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]. As there is more experience and better evidence for treatment regimens that include isoniazid or a macrolide as a companion drug, these drugs are preferred [25–28]. Three studies reported results for patients treated with combined antibiotic and surgical therapy, compared with antibiotic therapy alone [30, 39, 89]. Twenty-two PICO questions are addressed in this Guideline. Side effects were common; 74 side effects were documented among 34 (62%) of 55 patients who received treatment. In patients with M. abscessus pulmonary disease caused by strains with inducible (typically M. abscessus or M. bolettii) or mutational macrolide resistance, we suggest a regimen that includes at least four active drugs, when possible. XVI: In patients with M. xenopi pulmonary disease, should a two-, three-, or four-drug regimen be used for treatment? The most common slowly growing NTM to do so are members of Mycobacterium avium complex which now consists of 12 separate species [49]. Predictors of spontaneous sputum culture conversion included younger age, higher body mass index, and negative sputum acid-fast bacilli smears at initial diagnosis. In patients with macrolide-susceptible MAC pulmonary disease, we suggest a treatment regimen with at least three drugs (including a macrolide and ethambutol) over a regimen with two drugs (a macrolide and ethambutol alone) (conditional recommendation, very low certainty in estimates of effect). 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. At the time of data collection, 8 patients had died: 6 with pulmonary and 2 with extrapulmonary disease. Our study had several limitations, including unknown specific subspecies of M. abscessus. 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. Recent work suggests a lack of consensus among treating physicians, with a variety of regimens employed against this organism ranging from two to five drugs in the initial phases of therapy [212]. Because NTM can be isolated from respiratory specimens due to environmental contamination and because some patients who have an NTM isolated from their respiratory tract do not show evidence of progressive disease, >1 positive sputum culture is recommended for diagnostic purposes, and the same NTM species (or subspecies in the case of M. abscessus) should be isolated in ≥2 sputum cultures. No randomized, controlled trials have been conducted to examine the impact of treatment on either survival or quality of life. In one study that reported outcomes of patients who underwent video assisted thoracoscopic surgery (VATS), culture conversion occurred in 84% of the patients, postoperative complications occurred in 7% of patients, and there were no operative or postoperative deaths reported [216]. In many settings, expert consultation is helpful. 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). 1981; 3 … Two randomized controlled studies in patients with M. xenopi pulmonary disease were conducted by the British Thoracic Society [36, 119, 131]. 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]. In vitro data suggest that MIC values of fluoroquinolones are low for M. xenopi: in vitro activity of moxifloxacin is equal to that of clarithromycin [190]. In addition, when patients are treated with a regimen that includes isoniazid, rifampicin, and ethambutol, we suggest treatment be given daily. Four studies compared treatment outcomes in patients with infections due to M. abscessus subsp. 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. The first study compared efficacy of a regimen containing rifampicin, ethambutol with or without isoniazid in 42 patients (20 vs 22) [36, 119]. Even so, treatment outcomes are often suboptimal, and reinfection with another strain or species is common. Importantly, just because a patient meets diagnostic criteria for NTM pulmonary disease does not necessarily mean antibiotic treatment is required. 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. Comment submitted successfully, thank you for your feedback. Amikacin or streptomycin is sometimes used for treating NTM pulmonary disease. The very large differences in culture conversion between the two subspecies were likely related to the nonfunctional erm(41) gene (no inducible resistance) in subsp. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Please use the form below to submit correspondence to the authors or contact them at the following address: Shannon Novosad, 3181 SW Sam Jackson Park Rd, UHN67, Portland, OR 97239, USA. Previous guidelines recommend using a multidrug regimen including ≥2 of these antibiotics to which the organism is susceptible in vitro. Clinical responses were reported in 20–100% and sputum conversion was reported in 18–67% of treatment refractory MAC pulmonary disease. Once rifampicin was included in the regimen, treatment outcomes improved dramatically, and thus a rifampicin-based regimen is recommended [4]. Of these 41 patients, 34 (83%) started antimicrobial drug therapy. An update was performed in May 2016 prior to the final meeting at the ATS International Conference and a final update was performed in June 2018 prior to manuscript submission. XIX: In patients with M. abscessus pulmonary disease, should a macrolide-based regimen or a regimen without a macrolide be used for treatment? XIII: In patients with rifampicin-susceptible M. kansasii pulmonary disease, should a three times per week or daily treatment regimen be used? Remarks: Data suggest that treatment outcomes improve if the duration of treatment increases [35, 37]. Isoniazid is widely used at present for treatment of M. kansasii pulmonary disease, and in the experience of the panel members, there have been good outcomes when using a regimen consisting of rifampicin, ethambutol, and isoniazid irrespective of the result of minimal inhibitory concentrations (MICs) for isoniazid and ethambutol [ 24 ]. Only regimens using rifamycin and ethambutol or clofazimine and ethambutol have been shown to prevent the emergence of macrolide resistance during treatment [22, 135]. The committee developed recommendations based on the GRADE evidence profiles for each question, with recommendations and their strength decided by committee consensus during face-to-face meetings. 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 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. Clinically significant MAC pulmonary disease is unlikely in patients who have a single positive sputum culture during the initial evaluation [5–7] but can be as high as 98% in those with ≥2 positive cultures [5]. Remarks: A priority in MAC pulmonary disease therapy is preventing the development of macrolide resistance. 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 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. Multiple antibiotics are typically required for prolonged periods of time and treatment is frequently poorly tolerated. massiliense were more likely to convert cultures to negative compared with patients infected with M. abscessus subsp. Randomized controlled trials comparing shorter treatment regimens are currently lacking. One clinical trial has examined 24-month long regimens for M. xenopi pulmonary disease; 12 of 34 (35%) patients treated showed a favorable response that could be sustained for three years after treatment; however, 18 patients (54%) deviated from the treatment protocol, for which no further details are available [131]. Centers for Disease Control and Prevention. The preference for azithromycin is primarily based on the expert panel’s perception of better tolerability of azithromycin and fewer drug-drug interactions mediated by the cytochrome P450 system [146] than with clarithromycin. abscessus despite receiving shorter durations of parenteral and total treatment: patients with M. abscessus subsp. A priority in MAC pulmonary disease therapy is preventing the development of macrolide resistance. 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. 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? Neither the aforementioned study nor the systematic review evaluated treatment outcomes by duration of treatment after culture conversion [134]. Also reported were 2 corneal, 1 peritoneal, 1 catheter-related, and 1 pacemaker pocket infection plus 1 case each of endocarditis and osteomyelitis. XIV: In patients with rifampicin susceptible M. kansasii pulmonary disease, should treatment be continued for <12 months or ≥12 months? 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. Mayo Clinic offers a Mycobacterial and Bronchiectasis Clinic at its campuses in Minnesota and Florida to help people living with the chronic lung conditions bronchiectasis, latent tuberculosis infection, nontuberculous mycobacterial pulmonary disease and tuberculosis. For patients with cavitary or advanced/severe bronchiectatic or macrolide-resistant MAC pulmonary disease, we suggest that parenteral amikacin or streptomycin be included in the initial treatment regimen (conditional recommendation, moderate certainty in estimates of effect). To learn more about treatment regimens and associated side effects, during March–December 2013, we asked EIN physician members to report recent cases of M. abscessus via an emailed electronic data collection form. Eur Respir J 2020; 56: 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. Five retrospective case series (N = 138 patients, 55 with MAC) with no comparator arm most commonly used inhaled doses of commercially available amikacin (parenteral forumation) ranging from 250 to 500 mg once daily up to 15 mg/kg once daily added to their oral antibiotic regimen [155–159]. The pooled culture conversion rate was 95.5% (42 of 44 patients in two studies) [29, 179], and recurrences were observed in 4.7% (6 of 127 patients in three studies) [28, 29, 179]. ), and a representative from an NTM nonprofit organization the goal of which is patient support, education, and research in NTM (P.L.). Usually, treatment consists of a combination of drugs. In the Mycobacterial and Bronchiectasis Clinic, pulmonologists are part of a multidisciplinary team … 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. A three-drug regimen that includes isoniazid, rifampicin, and ethambutol was recommended in the 2007 Guideline [4]. The 2007 Guideline suggested a treatment duration of 12 months beyond culture conversion, acknowledging that the optimal duration was unknown [4]. 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). 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. Similarly for extrapulmonary disease, macrolide-based treatment regimens based on susceptibility testing results are recommended (1,2). Remarks: Isoniazid is widely used at present for treatment of M. kansasii pulmonary disease, and in the experience of the panel members, there have been good outcomes when using a regimen consisting of rifampicin, ethambutol, and isoniazid irrespective of the result of minimal inhibitory concentrations (MICs) for isoniazid and ethambutol [24]. Supplementary materials are available at Clinical Infectious Diseases online. A panel of experts was carefully selected and screened for conflicts of interest and included specialists in pulmonary medicine, infectious diseases and clinical microbiology, laboratory medicine, and patient advocacy. 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 2007 guideline included clinical, radiographic and microbiologic criteria for diagnosing NTM pulmonary disease [4]. 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]. Although ethambutol is usually the preferred companion drug, the choice of an additional companion drug may be isoniazid, a macrolide, or a fluoroquinolone. 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. Ryu YJ, Koh WJ, Daley CL. In addition to microbiologic assessments, clinical and radiographic response to therapy should be used to determine if the patient is responding to therapy. Treatment of Mycobacterium abscessus Infection. Both azithromycin and clarithromycin have been reported to be associated with severe adverse effects, including sudden death presumably mediated by QTc prolongation [147, 148]. 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]. 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. For patients with NB MAC lung disease, the priorities are typically to treat the underlying bronchiectasis and determine the course and impact of the MAC infection over time. 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. The relative and absolute effect estimates and 95% confidence intervals (CIs) for each outcome (Table E3.1) and discussion of value preferences, feasibility, cost, acceptability, and health inequality (Table E4.1) can be found in the supplement. The recommendations were developed based on the evidence that was appraised using GRADE (Grading of Recommendations Assessment, Development, and Evaluation) and are summarized below [1, 2]. 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]. 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]. Remarks: 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]. We suggest treatment be continued for ≥12 months after culture conversion. Our survey revealed that therapeutic regimens for M. abscessus infection vary widely. This Guideline is dedicated to the memory of Won-Jung Koh, MD, whose passion, leadership, and work led to evidence that helped to support recommendations in this Guideline. Because of the uncertain value of isoniazid [173] and excellent in vitro activity of the macrolides [174–177], some clinicians have begun to substitute a macrolide for isoniazid in rifampicin-containing regimens [178]. An increase of NaOH concentrations lowers contamination rates but decreases sensitivity of culture [56]. 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. 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. 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]. Treatment of Mycobacterium avium complex lung disease (MAC-LD) is challenging because it requires long-term therapy with multiple antibiotics, and the treatment outcomes are relatively poor.1,2 Moreover, there is a high rate of recurrence, either by relapse or reinfection.3 Although MAC-LD treatment guidelines in the United States recommended 12 months of treatment … 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. Although the burden of MAC-LD has increased over the past two decades, treatment remains difficult because of intolerance of long-term antibiotics, lack of adherence to guidelines, and disease recurrence. In a randomized controlled trial of rifabutin added to clarithromycin and ethambutol for treatment of disseminated MAC infection, response rates, with or without rifabutin, were equivalent but development of macrolide resistance was lower (P = .055) in patients on the three-drug regimen [161]. No patients with extrapulmonary disease completely stopped therapy because of side effects. 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]. massiliense, a shorter or less intensive course of therapy may be possible. 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]. In addition, the panel members felt that some subgroups of patients should be considered separately in determining the length of therapy such as: patients with nodular/bronchiectatic versus cavitary disease, patients affected by lung disease caused by different M. abscessus subspecies and importantly, depending on susceptibility to macrolides and amikacin. Those treated with a two-week course of parenteral therapy followed by at least 12 months of an oral macrolide post conversion had a culture conversion rate of 91% compared with 100% in those who received a four-week course and oral macrolide for 24 months. The committee was chaired by C.D. Table 6 lists common adverse reactions associated with the drugs used to treat NTM pulmonary disease and an approach to monitoring. XV: In patients with M. xenopi pulmonary disease, should a treatment regimen that includes a fluoroquinolone or a regimen without a fluoroquinolone be used? 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