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Improving Tolerance of Treatment of Pulmonary MAC Infections (ITT-MAC)

Primary Purpose

Mycobacterium Avium Complex, Adverse Effects

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Zofran (8mg)
Ensure
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mycobacterium Avium Complex

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Physician diagnosis of Mycobacterium avium Complex with nodular bronchiectasis
  • On daily treatment for Mycobacterium avium Complex consisting of 250mg of Azithromycin, 600mg of Rifampin, and 15mg/kg of Ethambutol
  • Experiencing gastrointestinal symptoms due to their multi-drug treatment regimen
  • Has access to the internet

Exclusion Criteria:

  • Claustrophobia
  • Currently smokes cigarettes
  • Persons with disseminated Mycobacterium avium Complex infections
  • Persons with a known and diagnosed immunosuppressive disorder (i.e. cancer, HIV)
  • Persons with physician diagnosed Irritable Bowel Syndrome, Crohn's Disease, or Ulcerative Colitis
  • Persons with moderate to severe kidney or liver dysfunction
  • Persons who are co-colonized with an NTM aside from Mycobacterium avium Complex
  • Persons who initially present with a prolonged QT interval (defined as greater 500 milliseconds) on any baseline ECG
  • Previous adverse reaction or allergy to Zofran (Ondansetron)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Zofran (8mg)

    Ensure

    Arm Description

    Participant will take Zofran (8mg) once per day before taking their antibiotic regimen

    Subject will drink a can of Ensure before taking their antibiotic regimen

    Outcomes

    Primary Outcome Measures

    Change in Gastroparesis Cardinal Symptom Index Score
    A survey instrument used to assess the severity of patient-reported gastrointestinal symptoms in clinical trials

    Secondary Outcome Measures

    Leptin
    Leptin is a natural hormone produced by your body's fat cells and acts as a signal which tells your brain you are no longer hungry

    Full Information

    First Posted
    October 22, 2012
    Last Updated
    April 2, 2013
    Sponsor
    University of Florida
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01719042
    Brief Title
    Improving Tolerance of Treatment of Pulmonary MAC Infections
    Acronym
    ITT-MAC
    Official Title
    Improving Tolerance of Treatment of Pulmonary Mycobacterium Avium Complex Infections
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2013
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No recruitment was achievable
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    March 2013 (Actual)
    Study Completion Date
    March 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Florida

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to improve tolerance of treatment of pulmonary Mycobacterium avium Complex disease via the use of therapeutic drug monitoring and the addition of anti-nausea medication or dietary supplements to the patients' daily drug regimen. The aims of this study are to use (1) Zofran® (Ondansetron 8mg), an anti-nausea medication or (2) a dietary supplement to decrease medication related gastrointestinal side effects of medications used to treat Mycobacterium avium Complex.
    Detailed Description
    As part of this study, investigators will review medical records to be sure that the patient meets the required criteria and is healthy enough to take part in this study. The study will consist of five separate visits to the Clinical research Center at the University of Florida and each visit will last anywhere from 6-8 hours. Patients will be given a diary of questionnaires where they will record when they take their medication and any side effects they might have. Patients will also have Electrocardiograms (ECGs) to make sure they are healthy enough to be a participant in the study and to measure the effects of their medication on their heart. During this study, patients will continue treatment of their Mycobacterium avium Complex infections. Patients will be observed taking their medication on each of the five separate days. On each of these days patients will have blood drawn at 2 and 6 hours after their drugs are taken in order to measure drug levels in their blood. We will also use this blood to measure levels of proteins and hormones and to make sure the medications are not affecting the patient's heart. The patient will fill out several questionnaires and do a dietary assessment online. Investigators will assess the patient's body make-up using a device called the Bod Pod. The patient will also be assigned to one of two treatment groups: (1) Ondansetron 8mg (Zofran®, GlaxoSmithKline, Research Triangle Park, NC) every morning before breakfast versus (2) a dietary supplement prior to taking daily medication. The patient will be assigned to the first treatment group for a period of two weeks. On the third study visit investigators will switch the patient to the second group. Although the incidence of tuberculosis has decreased in the United States over the last few decades, the incidence of chronic pulmonary infections with nontuberculous mycobacteria (NTM) appears to be increasing. Unfortunately, a common problem in the management of these infections is the inability of elderly patients to tolerate the currently recommended multidrug regimen of (1) azithromycin or clarithromycin, (2) rifampin or rifabutin, and (3) ethambutol. The most frequent adverse reactions of MAC treatment are gastrointestinal (GI), most commonly associated with the macrolides and rifampin. Although macrolide toxicity is generally dose-related, the role of routine monitoring of drug concentrations and subsequent dose adjustment has not been studied. The role of anti-emetics or dietary supplements to mitigate these symptoms is also not defined.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mycobacterium Avium Complex, Adverse Effects

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Zofran (8mg)
    Arm Type
    Active Comparator
    Arm Description
    Participant will take Zofran (8mg) once per day before taking their antibiotic regimen
    Arm Title
    Ensure
    Arm Type
    Active Comparator
    Arm Description
    Subject will drink a can of Ensure before taking their antibiotic regimen
    Intervention Type
    Drug
    Intervention Name(s)
    Zofran (8mg)
    Other Intervention Name(s)
    Ondansetron
    Intervention Description
    Subject will take 8mg of Zofran before taking antibiotic regimen and will record symptoms in a diary just before taking medication and two hours after taking medication every day for two weeks
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Ensure
    Other Intervention Name(s)
    Ensure Plus
    Intervention Description
    Subject will drink one cam of Ensure before taking antibiotic regimen and will record symptoms in a diary just before taking medication and two hours after taking medication every day for two weeks
    Primary Outcome Measure Information:
    Title
    Change in Gastroparesis Cardinal Symptom Index Score
    Description
    A survey instrument used to assess the severity of patient-reported gastrointestinal symptoms in clinical trials
    Time Frame
    Change from baseline at the end of nine weeks
    Secondary Outcome Measure Information:
    Title
    Leptin
    Description
    Leptin is a natural hormone produced by your body's fat cells and acts as a signal which tells your brain you are no longer hungry
    Time Frame
    Baseline
    Other Pre-specified Outcome Measures:
    Title
    Change in QTc on Electrocardiogram greater than 500 milliseconds
    Description
    To determine if the drug-drug interaction of azithromycin and Zofran (ondansetron) causes significant prolongation of the corrected QT (QTc) interval in this population of older female patients
    Time Frame
    Change from baseline at the end of nine weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Physician diagnosis of Mycobacterium avium Complex with nodular bronchiectasis On daily treatment for Mycobacterium avium Complex consisting of 250mg of Azithromycin, 600mg of Rifampin, and 15mg/kg of Ethambutol Experiencing gastrointestinal symptoms due to their multi-drug treatment regimen Has access to the internet Exclusion Criteria: Claustrophobia Currently smokes cigarettes Persons with disseminated Mycobacterium avium Complex infections Persons with a known and diagnosed immunosuppressive disorder (i.e. cancer, HIV) Persons with physician diagnosed Irritable Bowel Syndrome, Crohn's Disease, or Ulcerative Colitis Persons with moderate to severe kidney or liver dysfunction Persons who are co-colonized with an NTM aside from Mycobacterium avium Complex Persons who initially present with a prolonged QT interval (defined as greater 500 milliseconds) on any baseline ECG Previous adverse reaction or allergy to Zofran (Ondansetron)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kevin P Fennelly, MD, MPH
    Organizational Affiliation
    University of Florida
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Improving Tolerance of Treatment of Pulmonary MAC Infections

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