Background: This document provides evidence-based clinical practice guidelines on the management of adult patients with community-acquired pneumonia.Methods: A multidisciplinary panel conducted pragmatic systematic reviews of the relevant research and applied Grading of Recommendations, Assessment, Development, and Evaluation methodology for clinical recommendations. It found that vancomycin plus rifampin increased the 14-day clinical cure rate and decreased the 60-day mortality rate, but had no effect on 28-day mortality. The panel's confidence in these estimated effects (ie, the quality of evidence) was very low because they were derived from observational studies with imprecision (ie, small studies with few events) and high risk of bias (clinicians may have been more likely to stop antibiotics early in less sick patients). Pneumonia was defined in the 2005 document as the presence of “new lung infiltrate plus clinical evidence that the infiltrate is of an infectious origin, which include the new onset of fever, purulent sputum, leukocytosis, and decline in oxygenation.” Nonetheless, the panel recognizes that there is no gold standard for the diagnosis of HAP or VAP. Clay Smith. 42nd and Emile, Omaha, NE 68198 There is an urgent need for studies comparing various antibiotic regimens in the treatment of pneumonia due to ESBL-producing gram-negative bacilli. The panel was concerned about the randomized trial's risk of bias because it was unblinded and stopped early due to benefit. Given the rising incidence and prevalence of viral causes of CAP, more research is needed to accurately identify clinical scenarios where antibiotic therapy can be safely withheld. We therefore decided to address the issue of the safety of antibiotic discontinuation when quantitative cultures are below the diagnostic threshold. Risk factors for mortality include the requirement for ventilatory support due to pneumonia and having septic shock. The recommendation is strong despite the very low quality of evidence because the panel judged that the upsides of the recommendation are more important to patients than the downsides and, therefore, most well-informed patients would want to receive the additional antibiotic. In addition, the doripenem FDA label was recently modified due to this drug's association with increased risk of death in patients with VAP due to P. aeruginosa [297]. The study by Ewig et al comprehensively illustrates the pathogenesis and the rationale behind it [38]. The guidelines were published July 14, 2016 and are titled: Management of Adults With Hospital-acquired and Ventilator-associated Pneumonia: 2016 Clinical Practice Guidelines by the Infectious Diseases Society of America and the American Thoracic Society. A trial that randomly assigned patients to ampicillin-sulbactam or intravenous colistin found no difference in mortality or clinical response [332]. The guideline panel's confidence in the estimated effects on mortality, ICU length of stay, and clinical cure rate in patients with HAP/VAP was very low, because most of the studies included in the meta-analyses were observational studies with a risk of bias due to the excess influence of one observational study [248]. In addition, the panel considered the possibility that the increased clinical cure rate might lead to shorter courses of antibiotics and, subsequently, less antibiotic toxicity and less antibiotic resistance. Which Antibiotic Should Be Used to Treat Patients With HAP/VAP Due to Extended-Spectrum β-Lactamase (ESBL)–Producing Gram-Negative Bacilli? The panel agreed that the question of whether or not invasive sampling with quantitative cultures reduces antibiotic use, antibiotic resistance, direct costs, and indirect costs should be a priority area for future research. I. There was no evidence of potential publication bias according to Egger test for funnel plot asymmetry. Such trials should use a concise definition that precludes overlap with VAP or, alternatively, combines the diagnosis of VAT and VAP and adjusts for severity of respiratory illness. This outcome is important due to the risks of acquiring antibiotic resistance, the risk of side effects, and the costs of unnecessary or excessive antibiotic therapy; however, the estimated effects of invasive sampling with quantitative culture on antibiotic exposure are inconsistent and, therefore, insufficient to guide therapy at this time [53–55]. These factors limit the applicability of these studies to the selection of empiric regimens in unselected patients with suspected VAP. The panel agreed that this approach was an appropriate balance between the competing goals of providing early appropriate antibiotic coverage to improve clinical outcomes such as mortality while avoiding superfluous treatment that may lead to antibiotic resistance, side effects, and increased cost. The evidence suggests that this is very uncommon and, therefore, the panel had a high level of confidence that the benefits of a short-course antibiotic regimen outweighed the harms, leading to their recommendation to use antibiotics for 7 days rather than 8–15 days in patients with VAP. Overall, 14 variables have resulted in potential predictive factors in 3 studies [41–43]. –Includes HAP and VAP KalilAC et al. The review selected 14 trials with 4221 patients and found that PCT-based decision making decreased antibiotic exposure (adjusted mean difference, −3.47 days; 95% CI, −3.78 to −3.17 days) and was not associated with increased mortality or treatment failure [359, 360]. X. The decision was based upon the evidence that combination therapy was associated with decreased mortality among patients with pneumonia complicated by septic shock. There were no differences in mortality or recurrence rate among patients who received a short course of antibiotics compared to those who received a long course [344]. The studies enrolled patients predominantly in North America, Europe, and Asia, with a small percentage from South America. We note that other infectious disease guidelines have suggested a similar threshold to inform empiric antibiotic choices [198]. Recommendation 2007 ATS/IDSA Guideline 2019 ATS/IDSA Guideline; Sputum culture: Primarily recommended in patients with severe disease We did not identify any RCTs assessing colistin as empiric therapy for VAP, but a systematic review and meta-regression of observational studies comparing colistin to other antibiotics found no differences in clinical response rates, mortality, or nephrotoxicity [184]. However, multiple sites of infection were included in both studies and small numbers of patients with pneumonia were evaluated, and a small number of patients with documented MRSA pneumonia were evaluated. It was the panel's impression that the data are most applicable to patients who are at low risk for resistant pathogens or in whom resistant pathogens have been excluded. Aminoglycosides: Our systematic review identified no recent trials comparing aminoglycoside monotherapy to other antimicrobial regimens in HAP/VAP and, therefore, there were no data related to the effects of such therapy in patients with HAP/VAP due to P. aeruginosa. It is therefore possible that short-term mortality benefits may be outweighed by long-term harms. We selected 24 studies that provided relevant data [11, 89, 92, 139, 155, 179, 214–231]. While many of the concepts addressed in these guidelines might be applicable to immunosuppressed patients, the recommendations are not intended for such patients. Imipenem: We identified a published systematic review of 20 randomized trials that compared imipenem to an alternative antibiotic in patients with P. aeruginosa [298]. An approved guideline for susceptibility testing is available [134]. Remarks: Risk factors for antimicrobial resistance are provided in Table 2. Therefore, the panel elected to inform its recommendation with unsystematic observations (ie, clinical experience) and clinical rationale. The distribution of many antibiotics can be severely altered by pathophysiological changes that are common to critically ill patients, leading to altered pharmacokinetics [250]. For this reason, the panel agreed that polymyxin susceptibility should be routinely assessed for Pseudomonas isolates in settings with a high prevalence of extensively resistant organisms. First, aminoglycosides penetrate the lung poorly; therefore, high peak serum concentrations are necessary to obtain microbiologically active concentrations in the alveoli, which increases the risk of nephrotoxicity and ototoxicity [266, 302, 303]. Of note, a significant increase in antibiotic resistance and a lack of survival benefits with carbapenems compared to other antibiotics was observed by our panel's analysis of the treatment of HAP/VAP due to P. aeruginosa (see section XVI). Intravenous colistin or polymyxin B is standard therapy for HAP/VAP caused by a carbapenem-resistant pathogen because such pathogens commonly demonstrate in vitro susceptibility to only the polymyxin antibiotic class. The panel suggests that ICU-level S. aureus methicillin resistance rates of >10%–20% merit selecting a gram-positive agent active against MRSA, and that ICU-level gram-negative resistance rates of >10% to an agent being considered for empiric gram-negative monotherapy merit using 2 gram-negative agents for empiric therapy of suspected VAP. The cutoffs used to distinguish patients who had HAP/VAP from those who did not varied among studies, ranging from 0.5 to 3.9 ng/mL. intubation (subset of HAP) § Microbiology overall is similar: § Gram (+): S. aureus, particularly MRSA § Gram (-): Pseudomonas, E. coli, Klebsiella § Pseudomonas, Stenotrophomonas, Acinetobacter more common in VAP IDSA/ATS Guidelines, Am J Resp Crit Care Med 2005. One study suggests that use of the CPIS to determine antibiotic duration decreases cost, antibiotic resistance, and superinfection [120], but 2 other studies suggest that use of the CPIS has no effect on most clinical outcomes [193, 364]. PK/PD targets associated with improved clinical outcomes have been reported in observational studies. Panelists were required to disclose to the ATS and IDSA and the chairs any new activities that had the potential to be viewed as a COI prior to engaging in the activity. 6 We also found no difference in the clinical cure rate when analyzed using an intention-to-treat strategy; however, there was improvement of the clinical cure rate among patients who received linezolid when analyzed using a modified intention-to-treat strategy (RR, 1.18; 95% CI, 1.00–1.40). 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