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Chronic Myeloproliferative DisordersPhase 1/2NCT01101412

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

A Phase 1/2 study testing Edetate Calcium Disodium, Ethanol and Trimethoprim-sulfamethoxazole in people with Chronic Myeloproliferative Disorders and Infection, run by M.D. Anderson Cancer Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Edetate Calcium Disodium, Ethanol and Trimethoprim-sulfamethoxazole
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Start not givento not given
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

About this study

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)

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.

Read the 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.

Being tested
Edetate Calcium Disodium, Ethanol, Trimethoprim-sulfamethoxazole, Hypertonic Saline
Keywords
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
Medical subject headings
Myeloproliferative Disorders, Infections, Leukemia, Lymphoma, Lymphoproliferative Disorders, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Edetate Calcium DisodiumDrug

    Also called Calcium Disodium Versenate, Calcium EDTA

    Given through CVC or PVC.

  • EthanolDrug

    Also called Ethyl Alcohol, Ehtyol, Ethamolin

    Given through CVC or PVC

  • Trimethoprim-sulfamethoxazoleDrug

    Also called Bactrim, Trimethoprim, sulfamethoxazole, Bactrim DS

    Given through CVC or PVC

  • Hypertonic SalineOther

    Also called Saline, Saline Solution

    Given through CVC or PVC

Study groups in NCT01101412
Study groupRoleWhat they receive
Arm I: Antimicrobial SolutionExperimentalAntimicrobial 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.
Receives: Drug: Edetate Calcium Disodium; Drug: Ethanol; Drug: Trimethoprim-sulfamethoxazole
Arm II: Saline SolutionActive comparatorSaline 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.
Receives: Other: Hypertonic Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 60 days

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

    Measured: 60 days

  3. Adverse events

    Measured: 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2010 (estimated)

Why it stopped: Study was not opened.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01101412
Sponsor's protocol ID
2009-0237
Other IDs
MDA-2009-0237, CDR0000668850
Status last verified
Feb 2013
First submitted
9 Apr 2010
Last updated
15 Feb 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Edetate Calcium Disodium, Ethanol and Trimethoprim-sulfamethoxazole in people with Chronic Myeloproliferative Disorders and Infection, run by M.D. Anderson Cancer Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of occlusion as defined by the inability to infuse or withdraw 3 cc of saline from the catheter (time frame: 60 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01101412.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2013.

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