IntroductionZika virus (ZIKV) infection during pregnancy is a known cause of microcephaly and other congenital and developmental anomalies. In the absence of a ZIKV vaccine or prophylactics, principal investigators (PIs) and international leaders in ZIKV research have formed the ZIKV Individual Participant Data (IPD) Consortium to identify, collect and synthesise IPD from longitudinal studies of pregnant women that measure ZIKV infection during pregnancy and fetal, infant or child outcomes.Methods and analysisWe will identify eligible studies through the ZIKV IPD Consortium membership and a systematic review and invite study PIs to participate in the IPD meta-analysis (IPD-MA). We will use the combined dataset to estimate the relative and absolute risk of congenital Zika syndrome (CZS), including microcephaly and late symptomatic congenital infections; identify and explore sources of heterogeneity in those estimates and develop and validate a risk prediction model to identify the pregnancies at the highest risk of CZS or adverse developmental outcomes. The variable accuracy of diagnostic assays and differences in exposure and outcome definitions means that included studies will have a higher level of systematic variability, a component of measurement error, than an IPD-MA of studies of an established pathogen. We will use expert testimony, existing internal and external diagnostic accuracy validation studies and laboratory external quality assessments to inform the distribution of measurement error in our models. We will apply both Bayesian and frequentist methods to directly account for these and other sources of uncertainty.Ethics and disseminationThe IPD-MA was deemed exempt from ethical review. We will convene a group of patient advocates to evaluate the ethical implications and utility of the risk stratification tool. Findings from these analyses will be shared via national and international conferences and through publication in open access, peer-reviewed journals.Trial registration numberPROSPERO International prospective register of systematic reviews (CRD42017068915).
Objective. Because there are few studies on the clinical implications of colonization by carbapenem-resistant gram-negative bacteria (CRB) this was analyzed in rectal smears (RS) and pharyngeals (PS) and its ability to predict infection/colonization. Methodology. A cross-sectional, retrospective study from adult inpatients between January 2016 and December 2019 was conducted. The isolates were characterized by MicroScan and spectrometry of masses applying EUCAST 2018 cutoff points. The detection of carbapenemases was performed by PCR and Sanger sequencing; sequencies was assigned by MLST. The genetic relationship between the clinical isolates was made by pulsed field electrophoresis using the enzymes Xbal, Spel or Apal. Results. A total of 308 (86.03%) RS and 50 (13.97%) positive PS were detected, the RS had a 85% sensibility, 100% specificity, 100% positive predictive value and 97% negative predictive value. In RS, the following were isolated: 44% (n=135) Acinetobacter baumannii, 26% (n =80) Enterobacterales (20 KPC, 29 OXA-48, 22 VIM, 2 IMP, 7 NDM), 17% (n=53) Pseudomonas aeruginosa and 13% (n=40) Stenotrophomonas maltophilia. In the PS were isolated 44% (n=22) S. maltophilia, 40% (n = 20) A. baumannii, 8% (n=4) P. aeruginosa and 8% (n=4) Enterobacterales (3 VIM, 1 OXA). From the patients with simultaneous RS and PS, 41 (40.6%) had positivity in both smears, 45 (44.6%) only in RS and 15 (14.9%) only in PS. Colonization preceded infection in 81.3% (n=13) of the isolates; association between infection and colonization was found (p<0.001; χ2); and the episodes where the information was found all the isolates from the clinical samples and from the smears were similar. Conclusions. The probability of predicting infection through the CRB colonized in different clinical samples is feasible. The RS has a major sensibility to detect colonization.
Introduction: Carbapenemase-producing Enterobacterales (CPE) have emerged as a substantial cause of morbi-mortality worldwide, with a prevalence of approximately 5% in areas with high endemicity. However, available data may not be representative of developing countries, such as Ecuador. In this study, the incidence of CPE in Ecuador and risk factors for infection/colonisation were evaluated.
Methodology: A prospective cohort study was performed from February to April 2016 in seven intensive-care units of Guayaquil, Ecuador. Samples were processed according to the Centers for Disease Control and Prevention laboratory protocol and the CHROMagar mSuper CARBA agar method. Resistance to carbapenems was defined according to Clinical and Laboratory Standards Institute breakpoints. A modified carbapenemase inactivation method was used to identify carbapenamase production phenotypically with molecular confirmation by multiplex polymerase chain reaction.
Results: In total, 640 patients were enrolled. The incidence of CPE was 36.4% (N = 233). A multivariate analysis indicated that several factors were associated with CPE acquisition, included a long intensive care unit stay (OR 1.05; 95% CI 1.03–1.08; p < 0.01), tracheostomy (OR 3.52; 95% CI 1.90–6.75; p < 0.01), hospitalisation 3 months prior to admission (OR 2.07; 95% CI 1.17–3.71; p < 0.01), vancomycin use (OR 3.31; 95% CI 2.02–5.18; p < 0.01), and macrolide use (OR 3.31; 95% CI 1.43–7.76; p < 0.01).
Conclusions: Macrolide use was a risk factor for CPE acquisition. This association should be evaluated further, especially in developing countries.
Background
In low‐ and middle‐income countries, the use of colistin in therapeutic regimens is common, to treat infections produced for Carbapenemase‐producing
Enterobacterales
(CPE) due to limited access to the recently discovered‐approved antibiotics. Furthermore, the technical limitations to perform colistin susceptibility tests make it difficult to assess the suitability of this treatment for each patient, as well as to monitor the rates of resistance. In the present study, we describe the use of agar dilution using a unique colistin concentration of 3 μg/ml to discriminate isolates with colistin resistance in CPE obtained from clinical samples.
Methods
Clinical Laboratory Standards Institute (CLSI) colistin broth microdilution method and dilution agar with a colistin concentration of 3 μg/ml were performed in 168 isolates of CPE obtained from clinical samples in Guayaquil, Ecuador. Broth microdilution was considered our gold standard using CLSI breakpoints as reference (≤2 μg/ml intermediate and ≥4 μg/ml resistant). Categorical agreement was defined as obtaining a reading within the same category with both methodologies.
Results
Isolates obtained from respiratory samples were the most prevalent (26.19%;
n
= 44).
Klebsiella pneumoniae
was the predominant specie (94.04%;
n
= 158). KPC‐like carbapenemase was present in all the isolates, and interestingly, colistin resistance was not mediated by MCR‐1 production. Categorical agreement between both methods resulted in 97.02%.
Conclusion
We propose the use of dilution agar with a colistin concentration of 3 μg/ml, as a valid method for screening colistin resistance in low‐ and middle‐income countries to monitor resistance and to perform epidemiological studies.
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