Mycobacterium Avium ComplexPhase 2ITT-MACNCT01719042
Improving Tolerance of Treatment of Pulmonary MAC Infections
A Phase 2 study testing Zofran (8mg) and Ensure in people with Mycobacterium Avium Complex and Adverse Effects, run by University of Florida.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Mycobacterium Avium Complex, Adverse Effects
- What is being tested?
- Zofran (8mg) and Ensure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Mar 2013
- Phase
- Phase 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
About this study
Official title: Improving Tolerance of Treatment of Pulmonary Mycobacterium Avium Complex Infections
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.
Read the 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.
- Conditions
- Mycobacterium Avium Complex, Adverse Effects
- Being tested
- Zofran (8mg), Ensure
- Medical subject headings
- Mycobacterium avium-intracellulare Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zofran (8mg)Drug
Also called Ondansetron
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
EnsureDietary supplement
Also called Ensure Plus
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
| Study group | Role | What they receive |
|---|---|---|
| Zofran (8mg) | Active comparator | Participant will take Zofran (8mg) once per day before taking their antibiotic regimen Receives: Drug: Zofran (8mg) |
| Ensure | Active comparator | Subject will drink a can of Ensure before taking their antibiotic regimen Receives: Dietary Supplement: Ensure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gastroparesis Cardinal Symptom Index Score
A survey instrument used to assess the severity of patient-reported gastrointestinal symptoms in clinical trials
Measured: Change from baseline at the end of nine weeks
Secondary outcomes (1)
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: No recruitment was achievable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycobacterium Avium ComplexStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin P Fennelly, MD, MPH, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719042
- Sponsor's protocol ID
- 187-2012
- Acronym
- ITT-MAC
- Status last verified
- Apr 2013
- First submitted
- 22 Oct 2012
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Tolerance of Treatment of Pulmonary Mycobacterium Avium Complex Infections
- ClinicalTrials.gov ID
- NCT01719042
- Acronym / sponsor ID
- ITT-MAC / 187-2012
- Conditions
- Mycobacterium Avium Complex, Adverse Effects
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No recruitment was achievable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 1 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zofran (8mg) | Active comparator | Drug: Zofran (8mg)Participant will take Zofran (8mg) once per day before taking their antibiotic regimen |
| Ensure | Active comparator | Dietary Supplement: EnsureSubject will drink a can of Ensure before taking their antibiotic regimen |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zofran (8mg)Also: OndansetronSubject 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 | Drug | Zofran (8mg) |
| EnsureAlso: Ensure PlusSubject 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 | Dietary supplement | Ensure |
Primary outcome
Change in Gastroparesis Cardinal Symptom Index Score
Time frame: Change from baseline at the end of nine weeks
A survey instrument used to assess the severity of patient-reported gastrointestinal symptoms in clinical trials
1 secondary outcome
Leptin
Time frame: Baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin P Fennelly, MD, MPH principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zofran (8mg) and Ensure in people with Mycobacterium Avium Complex and Adverse Effects, run by University of Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. 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 4 Apr 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 phase mean?
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?
Change in Gastroparesis Cardinal Symptom Index Score (time frame: Change from baseline at the end of nine weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2013.