Fort Worth, Texas
Determining the Prevalence of Primary and Secondary Central Line Associated Blood Stream Infection (CLABSI) at the Tertiary Care Hospital
Subjects and Methods Study Design: This cross-sectional descriptive study will be conducted on admitted patients in Cardiovascular Unit at the Tertiary Care Hospital in Port Said hospitals. Subjects: From each patient the following data will be collected: full medical history, symptoms and signs, lab investigations including serum electrolytes, procalcitonin, liver and kidney function tests, receipt of antibiotics and its response. Inclusion criteria: - Patients diagnosed with sepsis based on medical history, lab investigations and clinical picture. - Both sex, and all age-groups. Exclusion criteria: - Patients diagnosed with sepsis proved by medical history, lab investigations and clinical picture who received non-beta lactam antibiotics for the past 24 hours. - Samples proved contaminated by microbial flora will be rejected. Methods: Study design This study will be conducted at the tertiary care hospital which offers a medical and surgery ICU and also has a cardiovascular Unit. Epidemiologic and clinical information of patients and classification of the bacteremia as Primary Bloodstream Infections (PBI), and Secondary Bloodstream Infections (SBI), based on CDC criteria (5) and its National Healthcare Safety Network (NHSN) yearly update. Sample collection 1. Venous blood samples from cases with suspected sepsis, or bacteremia will be incubated with a medium which encourages promotes bacterial growth. 2. We will take samples of 2 or more sets of aerobic and anaerobic blood cultures (3or 8 mL per small or large bottle) 3. Two blood cultures drawn from different areas are frequently enough to diagnose bacteremia. Two out of 2 cultures growing identical type of bacteria often represents a real bacteremia, in particular if the organism which grows isn't a frequent contaminant. 4. Bacterial isolates from blood will be analysed by utilizing an automatic blood culture system (Bact/Alert). 5. Positive samples will be cultured on different selective media. Primary organism recognition will be done with matrix assisted laser desorption ionization time of flight MS on a Vitek MS system (BioMerieux, Inc. France). 6. Calibration will be performed using standard strains to validate the run. 7. Minimum Inhibitory Concentration (MIC) outcomes will be interpreted based on the Clinical and Laboratory Standards Institute (CLSI) protocols. 8. Biochemical tests which include CRP of Procalcitonin is most of time increased among cases with BSI. Sample size: Number of Samples is calculated according to the next equation: N= (Z α\2)²×P(1-P)\d² (Daniel, 2009) In which; N= the required sample size (Z α\2) = A normal deviation reflect the type 1 error = 1.96 P = the prevalence of atypical bacteria in sputum samples = (46%) (13). D = the accuracy of estimate (how close to the true population) = 0.1 Thus; N= 60 blood samples. Data Management and Statistical Analysis The results of the collected data will entered into SPSS-19 program for statistical analysis. Descriptive data will be managed based on its type; mean, SD and range will summarize continuous data. While qualitative data will be summarized by frequencies. With regard to analytic data, chi square test will be utilized to determine the difference between qualitative data, while T test and ANOVA will be utilized to determine the difference between quantitative data. Ethical considerations - The samples will be collected from patients after taking written informed consent. - The study will be conducted after taking the permission from chairman of each department. - The results of the patient will be confidential. - The patient will be informed of the results and will be treated accordingly. - The patient has the right to leave the study without compromising the patient's treatment or the patient's relationship with the care provider.
Phase
N/ASpan
49 weeksSponsor
Port Said UniversityPort Said
Recruiting
Predictors of COVID-19 Infection and Disease Progression
The COVID-19 pandemic put tremendous pressures on the public health system and the health workers in almost every country around the world. Egypt was no exception, one of the main challenges faced is the limited number of CPR centers, equipment and kits which consequently affecting the number of tests that could be performed. Although testing is critical, clinical judgement is the first mean to evaluate patients for COVID-19. Ancillary Diagnostic Tests and Chest imaging are also important tools before proceeding to the PCR testing. However, important gaps remain in screening asymptomatic persons in the incubation phase, as well as in the accurate determination of live viral shedding during convalescence to inform decisions to end isolation. The main objectives of the study: To set an evidence-based protocol with some criteria and procedures to reach - as accurate as possible - diagnosis without compromising the limited available resources. Such protocol shall make full use of the three main traditional pillars: Clinical picture, Ancillary Diagnostic Tests and Chest imaging before proceeding to the PCR testing: 1. Clinical Picture: Symptomatic COVID-19 presents with a recognizable clinical syndrome that is predictable prior to testing. Clinical judgement remains important, particularly when interpreting negative test results; 2. Biomarkers Associated with COVID-19 Patients: The most common laboratory features reported in patients with COVID-19 include: • Decreased albumin; • Elevated C-reactive protein ; • Elevated lactate dehydrogenase levels ; and • Lymphopenia . 3. Other biomarkers that have been reported include increased erythrocyte sedimentation rates; elevated aspartate aminotransferase, alanine aminotransferase, and creatine kinase levels, leukopenia, leukocytosis, increased bilirubin and creatinine levels. No biomarker or combination of biomarkers currently exists that is sensitive or specific enough to establish a diagnosis of COVID-19, or to pragmatically predict its clinical course. 4. Radiographic Tests: Many centers have evaluated the utility of chest imaging for diagnosis: • On chest radiography, bilateral pneumonia is the most frequently reported feature (range,11.8% to 100%) and is more common than a unilateral focus; • Computed tomography is regarded as more sensitive than radiography, with several cohort studies reporting that most patients (77.8% to 100%) had ground glass opacities. Other features commonly reported with COVID-19 on chest computed tomography include a peripheral distribution, fine reticular opacities, and vascular thickening. Compared with serial nasopharyngeal sampling, chest computed tomography may be more sensitive than an RT-PCR test at a single time point for the diagnosis of COVID-19. In addition, artificial intelligence may help distinguish COVID-19 from other etiologic agents of community-acquired pneumonia. However, these findings are not completely specific to COVID-19 and do not exclude a co-infection or an alternative diagnosis. CPR: Who Should Be Tested? The current situation exemplifies the challenge of how to best utilize testing during outbreaks of novel pathogens. The initial testing criteria were too narrow to monitor and control the spread of the disease, but the sudden pivot to a far broader testing approach, even as capacity remains limited, may be an overcorrection. As of March 4, CDC discontinued specific guidance and recommends that "clinicians should use their judgment to determine if a patient has signs and symptoms compatible with COVID-19 and whether the patient should be tested," advising that "decisions on which patients receive testing should be based on the local epidemiology of COVID-19, as well as the clinical course of illness." High priorities for testing include patients with serious, unexplained respiratory illness and contacts of known cases, Methods: It is a comparative study between tests to diagnose COVID-19. In developed countries (in which Egypt is one of them) PCR is high cost. Though much of cases escape Diagnosis and clinician depend on clinical picture only. This study would allow to find what degree of dependence on other tests. In this study, 100 cases positive COVID-19 by PCR will be analyzed and tested for other ancillary tests and CT chest to compare them and find out which is the most sensitive in both moderate and severe clinical condition.
Phase
N/ASpan
27 weeksSponsor
Port Said UniversityPort Said
Recruiting
Healthy Volunteers
Adding Prednisolone During Ovulation Induction With CC in Lean Women With CC Resistant PCOS
Women will be randomly divided into two groups; CC-Prednisolone group and CC-placebo group. Women in the CC-Prednisolone group will receive CC (150 mg/day for 5 consecutive days from day 2 of the cycle) and prednisolone tablet (5 mg/day for 10 consecutive days from day 2 of the cycle). Women in the CC-placebo group will receive CC alone (150 mg/day for 5 consecutive days from day 2 of the cycle) and folic acid tablet (0.5 mg/day for 10 consecutive days from day 2 of the cycle). Transvaginal sonography (TVS) scan will be performed regularly for monitoring of follicular growth (folliculometry); starting from day 10 of the stimulation cycle and repeated every 2-3 days. When there will be at least one follicle ≥ 18 mm in diameter, final oocyte maturation will be induced by intramuscular administration of 10000 IU of human chorionic gonadotropin (HCG) and timed intercourse will be advised. If there will be no follicle ≥ 12 mm by day 16 of the cycle, monitoring of follicular growth will be discontinued and the cycle will be presumed to be anovulatory. Ovulation will be documented by TVS scan one week after triggering of oocyte maturation and will be confirmed by assessing the mid-luteal serum progesterone level. Each woman will be subjected to ovarian stimulation for a maximum of 3 consecutive cycles except if she gets pregnant in the first or second cycle
Phase
4Span
209 weeksSponsor
Mahmoud ThabetPort Said
Recruiting
Vaginal Progesterone Versus Cervical Cerclage for Pregnant Women With Short Cervix and History of PTL and/or MTM
Women with singleton pregnancy and history of preterm labor and/or midtrimester miscarriage in a previous pregnancy will be selected for serial assessment of the cervical length by transvaginal sonography (TVS) starting from 16 weeks till 24 weeks of gestation. Eligible participants in our study will be those who have cervical length of 15-25 mm at 16-24 weeks of gestation. At 16-24 weeks gestational age, all women participating in the study will be randomly allocated into two groups; progesterone group and cerclage group. For women in the progesterone group, vaginal progesterone suppositories will be given in a dose of 400 mg/day. For women in the cerclage group, McDonald cervical cerclage will be performed.
Phase
4Span
418 weeksSponsor
Mohamed Sayed AbdelhafezPort Said
Recruiting
Effect of Myomectomy for Intramural Myoma on Fertility Outcomes in Infertile Women
All women participating in the study will be randomly allocated into two groups; myomectomy group and conservative management group. Women in the myomectomy group will be subjected to laparotomy to remove the myomas while women in the conservative management group will not be subjected to surgery. Women in the myomectomy group will be asked to abstain from having sexual intercourse (or use a barrier contraception method) for 3 months after surgery then to start having regular fertility-oriented intercourse after that. Women in the conservative management group will be asked to immediately start having regular fertility-oriented intercourse. Women in both groups will be monitored form the time of starting regular intercourse and for one year for occurrence of clinical pregnancy.
Phase
N/ASpan
214 weeksSponsor
Mansoura UniversityPort Said
Recruiting