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Long-term Safety and Tolerability of Omadacycline for the Treatment of Mycobacterium abscessus Infections

Mingora, Christina M; Bullington, Wendy; Faasuamalie, Paige E; Levin, Adrah; Porter, Gabriella; Stadnick, Ryan; Varley, Cara D; Addrizzo-Harris, Doreen; Daley, Charles L; Olivier, Kenneth N; Winthrop, Kevin L; Dorman, Susan E; Flume, Patrick A
BACKGROUND/UNASSIGNED: METHODS/UNASSIGNED:infections. All patients treated with omadacycline as part of a multidrug therapeutic regimen through December 2021 were included. Clinical data from time of omadacycline initiation and up to 12 months of follow-up were collected. Descriptive statistics were performed. RESULTS/UNASSIGNED:. In isolates with reported drug susceptibility testing, 15 of 70 (21.4%) had confirmed susceptibility to macrolides. The most common site of infection was lungs. Median duration omadacycline treatment was 8 months (range, 0.25-33 months; interquartile range, 4-15 months). Omadacycline was discontinued in 60 patients (51.3%); 20 completed planned treatment course, 23 experienced intolerance or adverse event leading to drug cessation, and 17 stopped due to cost, death (unrelated to NTM infection or therapy), or another reason. In those with pulmonary disease, 44 of 95 (46%) had 1 or more negative cultures at time of final microbiological assessment, with 17 of 95 (18%) achieving culture conversion. CONCLUSIONS/UNASSIGNED:infections.
PMID: 37476076
ISSN: 2328-8957
CID: 5536092

The 6th World Bronchiectasis and Nontuberculous Mycobacteria Conference Abstract Presentations

Aksamit, Timothy R.; Emery, Elizabeth J.; Basavaraj, Ashwin; Metersky, Mark L.; Donnell, Anne E.; Addrizzo-Harris, Doreen J.
ISSN: 2372-952x
CID: 5615422

Anti-Mycobacterials and Micro-Aspiration Drive Lower Airway Dysbiosis in NTM Bronchiectasis [Meeting Abstract]

Singh, S.; Hoque, A.; Sulaiman, I.; Li, Y.; Wu, B.; Chang, M.; Kyeremateng, Y.; Collazo, D. E.; Kamelhar, D.; Addrizzo-Harris, D. J.; Segal, L. N.
ISSN: 1073-449x
CID: 5238232

Amikacin Liposome Inhalation Suspension for Refractory MAC Lung Disease: Sustainability and Durability of Culture Conversion and Safety of Long-Term Exposure

Griffith, David E; Thomson, Rachel; Flume, Patrick A; Aksamit, Timothy R; Field, Stephen K; Addrizzo-Harris, Doreen J; Morimoto, Kozo; Hoefsloot, Wouter; Mange, Kevin C; Yuen, Dayton W; Ciesielska, Monika; Wallace, Richard J; van Ingen, Jakko; Brown-Elliott, Barbara A; Coulter, Chris; Winthrop, Kevin L
BACKGROUND:In the CONVERT study, treatment with amikacin liposome inhalation suspension (ALIS) added to guideline-based therapy (GBT) met the primary end point of increased culture conversion by month 6 in patients with treatment-refractory Mycobacterium avium complex (MAC) lung disease (ALIS+GBT, 29% [65/224] vs GBT-alone, 8.9% [10/112], P<.0001). RESEARCH QUESTION/OBJECTIVE:In patients who had culture conversion by month 6 in CONVERT, was conversion sustained (negative sputum cultures for 12 months on treatment) and durable (negative sputum culture for 3 months off treatment), and were there any additional safety signals associated with a full treatment course of 12 months post-conversion? STUDY DESIGN AND METHODS/METHODS:Adults were randomized 2:1 to receive ALIS+GBT or GBT-alone. Patients achieving culture conversion by month 6 continued therapy for 12 months followed by off-treatment observation. RESULTS:More patients randomized to ALIS+GBT (intention-to-treat) had conversion that was both sustained and durable 3 months off treatment vs patients randomized to GBT-alone (ALIS+GBT, 16.1% [36/224] vs GBT-alone, 0% [0/112], P<.0001). Of the patients who had culture conversion by month 6, 55.4% of converters (36/65) in the ALIS+GBT-treated arm vs no converters (0/10) in the GBT-alone arm had sustained and durable conversion (P=.0017). Relapse rates through 3 months off treatment were 9.2% (6/65) in the ALIS+GBT and 30.0% (3/10) in the GBT-alone arm. Common adverse events among ALIS+GBT-treated patients (dysphonia, cough, dyspnea, hemoptysis) mainly occurred within the first 8 months of treatment. INTERPRETATION/CONCLUSIONS:In a refractory population, conversion was sustained and durable in more patients treated with ALIS+GBT for 12 months postconversion than in those treated with GBT-alone. No new safety signals were associated with 12 months of postconversion treatment.
PMID: 33887244
ISSN: 1931-3543
CID: 4847382

Outcomes of robotic surgery in patients with pulmonary nontuberculous mycobacterial disease [Meeting Abstract]

Mcguire, E L; Saini, S; Luoma, K; Zervos, M; Cerfolio, R J; Addrizzo-Harris, D J
Rationale: Treatment for patients with pulmonary nontuberculous mycobacterial (NTM) disease includes long, multi-drug, and toxic medication regimens. Despite medical therapy, the rate of sputum culture conversion is low. Surgical resection is an alternative treatment for patients with localized or refractory NTM infection. Traditionally, resection of the affected lung was achieved via open thoracotomy. Robot-assisted surgery is less invasive and similarly effective, but has not been used routinely in this population. To our knowledge, this is the first report of robotic surgery for patients with complex NTM disease.
Method(s): Using the electronic medical record we identified patients with NTM disease that underwent robotic anatomic pulmonary resection by an experienced surgeon. All surgeries were done at NYU Langone Medical Center between August 2017 and February 2020. We collected data on demographics, NTM species, antibiotic course, pre- and post-operative sputum cultures, and surgical complications.
Result(s): We identified 8 patients that met the criteria. 100% of the patients were female and 88% were white. Mean age at time of surgery was 53 years. The most common indication for surgery was cavitary disease, followed by failure of medical therapy, and hemoptysis. All of the patients had pre-operative sputum cultures positive Mycobacterium avium complex. Prior to surgery, 63% of patients required IV antibiotics. Lobectomy was the most common operation performed and none of the surgeries were converted to open thoracotomy. There were no post-operative bleeds requiring transfusion, pneumonias, pneumothoraces, or bronchopleural fistulas. One patient had an air leak > 5 days. None of the patients required an ICU stay and the median length of hospital stay was 2.5 days. There were no deaths. Patients were considered cured if they had sputum culture conversion or no longer required antibiotics. Partial cure was defined as symptom improvement or de-escalation of medical regimen. Six of the patients were completely cured, one patient was partially cured, and one patient was lost to follow-up.
Conclusion(s): Surgical resection for patients with complex NTM disease can be performed using minimally invasive, robotic techniques safely and without the need for conversion to open thoracotomy, blood transfusions, or ICU stay. In this small cohort of patients, robotic surgery had a high rate of cure, few post-operative complications, and a short length of hospital stay. Larger studies can assist with validating robotic surgery as the preferred approach in these patients
ISSN: 1535-4970
CID: 4915762

Exercise-Induced Small Airway Dysfunction Detected by Oscillometry Uncovers Mechanisms for Unexplained Dyspnea [Meeting Abstract]

Sharpe, A. L.; Oppenheimer, B. W.; Goldring, R. M.; Sterman, D. H.; Addrizzo-Harris, D. J.; Weinstein, T.; Kwok, B.; Bohart, I.; Berger, K. I.
ISSN: 1073-449x
CID: 5266052

Pseudomonas aeruginosa associated with severity of non-cystic fibrosis bronchiectasis measured by the modified bronchiectasis severity score (BSI) and the FACED: The US bronchiectasis and NTM Research Registry (BRR) study

Choate, Radmila; Aksamit, Timothy R; Mannino, David; Addrizzo-Harris, Doreen; Barker, Alan; Basavaraj, Ashwin; Daley, Charles L; Daniels, M Leigh Anne; Eden, Edward; DiMango, Angela; Fennelly, Kevin; Griffith, David E; Johnson, Margaret M; Knowles, Michael R; McShane, Pamela J; Metersky, Mark L; Noone, Peadar G; O'Donnell, Anne E; Olivier, Kenneth N; Salathe, Matthias A; Schmid, Andreas; Thomashow, Byron; Tino, Gregory; Winthrop, Kevin L; Stone, Glenda
RATIONALE/BACKGROUND:Non-cystic fibrosis bronchiectasis (NCFB) is characterized by dilated bronchi, poor mucus clearance and susceptibility to bacterial infection. Pseudomonas aeruginosa (PA) is one of the most frequently isolated pathogens in patients with NCFB. The purpose of this study was to evaluate the association between presence of PA and disease severity in patients within the US Bronchiectasis and Nontuberculous mycobacteria (NTM) Research Registry (BRR). METHODS:Baseline US BRR data from adult patients with NCFB collected between 2008 and 2018 was used for this study. The presence of PA was defined as one or more positive PA cultures within two years prior to enrollment. Modified Bronchiectasis Severity Index (m-BSI) and modified FACED (m-FACED) were computed to evaluate severity of bronchiectasis. Unadjusted and multivariable multinomial regression models were used to assess the association between presence of PA and severity of bronchiectasis. RESULTS: = 2.06 (95%CI:1.37-3.09) severity vs. low severity on m-BSI. CONCLUSION/CONCLUSIONS:The presence of PA is common in patients with NCFB within the Bronchiectasis and NTM Research Registry. Severity of bronchiectasis is significantly greater in patients with PA which emphasizes high burden of the disease.
PMID: 33401148
ISSN: 1532-3064
CID: 4738812

Airway clearance techniques in bronchiectasis: Analysis from the United States Bronchiectasis and NTM Research Registry

Basavaraj, Ashwin; Choate, Radmila; Addrizzo-Harris, Doreen; Aksamit, Timothy R; Barker, Alan; Daley, Charles L; Anne Daniels, M Leigh; Eden, Edward; DiMango, Angela; Fennelly, Kevin; Griffith, David E; Johnson, Margaret M; Knowles, Michael R; Metersky, Mark L; Noone, Peadar G; O'Donnell, Anne E; Olivier, Kenneth N; Salathe, Matthias A; Schmid, Andreas; Thomashow, Byron; Tino, Gregory; Winthrop, Kevin L
BACKGROUND:In patients with bronchiectasis, airway clearance techniques (ACTs) are important management strategies. RESEARCH QUESTION/OBJECTIVE:The primary objective was to describe differences in patients with bronchiectasis and productive cough who utilized ACTs and those who did not. Secondary objectives included assessment of bronchiectasis exacerbation frequency and change in pulmonary function at one-year follow-up. STUDY DESIGN/METHODS:and methods:Adult patients with bronchiectasis and productive cough in the United States Bronchiectasis and NTM Research Registry were included in the analyses. ACTs included the use of instrumental devices and manual techniques. Stratified analyses of demographic and clinical characteristics were performed by use of ACTs at baseline and follow-up. Association between ACT use and clinical outcomes was assessed using unadjusted and adjusted multinomial logistic regression models. RESULTS:Of the overall study population (n=905), 59% utilized ACTs at baseline. A greater proportion of patients using ACTs at baseline and follow-up continuously had Pseudomonas aeruginosa (47% vs. 36%, p=0.021) and experienced an exacerbation (81% vs. 59%, p<0.0001) or hospitalization for pulmonary illness (32% vs. 22%, p=0.001) in the prior two years, compared to those not using ACTs. Fifty-eight percent of patients who utilized ACTs at baseline did not use ACTs at one-year follow-up. There was no significant change in pulmonary function for those that used ACTs at follow-up, compared to baseline. Patients using ACTs at baseline and follow-up had greater odds for experiencing exacerbations at follow-up compared to those not using ACTs.
PMID: 32622820
ISSN: 1931-3543
CID: 4517182

Nutrition and Markers of Disease Severity in Patients With Bronchiectasis

Despotes, Katherine A; Choate, Radmila; Addrizzo-Harris, Doreen; Aksamit, Timothy R; Barker, Alan; Basavaraj, Ashwin; Daley, Charles L; Eden, Edward; DiMango, Angela; Fennelly, Kevin; Philley, Julie; Johnson, Margaret M; McShane, Pamela J; Metersky, Mark L; O'Donnell, Anne E; Olivier, Kenneth N; Salathe, Matthias A; Schmid, Andreas; Thomashow, Byron; Tino, Gregory; Winthrop, Kevin L; Knowles, Michael R; Daniels, Mary Leigh Anne; Noone, Peadar G
Background/UNASSIGNED:Increasing numbers of patients are being diagnosed with bronchiectasis, yet much remains to be elucidated about this heterogeneous patient population. We sought to determine the relationship between nutrition and health outcomes in non-cystic fibrosis (non-CF) bronchiectasis, using data from the U.S. Bronchiectasis Nontuberculous Mycobacterial Research Registry (U.S. BRR). Methods/UNASSIGNED:This was a retrospective, observational, longitudinal study using 5-year follow-up data from the BRR. Bronchiectasis was confirmed on computed tomography (CT). We stratified patients into nutrition categories using body mass index (BMI), and correlated BMI to markers of disease severity. Results/UNASSIGNED:, non-tuberculous mycobacteria, or by cause of bronchiectasis. The majority of patients demonstrated stable BMI over 5 years. Conclusions/UNASSIGNED:Although underweight patients with bronchiectasis have lower lung function, lower BMI does not appear to relate to other markers of disease severity in this patient population.
PMID: 33108111
ISSN: 2372-952x
CID: 4646522

Esophageal motility disorders and gerd in patients with bronchiectasis [Meeting Abstract]

Fass, O; Krishna, M; Kamelhar, D; Addrizzo-Harris, D; Segal, L; Khan, A; Knotts, R M
INTRODUCTION: Bronchiectasis is a common chronic pulmonary condition characterized by inflammation and recurrent infections. There is evidence that gastroesophageal reflux disease (GERD) is associated with bronchiectasis and can increase the severity of pulmonary disease. Data regarding esophageal function in this population is sparse. We aimed to assess whether patients with bronchiectasis have an increased prevalence of esophageal motility disturbances and GERD.
METHOD(S): We conducted a single-center matched cohort study of all adult patients with confirmed bronchiectasis who underwent esophageal high-resolution manometry (HRM) between 11/ 2014-3/2018. All cases were randomly matched with a control by age (65 years) and sex. Chicago Classification 3.0 was used to characterize HRM findings. Combined multichannel intraluminal impedance-pH (pH-MII) was utilized to assess reflux burden. Statistical relationships between proportions were evaluated by Chi-square or Fisher's exact test and continuous variables were compared using t-test or rank sum test.
RESULT(S): 63 bronchiectasis patients underwent HRM, of which 54 underwent pH-MII. Of the controls, 63 underwent HRM, of which 39 underwent pH-MII. Baseline characteristics between cases and controls were similar. Mean age of bronchiectasis patients was 65 (SD 12.73), mean body mass index was 25.51 (SD 8.50), 70% were female, and 48% had a smoking history (Table). HRM did not demonstrate any significant differences between cases and controls. pH-MII trended towards a greater reflux burden among controls. However, nearly half of cases had conclusive evidence of pathologic reflux by esophageal acid exposure on pH-MII. On endoscopy, no significant differences were noted.
CONCLUSION(S): Esophageal motility and acid exposure did not significantly differ among patients with bronchiectasis and controls, which may indicate that esophageal physiology in bronchiectasis is not unique. Nevertheless, more than half of the bronchiectasis group had evidence of abnormal esophageal motility and almost half of patients had conclusive evidence of pathologic reflux. Small differences are likely due to the high prevalence of GERD and associated motility disorders in the control group. Larger studies are warranted to further characterize esophageal physiology in these patients and the potential impact on pulmonary pathology. (Table Presented)
ISSN: 1572-0241
CID: 4720662