Phase
Condition
Mac Infection (Mycobacterium Avium Complex)
Treatment
SPR720 500 mg
SPR720 1000 mg
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Has a prior diagnosis of NTM-PD due to MAC according to American Thoracic Society (ATS) criteria
Has at least one prior lower respiratory culture (sputum or bronchoalveolar lavage [BAL]) positive for MAC in the 12 months prior to consent
Has an induced sputum culture at Screening positive for MAC by quantitative cultureon solid agar
Is either treatment naïve and has not received any prior treatment for MAC, OR ifpreviously treated for MAC and meets all of the following criteria:
Has a history of successful treatment with sputum culture conversion tonegative
Has recent sputum or BAL culture evidence of recurrent or relapsed disease and
Has been off therapy for at least 3 months prior to consent
Has clinical signs and symptoms within the 6 weeks prior to consent that areconsistent with NTM-PD with ≥2 of the following:
chronic cough
fatigue
frequent throat clearing
shortness of breath (dyspnea)
coughing up of blood (hemoptysis)
excessive mucus (sputum) production
fever (temperature >38ºC or >100.4ºF)
night sweats
loss of appetite
unintended weight loss
wheezing
chest pain
Has a measured forced expiratory volume in the first second following maximalinhalation (FEV1) % predicted ≥30% within 3 months prior to consent. If prior FEV1%predicted test result is not available, obtain FEV1% predicted at Screening toconfirm eligibility
Exclusion
Exclusion Criteria:
In the opinion of the Investigator, is not a candidate for a 5-month delay ininitiation of standard multidrug therapy to participate in a placebo-controlledclinical trial (e.g., participant has severe symptoms or, extensive disease burden)
Has disseminated or extrapulmonary NTM disease
Has end-stage NTM-PD or treatment-refractory NTM-PD
Has isolation on lower respiratory (sputum or BAL) cultures of any Mycobacteriumspecies other than those included in MAC within the 6 months prior to consent
Has any other condition or prior therapy, which, in the opinion of the Investigator,would make the participant unsuitable for this study, including compliance with allstudy assessments and adherence to the protocol schedule of assessment
Prior exposure to SPR720. Participants who are unable to comply with therequirements of the study or who in the opinion of the Investigator should notparticipate in the study are not eligible
- Other inclusion and exclusion criteria as per protocol may apply.
Study Design
Connect with a study center
Medical Facility
Birmingham, Alabama 35233
United StatesSite Not Available
Medical Facility
Birmingham 4049979, Alabama 4829764 35233
United StatesSite Not Available
Medical Facility
Fresno, California 93701
United StatesSite Not Available
Medical Facility
Los Angeles, California 90033
United StatesSite Not Available
Medical Facility
Newport Beach, California 92663
United StatesSite Not Available
Medical Facility
Northridge, California 91324
United StatesSite Not Available
Medical Facility
Santa Clarita, California 91355
United StatesSite Not Available
Medical Facility
Fresno 5350937, California 5332921 93701
United StatesSite Not Available
Medical Facility
Los Angeles 5368361, California 5332921 90033
United StatesSite Not Available
Medical Facility
Newport Beach 5376890, California 5332921 92663
United StatesSite Not Available
Medical Facility
Northridge 5377985, California 5332921 91324
United StatesSite Not Available
Medical Facility
Santa Clarita 5393049, California 5332921 91355
United StatesSite Not Available
Medical Facility
Washington, District of Columbia 20007
United StatesSite Not Available
Medical Facility
Washington D.C. 4140963, District of Columbia 4138106 20007
United StatesSite Not Available
Medical Facility
Kissimmee, Florida 34746-4654
United StatesSite Not Available
Medical Facility
Loxahatchee Groves, Florida 33470
United StatesSite Not Available
Medical Facility
Miami, Florida 33136
United StatesSite Not Available
Medical Facility
Sebring, Florida 33870
United StatesSite Not Available
Medical Facility
Tampa, Florida 33606
United StatesSite Not Available
Medical Facility
Kissimmee 4160983, Florida 4155751 34746-4654
United StatesSite Not Available
Medical Facility
Loxahatchee Groves 4162948, Florida 4155751 33470
United StatesSite Not Available
Medical Facility
Miami 4164138, Florida 4155751 33136
United StatesSite Not Available
Medical Facility
Sebring 4172383, Florida 4155751 33870
United StatesSite Not Available
Medical Facility
Tampa 4174757, Florida 4155751 33606
United StatesSite Not Available
Medical facility
Atlanta, Georgia 30342
United StatesSite Not Available
Medical facility
Atlanta 4180439, Georgia 4197000 30342
United StatesSite Not Available
Medical Facility
Iowa City, Iowa 52242
United StatesSite Not Available
Medical Facility
Iowa City 4862034, Iowa 4862182 52242
United StatesSite Not Available
Medical Facility
Kansas City, Kansas 66103
United StatesSite Not Available
Medical Facility
Kansas City 4273837, Kansas 4273857 66103
United StatesSite Not Available
Medical Facility
New Bedford, Massachusetts 02740
United StatesSite Not Available
Medical Facility
New Bedford 4945121, Massachusetts 6254926 02740
United StatesSite Not Available
Medical Facility
Rochester, Minnesota 55905
United StatesSite Not Available
Medical Facility
Rochester 5043473, Minnesota 5037779 55905
United StatesSite Not Available
Medical Facility
Lebanon, New Hampshire 03756
United StatesSite Not Available
Medical Facility
Lebanon 5088597, New Hampshire 5090174 03756
United StatesSite Not Available
Medical Facility
New Hyde Park, New York 11042
United StatesSite Not Available
Medical Facility
New Hyde Park 5128514, New York 5128638 11042
United StatesSite Not Available
Medical Facility
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Medical Facility
Winston-Salem, North Carolina 27103
United StatesSite Not Available
Medical Facility
Chapel Hill 4460162, North Carolina 4482348 27599
United StatesSite Not Available
Medical Facility
Winston-Salem 4499612, North Carolina 4482348 27103
United StatesSite Not Available
Medical Facility
Cleveland, Ohio 44106
United StatesSite Not Available
Medical Facility
Cleveland 5150529, Ohio 5165418 44106
United StatesSite Not Available
Medical Facility
Portland, Oregon 97239
United StatesSite Not Available
Medical Facility
Portland 5746545, Oregon 5744337 97239
United StatesSite Not Available
Medical Facility
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Medical Facility
Pittsburgh 5206379, Pennsylvania 6254927 15213
United StatesSite Not Available
Medical Facility
Charleston, South Carolina 29425
United StatesSite Not Available
Medical Facility
Charleston 4574324, South Carolina 4597040 29425
United StatesSite Not Available
Medical Facility
Denison, Texas 75020
United StatesSite Not Available
Medical Facility
Sherman, Texas 75090
United StatesSite Not Available
Medical Facility
Tyler, Texas 75708
United StatesSite Not Available
Medical Facility
Denison 4685892, Texas 4736286 75020
United StatesSite Not Available
Medical Facility
Sherman 4728328, Texas 4736286 75090
United StatesSite Not Available
Medical Facility
Tyler 4738214, Texas 4736286 75708
United StatesSite Not Available
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