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Clinical Trials
Our laboratory has participated in ≥10 clinical trials (including several for Branhamella and Haemophilus influenzae) since 1988. The below is a list of the NTM trials since 1990.
Trial Title: An Open Study of Clarithromycin for the Treatment of Infections Caused by Nontuberculous
Mycobacteria (NTM)
Purpose: To determine safety and efficacy of clarithromycin in the treatment of patients
with nontuberculous mycobacterial infections (NTM).
Sponsor: Abbott Laboratories
Trial #: 263
Trial Title: Azithromycin in Treatment of Mycobacterium avium Complex (MAC) Lung Disease
Purpose: To determine the safety and efficacy of azithromycin in the treatment of MAC lung
disease.
Sponsor: Pfizer Laboratories
Trial #: 340
Trial Title: Open, Non-comparative Trial of Multidrug Regimens Containing Azithromycin and Rifabutin
Administered Three Times per Week for the Treatment of M. avium Complex (MAC) Lung
Disease
Purpose: To determine safety and efficacy of multidrug regimens containing azithromycin and
rifabutin administered three times per week for the treatment of MAC lung disease.
Sponsor: Pfizer Laboratories
Trial #: 426
Trial Title: Open, noncomparative trial of multidrug regimens containing clarithromycin and rifabutin
administered three times per week for the treatment of Mycobacterium avium complex
(MAC) lung disease or other Nontuberculous Mycobacteria (NTM).
Purpose: To determine safety and efficacy of a multi-drug regimen of clarithromycin, rifampin/rifabutin,
and ethambutol given 3 times weekly for the treatment of lung infections with Mycobacterium
avium complex (MAC) or other nontuberculous mycobacteria (NTM).
Sponsor: Abbott Laboratories
Trial #: 447
Trial Title: Clinical Efficacy of Rifabutin (formerly Ansamycin LM427 in the Treatment of Serious
and Life Threatening Infections due to Mycobacterium avium Complex, or Drug Resistant
Mycobacterium tuberculosis, or other Drug Resistant Mycobacterium sp.
Purpose: To assess the clinical efficacy of rifabutin in the treatment of serious infections
due to drug resistant Mycobacterium sp.
Sponsor: Pharmacia
Trial #: 72
Trial Title: Use of Tigecycline for Treatment of Serious Infection Due to Rapidly Growing Mycobacteria
(especially M. abscessus).
Purpose: To determine the safety and efficacy of tigecycline (GAR-936) in the treatment of
serious infection due to drug resistant rapidly growing mycobacteria (especially M.
abscessus).
Sponsor: Wyeth Research
Trial #: 660
Trial Title: Durable Culture Conversion with Amikacin Liposome Inhalation Suspension for Mycobacterium
avium complex Lung Disease
Purpose: To assess the durability of sustained conversion in treatment of refractory MAC
lung disease patients and to determine if any safety issues were associated with amikacin
liposome inhalation suspension.
Sponsor: Insmed
Trial #: INS212
Trial Title: Safety and Tolerability of Amikacin Liposome Inhalation Suspension in Treatment
Refractory M. avium Complex Lung Disease: A 12 Month Open Label Extension Study
Purpose: To assess the safety, tolerability and clinical efficacy of amikacin liposome inhalation
suspension in the treatment of Mycobacterium avium complex lung disease.
Sponsor: Insmed
Trial #: INS312