Clinical Trial: Improving Tolerance of Treatment of Pulmonary MAC Infections

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Improving Tolerance of Treatment of Pulmonary Mycobacterium Avium Complex Infections

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 Summary:

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 infe
Sponsor: University of Florida

Current 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


Original Primary Outcome: 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


Current Secondary Outcome: Leptin [ Time Frame: Baseline ]

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


Original Secondary Outcome: Same as current

Information By: University of Florida

Dates:
Date Received: October 22, 2012
Date Started: January 2013
Date Completion:
Last Updated: April 2, 2013
Last Verified: April 2013