Performance of a Quantitative PCR-Based Assay and Beta-d-Glucan Detection for Diagnosis of Invasive Candidiasis in Very-Low-Birth-Weight Preterm Neonatal Patients (CANDINEO Study)
| Autor: | Jon López de Heredia, Carmen Rosa Pallás-Alonso, Manuel Cuenca-Estrella, Candelaria Santana Reyes, Alfredo Perez Rivilla, Sonia Villar, Elena Bergon-Sendin, María Isolina Campos-Herrero, Paloma Anguita Alonso, María Cruz López Herrera, Mariano Andreu, Emilio Bouza, José Tomás Ramos, Caridad Tapia Collados |
|---|---|
| Přispěvatelé: | Astellas Pharma |
| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Male Pathology Antifungal Agents beta-Glucans polymerase chain reaction Gastroenterology Echinocandins 0302 clinical medicine serum beta-d-glucan Amphotericin B Epidemiology Infant Very Low Birth Weight 030212 general & internal medicine Fluconazole Candida invasive candidiasis Polymerase chain reaction Invasive candidiasis Real-time polymerase chain reaction PCR Drug Therapy Combination Female Proteoglycans medicine.symptom Infant Premature medicine.drug Serum beta-d-glucan Microbiology (medical) medicine.medical_specialty 030106 microbiology Mycology Real-Time Polymerase Chain Reaction Sensitivity and Specificity Sepsis 03 medical and health sciences Lipopeptides Internal medicine medicine Humans Candidiasis Invasive business.industry Case-control study Infant Newborn Infant medicine.disease Confidence interval Low birth weight Case-Control Studies Micafungin business Biomarkers |
| Zdroj: | Journal of Clinical Microbiology Repisalud Instituto de Salud Carlos III (ISCIII) Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid Consejería de Sanidad de la Comunidad de Madrid |
| ISSN: | 1098-660X |
| Popis: | An epidemiological, multicenter, noninterventional, observational case-control study was conducted to describe the performance of serum beta-d-glucan (BDG) and Candida PCR in blood, serum, and sterile samples for the diagnosis of invasive candidiasis (IC) in very-low-birth-weight (VLBW) preterm neonates and to compare these techniques with culture of samples from blood and other sterile sites. Seventeen centers participated in the study, and the number of episodes analyzed was 159. A total of 9 episodes of IC from 9 patients (7 confirmed and 2 probable) and 150 episodes of suspected sepsis from 117 controls were identified. The prevalence of IC was 5.7% (95% confidence interval [95% CI], 2.1 to 9.3). The mortality was significantly higher in episodes of IC (44.4%) than in the non-IC episodes (11.1%, P < 0.01). The sensitivity and specificity of the PCR performed on blood/serum samples were 87.5% and 81.6%, respectively. The sensitivity and specificity of the BDG results were lower (75.0% and 64.6%). For cases with negative culture results, the PCR and the BDG results were positive in 27 (17.4%) and 52 (33.5%) episodes, respectively. The presence of multiorgan failure, improvement with empirical antifungal therapy, thrombocytopenia, and Candida colonization were significantly associated (P < 0.01) with PCR or BDG positivity regardless of the results of the cultures. Serum BDG analysis and Candida PCR could be used as complementary diagnostic techniques to detect IC in VLBW neonates. This study was initiated and financially supported by Astellas Pharma Inc. Manuel Cuenca-Estrella has received grant support from Astellas Pharma Inc., bioMérieux, Basilea, Gilead Sciences, Merck Sharp & Dohme, Pfizer, Schering Plough, Soria Melguizo SA, Ferrer International, the European Union, the ALBAN program, the Spanish Agency for International Cooperation, the Spanish Ministry of Culture and Education, the Spanish Health Research Fund, Instituto de Salud Carlos III (Spanish Ministry of Economy and Competitiveness), the Ramon Areces Foundation, and the Mutua Madrileña Foundation. Jose T. Ramos has received fees for conferences from Gilead Sciences, ViiV Healthcare, and Janssen-Cilag and grant support from the Gilead Fellowship Program. Elena Bergon-Sendin received grant support from Astellas Pharma Inc. during the conduct of the study. Paloma Anguita Alonso is an employee of Astellas Pharma Inc. The rest of us have no conflicts to report. Medical writing support was provided by Lucy Kanan on behalf of Bioscript Medical Ltd., funded by Astellas Pharma Inc Sí |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|