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Article ; Online: COVID-19 Prevention in Solid Organ Transplant Recipients: Current State of the Evidence.

Vafea, Maria Tsikala / Haidar, Ghady

Infectious disease clinics of North America

2023 Volume 37, Issue 3, Page(s) 459–473

Abstract: Although COVID-19 vaccines are safe, most organ transplant recipients fail to mount an antibody response after two mRNA vaccines. Thus, three mRNA vaccines constitute a primary vaccine series after solid organ transplant. However, neutralizing antibodies ...

Abstract	Although COVID-19 vaccines are safe, most organ transplant recipients fail to mount an antibody response after two mRNA vaccines. Thus, three mRNA vaccines constitute a primary vaccine series after solid organ transplant. However, neutralizing antibodies after three or greater mRNA vaccines are lower against Omicron versus older variants. Predictors of attenuated responses include age, vaccination within 1 year from transplant, mycophenolate, and BNT162b2. Some seronegative transplant recipients exhibit durable T-cell responses. Vaccine effectiveness in transplants is lower than in the general population. Immunosuppression reduction around revaccination warrants further study. Monoclonal antibody pre-exposure prophylaxis may be protective against susceptible variants.
MeSH term(s)	Humans ; BNT162 Vaccine ; COVID-19/prevention & control ; COVID-19 Vaccines/administration & dosage ; Organ Transplantation ; Transplant Recipients
Chemical Substances	BNT162 Vaccine ; COVID-19 Vaccines
Language	English
Publishing date	2023-03-22
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	1077676-x
ISSN	1557-9824 ; 0891-5520
ISSN (online)	1557-9824
ISSN	0891-5520
DOI	10.1016/j.idc.2023.03.002
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Article ; Online: Corrigendum to 'Worse clinical outcomes in patients with cancer treated with immune checkpoint inhibitors: A systematic review and meta-analysis'.

Tsikala-Vafea, Maria / Farmakiotis, Dimitrios

International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases

2021 Volume 113, Page(s) 34–35

Language	English
Publishing date	2021-08-22
Publishing country	Canada
Document type	Published Erratum
ZDB-ID	1331197-9
ISSN	1878-3511 ; 1201-9712
ISSN (online)	1878-3511
ISSN	1201-9712
DOI	10.1016/j.ijid.2021.08.046
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Article: Lower Glycosylated Hemoglobin Is Associated With Lower In-Hospital Mortality in Patients With COVID-19: A Systematic Review of the Literature and Meta-Analysis.

Tsikala Vafea, Maria / Traboulsi, Cindy / Stefanovic-Racic, Maja

Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists

2023 Volume 30, Issue 1, Page(s) 70–77

Abstract: Objective: Poor glycemic control during COVID-19 hospitalization is associated with higher mortality. However, the association between long-term glycemic control, as reflected by the glycosylated hemoglobin (HbA1c) and outcomes has yet to be clarified, ... ...

Abstract	Objective: Poor glycemic control during COVID-19 hospitalization is associated with higher mortality. However, the association between long-term glycemic control, as reflected by the glycosylated hemoglobin (HbA1c) and outcomes has yet to be clarified, with some studies reporting no association. The aim of this study is to determine the association between HbA1c and in-hospital mortality in patients with COVID-19. Methods: Pubmed, Embase, and Web of Science databases were searched for studies examining the association between HbA1c level and in-hospital COVID-19 mortality. Random-effects meta-analysis was performed. Heterogeneity was assessed using the I2 statistic. Publication bias was assessed using funnel plots. Results: Among 4142 results, 22 studies were included in the final analysis with a total of 11 220 patients. Lower Hba1c was associated with lower in-hospital mortality [odds ratio (OR), 0.53; 95% CI, 0.37-0.76; I2 81%], in using HbA1c as a dichotomous variable. When only patients with diabetes were included in the analysis, the association remained statistically significant (OR, 0.67; 95% CI, 0.47-0.96). In the subgroup analysis, the association remained statistically significant in studies using as cutoff the HbA1c value of 6.5% (OR, 0.34; 95% CI, 0.15-0.77) and 7% (OR, 0.54; 95% CI 0.32-0.90), but not with greater HbA1c cutoff values; 7.5% and ≥8%. In studies using HbA1C as a continuous variable, HbA1c level did not have a statistically significant association with in-hospital mortality, either in univariate or multivariate analyses. Conclusion: A better glycemic control prior to hospitalization, as reflected by lower HbA1c, is associated with lower in-hospital mortality in patients with COVID-19.
MeSH term(s)	Humans ; COVID-19/mortality ; COVID-19/physiopathology ; Diabetes Mellitus/epidemiology ; Glycated Hemoglobin/analysis ; Hospital Mortality ; Hyperglycemia
Chemical Substances	Glycated Hemoglobin ; hemoglobin A1c protein, human
Language	English
Publishing date	2023-09-27
Publishing country	United States
Document type	Systematic Review ; Meta-Analysis ; Journal Article ; Review
ZDB-ID	1473503-9
ISSN	1530-891X
ISSN	1530-891X
DOI	10.1016/j.eprac.2023.09.009
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Zs.A 5034: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article: Factors Associated With Enrollment into Inpatient Coronavirus Disease 2019 Randomized Controlled Trials: A Cross-sectional Analysis.

Kaczynski, Matthew / Benitez, Gregorio / Mylona, Evangelia K / Tran, Quynh-Lam / Atalla, Eleftheria / Tsikala-Vafea, Maria / Kalagara, Saisanjana / Shehadeh, Fadi / Mylonakis, Eleftherios

Open forum infectious diseases

2023 Volume 10, Issue 5, Page(s) ofad197

Abstract: Background: Clinical trials for coronavirus disease 2019 (COVID-19) have struggled to achieve diverse patient enrollment, despite underrepresented groups bearing the largest burden of the disease and, presumably, being most in need of the treatments ... ...

Abstract	Background: Clinical trials for coronavirus disease 2019 (COVID-19) have struggled to achieve diverse patient enrollment, despite underrepresented groups bearing the largest burden of the disease and, presumably, being most in need of the treatments under investigation. Methods: To assess the willingness of patients to enroll into inpatient COVID-19 clinical trials when invited, we conducted a cross-sectional analysis of adults hospitalized with COVID-19 who were approached regarding enrollment. Associations between patient and temporal factors and enrollment were assessed by multivariable logistic regression analysis. Results: A total of 926 patients were included in this analysis. Overall, Hispanic/Latinx ethnicity was associated with a nearly half-fold decrease in the likelihood to enroll (adjusted odds ratio [aOR], 0.60 [95% confidence interval {CI}, .41-.88]). Greater baseline disease severity (aOR, 1.09 [95% CI, 1.02-1.17]), age 40-64 years (aOR, 1.83 [95% CI, 1.03-3.25]), and age ≥65 years (aOR, 1.92 [95% CI, 1.08-3.42]) were each independently associated with higher likelihood to enroll. Over the course of the pandemic, patients were less likely to enroll during the summer 2021 wave in COVID-19-related hospitalizations (aOR, 0.14 [95% CI, .10-.19]) compared with patients from the first wave in winter 2020. Conclusions: The decision to enroll into clinical trials is multifactorial. Amid a pandemic disproportionately affecting vulnerable groups, Hispanic/Latinx patients were less likely to participate when invited, whereas older adults were more likely. Future recruitment strategies must consider the nuanced perceptions and needs of diverse patient populations to ensure equitable trial participation that advances the quality of healthcare for all.
Language	English
Publishing date	2023-04-12
Publishing country	United States
Document type	Journal Article
ZDB-ID	2757767-3
ISSN	2328-8957
ISSN	2328-8957
DOI	10.1093/ofid/ofad197
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Article ; Online: Mortality in mechanically ventilated patients with COVID-19: a systematic review.

Tsikala Vafea, Maria / Zhang, Raina / Kalligeros, Markos / Mylona, Evangelia K / Shehadeh, Fadi / Mylonakis, Eleftherios

Expert review of medical devices

2021 Volume 18, Issue 5, Page(s) 457–471

Abstract: ... ...

Abstract	Introduction
MeSH term(s)	Adenosine Monophosphate/analogs & derivatives ; Adenosine Monophosphate/pharmacology ; Adenosine Monophosphate/therapeutic use ; Alanine/analogs & derivatives ; Alanine/pharmacology ; Alanine/therapeutic use ; Antibodies, Monoclonal, Humanized/pharmacology ; Antibodies, Monoclonal, Humanized/therapeutic use ; COVID-19/mortality ; COVID-19/therapy ; COVID-19/virology ; Humans ; Respiration, Artificial/mortality ; SARS-CoV-2/drug effects ; SARS-CoV-2/physiology ; Treatment Outcome
Chemical Substances	Antibodies, Monoclonal, Humanized ; remdesivir (3QKI37EEHE) ; Adenosine Monophosphate (415SHH325A) ; tocilizumab (I031V2H011) ; Alanine (OF5P57N2ZX)
Language	English
Publishing date	2021-04-30
Publishing country	England
Document type	Journal Article ; Systematic Review
ZDB-ID	2250857-0
ISSN	1745-2422 ; 1743-4440
ISSN (online)	1745-2422
ISSN	1743-4440
DOI	10.1080/17434440.2021.1915764
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Article ; Online: Use of antibiotics is associated with worse clinical outcomes in patients with cancer treated with immune checkpoint inhibitors: A systematic review and meta-analysis.

Tsikala-Vafea, Maria / Belani, Neel / Vieira, Kendra / Khan, Hina / Farmakiotis, Dimitrios

International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases

2021 Volume 106, Page(s) 142–154

Abstract: Objectives: Observational and experimental studies suggest that the use of antibiotics close to administration of immune checkpoint inhibitors (ICI) can have a negative effect on tumour response and patient survival, due to microbiome dysbiosis and the ... ...

Abstract	Objectives: Observational and experimental studies suggest that the use of antibiotics close to administration of immune checkpoint inhibitors (ICI) can have a negative effect on tumour response and patient survival, due to microbiome dysbiosis and the resultant suppression of host immune response against neoplastic cells. Methods: A systematic search of PUBMED and EMBASE was undertaken for studies published between 1 January 2017 and 1 June 2020, evaluating the association between the use of antibiotics and clinical outcomes in patients with cancer treated with ICIs. A meta-analysis of the association between the use of antibiotics and clinical outcomes was also performed. Results: Forty-eight studies met the inclusion criteria (12,794 patients). Use of antibiotics was associated with shorter overall survival [hazard ratio (HR) 1.88, 95% confidence interval (CI) 1.59-2.22; adjusted HR 1.87, 95% CI 1.55-2.25] and progression-free survival (HR 1.52, 95% CI 1.36-1.70; adjusted HR 1.93, 95% CI 1.59-2.36), decreased response rate [odds ratio (OR) 0.54, 95% CI 0.34-0.86] and more disease progression (OR 2.00, 95% CI 1.27-3.14). The negative association between the use of antibiotics and progression-free survival was stronger in patients with renal cell carcinoma or melanoma compared with lung cancer. Only antibiotic administration >1 month prior to ICI initiation was associated with increased disease progression. Heterogeneity was substantial for all outcomes. Conclusions: Recent use of antibiotics in patients with cancer treated with ICIs was associated with worse clinical outcomes. Such patients may benefit from dedicated antimicrobial stewardship programmes.
MeSH term(s)	Anti-Bacterial Agents/pharmacology ; Drug Interactions ; Humans ; Immune Checkpoint Inhibitors/pharmacology ; Immune Checkpoint Inhibitors/therapeutic use ; Neoplasms/drug therapy ; Neoplasms/immunology ; Treatment Outcome
Chemical Substances	Anti-Bacterial Agents ; Immune Checkpoint Inhibitors
Language	English
Publishing date	2021-03-23
Publishing country	Canada
Document type	Journal Article ; Meta-Analysis ; Systematic Review
ZDB-ID	1331197-9
ISSN	1878-3511 ; 1201-9712
ISSN (online)	1878-3511
ISSN	1201-9712
DOI	10.1016/j.ijid.2021.03.063
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Article ; Online: A Pilot Trial of Thymalfasin (Thymosin-α-1) to Treat Hospitalized Patients With Hypoxemia and Lymphocytopenia Due to Coronavirus Disease 2019 Infection.

Shehadeh, Fadi / Benitez, Gregorio / Mylona, Evangelia K / Tran, Quynh-Lam / Tsikala-Vafea, Maria / Atalla, Eleftheria / Kaczynski, Matthew / Mylonakis, Eleftherios

The Journal of infectious diseases

2022 Volume 227, Issue 2, Page(s) 226–235

Abstract: Background: Thymosin-α-1 (Tα1) may be a treatment option for coronavirus disease 2019 (COVID-19), but efficacy and safety data remain limited.: Methods: Prospective, open-label, randomized trial assessing preliminary efficacy and safety of ... ...

Abstract	Background: Thymosin-α-1 (Tα1) may be a treatment option for coronavirus disease 2019 (COVID-19), but efficacy and safety data remain limited. Methods: Prospective, open-label, randomized trial assessing preliminary efficacy and safety of thymalfasin (synthetic form of Tα1), compared with the standard of care, among hospitalized patients with hypoxemia and lymphocytopenia due to COVID-19. Results: A total of 49 patients were included in this analysis. Compared with control patients, the incidence of clinical recovery was higher for treated patients with either baseline low-flow oxygen (subdistribution hazard ratio, 1.48 [95% confidence interval, .68-3.25]) or baseline high-flow oxygen (1.28 [.35-4.63]), although neither difference was significant. Among patients with baseline low-flow oxygen, treated patients, compared with control patients, had an average difference of 3.84 times more CD4+ T cells on day 5 than on day 1 (P = .01). Nine serious adverse events among treated patients were deemed not related to Tα1. Conclusions: Tα1 increases CD4+ T-cell count among patients with baseline low-flow oxygen support faster than the standard of care and may have a role in the management of hospitalized patients with hypoxemia and lymphocytopenia due to COVID-19. Clinical trials registration: NCT04487444.
MeSH term(s)	Humans ; Thymalfasin/therapeutic use ; Thymosin/therapeutic use ; COVID-19/complications ; Pilot Projects ; Prospective Studies ; Lymphopenia ; Hypoxia/therapy ; Hypoxia/drug therapy ; Oxygen
Chemical Substances	Thymalfasin (W0B22ISQ1C) ; Thymosin (61512-21-8) ; Oxygen (S88TT14065)
Language	English
Publishing date	2022-09-02
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	3019-3
ISSN	1537-6613 ; 0022-1899
ISSN (online)	1537-6613
ISSN	0022-1899
DOI	10.1093/infdis/jiac362
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Article: Fatal Mucormycosis and Aspergillosis in an Atypical Host: What Do We Know about Mixed Invasive Mold Infections?

Tsikala-Vafea, Maria / Cao, Weibiao / Olszewski, Adam J / Donahue, John E / Farmakiotis, Dimitrios

Case reports in infectious diseases

2020 Volume 2020, Page(s) 8812528

Abstract: Mixed invasive mold infections (MIMIs) are considered rare. We present a case of fatal aspergillosis and mucormycosis in an elderly host with history of chronic lymphocytic leukemia (CLL) and potential mold exposures. Notably, he had no classic risk ... ...

Abstract	Mixed invasive mold infections (MIMIs) are considered rare. We present a case of fatal aspergillosis and mucormycosis in an elderly host with history of chronic lymphocytic leukemia (CLL) and potential mold exposures. Notably, he had no classic risk factors for IMI other than high-dose corticosteroids, which may be an important risk factor for (M)IMI, based on the current and previous reports. There is an urgent need for studies on the "net state of immunosuppression," environmental exposure as risk factors for (M)IMIs, and noninvasive fungal diagnostics.
Language	English
Publishing date	2020-08-25
Publishing country	Egypt
Document type	Case Reports
ZDB-ID	2627642-2
ISSN	2090-6633 ; 2090-6625
ISSN (online)	2090-6633
ISSN	2090-6625
DOI	10.1155/2020/8812528
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Article ; Online: Clinical Outcomes of Adult Patients Hospitalized with COVID-19 after Vaccination.

Kalligeros, Markos / Shehadeh, Fadi / Mylona, Evangelia K / Kaczynski, Matthew / Kalagara, Saisanjana / Atalla, Eleftheria / Tsikala Vafea, Maria / Mylonakis, Eleftherios

Tropical medicine and infectious disease

2021 Volume 6, Issue 4

Abstract: Vaccination remains the most effective way to prevent COVID-19. The aim of the present study was to assess the incidence of COVID-19 hospitalizations after vaccination, as well as the effect of prior vaccination on hospitalization outcomes among patients ...

Abstract	Vaccination remains the most effective way to prevent COVID-19. The aim of the present study was to assess the incidence of COVID-19 hospitalizations after vaccination, as well as the effect of prior vaccination on hospitalization outcomes among patients with COVID-19. We analyzed and compared all consecutive patients, with or without prior vaccination, who were admitted to our hospital network due to COVID-19 from January to April 2021. Our primary outcome was to identify and describe cases of COVID-19 hospitalized after vaccination. We also utilized a multivariate logistic regression model to investigate the association of previous vaccination with hospitalization outcomes. We identified 915 consecutive patients hospitalized due to COVID-19 with 91/915 (10%) previously vaccinated with at least one dose of a COVID-19 vaccine. Utilizing our multivariate logistic regression model, we found that prior vaccination, regardless of the number of doses or days since vaccination, was associated with decreased mortality (aOR 0.44, 95% CI: 0.20-0.98) when compared to unvaccinated individuals. Our study showed that COVID-19 related hospitalization after vaccination may occur to a small percentage of patients, mainly those who are partially vaccinated. However, our findings underline that prior vaccination, even when partial, is associated with a decreased risk of death. Ongoing vaccination efforts should remain an absolute priority.
Language	English
Publishing date	2021-09-26
Publishing country	Switzerland
Document type	Journal Article
ISSN	2414-6366
ISSN (online)	2414-6366
DOI	10.3390/tropicalmed6040175
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Article ; Online: Impact of Influenza Infection Among Adult and Pediatric Populations With Hematologic Malignancy and Hematopoietic Stem Cell Transplant: A Systematic Review and Meta-Analysis.

Atalla, Eleftheria / Kalligeros, Markos / Mylona, Evangelia K / Tsikala-Vafea, Maria / Shehadeh, Fadi / Georgakas, Joanna / Mylonakis, Eleftherios

Clinical therapeutics

2021 Volume 43, Issue 5, Page(s) e66–e85

Abstract: Purpose: Influenza is increasingly recognized as a leading cause of morbidity and mortality in patients with hematologic malignancies and recipients of hematopoietic stem cell transplantation (HSCT). However, the impact of influenza on this population ... ...

Abstract	Purpose: Influenza is increasingly recognized as a leading cause of morbidity and mortality in patients with hematologic malignancies and recipients of hematopoietic stem cell transplantation (HSCT). However, the impact of influenza on this population has not been previously evaluated in a systematic review. This study systematically reviewed and summarized the outcomes of influenza infection as to in-hospital influenza-related mortality, development of lower respiratory tract infection and acute respiratory distress syndrome, need for hospitalization, intensive care unit admission, and mechanical ventilation. Methods: We conducted a systematic search of literature using the PubMed and EMBASE databases for articles published from January 1989 through January 19, 2020, reporting laboratory-confirmed influenza in patients of any age with hematologic malignancies and HSCT. Time from transplantation was not included in the search criteria. The impact of antiviral therapy on influenza outcomes was not assessed due to heterogeneity in antiviral treatment provision across the studies. Patients with influenza-like illness, solid-tumor cancers, or nonmalignant hematologic diseases were excluded from the study. A random-effects meta-analysis was performed to estimate the prevalences and 95% CIs of each outcome of interest. A subgroup analysis was carried out to assess possible sources of heterogeneity and to evaluate the potential impact of age on the influenza infection outcomes. Heterogeneity was assessed using the I Findings: Data from 52 studies providing data on 1787 patients were included in this analysis. During seasonal epidemics, influenza-related in-hospital mortality was 16.60% (95% CI, 7.49%-27.7%), with a significantly higher death rate in adults compared to pediatric patients (19.55% [95% CI, 10.59%-29.97%] vs 0.96% [95% CI, 0%-6.77%]; P < 0.001). Complications from influenza, such as lower respiratory tract infection, developed in 35.44% of patients with hematologic malignancies and HSCT recipients, with a statistically significant difference between adults and children (46.14% vs 19.92%; P < 0.001). However, infection resulted in a higher hospital admission rate in pediatric patients compared to adults (61.62% vs 22.48%; P < 0.001). For the 2009 H1N1 pandemic, no statistically significant differences were found between adult and pediatric patients when comparing the rates of influenza-related in-hospital mortality, lower respiratory tract infection, and hospital admission. Similarly, no significant differences were noted in any of the outcomes of interest when comparing H1N1 pandemic with seasonal epidemics. Implications: Regardless of influenza season, patients, and especially adults, with underlying hematologic malignancies and HSCT recipients with influenza are at risk for severe outcomes including lower respiratory tract infection and in-hospital mortality.
MeSH term(s)	Adult ; Antiviral Agents/therapeutic use ; Child ; Hematologic Neoplasms/drug therapy ; Hematopoietic Stem Cell Transplantation/adverse effects ; Humans ; Influenza A Virus, H1N1 Subtype ; Influenza, Human/drug therapy ; Influenza, Human/epidemiology
Chemical Substances	Antiviral Agents
Language	English
Publishing date	2021-04-01
Publishing country	United States
Document type	Journal Article ; Meta-Analysis ; Systematic Review
ZDB-ID	603113-4
ISSN	1879-114X ; 0149-2918
ISSN (online)	1879-114X
ISSN	0149-2918
DOI	10.1016/j.clinthera.2021.03.002
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