Improving Tolerance of Treatment of Pulmonary MAC Infections

• Status: Withdrawn
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Ondansetron

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)