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1.
Antibiotics (Basel) ; 10(8)2021 Jul 30.
Article in English | MEDLINE | ID: covidwho-1334980

ABSTRACT

SARS-CoV-2 in patients who need intensive care unit (ICU) is associated with a mortality rate ranging from 10 to 40-45%, with an increase in morbidity and mortality in presence of sepsis. We hypothesized that IgM and IgA enriched immunoglobulin G may support the sepsis-related phase improving patient outcome. We conducted a retrospective case-control study on 47 consecutive patients admitted to our ICU. At the time of admission, patients received anticoagulants (heparin sodium) together with the standard supportive treatment. We decided to add IgM and IgA enriched immunoglobulin G to the standard therapy. Patients receiving IgM and IgA enriched immunoglobulin G were compared with patients with similar baseline characteristics and treatment, receiving only standard therapy. The mortality resulted significantly higher in patients treated with standard therapy only (56.5 vs. 37.5%, p < 0.01) and, at day 7, the probability of dying was 3 times higher in this group. Variable life adjustment display (VLAD) was 2.4 and -2.2 (in terms of lives saved in relation with those expected and derived from Simplified Acute Physiology Score II) in the treated and not treated group, respectively. The treatment based on IgM and IgA enriched immunoglobulin G infusion seems to give an advantage on survival in SARS-CoV-2 severe infection.

2.
Infection ; 50(1): 139-148, 2022 Feb.
Article in English | MEDLINE | ID: covidwho-1309093

ABSTRACT

PURPOSE: To investigate the prevalence, incidence and characteristics of bacterial infections and their impact on outcome in critically ill patients infected with COVID-19. METHODS: We conducted a prospective observational study in eight Italian ICUs from February to May 2020; data were collected through an interactive electronic database. Kaplan-Meier analysis (limit product method) was used to identify the occurrence of infections and risk of acquisition. RESULTS: During the study period 248 patients were recruited in the eight participating ICUs. Ninety (36.3%) patients developed at least one episode of secondary infection. An ICU length of stay between 7 and 14 days was characterized by a higher occurrence of infectious complications, with ventilator-associated pneumonia being the most frequent. At least one course of antibiotic therapy was given to 161 (64.9%) patients. Overall ICU and hospital mortality were 33.9% and 42.9%, respectively. Patients developing bacteremia had a higher risk of ICU mortality [45.9% vs. 31.6%, odds ratio 1.8 (95% CI 0.9-3.7), p = 0.069] and hospital mortality [56.8% vs. 40.3%, odds ratio 1.9 (95% CI 1.1-3.9), p = 0.04]. CONCLUSION: In critically ill patients infected with COVID-19 the incidence of bacterial infections is high and associated with worse outcomes. Regular microbiological surveillance and strict infection control measures are mandated.


Subject(s)
Bacterial Infections , COVID-19 , Bacterial Infections/epidemiology , Critical Illness , Humans , Intensive Care Units , Prospective Studies , SARS-CoV-2
3.
BMJ Open ; 11(2): e036616, 2021 02 11.
Article in English | MEDLINE | ID: covidwho-1228874

ABSTRACT

INTRODUCTION: In patients with septic shock, low levels of circulating immunoglobulins are common and their kinetics appear to be related to clinical outcome. The pivotal role of immunoglobulins in the host immune response to infection suggests that additional therapy with polyclonal intravenous immunoglobulins may be a promising option in patients with septic shock. Immunoglobulin preparations enriched with the IgM component have largely been used in sepsis, mostly at standard dosages (250 mg/kg per day), regardless of clinical severity and without any dose adjustment based on immunoglobulin serum titres or other biomarkers. We hypothesised that a personalised dose of IgM enriched preparation based on patient IgM titres and aimed to achieve a specific threshold of IgM titre is more effective in decreasing mortality than a standard dose. METHODS AND ANALYSIS: The study is designed as a multicentre, interventional, randomised, single-blinded, prospective, investigator sponsored, two-armed study. Patients with septic shock and IgM titres <60 mg/dL will be randomly assigned to an IgM titre-based treatment or a standard treatment group in a ratio of 1:1. The study will involve 12 Italian intensive care units and 356 patients will be enrolled. Patients assigned to the IgM titre-based treatment will receive a personalised daily dose based on an IgM serum titre aimed at achieving serum titres above 100 mg/dL up to discontinuation of vasoactive drugs or day 7 after enrolment. Patients assigned to the IgM standard treatment group will receive IgM enriched preparation daily for three consecutive days at the standard dose of 250 mg/kg. The primary endpoint will be all-cause mortality at 28 days. ETHICS AND DISSEMINATION: The study protocol was approved by the ethics committees of the coordinating centre (Comitato Etico dell'Area Vasta Emilia Nord) and collaborating centres. The results of the trial will be published within 12 months from the end of the study and the steering committee has the right to present them at public symposia and conferences. TRIAL REGISTRATION DETAILS: The trial protocol and information documents have received a favourable opinion from the Area Vasta Emilia Nord Ethical Committee on 12 September 2019. The trial protocol has been registered on EudraCT (2018-001613-33) on 18 April 2018 and on ClinicalTrials.gov (NCT04182737) on 2 December 2019.


Subject(s)
COVID-19 , Shock, Septic , Humans , Immunization, Passive , Immunoglobulin M , Prospective Studies , SARS-CoV-2 , Shock, Septic/drug therapy , Treatment Outcome
4.
Ther Drug Monit ; 42(2): 165-168, 2020 04.
Article in English | MEDLINE | ID: covidwho-11505

ABSTRACT

BACKGROUND: Dalbavancin, albeit indicated for the treatment of skin structure infections, is used for a much wider range of infections. This drug is characterized by a long half-life (more than 200 hours), a favorable safety profile, and an activity against a wide array of gram-positive organisms, including several strains of Staphylococci and Enterococci. METHODS: In this study, we presented 3 cases of critically ill patients treated with dalbavancin. All patients were therapeutically monitored for plasma dalbavancin concentrations; ultrafiltrate dalbavancin concentrations were assessed in a patient undergoing continuous renal-replacement therapy. Dalbavancin concentrations were measured using a validated liquid chromatographic method coupled with mass spectrometry. RESULTS: All 3 severely ill patients experiencing necrotizing fasciitis were successfully treated during the acute phase with dalbavancin. Dalbavancin clearance in patient 3 (0.334 L/h) was considerably increased compared with values measured in the other 2 patients (0.054 and 0.075 L/h) and with data reported in the literature (0.04-0.06 L/h). CONCLUSIONS: Our case reports presented preliminary evidence that dalbavancin can be considered a therapeutic option for necrotizing fasciitis in intensive care unit patients. The role of hypoalbuminemia during dalbavancin exposure merits further investigation.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Critical Illness , Drug Monitoring/methods , Fasciitis, Necrotizing/drug therapy , Teicoplanin/analogs & derivatives , Adult , Anti-Bacterial Agents/pharmacokinetics , Half-Life , Humans , Male , Metabolic Clearance Rate , Microbial Sensitivity Tests , Middle Aged , Severity of Illness Index , Teicoplanin/pharmacokinetics , Teicoplanin/therapeutic use
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