrent mycosis fungoides/Sezary syndrome
- adult grade III lymphomatoid granulomatosis
- adult nasal type extranodal NK/T-cell lymphoma
- recurrent adult grade III lymphomatoid granulomatosis
- post-transplant lymphoproliferative disorder
- cutaneous B-cell non-Hodgkin lymphoma
- refractory multiple myeloma
- recurrent adult acute lymphoblastic leukemia
- polycythemia vera
- essential thrombocythemia
- refractory hairy cell leukemia
- prolymphocytic leukemia
- contiguous stage II mantle cell lymphoma
- noncontiguous stage II mantle cell lymphoma
- stage II cutaneous T-cell non-Hodgkin lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- accelerated phase chronic myelogenous leukemia
- adult acute lymphoblastic leukemia in remission
- myelodysplastic/myeloproliferative neoplasm, unclassifiable
- chronic eosinophilic leukemia
- chronic neutrophilic leukemia
- atypical chronic myeloid leukemia, BCR-ABL negative
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- stage I mantle cell lymphoma
- isolated plasmacytoma of bone
- extramedullary plasmacytoma
- acute undifferentiated leukemia
- stage I adult Hodgkin lymphoma
- stage II adult Hodgkin lymphoma
- stage I adult Burkitt lymphoma
- contiguous stage II adult Burkitt lymphoma
- contiguous stage II adult immunoblastic large cell lymphoma
- stage I adult immunoblastic large cell lymphoma
- untreated adult acute lymphoblastic leukemia
- meningeal chronic myelogenous leukemia
- contiguous stage II grade 3 follicular lymphoma
- stage I grade 3 follicular lymphoma
- contiguous stage II adult diffuse large cell lymphoma
- contiguous stage II adult diffuse mixed cell lymphoma
- stage I adult diffuse large cell lymphoma
- stage I adult diffuse mixed cell lymphoma
- stage II mycosis fungoides/Sezary syndrome
- mast cell leukemia
- progressive hairy cell leukemia, initial treatment
- stage I adult T-cell leukemia/lymphoma
- stage II adult T-cell leukemia/lymphoma
- T-cell large granular lymphocyte leukemia
- untreated hairy cell leukemia
- contiguous stage II adult lymphoblastic lymphoma
- stage I adult lymphoblastic lymphoma
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Lymphatic Diseases
- Immunoproliferative Disorders
- Disease Attributes
- Bone Marrow Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Precancerous Conditions
- Neoplasms
- Lymphoma
- Syndrome
- Myelodysplastic Syndromes
- Disease
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Infections
- Communicable Diseases
- Leukemia
- Preleukemia
- Plasmacytoma
- Lymphoproliferative Disorders
- Myeloproliferative Disorders
- Myelodysplastic-Myeloproliferative Diseases
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Central Nervous System Depressants
- Enzyme Inhibitors
- Protective Agents
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Anticoagulants
- Antiprotozoal Agents
- Antiparasitic Agents
- Antidotes
- Chelating Agents
- Sequestering Agents
- Antimalarials
- Folic Acid Antagonists
- Anti-Dyskinesia Agents
- Iron Chelating Agents
- Calcium Chelating Agents
- Anti-Infective Agents, Urinary
- Renal Agents
- Cytochrome P-450 CYP2C8 Inhibitors
- Ethanol
- Calcium
- Calcium, Dietary
- Edetic Acid
- Pentetic Acid
- Trimethoprim
- Sulfamethoxazole
- Trimethoprim, Sulfamethoxazole Drug Combination
Other Study ID Numbers
- 2009-0237
- MDA-2009-0237
- CDR0000668850 (Other Identifier: NCI PDQ)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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