Improving Tolerance of Treatment of Pulmonary MAC Infections

NCT01719042 | Withdrawn Phase 2

• 1 other identifier: 187-2012
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mycobacterium Avium Complex; Adverse Effects

Outcome Measures

Primary Outcomes (1)

• Change in Gastroparesis Cardinal Symptom Index Score

  A survey instrument used to assess the severity of patient-reported gastrointestinal symptoms in clinical trials

  Change from baseline at the end of nine weeks

Secondary Outcomes (1)

• Leptin

  Baseline

Other Outcomes (1)

• Change in QTc on Electrocardiogram greater than 500 milliseconds

  Change from baseline at the end of nine weeks

Study Arms (2)

Zofran (8mg)

ACTIVE COMPARATOR

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

Drug: Zofran (8mg)

Ensure

ACTIVE COMPARATOR

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

Dietary Supplement: Ensure

Interventions

Zofran (8mg) DRUG

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

Also known as: Ondansetron

Zofran (8mg)

Ensure DIETARY_SUPPLEMENT

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

Also known as: Ensure Plus

Ensure

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Florida: lead

MeSH Terms

Conditions

Mycobacterium avium-intracellulare Infection

Interventions

Ondansetron; Ensure Plus

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Kevin P Fennelly, MD, MPH

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2012
• First Posted: November 1, 2012
• Study Start: January 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 4, 2013

Record last verified: 2013-04