Effectiveness, safety and cost analysis of dalbavancin in clinical practice.

OBJECTIVES: Dalbavancin is approved for the treatment of complicated skin and soft tissue infections. However, there is growing evidence that other gram-positive infections could be treated with this antibiotic. A study was undertaken in a tertiary hospital in Spain to evaluate the effectiveness and safety of dalbavancin in off-label indications and the potential healthcare cost savings. METHODS: A retrospective observational study including all patients treated with dalbavancin in our hospital from October 2016 to August 2019 was carried out. Demographic, clinical and safety variables were collected. Effectiveness was assessed using the clinical and microbiological resolution of the infection and the absence of hospital admissions due to the same infection in the following 3 months. RESULTS: A total of 102 patients were included (69.9% men, n=71; median age 72.5 years (range 56.0-84.0)). Treatment was off label in 71 cases (69.6%). The most frequent off-label indications were catheter-related bacteraemia (15.7%, n=16) and endocarditis (13.6%, n=14). All patients had previously received antibiotics. The main reason for switching to dalbavancin was patient discharge (79.4%, n=81). Dalbavancin was administered during hospitalisation in 66.7% of the patients and in the outpatient setting in 13.7%. The median reduction in length of hospital stay was 14 days per patient. A saving of about 4550 Euros per patient was estimated. 89 patients (93.7%) had clinical and microbiological resolution of the infection at the end of the study. One patient did not finish the dalbavancin infusion due to an allergic reaction. CONCLUSIONS: Our results suggest that dalbavancin is a safe and effective alternative to the off-label treatment of gram-positive infections. Its dosage facilitates early discharge and outpatient management of these patients.

Safety of tocilizumab in COVID-19 pregnant women and their newborn: A retrospective study.

WHAT IS KNOWN AND OBJECTIVE: Tocilizumab is an IL-6 receptor inhibitor agent which has been proposed as a candidate to stop the inflammatory phase of infection by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). However, safety data of tocilizumab in pregnant women and their newborn are scarce. We aimed to describe maternal and neonatal safety outcomes associated with tocilizumab treatment in pregnant women with severe COVID-19. METHODS: This is a retrospective study of severe COVID-19 pregnant women, treated with tocilizumab in two Spanish hospitals between 1 March and 31 April 2020. Demographics, medical history, clinical and radiologic findings, treatment information and laboratory data of mothers and their newborns were collected from electronic medical records. RESULTS AND DISCUSSION: A total of 12 pregnant women were identified to have received tocilizumab during pregnancy in the two hospitals. Median gestational age at admission was 27.7 weeks (interquartile range, 18.0-36.4). Most of them received lopinavir/ritonavir, azithromycin and hydroxychloroquine, two patients received corticosteroids and one received interferon beta 1B. All 12 pregnancies resulted in live births. Somatometric values were normal for all newborns, and evolution at 14 and 28 days was favourable for all of them. Hepatotoxicity was observed in 2 patients, which improved or resolved at discharge. Cytomegalovirus reactivation was detected in another patient who had also received corticosteroids for 15 days, causing a congenital infection in her newborn. Both hepatotoxicity and viral reactivation adverse events were classified as possibly related to tocilizumab administration according to Naranjo's causality algorithm. WHAT IS NEW AND CONCLUSIONS: It does not appear that tocilizumab has detrimental effects for the mother and newborn. Close monitoring of infections should be considered, especially if other immunosuppressive agents are used.

Blood and urine samples as useful sources for the direct detection of tuberculosis by polymerase chain reaction.

The aim of the study was to assess the utility of the polymerase chain reaction (PCR) assay in blood and urine for the diagnosis of tuberculosis (TB). We prospectively evaluated the usefulness of PCR performed in blood and urine samples from patients with proved or probable TB compared with a control group of patients. The PCR technique was performed using IS6110 primers. We included in the study 57 patients (43 with definite TB and 14 with probable TB) and 26 controls. Blood and urine samples were drawn at the time of microbiologic diagnosis and 3, 6, 9, and 12 months later. Cultures were positive in the early period (<1 month after treatment) in 11 of 57 patients (19%) with probable or definite TB, in comparison with 42% of patients (24/57) who yielded a positive PCR (P = 0.02). Urine samples increased the sensitivity of PCR determination in blood samples by 10%. The PCR in blood and/or urine was positive in 41% of patients with pulmonary TB, in 36% of patients with extrapulmonary TB, and in 50% of patients with disseminated TB. Mycobacterium tuberculosis was still detectable by PCR in 5 of 13 patients with cured TB after 1 or more months of antituberculous treatment. The PCR detection of M. tuberculosis in blood and urine samples is useful for the diagnosis of different clinical forms of TB, mostly in those patients in which sample extraction is difficult or requires aggressive techniques. The sensitivity of this technique could be improved studying more than 1 sample in each patient, even after initiating an antituberculous treatment.