BackgroundOsteomyelitis is a challenging infection that can involve 4–6 weeks of intravenous (IV) antibiotics. Dalbavancin, approved for acute bacterial skin and skin structure infections, has potent activity against gram-positive pathogens. This study assessed the efficacy and safety of dalbavancin as a 2-dose regimen for osteomyelitis.MethodsThis study was a randomized, open-label, comparator-controlled trial in adults with a first episode of osteomyelitis defined by clinical symptoms, radiologic findings, and elevated C-reactive protein. Patients were randomized 7:1 to dalbavancin (1500 mg IV on days 1 and 8) or standard of care (SOC) for osteomyelitis (oral or IV) per investigator judgment for 4–6 weeks. The primary endpoint was clinical response at day 42, defined as recovery without need for additional antibiotics in the clinically evaluable (CE) population. Clinical response was also assessed at day 21, 6 months, and 1 year.ResultsEighty patients were randomized to dalbavancin (n = 70) or SOC (n = 10). All had baseline debridement; Staphylococcus aureus was the most common pathogen (60% of patients). Clinical cure at day 42 was seen in 65/67 (97%) and 7/8 (88%) patients in the dalbavancin group and SOC group in the CE population, respectively. Clinical response was similar in the dalbavancin group at day 21 (94%), 6 months, and 1 year (96%). Treatment-emergent adverse events occurred in 10 patients in the dalbavancin group; no patient discontinued treatment due to an adverse event.ConclusionsA 2-dose regimen of weekly dalbavancin is effective and well tolerated for the treatment of osteomyelitis in adults.Clinical Trials RegistrationNCT02685033.

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e Rapid and definitive diagnosis of viral respiratory infections is imperative in patient triage and management. We compared the outcomes for adult patients with positive tests for respiratory viruses at a tertiary care center across two consecutive influenza seasons (winters of 2010-2011 and 2012). Infections were diagnosed by conventional methods in the first season and by multiplex PCR (FilmArray) in the second season. FilmArray decreased the time to diagnosis of influenza compared to conventional methods (median turnaround times of 1.7 h versus 7.7 h, respectively; P ‫؍‬ 0.015); FilmArray also decreased the time to diagnosis of non-influenza viruses (1.5 h versus 13.5 h, respectively; P < 0.0001). Multivariate logistic regression found that a diagnosis of influenza by FilmArray was associated with significantly lower odds ratios (ORs) for admission (P ‫؍‬ 0.046), length of stay (P ‫؍‬ 0.040), duration of antimicrobial use (P ‫؍‬ 0.032), and number of chest radiographs (P ‫؍‬ 0.005), when controlling for potential confounders. We conclude that the rapid turnaround time, multiplex nature of the test (allowing simultaneous detection of an array of viruses), and superior sensitivity of FilmArray may improve the evaluation and management of patients suspected of having respiratory virus infections. R espiratory viruses can cause not only mild upper respiratory tract infections but severe pneumonia, especially in immunocompromised hosts. Rapid and definitive diagnosis is critical in the management of viral respiratory infections and in timely isolation of infected patients. The 2009 H1N1 pandemic revealed the need for better diagnostic tests for influenza viruses. In addition, overlapping clinical presentations impede clinicians' ability to predict causative pathogens (whether bacterial or viral) and may lead to unnecessary antimicrobial use (1, 2). Nucleic acid amplification testing (NAAT)-based methods for detection of viral pathogens are increasingly used due to their excellent sensitivity and specificity and their ability to detect a wide spectrum of viral agents. Therefore, NAAT has many potential advantages over traditional methods, such as rapid antigen testing (which is Ͻ40 to 60% sensitive for influenza in adults), direct fluorescent-antibody (DFA) testing (which requires specialized laboratory training), or viral culture (which can take up to 10 days for a result) (3). Multiplex PCR using FilmArray (BioFire Diagnostics, Inc., a bioMérieux company, Salt Lake City, UT) is an NAAT method which can detect multiple viral pathogens with a single test (4). The FilmArray respiratory viral panel (RVP) was FDA cleared in May 2011 to detect 15 respiratory viral pathogens: influenza A virus and subtypes (influenza A H1, influenza A H1 2009, and influenza A H3 viruses), influenza B virus, parainfluenza 1 virus, parainfluenza 2 virus, parainfluenza 3 virus, parainfluenza 4 virus, respiratory syncytial virus (RSV), human metapneumovirus, adenovirus, rhinovirus/enterovirus, coronavirus NL63, and coronavirus HKU1.In Febr...

Background Topical antibiotics are frequently used to treat acne vulgaris. Their prolonged use, often for longer durations than recommended, has led to antibiotic resistance in Cutibacterium acnes (C. acnes) , a bacterium implicated in acne pathophysiology. Bacteriophage (phage), which specifically target C. acnes by a different mechanism of action and do not harm potentially beneficial bacteria, may offer an alternative approach for improvement of the appearance of acne prone skin. Objectives To identify and characterize C. acnes targeting phage, carry out a comprehensive preclinical safety evaluation of phages selected for further development and examine their safety, tolerability and ability to target facial C. acnes when applied topically in a cosmetic clinical study including participants with mild‐to‐moderate acne. Methods Phages were isolated by conventional microbiological methods also used to examine their breadth of host range on different C. acnes strains and specificity to this bacterial species. Safety assessment of three selected phages was carried out by complete genomic analysis to assure the absence of undesired sequences and by ex vivo models employed to evaluate the safety, irritability and potential systemic bioavailability of phage applied topically. A randomized, controlled clinical study assessed safety, tolerability and efficacy in targeting facial C. acnes . Results Wide host range phages that also target antibiotic resistant C. acnes were identified. Their genomes were shown to be free of undesired genes. The three‐phage cocktail, BX001, was not irritant to human skin or ocular tissues in ex vivo models and did not permeate through human epidermis. In a cosmetic clinical study, topically applied BX001 was safe and well tolerated and reduced the facial burden of C. acnes . Conclusions Combined in silico and ex vivo approaches successfully predicted the observed safety and efficacy of C. acnes targeting phage when these were topically administered in a well‐controlled cosmetic clinical study.

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