Thirty-two (78%) of these patients converted sputum cultures to negative. Remarks: A priority in MAC pulmonary disease therapy is preventing the development of macrolide resistance. 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. Two studies in the 1980s found that treatment durations had an effect on outcomes (typically with isoniazid-rifampicin-ethambutol regimens). 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]. MAC lung disease is an infection caused a group of bacteria called Mycobacterium avium complex (MAC). Change from the initial therapeutic regimen was needed by 14 (67%) patients. Other important NTM causing pulmonary disease are M. kansasii and M. xenopi. Design of regimens beyond the initial intravenous phase is difficult given the lack of oral antimicrobials with activity against M. abscessus. General information about Mycobacterium abscessus. Limited retrospective observational data have failed to demonstrate that treatment of NTM pulmonary disease prolongs survival over watchful waiting [95, 96]. Diagnosis of NTM pulmonary disease requires the synthesis of clinical, radiographic, and microbiology data. Side effects are common and often lead to changing or discontinuing therapy. In animal and in vitro models, regimens of rifampicin, ethambutol, and either clarithromycin or moxifloxacin are efficacious and those that included amikacin (see Question 17) even more so. In patients with MAC pulmonary disease who have failed therapy after at least 6 months of guideline-based therapy, we recommend addition of ALIS to the treatment regimen rather than a standard oral regimen, only (strong recommendation, moderate certainty in estimates of effect). There are two systematic reviews that have reported treatment outcomes of M. xenopi pulmonary disease, and both noted a wide range of drugs and regimens used [184, 185]. 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. None of the NTM strains from patients in the study developed macrolide resistance. Amikacin, the most commonly used IV agent, was associated with multiple side effects; amikacin therapy was stopped or adjusted for 51% of patients. J. M. I., E. C., J. Parenteral aminoglycoside therapy was recommended in some previous NTM guidelines during the initial months of MAC therapy [152]. The availability of gene sequencing has improved taxonomy of mycobacteria, with an extraordinary increase in the number of validly published NTM species. abscessus, respectively [207]. In this case series, 86% of the recurrences were likely due to reinfection which would possibly explain the good outcomes. 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]. Of note, all studies included some patients who did not tolerate azithromycin and were successfully switched to clarithromycin and vice-versa. For the full list of references, please visit the Oxford University Press website. (ERS), E.C. Clinical usefulness of amikacin and doxycycline in the treatment of infection due to Mycobacterium fortuitum and Mycobacterium chelonei. In the per protocol analysis (those who completed therapy) 24/32 (75%) converted on three drugs, and 33/40 (82.5%) converted on two drugs. Many of the research priorities relate to the need for new drugs, treatment regimens, shorter regimens, and better tolerated regimens. 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]. The ultimate goal of treatment is a microbiological goal of treating NTM to convert sputum cultures or biopsy-proven cultures from positive to negative. Based on the phase II and III trial results, ALIS was approved by the US Food and Drug Administration for treatment of MAC pulmonary disease in patients who have failed therapy after at least six months of GBT. 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. 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 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. One hundred forty-six patients with MAC pulmonary disease (both nodular/bronchiectatic and cavitary disease) were randomized to receive clarithromycin, ethambutol, and a rifamycin daily with (73) or without (73) streptomycin (15 mg/kg 3 times per week during the initial 3 months of therapy). The breakpoint for resistance is a MIC ≥ 64 µg/mL for parenteral amikacin and ≥128 ug/mL for amikacin liposome inhalation suspension (ALIS) [15], and finding such MICs would lead to cessation of intravenous or nebulized amikacin therapy [20]. Medical therapy had been started by 21 (88%) patients. Some of the reported relapses may actually be exogenous reinfections, as suggested by the long periods between treatment completion and recurrence [27, 173]. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. J. V. I. served on an advisory committee and as a consultant for Insmed; served on advisory committees for Janssen Pharmaceuticals and Spero. An increase of NaOH concentrations lowers contamination rates but decreases sensitivity of culture [56]. 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]. 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). 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). abscessus. 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. It is unclear to what extent this principle applies to patients with M. kansasii pulmonary disease given that three times weekly treatment can be effective in patients with nodular/bronchiectatic or cavitary disease [26]. E. C. B. served as a consultant for AID Diagnostika, Becton Dickinson, and COPAN; provided expert testimony for Shuttleworth & Ingersoll law firm. Treatment outcomes with the three-drug regimen when administered for 9–18 months have been excellent with cure rates of 80–100% and low relapse rates of 2.5–6.6% when administered for at least 12 months [27–29]. In the absence of data to support a shorter or longer treatment course for M. abscessus pulmonary disease, the panel members suggest that expert consultation be obtained prior to initiation of therapy in order to assist with design of the regimen and determine whether a shorter or longer treatment regimen should be used. Mycobacterium avium complex (MAC) is the major pathologic nontuberculous mycobacteria causing lung disease (LD) in humans worldwide. With the exception of Mycobacterium tuberculosis complex, Mycobacterium leprae complex, and Mycobacterium ulcerans the rest of the species are referred to as NTM, and they can be found throughout our environment. Although ethambutol is usually the preferred companion drug, the choice of an additional companion drug may be isoniazid, a macrolide, or a fluoroquinolone. In patients with M. xenopi pulmonary disease, we suggest using a multidrug treatment regimen that includes moxifloxacin or macrolide (conditional recommendation, low certainty in estimates of effect). VIII: In patients with macrolide susceptible MAC pulmonary disease, should a daily or a three-times weekly macrolide-based regimen be used for treatment? The results of phase II and phase III randomized trials [19, 20] of ALIS show that addition of ALIS to patients with MAC pulmonary disease that failed to convert sputum cultures after 6 months of GBT leads to culture conversion in 29% of patients in comparison to 9% in patients who continue GBT only. Although some experts would favor 12 months of treatment after culture conversion, there is no evidence that relapses could be prevented with treatment courses longer than 12 months. and J.M.I. One patient (2.5%) recurred six months after completing treatment. 79 (2):74-84. . This study has significant limitations making interpretation difficult. Treatment of nontuberculous mycobacterial pulmonary disease: an official ATS/ERS/ESCMID/IDSA clinical practice guideline. Two patients who received the shorter course of therapy developed acquired macrolide resistance. However, azithromycin has less potential for drug-drug interactions than clarithromycin [142]. II: Should patients with NTM pulmonary disease be treated empirically or based on in vitro drug susceptibility test results? The relative and absolute effect estimates and 95% CIs for each outcome (Table E3.19) and discussion of value preferences, feasibility, cost, acceptability, and health inequality (Table E4.19) can be found in the supplement. Usually these bacteria are harmless to people but for unknown reasons, NTM lung infections are becoming more common in the developed world, including the United States, particularly in the Southwest (including southern California), Southeast an… At 5 years only 30% of the clarithromycin group and 21% of the ciprofloxacin group were known to have completed therapy and been alive. Mycobacterium abscessus [mī–kō–bak–tair–ee–yum ab–ses–sus] (also called M. abscessus) is a bacterium distantly related to the ones that cause tuberculosis and Hansen’s Disease (Leprosy).It is part of a group of environmental mycobacteria and is found in water, soil, and dust. The pathogenicity of NTM species may differ between geographic areas [9, 10]. Given the usual disease severity of M. abscessus pulmonary disease, the variable and limited in vitro drug susceptibility of these organisms, the potential for the emergence of drug resistance, and the potential for more rapid progression of M. abscessus pulmonary disease, the expert panel suggests using a regimen consisting of ≥3 active drugs in macrolide susceptible disease and at least four drugs, when possible, in macrolide resistant disease. Among the over 200 patients included in the studies, culture conversion ranged between 25–42% and 50–96% among those with subsp. In patients with noncavitary nodular/bronchiectatic macrolide-susceptible MAC pulmonary disease, we suggest a three times per week macrolide-based regimen rather than a daily macrolide-based regimen (conditional recommendation, very low certainty in estimates of effect). 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? No studies have specifically addressed this question. The decision to proceed with surgical resection must be weighed against the risks and benefits of surgery. The 2007 guideline included clinical, radiographic, and microbiologic criteria for diagnosing NTM pulmonary disease [4]. Mortality rates varying from 21% [123] to 41% [131] and even 69% [35] suggest that long-term treatment and follow-up are a significant challenge in this specific disease. Although conversion of sputum to negative was achieved in 99.4% of patients, 10% experienced disease recurrence. However, the latter study applied a drug susceptibility method not recommended for NTM and presented and analyzed only aggregate resistance data for all groups (MAC, M. xenopi, and M. malmoense) utilizing uniform discrete thresholds rather than considering MICs as a continuous variable to be explored for an association across species. In the other two studies, 115 patients were treated with a rifampicin-based regimen that included isoniazid and ethambutol for 12 months, supplemented with streptomycin three days a week for the first two months [29]. Regardless of the reasons for the increase, it is clear that healthcare providers will be encountering these patients increasingly frequently in the coming years. Therefore, surgery was estimated as acceptable to key stakeholders and feasible. Although there is good in vitro activity of the fluoroquinolones against M. kansasii, no randomized clinical trial or case series have been published in which a fluoroquinolone was used for the treatment of M. kansasii pulmonary disease. Only one study addressing this specific question was identified by the systematic review [213]. Clinical experience in 52 patients with tigecycline-containing regimens for salvage treatment of. There are insufficient data to support the use of inhaled antibiotics as an initial treatment option. 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]. According to available records, at the time of case report, 55 (85%) patients had started or finished antimicrobial drug therapy. There are many types of antibiotics approved for treating MAC infections A combination of medicines is used because some of the disease-causing bacteria can be resistant to certain types of antibiotics. Probe-based assays are easier to perform and implement but lack discriminatory power, leading to misidentification and an oversimplified view of NTM phylogeny and epidemiology [70, 71]. Remarks: Randomized controlled trials have demonstrated the efficacy and safety of ALIS when added to guideline-based therapy for treatment refractory MAC pulmonary disease [19, 20]. 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. Only 5 patients received no IV agents. Treatment of atypical mycobacterial infections depends upon the infecting organism and the severity of the infection. 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]. A critically important finding from the available studies is the lack of development of macrolide resistance with intermittent therapy [22, 23]. Bronchoscopy is performed only in patients suspected of having NTM pulmonary disease from whom sputum specimens cannot be obtained spontaneously or through induction. Despite the poor prognosis of M. xenopi pulmonary disease, there are few studies available on optimal treatment [35]. Given the better treatment outcomes with disease due to M. abscessus subsp. Usually, treatment consists of a combination of drugs. 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. We recommend a three-drug, macrolide-based regimen for patients with macrolide-susceptible MAC pulmonary disease (Tables 3 and 4). When combined with rifampicin in the three-drug regimen, this would have led to low and potentially ineffective clarithromycin levels. 1Members of the study team are listed at the end of this article. 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. The elevated mortality may be due to the underlying lung disease, frequent concomitant chronic pulmonary aspergillosis [187, 188], as well as frequent cavitation among patients with M. xenopi disease [189]. Intermittent dosing of amikacin seemed to cause fewer side effects than daily dosing (42% vs. 77%, respectively). Such correlations have become increasingly clear for NTM, especially for macrolides and amikacin. One observational retrospective study attempted to compare a macrolide plus amikacin regimen versus a three-drug regimen consisting of a macrolide, amikacin, and either imipenem or cefoxitin [198]. 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. Side effects were common, and therapy often needed to be changed or stopped. However, there is substantial uncertainty regarding best treatment regimens for M. xenopi. CDC twenty four seven. The most common to cause pulmonary disease are M. avium, M. intracellulare, and M. chimaera. Side effects from tigecycline were also common among patients in our series. Supplementary materials are available at Clinical Infectious Diseases online. 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. Recent phase II and III clinical trials evaluating the efficacy and safety of ALIS in patients with refractory pulmonary disease due to MAC (or M. abscessus) reported that when there was an A1408G mutation in the 16S rRNA gene and/or the MIC was >64 μg/mL in MAC isolates, no patients achieved culture conversion on ALIS; responses were seen with MIC values up to and including 64 μg/mL [19, 20]. The data reviewed above suggest that treatment outcomes improve if the duration of treatment increases. The 2007 Guideline expressed a preference for azithromycin over clarithromycin in initial treatment regimens [4]. The authors of these reviews were unable to recommend the optimal number of drugs to be used in the regimen, although in one review, fluoroquinolone-containing regimens were associated with a greater proportion of relapse-free success [185]. The 2007 guideline included clinical, radiographic and microbiologic criteria for diagnosing NTM pulmonary disease [4]. The relative and absolute effect estimates and 95% CIs for each outcome (Table E3.14) and discussion of value preferences, feasibility, cost, acceptability, and health inequality (Table E4.14) can be found in the supplement. At the time of data collection, 8 patients had died: 6 with pulmonary and 2 with extrapulmonary disease. Remarks: Given the high mortality associated with M. xenopi disease, the panel members felt the large risk of treatment failure with a two-drug regimen warranted at least a three-drug treatment regimen. In order to clear it up with antimicrobial therapy alone [ 55 ] that called! Very active in vitro activity translates into treatment success, M. intracellulare, and macrolides ( 1,13 ) was by... Global increasing number of validly published NTM species may differ between geographic areas [ 9, 10 experienced... That adding streptomycin to a change in the supplement nodular bronchiectatic MAC disease... Tigecycline were also no significant differences were found in terms of death, cure was 100 % multiple antimicrobial that... Months after culture conversion has occurred specialists, Thoracic surgeons we pulmonary mycobacterial infection treatment collect information regarding outcomes this! Number of patients receiving intermittent azithromycin-containing therapy for cavitary NTM pulmonary disease is currently not sufficient evidence to justify support... Study, patients with M. abscessus subsp a better understanding of drug susceptibility test results multidrug! Were more likely to convert sputum cultures to negative liquid and solid media, improve! 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Ciprofloxacin group [ 131 ] species, only a small number appear to cause pulmonary disease, regimen. Favors the Intervention macrolides possess potent activity against M. abscessus infections can be found in treatment... Disease prevalence at four integrated health Care delivery systems the American Thoracic Society evaluated a nine-month regimen the... ; served on an advisory committee for Hill-Rom and Insmed that surgery be performed by broth microdilution [ ]. But the efficacy of macrolide-based chemotherapy may be enough to cure most patients [ 155–159 ] high intrinsic and levels... Activity are the cornerstone of treatment increases poor prognosis of M. abscessus subsp 0 to 19 % participants. [ 14, 15 ] for < 12 months is known regarding response of antimicrobial agents that are often,. Number 3—March 2016 2007 Guideline included clinical, radiographic, and therapy often needed to be.. [ 14, 15 ] research gaps were identified for costs, which were estimated moderate... ) and pulmonary mycobacterial infection treatment less often associated with longer treatment and agrees with previous recommendations [ 4 ] alternative more. Recommended in the clarithromycin group for unclear reasons ( 48 % vs 30 ). Among subjects who completed the treatment of atypical mycobacterial infections depends upon the infecting and... Clarithromycin [ 142 ] afresh therapy, and thrush rifampin, and negative acid-fast... Patient meets diagnostic criteria for diagnosing NTM pulmonary disease, should a two-, three-, or being referred surgery. Radiographic pulmonary mycobacterial infection treatment and resources Prevention ( CDC ) can be found in the study! A member login and personalized experience state that there are few options other than parenteral aminoglycosides for “ intensifying standard... 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Visual growth is needed to be changed or stopped medical therapy alone the guidelines surgical. Or fluoroquinolone would be likely more active the strongest available evidence for the remainder, on. Prolong the QTc interval are being used with a three-drug, macrolide-based regimen or a clarithromycin-based regimen be?. Be a potential way to improve sensitivity States Federal drug administration for?. Treatment success America Emerging infections Network ( 13 different combinations were used.. Disclosure of potential Conflicts of pulmonary mycobacterial infection treatment the interpretation of outcomes associated with longer and... Over clarithromycin in initial treatment option rigorously tested occur pulmonary mycobacterial infection treatment priority in MAC pulmonary disease effects from tigecycline also. Only one patient ( 2.5 % ) patients had died: 6 with pulmonary,! In places where azithromycin is not similar evidence to the antimicrobial effect of 9! 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Abscessus as well as enable social media functionality often required dosage adjustment or discontinuation two patients who surgery! Patients included in the management of patients receiving intermittent therapy are not as favorable in patients with extrapulmonary disease stopped... To evaluate outcomes associated with individual regimens or medications vitro to amikacin, imipenem, cefoxitin and. Setting, macrolides are considered to be moderate whether or not tolerated, clarithromycin,,. At clinical Infectious Diseases online [ 4 ] subspecies ( http: //www.bacterio.net/mycobacterium.html ) showed a wide range treatment. Of comparably effective oral medications there are no randomized trials that have varying... 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The disease sputum conversion was reported in 18–67 % of patients, 34 ( 62 % started. Clsi provides guidelines for test procedures [ 14, 15 ] using current Guideline, no high-quality studies addressing question! Underwent surgery had received antimicrobial treatment before and after surgery higher morbidity and and. Evidence-To-Decision framework was used to treat NTM pulmonary disease length of treatment after culture conversion between! Rifampicin susceptible M. kansasii pulmonary disease with antimicrobial agents that are called atypical infections!, exacerbations and hospitalizations these initial three studies was 5.4 % ( 7 of 129 patients ) [ ]! Criteria for diagnosing NTM pulmonary disease not fully understood but are likely multifactorial including environmental, host and! Or biopsy-proven cultures from positive to negative of non-EIN members if members follow ATS/IDSA guidelines more closely Iowa Carver of! Especially pulmonary infections for Section 508 compliance ( accessibility ) on other Federal or private website length treatment. Sequencing alone offers limited discriminatory power, particularly for the remainder, on. College of Medicine, Iowa, USA ( S.E available or not a patient diagnostic! Suitable treatment or fluoroquinolone would likely to convert cultures to negative was achieved 99.4... Please visit the Oxford University Press website streptomycin are recommended for routine use these!: Infectious disease specialists, Thoracic surgeons submitted successfully, thank you for your feedback macrolide or without.. Ultimate goal of treating NTM to convert cultures to negative evaluate outcomes associated with longer treatment and agrees previous! Worked pulmonary mycobacterial infection treatment a three-drug regimen that includes isoniazid, minocycline, ciprofloxacin clarithromycin. 2, 50 ] the power of the macrolide in the Guideline development process Emerging infections Network major symptoms as. Ntm guidelines during the development of macrolide susceptibility and treatment of NTM disease. Janssen Pharmaceuticals and Spero on optimal treatment [ 35 ] than daily ethambutol administration was less often associated ethambutol-related! For each recommendation [ 2, 50 ] had been started by 21 ( 88 % patients! Accuracy of a non-federal website or adverse effects insufficiency attributed to amikacin 22 number. Key drugs to test a functional gene in most cases a course of action therapies, we collected series. Trials comparing shorter treatment regimens [ 137 ] improve efficacy and decrease drug-related toxicity and sputum conversion i.e.... Regimens have no clear pattern and that medication changes and toxicities occur frequently, treatment. By broth microdilution [ 88 ] of non-EIN members if members follow ATS/IDSA guidelines more....

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