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BACKGROUND: Respiratory viral infections (RVIs) commonly cause morbidity and mortality in hematopoietic stem cell transplant (HSCT) recipients. This study aimed at the prevalence of RVIs in adult HSCT recipients and their outcomes. METHODS: A retrospective observational cohort study was conducted on all adult patients who underwent HSCT in the period between January 2016 and December 2020. Data were retrospectively abstracted from electronic medical records from a total of 400 patients. All cases with polymerase chain reaction-confirmed RVIs based on real-time reverse transcription polymerase chain reaction were included in the data analysis. RESULT: A total of 79 patients had positive results. Sixty-three patients had allogeneic stem cell transplants. Women were 53% of the patients, and the mean age was 32 years (±13.5). The prevalence of documented respiratory virus infections was around 20% during the 4 years of the study. The most common virus was rhinovirus (60.76%), followed by respiratory syncytial virus (15.19%), then parainfluenza (11.39%). Among the 9 patients (11%) who required intensive care unit admission, 67% had lymphopenia (P = .03), 71% had abnormal chest computed tomography scan with pleural effusion (P = .03), 22% required renal support (P = .057), and 2 patients (22%) died (P = .057). CONCLUSIONS: The study highlights the associated morbidity and mortality with RVIs among HSCT recipients and the need for more preventive measures and treatment studies.
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Transplante de Células-Tronco Hematopoéticas , Infecções Respiratórias , Viroses , Adulto , Humanos , Feminino , Infecções Respiratórias/diagnóstico , Infecções Respiratórias/epidemiologia , Estudos Retrospectivos , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Transplante de Células-Tronco , Viroses/epidemiologia , TransplantadosRESUMO
Introduction: Spondylodiscitis is rare yet the most common form of spinal infection. It is characterized by inflammation of the intervertebral disk space and adjacent vertebral body. In Western countries, the incidence of spondylodiscitis is increasing. Clinical outcomes most commonly reported in the literature are the 1-year mortality rate (range, 6%-12%) and neurologic deficits. Methods: This multicenter retrospective cohort study assessed patients diagnosed with infectious spondylodiscitis who received treatment at King Abdulaziz Medical City in Riyadh and Jeddah, Saudi Arabia. All enrolled patients were ≥18 years old and were diagnosed per radiologic and microbiological findings and clinical manifestations between January 2017 and November 2021. Results: This study enrolled 76 patients with infectious spondylodiscitis, with a median age of 61 years. All patients presented with back pain for a median 30 days. Patients were stratified into 3 groups based on the causative pathogen: brucellar spondylodiscitis (n = 52), tuberculous spondylodiscitis (n = 13), and pyogenic spondylodiscitis (n = 11). All laboratory data and biochemical markers were not significantly different. However, C-reactive protein, erythrocyte sedimentation rate, and white blood cells were significantly different in the pyogenic spondylodiscitis group, with medians of 121â mg/dL (P = .03), 82â mmol/h (P = .04), and 11.2 × 109/L (P = .014), respectively. Conclusions: Back pain is a common clinical feature associated with infectious spondylodiscitis. The immense value of microbiological investigations accompanied with histologic studies in determining the causative pathogen cannot be emphasized enough. Treatment with prolonged intravenous antimicrobial therapy with surgical intervention in some cases produced a cure rate exceeding 60%.
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Chronic active Epstein-Barr virus infection (CAEBV) is a rare and lethal condition caused by persistent Epstein-Barr virus (EBV) infection. Signs and symptoms of CAEBV infection include fever, lymphadenopathy, and hepatosplenomegaly. Due to life-threatening consequences such as multiple organ failure, hemophagocytic syndrome, EBV-positive lymphoproliferative illness, and coagulopathy, early identification is important for successful therapy. However, because of the wide range of clinical symptoms, it might be difficult to diagnose the disease due to limited clinical experience and a low number of reports. We report a case of CAEBV in a 59-year-old woman from Saudi Arabia. We present the hospital course of the patient from admission until the patient's death as well as the clinical and pathological findings with a review of the literature. This is a rare case of CAEBV in Saudi Arabia.
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Idiopathic granulomatous mastitis (IGM) is defined as an uncommon, benign, chronic inflammatory disease of unknown etiology that affects the breast and can mimic breast cancer. It usually manifests as a solid, ill-defined breast lump in postpartum women of reproductive age. Furthermore, because it lacks a particular radiographic finding, core biopsy and histology are the only ways to make a conclusive diagnosis. There is no agreement on the best way to treat IGM. Ideally, a multidisciplinary approach should be used to weigh the benefits and drawbacks of each treatment option, with options such as observation, antibiotics, surgery, and medication therapy being examined (steroids and immunosuppressants). In this report, we review a case of a patient who had IGM with superimposed Enterococcus avium infection. To our knowledge, such a report is considered unprecedented in the Middle East. A literature review on IGM will be presented, as well as the clinical presentation, association with bacterial infection, treatment, and pathological and radiographic findings.
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Pseudomonas otitidis is a rare and unique species among the Pseudomonas genus that has not been previously reported as a cause of male genitourinary tract infection. In this report, we describe a case of a 20-year-old immunocompetent male who presented with recurrent epididymo-orchitis, which was initially misidentified as Vibrio vulnificus and treated successfully. The causative agent could not be identified appropriately using the available routine methods, but a final identification was established using 16S rRNA targeted sequencing followed by whole-genome sequencing.
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INTRODUCTION: Immunomodulators, including dexamethasone (DEX), have been recommended by the Infectious Disease Society of America (IDSA) to treat moderate, severe, and critical COVID-19. Tocilizumab (TCZ) was added to the treatment recommendations based on recent data from two large randomized controlled trials and its potential synergistic effect with DEX. METHOD: We included adult patients admitted from June until October 2020 with a PCR confirmed SARS-CoV-2 infection. 135 patients with severe to critical COVID-19 and received TCZ and/or corticosteroid or DEX were retrospectively evaluated and followed until hospital discharge or death. RESULTS: The cohort was divided into two different groups of patients; TCZ group received TCZ ± corticosteroid, N = 100 and DEX group received DEX, N = 35. Groups were analyzed for hospital mortality. The rate of hospital mortality was 36% in TCZ and 37% in the DEX group, p = 0.91. Age of 60 years and above was associated with higher mortality rate with OR = 1.030 and 95% CI = (1.004, 1.057). More than 50% of patients required MV in both groups. Development of bacterial or fungal infection post immunomodulator were similar in TCZ and DEX groups, 29% vs. 31.4%. CONCLUSION: Our study revealed that age of 60 years and above is the only factor associated with higher mortality rate regardless of the type of immunomodulator therapy. Findings of this study also revealed the lack of synergistic effect between TCZ and DEX on the hospital mortality.
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Tratamento Farmacológico da COVID-19 , Corticosteroides/uso terapêutico , Adulto , Anticorpos Monoclonais Humanizados , Dexametasona/uso terapêutico , Humanos , Pessoa de Meia-Idade , Estudos Retrospectivos , SARS-CoV-2RESUMO
Background: Candida bloodstream infections cause significant excess morbidity and mortality in the health-care setting. There is limited evidence regarding Candida species causing invasive infections in Saudi Arabia. Objective: To identify Candida species causing bloodstream infection and determine the clinical outcome and factors associated with mortality in a tertiary center in Saudi Arabia. Materials and Methods: This retrospective study included all cases of positive blood culture for Candida in patients admitted to King Abdulaziz Medical City, a tertiary care center in Riyadh, Saudi Arabia, between January 1, 2013 and June 30, 2019. Results: A total of 532 patients with candidemia were identified (male: 55.4%; mean age: 54 ± 26.2 years). The most common Candida species isolated was Candida albicans (26.7%), followed by Candida glabrata (22.7%), Candida parapsilosis (22.2%), and Candida tropicalis (18.4%). Non-albicans candidemia was more common in patients with diabetes (76.7%; P = 0.0560), neutropenia (89.8%; P = 0.0062), recent exposure to fluconazole (85.7%; P = 0.0394), and active chemotherapy (83.1%; P = 0.0128). In non-albicans, susceptibility to fluconazole varied from 95.9% with C. tropicalis to 41.5% with C. parapsilosis; nonetheless, all species were highly susceptible to echinocandins. The overall 30- and 90-day mortality rates were 39.9% and 56.4%, respectively. The mortality rate was nonsignificantly higher with non-albicans species at 30 days (41.2% vs. 35.9%; P = 0.2634) and 90 days (58.2% vs. 51.4%; P = 0.1620). Conclusion: This study found a changing pattern in the Candida species causing bloodstream infections and an epidemiological shift toward more non-albicans Candida species in Saudi Arabia.
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OBJECTIVE: To evaluate whether favipiravir reduces the time to viral clearance as documented by negative RT-PCR results for severe acute respiratory syndrome coronavirus 2 in mild cases of coronavirus disease 2019 (COVID-19) compared to placebo. METHODS: In this randomized, double-blinded, multicentre, and placebo-controlled trial, adults with PCR-confirmed mild COVID-19 were recruited in an outpatient setting at seven medical facilities across Saudi Arabia. Participants were randomized in a 1:1 ratio to receive either favipiravir 1800 mg by mouth twice daily on day 1 followed by 800 mg twice daily (n = 112) or a matching placebo (n = 119) for a total of 5 to 7 days. The primary outcome was the effect of favipiravir on reducing the time to viral clearance (by PCR test) within 15 days of starting the treatment compared to the placebo group. The trial included the following secondary outcomes: symptom resolution, hospitalization, intensive care unit admissions, adverse events, and 28-day mortality. RESULTS: Two hundred thirty-one patients were randomized and began the study (median age, 37 years; interquartile range (IQR): 32-44 years; 155 [67%] male), and 112 (48.5%) were assigned to the treatment group and 119 (51.5%) into the placebo group. The data and safety monitoring board recommended stopping enrolment because of futility at the interim analysis. The median time to viral clearance was 10 days (IQR: 6-12 days) in the favipiravir group and 8 days (IQR: 6-12 days) in the placebo group, with a hazard ratio of 0.87 for the favipiravir group (95% CI 0.571-1.326; p = 0.51). The median time to clinical recovery was 7 days (IQR: 4-11 days) in the favipiravir group and 7 days (IQR: 5-10 days) in the placebo group. There was no difference between the two groups in the secondary outcome of hospital admission. There were no drug-related severe adverse events. CONCLUSION: In this clinical trial, favipiravir therapy in mild COVID-19 patients did not reduce the time to viral clearance within 15 days of starting the treatment.
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Tratamento Farmacológico da COVID-19 , Adulto , Amidas/uso terapêutico , Método Duplo-Cego , Humanos , Masculino , Pirazinas/efeitos adversos , Resultado do TratamentoRESUMO
Background Methicillin-resistant Staphylococcus aureus (MRSA) has become increasingly common in hospitals worldwide. In an era of pandemics, it is important to understand all types of infectious diseases in order to control its outcome and reduce mortality rates related to it. This study aims to identify the epidemiology of MRSA bloodstream infection, risk factors, and mortality in King Abdulaziz Medical City in Riyadh. Methods This is a retrospective chart review study from January 2013 to June 2017. All patients with positive blood culture for MRSA at King Abdulaziz Medical City (KAMC), which is a tertiary care center in Riyadh, Saudi Arabia, were included. Data were extracted from electronic and paper medical records for patients who had a positive blood culture for MRSA. Data collected included demographics, microbiological details, risk factors, and 30-day mortality. Results From 2013 through June 2017, 633 Staphylococcus aureus bacteremia were reported in KAMC, of which 184 (29.1%) were MRSA with a mean age of 60±19 years. Almost all of our isolates were susceptible to vancomycin, linezolid, and tigecycline. The most common infectious syndrome these patients presented with was an endovascular infection which accounts for 30.4% while 19.9% presented as a case of pneumonia. The mortality within 30 days of collection of the positive blood culture was 20.65%. Male gender (OR = 2.33; 95% CI = 1.34-4.05; P-value = 0.003) and patients with history of recent hospital (OR = 2.34; 95% CI = 1.27-4.34; P-value = 0.007) or ICU (OR = 1.66; 95% CI = 1.09-2.52; P-value = 0.018) admissions were more likely to acquire MRSA. Conclusions The incidence of MRSA bacteremia at King Abdulaziz Medical City is high and increasing in conjunction with incidence rate posing a significantly high rate of mortality. Recent history of hospital admission, ICU admission and males were found to be significantly associated with higher rates of MRSA infection. Some modifiable risk factors that could be used to facilitate the reduction of MRSA acquisition rates is to avoid unnecessary hospital and ICU admissions.
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Human coronaviruses (HCoVs) have become evident sources of human respiratory infections with new emerging HCoVs as a significant cause of morbidity and mortality. The common four coronaviruses (229E, HKU1, NL63, and OC43) are known to cause respiratory illness in humans, but their clinical impact is poorly described in the literature. We analyzed the data of all patients who tested positive for at least one of the four HCoVs from October 2015 to January 2020 in a tertiary care center. HCoVs were detected in 1062 specimens, with an incidence rate of 1.01%, out of all documented respiratory illnesses. Detection of these viruses was reported sporadically throughout the years, with a peak of occurrence during winter seasons. OC43 had the highest incidence (53.7%), followed by NL63 (21.9%), HKU1 (12.6%), and 229E (11.8%). Most of these infections were community-acquired, with symptoms of both upper and lower respiratory tract. Co-detection with other viruses were observed, mostly with rhinovirus. 229E was the most frequent (26.4%) HCoV in patients requiring intensive care, while NL63 and 229E were the most common in patients requiring invasive ventilation. The highest 30-day mortality rate was observed in patients infected with 229E (6.4%). HCoVs are common circulating pathogens that have been present for decades, with 229E being the most virulent in this study cohort.
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INTRODUCTION: A novel coronavirus, designated SARS-CoV-2, caused an international outbreak of a respiratory illness, termed COVID-19 in December 2019. There is a lack of specific therapeutic agents based on evidence for this novel coronavirus infection; however, several medications have been evaluated as a potential therapy. Therapy is required to treat symptomatic patients and decrease the virus carriage duration to limit the communitytransmission. METHODS AND ANALYSIS: We hypothesise that patients with mild COVID-19 treated with favipiravir will have a shorter duration of time to virus clearance than the control group. The primary outcome is to evaluate the effect of favipiravir on the timing of the PCR test conversion from positive to negative within 15 days after starting the medicine.Adults (>18 years, men or nonpregnant women, diagnosed with mild COVID-19 within 5 days of disease onset) are being recruited by physicians participating from the Ministry of National Guard Health Affairs and the Ministry of Health ethics committee approved primary healthcare centres. This double-blind, randomised trial comprises three significant parts: screening, treatment and a follow-up period. The treating physician and patients are blinded. Eligible participants are randomised in a 1:1 ratio to either the therapy group (favipiravir) or a control group (placebo) with 1800 mg by mouth two times per day for the first day, followed by 800 mg two times per day for 4-7 days. Serial nasopharyngeal/oropharyngeal swab samples are obtained on day 1 (5 days before therapy). On day5±1 day, 10±1 day, 15±2 days, extra nasopharyngeal/oropharyngeal PCR COVID-19 samples are requested.The primary analysis population for evaluating both the efficacy and safety outcomes will be a modified intention to treat population. Anticipating a 10% dropout rate, we expect to recruit 288 subjects per arm. The results assume that the hazard ratio is constant throughout the study and that the Cox proportional hazard regression is used to analyse the data. ETHICS AND DISSEMINATION: The study was approved by the King Abdullah International Medical Research Centre Institutional Review Board (28 April 2020) and the Ministry of Health Institutional Review Board (1 July 2020). Protocol details and any amendments will be reported to https://clinicaltrials.gov/ct2/show/NCT04464408. The results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: National Clinical Trial Registry (NCT04464408).
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Amidas/uso terapêutico , Tratamento Farmacológico da COVID-19 , Pirazinas/uso terapêutico , Adulto , Feminino , Humanos , Masculino , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do TratamentoRESUMO
INTRODUCTION: Antiviral drugs have shown limited effectiveness in treating patients with coronavirus disease 2019 (COVID-19). We aimed to assess the effects of a favipiravir and hydroxychloroquine combination on treating moderate-to-severe COVID-19 patients. METHODS: An investigator-initiated, multicenter, open-label, randomized trial at nine hospitals. Eligible patients were adults with moderate-to-severe COVID-19 defined as oxygen saturation (SaO2) of ≤ 94% while breathing ambient air or significant clinical symptoms with chest x-ray changes requiring hospital admission. Randomization was in a 1:1 ratio to receive standard care (control group) or standard care plus favipiravir and hydroxychloroquine. The primary outcome was time to clinical improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital within 14 days. Analyses were done in an intention-to-treat population. RESULTS: From May 2020 to Jan 2021, 254 patients were enrolled; 129 were assigned to standard of care and 125 to the treatment. The mean age was 52 (± 13) years, and 103 (41%) were women. At randomization, six patients were on invasive mechanical ventilation, 229 (90.15%) were requiring supplemental oxygen only (with or without non-invasive ventilation), and 19 (7.48%) were receiving neither. The time to clinical improvement was not significantly different between the groups: median of 9 days in the treatment group and 7 days in the control group (HR: 0.845; 95% CI 0.617-1.157; p-value = 0.29). The 28-day mortality was not significantly different between the groups (7.63% treatment) vs. (10.32% control); p-value = 0.45. The most prevalent adverse events were headache, elevation in ALT, and the prolonged QTc interval in the treatment group. CONCLUSION: The combination of favipiravir and hydroxychloroquine did not result in a statistically significant clinical benefit in patients with moderate-to-severe COVID-19. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT04392973).
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While methicillin-resistant Staphylococcus aureus (MRSA) bacteremia has poor outcomes, we describe our experience with Ceftobiprole mainly as a combination therapy for the treatment of MRSA bacteremia. All the cases of MRSA bacteremia in our center at the King Abdulaziz Medical City (KAMC), Riyadh, that had undergone Ceftobiprole treatment were included. We had six cases of MRSA bacteremia between 2018 and 2019, secondary to different infectious syndromes including endocarditis. There was a severe infection that required intensive care unit (ICU) admission in four cases. Ceftobiprole is used in combination with vancomycin in four cases. On day 14, all cases had a favorable outcome with microbiological and clinical improvement. However, three patients died after months of suffering from bacteremia from unrelated causes for the infection. The clinical outcome in our series of treatment of MRSA bacteremia using Ceftobiprole was favorable. Further studies for the evaluation of the use of Ceftobiprole in MRSA bacteremia should be encouraged.
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INTRODUCTION: Preemptive therapy (PET) for cytomegalovirus (CMV) reactivation post allogeneic hematopoietic stem cell transplantation (SCT) was shown to decrease the incidence of CMV disease. However, the optimal PET threshold is elusive. PURPOSE OF THE STUDY: To examine the efficacy of PET initiation at a viral threshold of 1000 copies/mL (1560 IU/mL) in a patient population with high prevalence of CMV seropositive status. PATIENTS AND METHODS: A single center retrospective review of patients that underwent allogeneic SCT was done. RESULTS: A total of 195 allogeneic SCT recipients were included with median follow up of 18.1 (0.7-95.6) months. A total of 178 (91 %) of patients had a positive CMV PCR with median days to initial reactivation post SCT of 17 (1-1187); 129 patients had peak CMV titer < 1000 copies/mL (low titer) whereas the remaining 49 patients had a peak titer ≥ 1000 copies/mL (high titer). 120 (93 %) of patients with low titers cleared spontaneously with median time to clearance of 40 days (4-188). One patient in the high titer group developed CMV disease. At multivariable analysis; age at SCT HR 1.02 (1.004-1.04; 0.017), malignant vs. benign condition HR 9.4 (2.47-61; 0.0005) and cGVHD HR 0.37 (0.2-0.65; 0.0005) were significant for OS. CONCLUSIONS: CMV reactivation post SCT was very common in patients with high prevalence of seropositive status. A PET threshold of 1000 copies/mL (1560 IU/mL) appears desirable as it was associated with spontaneous clearance in over 90 % of patients while minimizing treatment related toxicity. Validation of these observations is warranted.
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Quimioprevenção , Infecções por Citomegalovirus/epidemiologia , Infecções por Citomegalovirus/prevenção & controle , Transplante de Células-Tronco Hematopoéticas , Condicionamento Pré-Transplante/métodos , Adolescente , Adulto , Anemia Aplástica/complicações , Anemia Aplástica/epidemiologia , Anemia Aplástica/terapia , Anemia Aplástica/virologia , Anemia Falciforme/complicações , Anemia Falciforme/epidemiologia , Anemia Falciforme/terapia , Anemia Falciforme/virologia , Antivirais/uso terapêutico , Calibragem , Quimioprevenção/métodos , Quimioprevenção/normas , Citomegalovirus/efeitos dos fármacos , Citomegalovirus/fisiologia , Infecções por Citomegalovirus/complicações , Feminino , Neoplasias Hematológicas/complicações , Neoplasias Hematológicas/epidemiologia , Neoplasias Hematológicas/terapia , Neoplasias Hematológicas/virologia , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Transplante de Células-Tronco Hematopoéticas/mortalidade , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Estudos Retrospectivos , Arábia Saudita/epidemiologia , Estudos Soroepidemiológicos , Condicionamento Pré-Transplante/normas , Transplante Homólogo/efeitos adversos , Carga Viral , Viremia/epidemiologia , Viremia/terapia , Ativação Viral/efeitos dos fármacos , Adulto JovemRESUMO
OBJECTIVES: The selected combination was based on limited evidence clinically and in vitro on the efficacy of the Favipiravir and Hydroxychloroquine in SARS-CoV-2. The two medications were listed in many guidelines as treatment options and ongoing trials assessing their efficacy and safety. Thus, we want to prove the clinical effectiveness of the combination as therapy. TRIAL DESIGN: This is an Open label, multicenter, randomized controlled clinical trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. It is a multicenter trial that will compare Favipiravir plus Hydroxychloroquine combination (experimental arm) to a control arm. PARTICIPANTS: All study procedures will be conducted in eight centres in Saudia Arabia: King Abdulaziz Medical City National Guard Health Affairs in Riyadh. King Abdulaziz Hospital - Al Ahsa, Saudi Arabia AlMadina General Hospital, Madnia, Saudi Arabia Al-Qatif Central Hospital, Saudi Arabia Imam Abdulrahman Al Faisal Hospital, Dammam, Saudi Arabia King Abdulaziz Medical City, Jeddah, Saudi Arabia King Abdulaziz Hospital, Makkah, Saudi Arabia Imam Abdulrahman Alfaisal Hospital, Riyadh, Saudi Arabia Inclusion Criteria ⢠Should be at least 18 years of age, ⢠Male or nonpregnant female, ⢠Diagnosed with COVID-19 by PCR confirmed SARS-coV-2 viral infection. ⢠Able to sign the consent form and agree to clinical samples collection (or their legal surrogates if subjects are or become unable to make informed decisions).. ⢠Moderate or Severe COVID-19, defined as oxygen saturation (Sao2) of 94% or less while they were breathing ambient air or significant clinical symptoms that require hospital admission. ⢠patients had to be enrolled within 10 days of disease onset. Exclusion Criteria ⢠Patients who are pregnant or breastfeeding. ⢠Will be transferred to a non-study site hospital or discharged from hospital within 72 hours. ⢠Known sensitivity/allergy to hydroxychloroquine or Favipiravir ⢠Current use of hydroxychloroquine for another indication ⢠Prior diagnosis of retinopathy ⢠Prior diagnosis of glucose-6-phosphate dehydrogenase (G6PD) deficiency ⢠Major comorbidities increasing the risk of study drug including: i. Hematologic malignancy, ii. Advanced (stage 4-5) chronic kidney disease or dialysis therapy, iii. Known history of ventricular arrhythmias, iv. Current use of drugs that prolong the QT interval, Severe liver damage (Child-Pugh score ≥ C, AST> 5 times the upper limit), HIV. ⢠The investigator believes that participating in the trial is not in the best interests of the patient, or the investigator considers unsuitable for enrollment (such as unpredictable risks or subject compliance issues). ⢠Clinical prognostic non-survival, palliative care, or in deep coma and no have response to supportive treatment within three hours of admission ⢠Patient with irregular rhythm ⢠Patient with a history of heart attack (myocardial infarction) ⢠Patient with a family history of sudden death from heart attack before the age of 50 ⢠Take other drugs that can cause prolonged QT interval ⢠Patient who is receiving immunosuppressive therapy (cyclosporin) which cannot be switched to another agent or adjusted while using the investigational drug ⢠Gout/history of Gout or hyperuricemia (above the ULN), hereditary xanthinuria or xanthine calculi of the urinary tract. INTERVENTION AND COMPARATOR: The treatment intervention would be for a maximum of 10 days from randomization and it would be as follows: Favipiravir for 10 days: Administer 1800 mg (9 tablets) by mouth twice daily for one day, followed by 800mg (4 tablets) twice daily (total days of therapy is 10 days) Hydroxychloroquine for 5 days: (400mg) twice daily on day 1; for days 2-5 (200mg) twice daily. Reference Comparator Therapy: Standard of care is defined as: Treatment that is accepted by medical experts as a proper treatment for Covid-19 disease. Standard care comprised of, as necessary, supplemental oxygen, noninvasive and invasive ventilation, antibiotic agents, vasopressor support, renal-replacement therapy, extracorporeal membrane oxygenation (ECMO), and antiviral therapy except Favipiravir. Also, it may include intravenous fluids and medications for symptoms relief . MAIN OUTCOMES: The primary endpoint is the time to clinical improvement, defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first (14 days from Randomization). RANDOMISATION: Eligible participants will be randomized in a 1:1 ratio to either the combination group (Favipiravir and Hydroxychloroquine) or a control group. The patients will be randomized utilizing Web based data entry System with a stratification based on the centre and the ICU admission. BLINDING (MASKING): This is an Open label study and only the analyst will be blinded during the study conduct. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): Under the classical two arm parallel design the total effective sample sizes needed is 472 subjects (236 subjects per group). TRIAL STATUS: Protocol version 3.1 (dated 11 Aug 2020), and currently recruitment is ongoing. The date recruitment started was May 21, 2020 and the investigators anticipate the trial will finish recruiting by the end of December 2020. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04392973 , 19 May 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
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Amidas/uso terapêutico , Antivirais/uso terapêutico , Betacoronavirus/patogenicidade , Infecções por Coronavirus/tratamento farmacológico , Hidroxicloroquina/uso terapêutico , Pneumonia Viral/tratamento farmacológico , Pirazinas/uso terapêutico , Amidas/efeitos adversos , Antivirais/efeitos adversos , COVID-19 , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/virologia , Quimioterapia Combinada , Feminino , Interações Hospedeiro-Patógeno , Humanos , Hidroxicloroquina/efeitos adversos , Pacientes Internados , Masculino , Estudos Multicêntricos como Assunto , Pandemias , Pneumonia Viral/diagnóstico , Pneumonia Viral/virologia , Pirazinas/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , SARS-CoV-2 , Arábia Saudita , Fatores de Tempo , Resultado do Tratamento , Tratamento Farmacológico da COVID-19RESUMO
Human immunodeficiency virus (HIV) infection usually presents with a wide range of manifestations. Although HIV patients are prone to pulmonary infections by opportunistic pathogens in the late stage of AIDS, manifesting the disease with pulmonary infections caused by Mycobacterium riyadhense (newly identified non-tuberculous mycobacteria) is extremely rare with only one case reported in the literature. We are describing two previously healthy patients who presented with M. riyadhense lung infection and were subsequently found to have HIV, illustrating the need for considering the possibility M. riyadhense lung infection as a presenting illness of HIV.
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Infecções Oportunistas Relacionadas com a AIDS/diagnóstico , Infecções por HIV/complicações , Infecções por Mycobacterium não Tuberculosas/diagnóstico , Mycobacterium/classificação , Mycobacterium/isolamento & purificação , Pneumonia Bacteriana/diagnóstico , Infecções Oportunistas Relacionadas com a AIDS/microbiologia , Infecções Oportunistas Relacionadas com a AIDS/patologia , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infecções por Mycobacterium não Tuberculosas/microbiologia , Infecções por Mycobacterium não Tuberculosas/patologia , Pneumonia Bacteriana/microbiologia , Pneumonia Bacteriana/patologiaRESUMO
INTRODUCTION: Carbapenem-resistant organisms have become major healthcare-associated pathogens and are responsible for significant morbidity and mortality worldwide. CASES AND MANAGEMENTS: This case-series describes our experience with ceftazidime-avibactam in the treatment of six cases with carbapenem-resistant organisms in King Abdulaziz Medical City in Riyadh, Saudi Arabia. After trying various combinations of antibiotic therapies without improvement, cases were treated with ceftazidime-avibactam. OUTCOMES: Five of the six achieved complete cure, both clinically and microbiologically.