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

This study has been withdrawn prior to enrollment.
(Study was not opened.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01101412
First received: April 9, 2010
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
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
Drug: Edetate Calcium Disodium
Drug: Ethanol
Drug: Trimethoprim-sulfamethoxazole
Other: Hypertonic Saline
Phase 1
Phase 2

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

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Lymphoma, Small Cleaved-cell, Diffuse Multiple Myeloma Chronic Myeloproliferative Disorders Leukemia, Myeloid Chronic Myeloid Leukemia Myelodysplastic Syndromes Acute Lymphoblastic Leukemia Hodgkin Lymphoma Waldenstrom Macroglobulinemia Acute Myelocytic Leukemia Acute Non Lymphoblastic Leukemia Myelodysplastic/myeloproliferative Disease Acute Myeloid Leukemia, Adult Follicular Lymphoma B-cell Lymphomas Myelofibrosis Burkitt Lymphoma Lymphoma, Large-cell Lymphomatoid Granulomatosis Lymphoma, Large-cell, Immunoblastic Lymphoblastic Lymphoma Anaplastic Large Cell Lymphoma Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Chronic Myelomonocytic Leukemia Chronic Neutrophilic Leukemia Hypereosinophilic Syndrome Mantle Cell Lymphoma Cutaneous T-cell Lymphoma AL Amyloidosis Leukemia, T-cell, Chronic Essential Thrombocythemia Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Hairy Cell Leukemia Mycosis Fungoides Sezary Syndrome Large Granular Lymphocyte Leukemia Anaplastic Plasmacytoma Polycythemia Vera Systemic Mastocytosis
U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Incidence of occlusion as defined by the inability to infuse or withdraw 3 cc of saline from the catheter [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • Time to development of a catheter-related bloodstream infections during the period of lock therapy administration [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]

Enrollment: 0
Arms Assigned Interventions
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.
Drug: Edetate Calcium Disodium
Given through CVC or PVC.
Other Names:
  • Calcium Disodium Versenate
  • Calcium EDTA
Drug: Ethanol
Given through CVC or PVC
Other Names:
  • Ethyl Alcohol
  • Ehtyol
  • Ethamolin
Drug: Trimethoprim-sulfamethoxazole
Given through CVC or PVC
Other Names:
  • Bactrim
  • Trimethoprim
  • sulfamethoxazole
  • Bactrim DS
  • Cotrim DS
  • Septra
  • Sulfatrim DS
  • Trisulfam
  • Uroplus DS
  • Uroplus SS
  • Co-trimoxazole
  • SMX-TMP
  • TMP-SMX
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.
Other: Hypertonic Saline
Given through CVC or PVC
Other Names:
  • Saline
  • Saline Solution

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01101412

Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Patrick Chaftari, MD M.D. Anderson Cancer Center
Study Chair: Jorge Cortes, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01101412     History of Changes
Other Study ID Numbers: 2009-0237, MDA-2009-0237, CDR0000668850
Study First Received: April 9, 2010
Last Updated: February 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
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

Additional relevant MeSH terms:
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
Neoplasms by Histologic Type
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions
Ethanol
Anti-Infective Agents
Sulfamethoxazole
Trimethoprim

ClinicalTrials.gov processed this record on April 16, 2014