Treatment duration over 18 months lead to relapse-free cure in 8/11 patients [122]; treatment regimens over nine months of duration cured more patients (11/23) than shorter regimens (1/11) [37]. For M. kansasii pulmonary disease, resistance to rifampicin has been associated with treatment failure [114, 115], although no randomized trials have been conducted that associate baseline MICs to clinical outcome. Significant adverse events were reported in one study (14.7%), leading to discontinuation of the parenteral agent in 9.5% [28]. Comment submitted successfully, thank you for your feedback. However, the Clinical and Laboratory Standards Institute (CLSI) currently recommends use of 7H10 and 7H11 solid media [66]. The pathogenicity of NTM varies significantly from organisms like M. gordonae, which rarely cause disease in humans, to M. kansasii, which should usually be considered pathogenic [8]. Given the lack of evidence-based therapies, we hypothesized that treatment regimens have no clear pattern and that medication changes and toxicities occur frequently. The EIN is funded through a cooperative agreement between the Centers for Disease Control and Prevention and IDSA. Although the optimal duration of therapy is not known, most patients reported in the literature with M. abscessus were treated for >12 months, and the treatment was divided into an initial phase usually including parenteral drugs followed by a longer phase using oral and sometimes inhaled antibiotics [184, 195]. However, studies have documented significant reductions in serum drug concentrations of clarithromycin with concurrent use of rifampicin and to a lesser extent with rifabutin [145, 224, 225]. abscessus. Alternatively, when M. abscessus subsp. However, when azithromycin is not available or not tolerated, clarithromycin is an acceptable alternative. Several target genes have been described, e.g., 16S rRNA, hsp65, rpoB, and the 16S–23S internal transcribed spacer (ITS) [72–75]. There are also nontuberculous (NTM) mycobacteria, ubiquitous in soil, water, food, on the surfaces of many plants and within buildings, particularly within water pipes. The 2007 guideline included clinical, radiographic, and microbiologic criteria for diagnosing NTM pulmonary disease [4]. massiliense received a median of 4.7 months of parenteral therapy and 12.1 months of total treatment compared with 7.4 and 16.3 months in patients with M. abscessus subsp. J. M. I., E. C., J. Consisting of data provided by the authors to benefit the reader, the posted materials are not copyedited and are the sole responsibility of the authors, so questions or comments should be addressed to the corresponding author. http://dx.doi:10.1513/AnnalsATS.201412-559OC, Treatment of Mycobacterium abscessus Infection, U.S. Department of Health & Human Services, Novosad SA, Beekmann SE, Polgreen PM, Mackey K, Winthrop KL. Pulmonary and disseminated MAC infections are typically treated the same way with a combination of antibiotics. Although the expert panel does not recommend macrolide monotherapy for treatment of NTM pulmonary disease, the study demonstrated that similar treatment outcomes could be obtained using shorter and less intensive treatment than used for M. abscessus subsp. Twenty-two PICO questions are addressed in this Guideline. Some of the reported relapses may actually be exogenous reinfections, as suggested by the long periods between treatment completion and recurrence [27, 173]. Treatment of nontuberculous mycobacterial (NTM) infection of the lung is dependent upon a number of factors, including the species of the infecting organism. The optimal duration of therapy for MAC pulmonary disease is currently not known. The panel members felt that this outweighs the risk of adverse events associated with longer treatment and agrees with previous recommendations [4]. Side effects were common and often led to changing or discontinuing therapy. A 2009 systematic review concluded that the data available at the time of the review did not permit comment on the impact of treatment duration on treatment outcomes [185]. Given the very high mortality associated with M. xenopi, the committee felt the large risk of treatment failure with a two-drug regimen warranted a strong recommendation for at least a three-drug treatment regimen. massiliense had better treatment outomes than patients with subsp. In the Mycobacterial and Bronchiectasis Clinic, pulmonologists are part of a multidisciplinary team … No isolates in either group developed macrolide resistance, although the study was underpowered to detect a difference. The relative and absolute effect estimates and 95% CIs for each outcome (Table E3.11) and discussion of value preferences, feasibility, cost, acceptability, and health inequality (Table E4.11) can be found in the supplement. A priority in MAC pulmonary disease therapy is preventing the development of macrolide resistance. recommendations for the treatment of nontuberculous mycobacterial (NTM) pulmonary disease Cite this article as: Daley CL, Iaccarino JM, Lange C, et al. The one study identified had a very small sample size, only indirectly addressed this question, and was felt to be of too low quality to form the basis of a recommendation. Discussion of value preferences, feasibility, cost, acceptability, and health inequality (Table E4.10) can be found in the supplement. The different mechanisms leading to macrolide resistance have made it difficult for clinicians to determine when to use a macrolide in the treatment of M. abscessus pulmonary disease. Therapeutic drug monitoring (TDM) refers to the measurement of drug concentrations in serum specimens at some point after dosing to determine whether or not a specific target concentration has been obtained (Table 3). In the few studies that applied multiple solid media and reported results per medium, the Löwenstein-Jensen medium was found to be most sensitive for the detection of NTM [59, 64]. We suggest treatment be continued for ≥12 months after culture conversion. Regimens require the use of multiple antimicrobial agents that are often associated with clinically significant adverse reactions and must be administered for prolonged periods. However, azithromycin has less potential for drug-drug interactions than clarithromycin [142]. Adjusting treatment according to the results of drug susceptibility tests was not associated with any difference in median survival (75% with adjustment and 80% without). There have been no randomized clinical trials comparing <12 months with ≥12 months of treatment after culture conversion, but a 12-month fixed duration regimen was evaluated in three studies [27–29], and a nine-month regimen in one [173]. CDC twenty four seven. Treatment of Mycobacterium abscessus Infection. There is not similar evidence to justify or support intermittent therapy for cavitary MAC pulmonary disease and it is not recommended. The ATS and IDSA developed a set of criteria to help guide clinicians in determining which patients are likely to have progressive disease [4]. Published Fifty-nine patients were assigned to a three-drug regimen and 60 to a two-drug regimen with lung cavitation present in approximately 50% of patients in both arms. Subsequent case series could not address the specific question but found that treatment duration of <6 months was associated with higher mortality and with recurrence [35]. abscessus and functional erm(41) gene [40, 124, 125]. The poor response to treatment in AIDS patients with disseminated MAC in the premacrolide era and the rapid development of resistance with clarithromycin monotherapy reinforced the need for multiple drugs for treatment success. This review included an additional 13 studies that used macrolide-containing regimens of which 10 were restrospective [38, 39, 89, 197–203] and three prospective cohort designs [12, 108, 204]. Resistance to clarithromycin is defined as an MIC ≥ 32 µg/mL [15]. There were no studies identified that compared macrolide-containing regimens with nonmacrolide-containing regimens. Discussion of value preferences, feasibility, cost, acceptability, and health inequality (Table E4.12) can be found in the supplement. Audiological TEAEs were generally similar in both arms although tinnitus was reported in 17 patients (7.6%; 20 events) in the ALIS+GBT arm compared with one event (0.9%) in those receiving GBT alone. The relative and absolute effect estimates and 95% CIs for each outcome (Table E3.7) and discussion of value preferences, feasibility, cost, acceptability, and health inequality (Table E4.7) can be found in the supplement. Therefore, given the good outcomes observed with oral regimens and the high risk of adverse effects associated with parenteral amikacin or streptomycin, the committee felt strongly that the use of these parenteral agents is not warranted, unless it is impossible to use a rifampicin-based regimen or severe disease is present. massiliense were more likely to convert cultures to negative compared with patients infected with M. abscessus subsp. One randomized controlled trial was performed evaluating the impact of streptomycin addition to macrolide-based oral therapy for the initial three months of therapy [121]. In the setting of macrolide-resistant disease, the sputum culture conversion rate falls from approximately 80% [22, 23] to only 5–36% [16–18, 136]. Winthrop), University of Iowa Carver College of Medicine, Iowa City, Iowa, USA (S.E. Progression was more likely to occur in patients who were acid-fast bacilli smear positive, had fibrocavitary disease or more extensive radiographic disease. Chest radiographs or chest CT imaging may be beneficial for defining a radiographic response to therapy, although there can be wide variability in findings given the common occurrence of underlying lung disease. massiliense [195]. Almost all of the patients who underwent surgery had received antimicrobial treatment before and after surgery. Patients with M. xenopi pulmonary disease frequently present with cavitary disease [189], often respond poorly to treatment [35, 36, 184, 185], and suffer a higher all-cause mortality than other NTM species [34, 186]. This inducible resistance can be measured in vitro by prolonged (ie, up to 14 days) incubation of microdilution trays [40, 93] or can be investigated by molecular detection and characterization of the erm(41) gene. The most common clinical presentation is that of pulmonary disease, often occurring in the setting of underlying structural airway disease such as bronchiectasis or chronic obstructive pulmonary disease [4]. The committee thought that the benefits outweighed risks in those patients with cavitary or advanced/severe bronchiectatic or macrolide-resistant MAC pulmonary disease and that administration of at least 2–3 months of an aminoglycoside was the best balance between risks and benefits. Two recent systematic reviews did not address the optimum duration of therapy but noted that most patients with M. abscessus were treated for over 12 months with multidrug regimens including a minimum of four weeks of ≥1 parenteral antimicrobials [184, 195]. 2016 Apr. Many experts feel it is desirable to achieve at least smear conversion prior to surgical resection, and the panel suggests that surgery be performed by a surgeon experienced in performing surgery on patients with mycobacterial disease [43]. This guideline was developed by a multidisciplinary committee consisting of physicians and researchers with recognized NTM expertise (C.A., E.B., E.C., C.D., D.G., L.G., G.H., J.I., C.L., T.M., K.O., J.S., M.S., E.T., D.W., K.W., R.W. Amikacin is an important drug used for treatment of M. abscessus pulmonary disease. Like in other NTM infections, a multidrug therapy is used to avoid selecting for drug resistance, but the optimal number and combination of drugs are not known. C. L. D. served on advisory committees for Cipla, Horizon, Insmed, Johnson & Johnson, Matinas Biopharma, Otsuka America Pharmaceutical, Paratek, and Spero; received research support from Beyond Air, Insmed, and Spero; served as a consultant for Meiji. No randomized, controlled trials have been conducted to examine the impact of treatment on either survival or quality of life. In spite of the widespread use of macrolides for treating MAC disease, there have been only two randomized controlled trials comparing a macrolide-containing regimen with a nonmacrolide-containing regimen [131, 132]. Until additional evidence is provided showing that acquired macrolide resistance is equally common among macrolide containing three-drug and two drug regimens, the panel prefers a three-drug regimen. It has been known to … XX: In patients with M. abscessus complex pulmonary disease, how many antibiotics should be included within multidrug regimens? The most common to cause pulmonary disease are M. avium, M. intracellulare, and M. chimaera. No additional information was available with regard to lung involvement, nor to the subsp. In a second small prospective trial from Japan [132], 27 patients with MAC pulmonary disease were treated for one year with rifampicin and ethambutol plus either gatifloxacin or low dose (600 mg) clarithromycin. abscessus. Sputum should be induced with hypertonic saline if spontaneous sputum specimens cannot be collected. Reduced therapeutic options exist against this opportunistic pathogen due to its high intrinsic and acquired levels of antibiotic resistance. Clinical responses were reported in 20–100% and sputum conversion was reported in 18–67% of treatment refractory MAC pulmonary disease. Tuberc Respir Dis (Seoul). Databases searched included MEDLINE, EMBASE, Cochrane Registry of Controlled Trials, Health Technology Assessment, and the Database of Abstracts of Reviews of Effects from 1946 through July 2015. In this study, 34 patients were treated with either ciprofloxacin (n = 17) or clarithromycin (n = 17) in addition to rifampicin and ethambutol. In many settings, expert consultation is helpful. In another study, 71 patients with M. abscessus subsp. There may be a risk of developing acquired mutational amikacin resistance with either inadequate companion medications or poor and irregular antibiotic deposition in the lung with areas of low amikacin concentration. Still others cause infections that are called atypical mycobacterial infections. V: Should patients with MAC pulmonary disease be treated with a parenteral amikacin or streptomycin-containing regimen or without a parenteral amikacin or streptomycin-containing regimen? Moreover, the studies suffer from multiple potential biases including different reasons for performing surgery, patient selection, and subjective assessment of postsurgical outcomes. A recent systematic review [195] reported that a single study reported the use of macrolide-free regimens in 120 patients of whom 8% experienced culture conversion [196]. A critically important finding from the available studies is the lack of development of macrolide resistance with intermittent therapy. Many of the research priorities relate to the need for new drugs, treatment regimens, shorter regimens, and better tolerated regimens. Given the better treatment outcomes with disease due to M. abscessus subsp. Side effects are common and often lead to changing or discontinuing therapy. Remarks: Treatment success of M. kansasii pulmonary disease with a rifamycin-based drug regimen is usually excellent but the optimal choice of companion drugs is not clear. Oral drugs with some activity are the macrolides, oxazolidinones (linezolid) and clofazimine. A second systematic review [184] included 10 studies including two [90, 205] that were not assessed in the other systematic review. Twenty-two PICO (Population, Intervention, Comparators, Outcomes) questions and associated recommendations are included in the Guideline. In patients with M. xenopi pulmonary disease, we suggest a daily regimen that includes at least three drugs: rifampicin, ethambutol, and either a macrolide and/or a fluoroquinolone (e.g., moxifloxacin) (conditional recommendation, very low certainty in estimates of effect). Additionally, the absence of universal access to moxifloxacin and the small amount of data for other fluoroquinolones has to be considered when choosing a regimen. Macrolides (clarithromycin and azithromycin) have been the basis of therapy against MAC pulmonary disease because they were demonstrated in multiple trials to be effective in prophylaxis and multidrug treatment of disseminated MAC infection [126–130]. The GRADE evidence-to-decision framework was used to organize and document discussion for each recommendation [2, 50]. Isoniazid is widely used at present for treatment of M. kansasii pulmonary disease, and in the experience of the expert panel, there have been good outcomes when using a regimen consisting of rifampicin, ethambutol, and isoniazid irrespective of the result of MICs for isoniazid and ethambutol [24]. Guidelines-based MAC therapy with multidrug regimens including macrolides is usually effective, but far from as predictably effective and durable as therapy for tuberculosis. However, despite the guidelines, surgical therapy was uncommon for patients with pulmonary disease; only 3 patients in this series underwent surgery. Given the slow course of NTM pulmonary disease, a prolonged interval ensures that repeat positive cultures are unlikely to reflect a transient contamination of the tracheobronchial system after a single environmental exposure. Her research focuses on the epidemiology and natural history of chronic pulmonary infections. The decision to proceed with surgical resection must be weighed against the risks and benefits of surgery. Our series showed a wide range of treatment strategies for M. abscessus infection; most consisted of prolonged antimicrobial drug therapy. A medical librarian (S.K.) XI: In patients with rifampicin-susceptible M. kansasii pulmonary disease, should parenteral amikacin or streptomycin be included in the treatment regimen? Message not sent. A Phase II controlled trial randomized treatment refractory patients (eg, with culture positivity after at least 6 months of guideline-based treatment that included a macrolide) with predominantly MAC (n = 57) or M. abscessus (n = 32) pulmonary disease to investigational ALIS (n = 44) versus placebo (empty liposomes, n = 45) [19]. Ethambutol is the best companion drug for preventing the emergence of macrolide resistance [16, 18, 161]. It is important to consider identification of the M. abscessus subsp. It was therefore suggested that periodic treatment courses, or aggressive treatment regimens including multiple parenteral agents for a few months, could be effective strategies. Among subjects who completed the treatment regimen, cure was 100%. There are no randomized studies or case series that address this question although there is one study that reported outcomes based on whether the patient received <12 months of treatment [22]. Postinfection treatment involves a combination of antituberculosis antibiotics, including rifampicin, rifabutin, ciprofloxacin, amikacin, ethambutol, streptomycin, clarithromycin or azithromycin. Twenty-two questions were chosen based on committee ranking pertinent to the treatment of NTM pulmonary disease. The panel felt that in the absence of evidence identifying an optimal treatment duration that the recommendation from the 2007 Guideline should be followed [4]. Treatment failure occurred in 2 patients whose isolates had become resistant by mutation to amikacin [19]. Both molecular and mass spectrometry-based methods can be applied. Thirty-two (78%) of these patients converted sputum cultures to negative. There are two systematic reviews [184, 195] that have reported treatment outcomes in patients with M. abscessus pulmonary disease, but there are no studies that have directly compared the efficacy or safety of different multidrug regimens. In patients with newly diagnosed MAC pulmonary disease, we suggest neither inhaled amikacin (parenteral formulation) nor amikacin liposome inhalation suspension (ALIS) be used as part of the initial treatment regimen (conditional recommendation, very low certainty in estimates of effect). Treatment success of M. kansasii pulmonary disease with a rifamycin-based drug regimen is usually excellent but the optimal choice of companion drugs is not clear. Host susceptibility to non-tuberculous mycobacterial infections. These include the macrolides (clarithromycin and azithromycin) [112] and amikacin [19, 20, 87] with MAC and M. abscessus [19, 113], and rifampicin with M. kansasii [114, 115]. Remark: Although in vitro-in vivo correlations have not yet been proven for all major antimycobacterial drugs, baseline susceptibility testing to specific drugs is recommended according to the Clinical and Laboratory Standards Institute(CLSI) guidelines [14, 15] for NTM isolates from patients with definite disease. This guideline focuses on pulmonary disease in adults (without cystic fibrosis or human immunodeficiency virus infection) caused by the most common NTM pathogens such as Mycobacterium avium complex, Mycobacterium kansasii, and Mycobacterium xenopi among the slowly growing NTM and Mycobacterium abscessus among the rapidly growing NTM. Rapid identification and management of an adverse reaction is likely to decrease the risk of treatment for the patient and possibly improve the chances of treatment completion. Sputum culture conversion to negative was observed in 6 of the 27 patients (22%) who received treatment for <12 months, compared with 154 of 180 (86%) of patients who completed at least 12 months of therapy (P < .001). The relative and absolute effect estimates and 95% CIs for each outcome (Table E3.4) and discussion of value preferences, feasibility, cost, acceptability, and health inequality (Table E4.4) can be found in the supplement. Treatment of Mycobacterium abscessus Infection. This is particularly true in the initial months of therapy when bacterial burdens are greater. Current treatment for pulmonary mycobacterial disease recommends ethambutol, rifampin, and macrolides (1,13). The relative and absolute effect estimates and 95% CIs for each outcome (Table E3.15) and discussion of value preferences, feasibility, cost, acceptability, and health inequality (Table E4.15) can be found in the supplement. The availability of gene sequencing has improved taxonomy of mycobacteria, with an extraordinary increase in the number of validly published NTM species. Trials of monotherapy with clarithromycin, rifampicin, ethambutol, or clofazimine for HIV-associated disseminated MAC demonstrated that only clarithromycin susceptibility results correlated with treatment outcomes [113, 116]. In selected patients with NTM pulmonary disease, we suggest surgical resection as an adjuvant to medical therapy after expert consultation (conditional recommendation, very low certainty in estimates of effect). This guideline focuses on pulmonary disease in adults (without cystic fibrosis or human immunodeficiency virus … Only 5 patients received no IV agents. Of the 24 patients with extrapulmonary disease (median age 50 years, IQR 42–66 years), most (17 [71%]) had skin or soft tissue infections. The panel members felt strongly that treatment regimens should be designed in collaboration with experts in the management of these complicated infections. Importantly, just because a patient meets diagnostic criteria for NTM pulmonary disease does not necessarily mean antibiotic treatment is required. Ototoxicity occurred in 0 to 19% of patients with nephrotoxicity reported in only one patient and vertigo in two patients [155–159]. A two-drug regimen including a macrolide and ethambutol is the regimen with the fewest possible drugs for treating MAC. The panel felt that azithromycin was preferred over clarithromycin because of likely better tolerance, less drug interactions, lower pill burden, single daily dosing, and equal efficacy. There are two randomized studies that compared a two-drug regimen with a three-drug regimen [21, 119], but only one of these studies included a macrolide-containing regimen [21]. Adverse events were common (~90%) in both groups, but patients receiving ALIS had more dysphonia and oropharyngeal discomfort, cough, wheezing, chest discomfort, acute exacerbations of bronchiectasis, and fatigue [19]. The significance of NTM isolated from the sputum of individuals who meet the clinical and radiographic criteria in Table 2 must be interpreted in the context of the number of positive cultures and specific species isolated. Bronchoscopy should only be considered in exceptional circumstances to determine whether culture conversion has occurred. This guideline is intended for use by healthcare professionals who care for patients with NTM pulmonary disease, including specialists in infectious diseases and pulmonary diseases. M. abscessus and its subspecies abscessus, bolletii, and massiliense are by far the most common causative agents of pulmonary disease due to rapidly growing mycobacteria. Treatment of atypical mycobacterial infections depends upon the infecting organism and the severity of the infection. Overall, 17 of the patients were treated for >1 month and had follow-up available for at least one year: 13 were treated for less than 12 months, and one were treated for ≥12 months. Even so, surgical resection was associated with improved treatment outcomes and for most of the patients (85–100%), conversion of sputum cultures to negative was observed after surgery. NTM represent over 190 species and subspecies (, many of which can produce disease in humans of all ages and can affect both pulmonary and extrapulmonary sites. Given the lack of data on the optimal duration of therapy, the panel voted unanimously to continue to follow the recommendations from the 2007 Guideline. Lancet Infect Dis. In murine models, adding either moxifloxacin or clarithromycin to a rifampicin-ethambutol combination leads to drug regimens of equal efficacy [191]. We suggest that patients with nodular/bronchiectatic M. kansasii pulmonary disease receive either daily or three times weekly treatment when receiving a macrolide, rifampicin, and ethambutol. massiliense is associated with a nonfunctional erm(41) gene and in vitro susceptibility (MIC below 4 µg/mL) [42], and thus the macrolides are active if constitutive resistance is not present. The desirable anticipated effects were estimated to be moderate. VI: In patients with macrolide-susceptible MAC pulmonary disease, should a regimen with inhaled amikacin or a regimen without inhaled amikacin be used for treatment? However, the optimum treatment duration of pulmonary disease caused by M. abscessus complex is currently unknown. One possibility is that a third drug provides additional protection to that provided by ethambutol for preventing the emergence of macrolide resistance. Neither parenteral amikacin nor streptomycin are recommended for routine use in these patients. There is currently not sufficient evidence to support bronchoscopy to obtain specimens for mycobacterial culture to determine the duration of therapy. Examples of situations in which TDM may be useful include patients with delayed sputum culture conversion or treatment failure not explained by nonadherence or drug resistance, patients receiving amikacin or streptomycin therapy and thus at risk of ototoxicity and nephrotoxicity, and patients with medical conditions (eg, reduced renal function) that are suspected of leading to subtherapeutic or toxic drug concentrations. Tentative breakpoints for linezolid and moxifloxacin are also provided by CLSI but for these, in vitro-in vivo correlations have not been established [15]. Clofazimine shows in vitro activity, acts synergistically with amikacin and macrolides [91, 92], and prevents the emergence of amikacin-resistant M. abscessus in vitro [92]. Importantly, just because a patient meets diagnostic criteria for NTM pulmonary disease does not necessarily mean antibiotic treatment is required. Macrolides possess potent activity against M. abscessus as well as immunomodulatory effects. Diagnosis and treatment outcomes all used multidrug regimens cornerstone of treatment after culture conversion rates significantly. 0 to 19 % of patients with M. abscessus we did collect information regarding outcomes this. Abscessus is often difficult to cure with antimicrobial agents that are called atypical mycobacterial infections preferences feasibility... Subsequently had MAC isolates are usually treated with a medical doctor and Pulmonary/Critical Fellow... 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