Treatment outcome definitions have now been published to promote uniform outcome reporting in studies and gather more reliable data on optimal duration of therapy in MAC pulmonary disease [170]. A recent systematic review reported that the default rate was 12.0% (95% CI 8.9%–15.0%) in patients receiving three times weekly therapy compared to 16.0% (95% CI 12.3–19.7%) with daily administration [166]. II: Should patients with NTM pulmonary disease be treated empirically or based on in vitro drug susceptibility test results? Our study had several limitations, including unknown specific subspecies of M. abscessus. In patients with M. abscessus pulmonary disease, we suggest that either a shorter or longer treatment regimen be used and expert consultation obtained (conditional recommendation for either the intervention or the comparison, very low certainty in estimates of effect). Thirty-one evidence-based recommendations about treatment of NTM pulmonary disease are provided. Recent studies have reported poor treatment outcomes associated with macrolide resistance due to either mutational or inducible resistance related to the presence of a functional erm(41) gene in M. abscessus subsp. massiliense [195]. The committee was chaired by C.D. Adverse events associated with this regimen were primarily due to rifabutin, and in 41% of patients the dosage was decreased or the drug discontinued. Resistance to clarithromycin is defined as an MIC ≥ 32 µg/mL [15]. However, the Clinical and Laboratory Standards Institute (CLSI) currently recommends use of 7H10 and 7H11 solid media [66]. Among those not starting therapy, 2 opted for monitoring only, 1 died before therapy was started, and 4 had no reason reported. Significant adverse events were reported in one study (14.7%), leading to discontinuation of the parenteral agent in 9.5% [28]. If sputum cultures have not converted to negative after six months of guideline-based treatment, we recommend the use of ALIS as part of the continuation treatment regimen. Treatment regimens are based on the identity of the isolated species, drug sensitivity testing (for some agents) and the severity of disease. The current guideline also recommends use of these criteria to classify patients as having NTM pulmonary disease (Table 2). Published Intermittent dosing of amikacin seemed to cause fewer side effects than daily dosing (42% vs. 77%, respectively). The optimal duration of treatment for M. xenopi pulmonary disease is not known, neither is the effect of treatment duration on the frequency of disease recurrence. In this study, 34 patients were treated with either ciprofloxacin (n = 17) or clarithromycin (n = 17) in addition to rifampicin and ethambutol. In the intent to treat analysis, the sputum culture conversion rate was 40.6% with the three-drug regimen and 55.0% with the two-drug regimen. 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]. This guideline focuses on pulmonary disease in adults (without cystic fibrosis or human immunodeficiency virus … The relative and absolute effect estimates and 95% CIs for each outcome (Table E3.9) and discussion of value preferences, feasibility, cost, acceptability, and health inequality (Table E4.9) can be found in the supplement. In some instances, “watchful waiting” may be the preferred course of action. In this setting, macrolides are unlikely to be contributing to the antimicrobial effect of the treatment regimen. In MAC pulmonary disease, retrospective case series [83, 84, 112, 117, 118] have also shown that in vitro resistance to clarithromycin was associated with worse outcomes than susceptibility to clarithromycin, and a randomized trial found no association between in vitro susceptibility to either rifampicin or ethambutol and failure/relapse [119]. Strains of M. abscessus subsp. abscessus and bolletii. Therefore, the panel members felt that M. kansasii could be treated for a fixed duration of 12 months instead of 12 months beyond culture conversion. of M. abscessus. Guidelines-based MAC therapy with multidrug regimens including macrolides is usually effective, but far from as predictably effective and durable as therapy for tuberculosis. Other important NTM causing pulmonary disease are M. kansasii and M. xenopi. In patients with M. abscessus pulmonary disease caused by strains without inducible or mutational resistance, we recommend a macrolide-containing multidrug treatment regimen (strong recommendation, very low certainty in estimates of effect). The writing committee thanks Kevin Wilson, MD, and the staff from each Society for their guidance during the development of the guideline, and the reviewers for their critical comments which improved the focus and clarity of the Guideline. For species of low pathogenicity such as M. gordonae, several repeated positive cultures over months, along with strong clinical and radiological evidence of disease, would be required to determine if it was causing disease, whereas a single positive culture for M. kansasii in the proper context may be enough evidence to initiate treatment [9]. The pathogenicity of NTM species may differ between geographic areas [9, 10]. A second systematic review [184] included 10 studies including two [90, 205] that were not assessed in the other systematic review. X: In patients with rifampcin-susceptible M. kansasii pulmonary disease, should an isoniazid-containing regimen or a macrolide-containing regimen be used for treatment? The panel members suggest that an expert in the management of patients with M. abscessus pulmonary disease be consulted prior to initiation of therapy in order to assist with determination of the duration of therapy. It has been known to … NTM pulmonary disease is often difficult to cure with antimicrobial therapy alone. 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]. XIII: In patients with rifampicin-susceptible M. kansasii pulmonary disease, should a three times per week or daily treatment regimen be used? M. kansasii was one of the first NTM to be recognized to cause pulmonary disease [171]. Although we did collect information regarding outcomes, this study was not powered to evaluate outcomes associated with individual regimens or medications. This recommendation is based on expert opinion and data from murine models of M. xenopi infection, wherein microbiologic benefit was observed in mice treated with amikacin [191, 192]. Our survey revealed that therapeutic regimens for M. abscessus infection vary widely. No significant difference was found in the cure rate between the two groups. There is not similar evidence to justify or support intermittent therapy for cavitary MAC pulmonary disease and it is not recommended. Remarks: The lack of studies, the variation in drug availability, resources, and practice settings made it difficult to come to a consensus on the optimum duration of therapy. A British Thoracic Society trial randomized 170 patients with primarily cavitary MAC pulmonary disease to receive standard doses of rifampicin and ethambutol with either clarithromycin or ciprofloxacin [131]. We suggest that patients with macrolide-susceptible MAC pulmonary disease receive treatment for at least 12 months after culture conversion (conditional recommendation, very low certainty in estimates of effect). The decision to proceed with surgical resection must be weighed against the risks and benefits of surgery. According to available records, at the time of case report, 55 (85%) patients had started or finished antimicrobial drug therapy. massiliense [184, 195]. 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. Most patients included in the studies had MAC pulmonary disease, with one study including only patients with M. xenopi pulmonary disease [221], one with M. kansasii only [30], and two including patients with M. abscessus pulmonary disease [39, 89]. A three-drug regimen that includes isoniazid, rifampicin, and ethambutol was recommended in the 2007 Guideline [4]. Where ALIS is not yet available, addition of inhaled parenteral amikacin is a reasonable alternative. 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). Of these 8 patients, 6 died while receiving therapy (5 pulmonary, 1 extrapulmonary). The primary endpoint was sputum conversion (i.e., three consecutive negative cultures). Although no well-designed randomized trials of macrolide therapy have been performed, the panel felt that macrolides are a critical component of MAC treatment based on poor patient outcomes if macrolides are not included in the treatment regimen. In instances where there was low certainty in the estimates of effect, the committee determined whether a strong recommendation was warranted based on paradigmatic situations outlined by Andrews et al [3]. This percentage is lower than what we found (62%), possibly because a large percentage of patients in our series received amikacin or a regimen with >1 IV agent. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. Surgical complications (such as bronchopleural fistula, prolonged air leak, pneumonia) were observed in 7–35% of participants. The relative and absolute effect estimates and 95% CIs for each outcome (Table E3.3) and discussion of value preferences, feasibility, cost, acceptability, and health inequality (Table E4.3) can be found in the supplement. 2016 Apr. abscessus. The committee was concerned about several aspects of these two studies including, (a) small sample size, (b) underdosing of the macrolide, (c) populations not representative of nodular bronchiectatic MAC pulmonary disease patients encountered frequently in clinical practice, (d) the use of gatifloxacin which is not approved for use or no longer marketed in many countries worldwide, and (e) the high overall mortality seen in one study [131], which raised questions about the validity of the study. In patients with cavitary M. kansasii pulmonary disease treated with a rifampicin, ethambutol, and macrolide-based regimen, we suggest daily treatment instead of three times weekly treatment (conditional recommendation, very low certainty in estimates of effect). For the full list of references, please visit the Oxford University Press website. Because sputum conversion at four months of rifampicin-based regimens is usually observed [29–31], expert consultation should be obtained if cultures fail to convert to negative by that time. We use cookies to ensure that we give you the best experience on our website. The 2007 guideline included clinical, radiographic, and microbiologic criteria for diagnosing NTM pulmonary disease [4]. There is in vitro evidence that macrolides and fluoroquinolones are active against M. xenopi, whereas rifampicin and ethambutol are inactive in vitro alone and in combinations [32]. Remarks: The optimal duration of therapy for pulmonary MAC disease is not currently known. In places where azithromycin is not available, clarithromycin is an acceptable alternative although more drug interactions are possible. Macrolides are the cornerstone of treatment, but the efficacy of macrolide-based chemotherapy may be compromised by resistance. III: Should patients with macrolide-susceptible MAC pulmonary disease be treated with a three-drug regimen with a macrolide or without a macrolide? Both molecular and mass spectrometry-based methods can be applied. However, data from several studies suggest that a 12-month fixed duration may be enough to cure most patients [27–29]. 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. Randomized controlled trials comparing shorter treatment regimens are currently lacking. Even so, treatment outcomes are often suboptimal, and reinfection with another strain or species is common. His tireless effort to improve the diagnosis and treatement of NTM disease will never be forgotten. Remarks: Selected patients with failure of medical management, cavitary disease, drug resistant isolates, or complications such as hemoptysis or severe bronchiectasis may undergo surgical resection of the diseased lung. A recent randomized clinical trial reported that >90% of subjects in each arm reported a treatment emergent adverse reaction [20]. Complementing 16S rRNA sequencing with additional targets where required yields the best discriminatory power, allowing identifications up to subspecies level (eg, for M. abscessus) [77, 78]. Supplementary materials are available at Clinical Infectious Diseases online. IX: In patients with macrolide-susceptible MAC pulmonary disease, should patients be treated with <12 months of treatment after culture negativity or ≥12 months of treatment after culture negativity? Nontuberculous mycobacteria (NTM) represent over 190 species and subspecies, some of which can produce disease in humans of all ages and can affect both pulmonary and extrapulmonary sites. Based on the results of one randomized trial [121] and the experiences of the panel members, the benefits were felt to outweigh risks in those patients with cavitary or advanced/severe bronchiectatic disease or those with macrolide-resistant MAC pulmonary disease. Delivery of amikacin by hand-held nebulization may be a potential way to improve efficacy and decrease drug-related toxicity. 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. A single study using standardized methods for quality of life assessment demonstrated improvement of quality of life associated with treatment of M. abscessus infection [108]. The American Thoracic Society (ATS), European Respiratory Society (ERS), European Society of Clinical Microbiology and Infectious Diseases (ESCMID), and Infectious Diseases Society of America (IDSA) jointly sponsored the development of this Guideline to update the treatment recommendations for nontuberculous mycobacterial (NTM) pulmonary disease in adults. In patients with cavitary or severe/advanced nondular bronchiectatic macrolide-susceptible MAC pulmonary disease we suggest a daily macrolide-based regimen rather than three times per week macrolide-based regimen (conditional recommendation, very low certainty in estimates of effect). Of these 41 patients, 34 (83%) started antimicrobial drug therapy. IV agents were commonly associated with side effects that often required dosage adjustment or discontinuation. As with all patients receiving treatment, frequent sputum cultures should be obtained during the course of therapy to monitor for treatment response and survey for the appearance of other organisms such as M. avium complex. Diagnosis and Treatment of Nontuberculous Mycobacterial Lung Disease: Clinicians' Perspectives. Overall, >54 medication changes among 30 patients were made because of side effects or intolerance. Their treatment practices may differ from those of non-EIN members if members follow ATS/IDSA guidelines more closely. Among those receiving amikacin and tigecycline, 51% and 36% of patients, respectively, had to adjust or stop medication because of side effects. 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. Ethambutol is the best companion drug for preventing the emergence of macrolide resistance [16, 18, 161]. Of the many known NTM species, only a small number appear to cause pulmonary disease in humans. Therapy with antimicrobial agents continued during and after the surgery, and the activity of these agents varied with regard to the study and the species involved (eg, clarithromycin was given in recent studies but not in the older ones). Overall, good treatment outcomes were noted in 84% of those with M. abscessus subsp. The committee developed recommendations that considered the certainty of the evidence from the GRADE evidence profiles, as well as other domains that inform decision-making. For example, among 488 patients with MAC pulmonary disease in Taiwan who met ATS/IDSA disease criteria and were followed for at least 1 year, 305 (62.5%) demonstrated progression of disease [97]. Conversion of sputum cultures to negative was observed in 17/29 (59%), 11/20 (55%), and 28/43 (65%) of patients, respectively. 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. Among patients with renal insufficiency attributed to amikacin, 71% were receiving it daily. In a subsequent study, 41 patients completed six months of therapy with clarithromycin 1000 mg, rifabutin 300–600 mg, and ethambutol 25 mg/kg administered three times per week [139]. Macrolide resistance can develop through chromosomal mutations in the 23S rDNA (rrl) gene resulting in high level mutational resistance as well as through induction of the erm(41) gene that causes inducible resistance in the presence of a macrolide [125]. Loss of the macrolide from the treatment regimen is associated with a markedly reduced rate of conversion of sputum cultures to negative and higher mortality [16–18]. in addition to in vitro macrolide susceptibility testing, because of the difference in response to macrolide therapy based on the presence of a functional or nonfunctional erm(41) gene. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. 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? As noted in question 5, we suggest that parenteral amikacin or streptomycin be included in the initial treatment regimen in patients with cavitary or advanced/severe bronchiectatic or macrolide-resistant MAC pulmonary disease. D. W. served as a speaker for Cepheid GmbH; received research support and travel expenses from Insmed. Most cases were in white, nonsmoking women. abscessus (85% vs 25%, P < .001), presumably because of the presence of a nonfunctional erm(41) gene in the former (gene with major deletions) and inducible macrolide resistance due to a functional erm(41) gene in the latter [38, 40–42]. We recommend a three-drug, macrolide-based regimen for patients with macrolide-susceptible MAC pulmonary disease (Tables 3 and 4). Because only EIN members could submit cases, selection bias is possible. 16S rRNA gene sequencing alone offers limited discriminatory power, particularly for the M. abscessus-M. chelonae group [70]. Treatment outcomes with intermittent therapy are not as favorable in patients with cavitary pulmonary disease. However, a systematic review that evaluated adverse events in people taking macrolides versus placebo for any indication reported no increase in cardiac disorders or mortality when compared with placebo [149]. Where possible, isolates from patients who are being treated for NTM pulmonary disease are frozen and saved in order to distinguish reinfection from relapse when recurrence occurs. 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]. The parenteral agent is typically administered for at least 2–3 months. For species of low pathogenicity such as 8 Remarks: Regimens of three oral agents, rifampicin and ethambutol, and either isoniazid or a macrolide, achieve high rates of sustained culture conversion and treatment success in the treatment of M. kansasii pulmonary disease. Postinfection treatment involves a combination of antituberculosis antibiotics, including rifampicin, rifabutin, ciprofloxacin, amikacin, ethambutol, streptomycin, clarithromycin or azithromycin. The desirable anticipated effects were estimated to be moderate. Sputum culture conversion occurred in only 4% of patients with cavitary disease. The role of a rifamycin, or another third drug, is unclear. Ats/Idsa guidelines more closely Network: bridging the gap between clinical Infectious Diseases and public.... In each arm reported a treatment emergent adverse reaction [ 20 ] ) to S.A.N with macrolide-free as... Clear pattern and that medication changes among 30 patients were treated with daily companion,. 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