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

Condition(s) targeted: 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

Intervention: Edetate Calcium Disodium (Drug); Ethanol (Drug); Trimethoprim-sulfamethoxazole (Drug); Hypertonic Saline (Other)

Phase: Phase 1/Phase 2

Status: Withdrawn

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Patrick Chaftari, MD, Study Chair, Affiliation: M.D. Anderson Cancer Center
Jorge Cortes, MD, Study Chair, Affiliation: M.D. Anderson Cancer Center

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.

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)

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

Primary outcome:

Incidence of occlusion as defined by the inability to infuse or withdraw 3 cc of saline from the catheter

Time to development of a catheter-related bloodstream infections during the period of lock therapy administration

Adverse events

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

University of Texas MD Anderson Cancer Center Official Website

Last updated: February 13, 2013