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Withdrawn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
About this trial
This is an interventional supportive care trial for Mycobacterium Avium Complex
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)
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
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Withdrawn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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