Browsing by Author "Pelemis, Mijomir (6507978433)"

Introduction: Surveillance of antimicrobial resistance is essential in establishing treatment guidelines for urinary tract infections. The aim of this pilot study was to analyse resistance rates of pathogens, across different demographics and determine whether adjustments in empiric therapy should be considered for different age and gender groups. Methodology: A 5-year retrospective study included 256 patients hospitalised, under the initial diagnosis of Fever of Unknown Origin who were then subsequently diagnosed with a urinary tract infection at the Clinic for Infectious and Tropical Diseases, Clinical Centre of Serbia. Patients were evaluated using demographic, clinical, and antimicrobial resistance data with appropriate statistical analysis including ANOVA significance testing, univariate, and multivariate analysis. Results: Resistance rates were above the threshold of 20% for the majority of the antimicrobials tested, the only exception being carbapenems. Amikacin, cefepime, and norfloxacin were agents that could be effectively used as empiric therapy in younger adults with resistance rates of 4.2, 8.0, and 10.0%, respectively. Moderate resistance rates of 17.4% for amikacin and 19.1% for cefepime were observed in the age group 35-64 years. High resistance rates were observed for all antimicrobials among patients 65 years and over. Among male patients, resistance rates to most antimicrobials were high. In female patients, amikacin and cefepime had resistance rates less than 20%. Younger age presented as a negative risk factor for infection by a multi-drug resistant pathogen. Conclusion: Age and gender demonstrated to be significant factors for determining proper empiric therapy; large-scale studies from Serbia are needed to solidify these findings. © 2016 Zec et al.

Introduction: Surveillance of antimicrobial resistance is essential in establishing treatment guidelines for urinary tract infections. The aim of this pilot study was to analyse resistance rates of pathogens, across different demographics and determine whether adjustments in empiric therapy should be considered for different age and gender groups. Methodology: A 5-year retrospective study included 256 patients hospitalised, under the initial diagnosis of Fever of Unknown Origin who were then subsequently diagnosed with a urinary tract infection at the Clinic for Infectious and Tropical Diseases, Clinical Centre of Serbia. Patients were evaluated using demographic, clinical, and antimicrobial resistance data with appropriate statistical analysis including ANOVA significance testing, univariate, and multivariate analysis. Results: Resistance rates were above the threshold of 20% for the majority of the antimicrobials tested, the only exception being carbapenems. Amikacin, cefepime, and norfloxacin were agents that could be effectively used as empiric therapy in younger adults with resistance rates of 4.2, 8.0, and 10.0%, respectively. Moderate resistance rates of 17.4% for amikacin and 19.1% for cefepime were observed in the age group 35-64 years. High resistance rates were observed for all antimicrobials among patients 65 years and over. Among male patients, resistance rates to most antimicrobials were high. In female patients, amikacin and cefepime had resistance rates less than 20%. Younger age presented as a negative risk factor for infection by a multi-drug resistant pathogen. Conclusion: Age and gender demonstrated to be significant factors for determining proper empiric therapy; large-scale studies from Serbia are needed to solidify these findings. © 2016 Zec et al.

Introduction: Pregnant women are at higher risk of developing severe influenza. Our aim was to analyze clinical course and risk factors for fatal outcome in pregnant women with influenza (H1N1) infection. Methodology: This retrospective study enrolled eleven pregnant women with confirmed Influenza A (H1N1) infection treated in the Clinic for Infectious and Tropical Diseases, Belgrade, Serbia in a 6-years period. Results: The mean age of pregnant women was 28.9 ± 5.2 years, and mean gestational age was 23.1 ± 7.0 weeks. Nine (81.8%) pregnant women had pneumonia (six had interstitial and three had bacterial pneumonia). Pregnant women developed pneumonia more often than other women in the reproductive period, but without statistical significance (81.8% vs. 65.7%, p = 0.330, OR (95% CI) 2.35 (0.47-11.80)). Nine (81.8%) pregnant women recovered. None of them experienced preterm delivery or abortion. Two women (18.2%) died due to acute respiratory distress syndrome. In one of them fetal death occurred one day before she died. The other one was performed caesarean section three days before death. Her newborn and children of all recovered women were healthy at birth. Prolonged time to initiation of oseltamivir and higher body mass index were statistically significantly associated with fatal outcome (p = 0.002, and p = 0.007, respectively). Gestational week of pregnancy, the etiology of pneumonia and comorbidity were not found to be risk factors for death (p = 0.128, p = 0.499 and p = 1.000, respectively). Conclusion: Pregnant women with H1N1 infection are at higher risk of pneumonia and death than other women in the reproductive period. Early antiviral therapy reduces the risk of unfavorable outcome. © 2018 Milosevic et al.

Introduction: Pregnant women are at higher risk of developing severe influenza. Our aim was to analyze clinical course and risk factors for fatal outcome in pregnant women with influenza (H1N1) infection. Methodology: This retrospective study enrolled eleven pregnant women with confirmed Influenza A (H1N1) infection treated in the Clinic for Infectious and Tropical Diseases, Belgrade, Serbia in a 6-years period. Results: The mean age of pregnant women was 28.9 ± 5.2 years, and mean gestational age was 23.1 ± 7.0 weeks. Nine (81.8%) pregnant women had pneumonia (six had interstitial and three had bacterial pneumonia). Pregnant women developed pneumonia more often than other women in the reproductive period, but without statistical significance (81.8% vs. 65.7%, p = 0.330, OR (95% CI) 2.35 (0.47-11.80)). Nine (81.8%) pregnant women recovered. None of them experienced preterm delivery or abortion. Two women (18.2%) died due to acute respiratory distress syndrome. In one of them fetal death occurred one day before she died. The other one was performed caesarean section three days before death. Her newborn and children of all recovered women were healthy at birth. Prolonged time to initiation of oseltamivir and higher body mass index were statistically significantly associated with fatal outcome (p = 0.002, and p = 0.007, respectively). Gestational week of pregnancy, the etiology of pneumonia and comorbidity were not found to be risk factors for death (p = 0.128, p = 0.499 and p = 1.000, respectively). Conclusion: Pregnant women with H1N1 infection are at higher risk of pneumonia and death than other women in the reproductive period. Early antiviral therapy reduces the risk of unfavorable outcome. © 2018 Milosevic et al.

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[No abstract available]

Introduction: Clostridium difficile is the leading cause of hospital-acquired diarrhoea. There is no defined protocol for treating severe Clostridium difficile infection (CDI) refractory to vancomycin or vancomycin and metronidazole combination therapy. The aim of this study was to evaluate the rate of clinical cure, time to resolution of diarrhoea and recurrence rate in patients with severe refractory CDI treated with oral teicoplanin. Methodology: A one-year prospective study was carried out in the Clinic for Infectious and Tropical Diseases, Clinical Center Serbia. Patients with severe and complicated CDI who failed to respond to oral vancomycin and intravenous metronidazole combination therapy were enrolled. They were given oral teicoplanin 100 mg bi-daily. Patients were followed for recurrence for eight weeks. Results: Nine patients with a mean age of 70.8±9.4 years were analyzed. All patients had pseudomembranous colitis, and five had complicated disease. In four patients intracolonic delivery of vancomycin was also performed in addition to oral vancomycin and intravenous metronidazole prior to initiating teicoplanin, but without improvement. After teicoplanin initiation all patients achieved clinical cure. The mean time to resolution of diarrhoea after teicoplanin introduction was 6.3±4.5 days. There was no statistically significant difference in time to resolution of diarrhoea according to initial leucocyte count, age over 65 years, the presence of ileus, complicated disease and the use of concomitant antibiotic therapy (p = 0.652, 0,652, 0.374, 0.374, and 0,548, respectively). None of the patients experienced recurrence. Conclusions: Oral teicoplanin might be a potential treatment for severe and complicated refractory CDI, but further studies are required. © 2015 Popovic et al.

Introduction: Clostridium difficile is the leading cause of hospital-acquired diarrhoea. There is no defined protocol for treating severe Clostridium difficile infection (CDI) refractory to vancomycin or vancomycin and metronidazole combination therapy. The aim of this study was to evaluate the rate of clinical cure, time to resolution of diarrhoea and recurrence rate in patients with severe refractory CDI treated with oral teicoplanin. Methodology: A one-year prospective study was carried out in the Clinic for Infectious and Tropical Diseases, Clinical Center Serbia. Patients with severe and complicated CDI who failed to respond to oral vancomycin and intravenous metronidazole combination therapy were enrolled. They were given oral teicoplanin 100 mg bi-daily. Patients were followed for recurrence for eight weeks. Results: Nine patients with a mean age of 70.8±9.4 years were analyzed. All patients had pseudomembranous colitis, and five had complicated disease. In four patients intracolonic delivery of vancomycin was also performed in addition to oral vancomycin and intravenous metronidazole prior to initiating teicoplanin, but without improvement. After teicoplanin initiation all patients achieved clinical cure. The mean time to resolution of diarrhoea after teicoplanin introduction was 6.3±4.5 days. There was no statistically significant difference in time to resolution of diarrhoea according to initial leucocyte count, age over 65 years, the presence of ileus, complicated disease and the use of concomitant antibiotic therapy (p = 0.652, 0,652, 0.374, 0.374, and 0,548, respectively). None of the patients experienced recurrence. Conclusions: Oral teicoplanin might be a potential treatment for severe and complicated refractory CDI, but further studies are required. © 2015 Popovic et al.

Background & Aims Tenofovir disoproxil fumarate (TDF) is active against lamivudine-resistant hepatitis B virus (HBV) infection, but data to support its clinical efficacy in this setting are limited. Methods In a prospective, double-blind, 96-week trial, patients were randomly assigned (1:1) to groups given TDF (300 mg, n = 141) or a combination of emtricitabine (FTC, 200 mg; n = 139) and TDF (300 mg, FTC/TDF). Patients were hepatitis B e antigen (HBeAg)-positive or HBeAg-negative, with levels of HBV DNA ≥3 log10 IU/mL and lamivudine resistance mutations (HBV polymerase or reverse transcriptase amino acid substitutions rtM204I/V ± rtL180M by INNO-LiPA Multi-DR v3; Innogenetics, Inc, Alpharetta, GA). The primary end point was proportion with HBV DNA <69 IU/mL (Roche COBAS Taqman assay; Roche Molecular Systems, Inc, Pleasanton, CA). Results Patient groups were well matched for demographic and disease characteristics, including region (60% from Europe), HBV genotype (45% genotype D), HBeAg status (47% HBeAg-positive), and duration of lamivudine treatment (mean, 3.8 years). At week 96 of treatment, 89.4% of patients in the TDF group and 86.3% in the FTC/TDF group had levels of HBV DNA <69 IU/mL (P =.43). HBeAg loss and seroconversion did not differ between groups; only 1 patient (0.7%) in the FTC/TDF group lost hepatitis B surface antigen. Treatment was well tolerated; confirmed renal events (creatinine increase of ≥0.5 mg/dL [>44 umol/L], creatinine clearance <50 mL/min, or level of PO4 <2 mg/dL [<0.65 mmol/L]) were generally mild and infrequent (<1%). Small reductions (<2%) in mean bone mineral density of hip and spine were detected by dual-energy x-ray absorptiometry in both groups. No TDF resistance developed through 96 weeks of treatment. Conclusions TDF alone is safe and effective for treatment of patients with lamivudine-resistant, chronic HBV infection. Clinical Trials.gov No, NCT00737568. © 2014 by the AGA Institute.

This study was a phase I double-blind, randomized, placebo-controlled trial to evaluate the safety and immunogenicity of a Serbian-produced seasonal trivalent split, inactivated influenza vaccine in healthy adults. The vaccine was manufactured in eggs by the Torlak Institute of Virology, Vaccines and Sera, Belgrade, Serbia and contained A/H1N1, A/H3N2 and B viruses. The clinical trial took place at the Clinical Center of Serbia in Belgrade. Sixty healthy volunteers, aged 18–45 years, were enrolled in the trial. On the day of immunization, volunteers were randomly assigned to receive either a single dose of the trivalent seasonal influenza vaccine (15 μg of hemagglutinin per strain) or placebo (phosphate-buffered saline). Subjects were monitored for adverse events through a clinical history and physical examination, and blood was taken for testing at screening and on day 8 to assess vaccine safety. Serum samples obtained before and 21 days after immunization were tested for influenza antibody titers using hemagglutination-inhibition (HAI) and microneutralization (MN) tests. No serious adverse events were reported. Pain and tenderness at the injection site were the most commonly reported symptoms in both vaccine and placebo groups. Overall, serum HAI responses of fourfold or greater magnitude were observed to H1, H3, and B antigen in 80%, 75%, and 70% of subjects, respectively. Seroprotection rates as measured by HAI were also high (100%, 100% and 86.67%, respectively, for H1, H3 and B). Thus, Torlak's seasonal trivalent influenza vaccine was not associated with adverse events, was well-tolerated and immunogenic. It should be further evaluated in clinical trials to provide sufficient safety and immunogenicity data for licensing in Serbia. © 2018 The Author(s). Published with license by Taylor & Francis Group, LLC © 2018, © Goran Stevanovic, Lidija Lavadinovic, Svetlana Filipovic Vignjevic, Renée Holt, Katarina Ilic, Francesco Berlanda Scorza, Erin Sparrow, Vera Stoiljkovic, Guido Torelli, Tamra Madenwald, Muriel Socquet, Aleksandra Barac, Yordanka Ilieva-Borisova, Mijomir Pelemis, and Jorge Flores.

This study was a phase I double-blind, randomized, placebo-controlled trial to evaluate the safety and immunogenicity of a Serbian-produced seasonal trivalent split, inactivated influenza vaccine in healthy adults. The vaccine was manufactured in eggs by the Torlak Institute of Virology, Vaccines and Sera, Belgrade, Serbia and contained A/H1N1, A/H3N2 and B viruses. The clinical trial took place at the Clinical Center of Serbia in Belgrade. Sixty healthy volunteers, aged 18–45 years, were enrolled in the trial. On the day of immunization, volunteers were randomly assigned to receive either a single dose of the trivalent seasonal influenza vaccine (15 μg of hemagglutinin per strain) or placebo (phosphate-buffered saline). Subjects were monitored for adverse events through a clinical history and physical examination, and blood was taken for testing at screening and on day 8 to assess vaccine safety. Serum samples obtained before and 21 days after immunization were tested for influenza antibody titers using hemagglutination-inhibition (HAI) and microneutralization (MN) tests. No serious adverse events were reported. Pain and tenderness at the injection site were the most commonly reported symptoms in both vaccine and placebo groups. Overall, serum HAI responses of fourfold or greater magnitude were observed to H1, H3, and B antigen in 80%, 75%, and 70% of subjects, respectively. Seroprotection rates as measured by HAI were also high (100%, 100% and 86.67%, respectively, for H1, H3 and B). Thus, Torlak's seasonal trivalent influenza vaccine was not associated with adverse events, was well-tolerated and immunogenic. It should be further evaluated in clinical trials to provide sufficient safety and immunogenicity data for licensing in Serbia. © 2018 The Author(s). Published with license by Taylor & Francis Group, LLC © 2018, © Goran Stevanovic, Lidija Lavadinovic, Svetlana Filipovic Vignjevic, Renée Holt, Katarina Ilic, Francesco Berlanda Scorza, Erin Sparrow, Vera Stoiljkovic, Guido Torelli, Tamra Madenwald, Muriel Socquet, Aleksandra Barac, Yordanka Ilieva-Borisova, Mijomir Pelemis, and Jorge Flores.