Acute bacterial skin and skin-structure infections are associated with substantial morbidity and health care costs. Omadacycline, an aminomethylcycline antibiotic that can be administered once daily ...either orally or intravenously, is active against pathogens that commonly cause such infections, including antibiotic-resistant strains.
In this double-blind trial, we randomly assigned adults with acute bacterial skin and skin-structure infections (in a 1:1 ratio) to receive omadacycline (100 mg given intravenously every 12 hours for two doses, then 100 mg given intravenously every 24 hours) or linezolid (600 mg given intravenously every 12 hours). A transition to oral omadacycline (300 mg every 24 hours) or oral linezolid (600 mg every 12 hours) was allowed after 3 days; the total treatment duration was 7 to 14 days. The primary end point was an early clinical response at 48 to 72 hours, defined as survival with a reduction in lesion size of at least 20% without rescue antibacterial therapy. A secondary end point was an investigator-assessed clinical response at the post-treatment evaluation 7 to 14 days after the last dose, with clinical response defined as survival with resolution or improvement in signs or symptoms of infection to the extent that further antibacterial therapy was unnecessary. For both end points, the noninferiority margin was 10 percentage points.
In the modified intention-to-treat population, omadacycline (316 patients) was noninferior to linezolid (311 patients) with respect to early clinical response (rate of response, 84.8% and 85.5%, respectively; difference, -0.7 percentage points; 95% confidence interval CI, -6.3 to 4.9). Omadacycline also was noninferior to linezolid with respect to investigator-assessed clinical response at the post-treatment evaluation in the modified intention-to-treat population (rate of response, 86.1% and 83.6%, respectively; difference, 2.5 percentage points; 95% CI, -3.2 to 8.2) and in the clinical per-protocol population (96.3% and 93.5%, respectively; difference, 2.8 percentage points; 95% CI, -1.0 to 6.9). In both groups, the efficacy of the trial drug was similar for methicillin-susceptible and methicillin-resistant Staphylococcus aureus infections. Adverse events were reported in 48.3% of the patients in the omadacycline group and in 45.7% of those in the linezolid group; the most frequent adverse events in both groups were gastrointestinal (in 18.0% and 15.8% of the patients in the respective groups).
Omadacycline was noninferior to linezolid for the treatment of acute bacterial skin and skin-structure infections and had a similar safety profile. (Funded by Paratek Pharmaceuticals; OASIS-1 ClinicalTrials.gov number, NCT02378480 .).
According to anti-SARS-CoV-2 seroresponse in patients with COVID-19 from Croatia, we emphasised the issue of different serological tests and need for combining diagnostic methods for COVID-19 ...diagnosis. Anti-SARS-CoV-2 IgA and IgG ELISA and IgM/IgG immunochromatographic assay (ICA) were used for testing 60 sera from 21 patients (6 with severe, 10 moderate, and 5 with mild disease). The main clinical, demographic, and haemato-biochemical data were analysed. The most common symptoms were cough (95.2%), fever (90.5%), and fatigue and shortness of breath (42.9%). Pulmonary opacities showed 76.2% of patients. Within the first 7 days of illness, seropositivity for ELISA IgA and IgG was 42.9% and 7.1%, and for ICA IgM and IgG 25% and 10.7%, respectively. From day 8 after onset, ELISA IgA and IgG seropositivity was 90.6% and 68.8%, and for ICA IgM and IgG 84.4% and 75%, respectively. In general, sensitivity for ELISA IgA and IgG was 68.3% and 40%, and for ICA IgM and IgG 56.7% and 45.0%, respectively. The anti-SARS-CoV-2 antibody distributions by each method were statistically different (ICA IgM vs. IgG,
p
= 0.016; ELISA IgG vs. IgA,
p
< 0.001). Antibody response in COVID-19 varies and depends on the time the serum is taken, on the severity of disease, and on the type of test used. IgM and IgA antibodies as early-stage disease markers are comparable, although they cannot replace each other. Simultaneous IgM/IgG/IgA anti-SARS-CoV-2 antibody testing followed by the confirmation of positive findings with another test in a two-tier testing is recommended.
...some differential MRI findings in favour of tuberculous spondylodiscitis have been suggested such as involvement of more than two vertebral bodies, thoracic spine involvement, severe vertebral ...destruction, mild disc destruction, a thin and smooth abscess wall, and subligamentous spread to three or more vertebral levels.2,3 In our Clinical Picture,1 MRI of the patient's lumbosacral spine showed high signal intensity of the vertebral disc and vertebral body at the L4 and L5 levels with an epidural abscess and granulation tissue; such findings are described in both tuberculous and pyogenic spondylodiscitis. The American Thoracic Society and the Centers for Disease Control and Prevention advocate treatments of 6-9 months for adults and 12 months for children with uncomplicated tuberculous spondylodiscitis caused by a fully sensitive M tuberculosis isolate.4 In our Clinical Picture,1 the patient's improvement started 10 days after the beginning of treatment, followed by a complete clinical recovery and return of systemic inflammatory markers to normal concentrations. 2 months after treatment in hospital, the follow-up MRI showed significant regression of the epidural abscess, which would have been highly improbable in tuberculous spondylodiscitis. ...in our opinion, the results suggest that C jejuni caused spondylodiscitis in the patient.
Delafloxacin is an investigational anionic fluoroquinolone in development for oral or intravenous administration for the treatment of infections caused by Gram-positive (including MRSA), ...Gram-negative, atypical and anaerobic organisms.
To establish the non-inferiority of delafloxacin compared with vancomycin plus aztreonam for the treatment of acute bacterial skin and skin structure infections and to compare the safety of the two antimicrobials.
A Phase 3, multicentre, randomized, double-blind, active-controlled study with 660 patients compared delafloxacin 300 mg or vancomycin 15 mg/kg plus aztreonam 2 g each administered twice daily intravenously for 5-14 days. Non-inferiority was evaluated by objective response (≥20% erythema reduction) at 48-72 h after initiation of study drug, investigator subjective assessment of outcome and microbiological responses. Clinical Trials Registration: NCT01811732. EudraCT number: 2012-001767-71.
In the ITT analysis set, the objective response was 78.2% in the delafloxacin arm and 80.9% in the vancomycin/aztreonam arm (mean treatment difference, -2.6%; 95% CI, -8.78% to 3.57%). Investigator-assessed cure was similar between the two groups at follow-up (52.0% versus 50.5%) and late follow-up (70.4% versus 66.6%). Bacterial eradication of MRSA was 100% and 98.5% in the delafloxacin group and the vancomycin/aztreonam group, respectively. Frequency of treatment-emergent adverse events in the delafloxacin and vancomycin/aztreonam groups was similar. Treatment-emergent adverse events leading to study drug discontinuation were higher in the vancomycin/aztreonam group compared with the delafloxacin group (4.3% versus 0.9%).
Delafloxacin, an anionic fluoroquinolone, was statistically non-inferior to vancomycin/aztreonam at 48-72 h following the start of therapy and was well tolerated as monotherapy in the treatment of acute bacterial skin and skin structure infections.
INTRODUCTIONSnakebite incidence varies across Europe. However, there is limited research from Central and Southeastern Europe. These regions are notable for the presence of the common European adder ...(Vipera berus) and the more venomous nose-horned viper (Vipera ammodytes). No standard European antivenom protocol exists. The aim was to assess the epidemiology and treatment of viper bites in this region, focusing on a comparison of bites from Vipera berus and Vipera ammodytes.METHODSWe conducted a prospective multicenter study in Central and Southeastern Europe from 2018 to 2020. This study included poison centres and toxicology-associated hospital wards in Poland, the Czech Republic, Slovakia, Hungary, Slovenia, Croatia, Serbia, and Bulgaria. The following data were collected: age, gender, Vipera species, snakebite site, clinical picture, laboratory results, Audebert's clinical severity grading score, and antivenom therapy.RESULTSThe annual incidence of viper bites in Central and Southeast Europe was estimated at 2.55 bites per million population. Within their respective geographical distribution areas, the incidence of Vipera ammodytes bites (1.61 bites per million population) was higher than Vipera berus bites (1.00 bites per million population). Patients bitten by Vipera ammodytes more frequently reported local pain and developed thrombocytopenia. Antivenom treatment was more commonly administered in Vipera ammodytes bites (72%) compared to Vipera berus bites (39%). The incidence of Vipera ammodytes bites treated with antivenom within its geographical distribution area was three times higher than Vipera berus bites treated with antivenom (1.16 bites per million population versus 0.39 bites per million population). No deaths were reported.CONCLUSIONSThe estimated incidence of viper bites in Central and Southeastern Europe is at least 2.55 per million population. Vipera ammodytes bites are more common and severe, characterized by higher frequencies of pain and thrombocytopenia. Antivenom is needed more often for Vipera ammodytes bites. It is vital that enough European Medicines Agency-approved Vipera ammodytes antivenom is produced and offered affordably.
Infektivne gangrene ili nekrotizirajuće infekcije mekih česti su teške infekcije potkožnog tkiva s visokim mortalitetom. Infekciji najčešće prethodi kirurški tretman ili trauma. Postoje brojne ...klasifikacije infektivnih gangrena, a u praksi je uobičajena mikrobiološka podjela na tip I (polimikrobni) i tip II (uzrokovan streptokokom). Klinička slika infektivne gangrene uključuje intezivnu bol u području rane, krepitacije, prisutnu sekreciju, pojavu bula i brzi razvoj septičkog šoka. Vanjski izgled rane nerijetko ne korelira s stvarnim stanjem te može biti razlogom za kasnu dijagnozu. Dijagnoza bolesti postavlja se temeljem kliničke slike, laboratorijskih nalaza, radioloških pretraga, mikrobioloških nalaza, a potvrđuje i kirurškom ekploracijom zahvaćenog područja koja je i terapijski postupak. Pojava plina u mekim tkivima je tipičan znak za nekrotizirajuće infekcije i indicira početak liječenja. Izostanak pravovremene i agresivne terapije najčešće dovodi do nepovoljnog ishoda bolesti. Liječenje se sastoji od brze i ekstenzivne kirurške ekploracije i odstranjena nekrotičnih masa, kombinirane antibiotske terapije, te potrebite simptomatske i suportivne terapije.
Koža je barijera koja je kolonizirana apatogenim bakterijama koje ograničavaju invaziju i rast patogenih bakterija. Najčešće bakterijske infekcije kože jesu piodermije uzrokovane beta hemolitičkim ...streptokokom (BHS) ili zlatnim stafilokokom (SA). Impetigo je površinska infekcija kože najčešće djece predškolske dobi uzrokovana BHS ili SA. Terapijski pristup ovisi o broju i veličini kožnih promjena. Apsces kože zahtjeva inciziju, evakuaciju gnoja, a ponekad i antimikrobnu terapiju. Folikulitis, furunkul i karbunklu su infekcije folikula dlake u pravilu uzrokovane SA koje se razlikuju u opsežnosti inflamacije. Erizipel i celulitis se patohistološki razlikuju po dubini zahvaćene kože, a klinički po izgledu i morfologiji kožnih lezija. Promjenama na koži prethode sistemske manifestacije infekcije. Etiološka dijagnoza erizipela/celulitisa rijetko se uspije postaviti. Osim BHS i SA i neke druge bakterije mogu uzrokovati celulitis, ali u nekim posebnim situacijama. Dijagnoza erizipela/celulitisa postavlja se na temelju kliničke slike. No, u pravilu se ne može uočiti klinička razlika između streptokokne i stafilokokne infekcije kože. Od značaja je na vrijeme prepoznati nekrotizirajuće infekcije mekih česti koje zahtjevaju brzi kiruški tretman. Liječenje erizipela/celultiisa podrazumijeva antimikrobnu terapiju u trajanju od 10 dana, a ponekad i duže. U osoba s ponavljajućim erizipelom/celulitisom potrebno je nakon uspješno provedenog liječenja provoditi odgovarajuće preventivne mjere koju uključuju odgovarajuće higijenske mjere, liječenje popratnih čimbenika rizika, eradikaciju potencijalnog kliconoštva, a u nekim slučajevima i profilaktičku primjenu antibiotika. Celulitis orbite je ozbiljna bolest koja može izazvati ozbiljne komplikacije te ga je potrebno razlikovati od preseptalnog celulitisa koji je blaga bolest. Perianalni apsces zahtijeva neodgodivu kirušku drenažu te ponekad i antimikrobnu terapiju.
Osnovno je liječenje influence simptomatsko, a teže oblike bolesti i hospitalizirane bolesnike te bolesnike s rizičnim čimbenicima za nastanak komplikacija u influenci poželjno je liječiti ...specifičnim protuvirusnim lijekovima. Stariji protuvirusni lijekovi (blokatori M2-ionskih kanala), amantadin i rimantadin vrlo su se rijetko upotrebljavali zbog toksičnosti i rezistencije virusa te neučinkovitosti prema virusu influence B. Novi protuvirusni lijekovi blokiraju aktivnost virusne neuraminidaze (inhibitori neuraminidaze) i tako sprečavaju izlazak virusa iz inficirane stanice. Inhibitori neuraminidaze dobro djeluju na sve viruse influence A i B. Danas se rabe dva inhibitora neuraminidaze – zanamivir i oseltamivir, a završnu fazu kliničkih istraživanja prošao je peramivir, dok je laninamivir u pretkliničkoj fazi istraživanja. Inhibitori neuraminidaze u sezonskoj i pandemijskoj influenci skraćuju trajanje bolesti i ublažuju simptome, smanjuju broj i težinu komplikacija, potrošnju antibiotika i potrebu hospitalizacije bolesnika. Liječenje treba početi u samome početku, odnosno u prvih 48 sati od početka bolesti.
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