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.

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.

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