1. Fluconazole Prophylaxis for the Prevention of Candidiasis in Premature Infants: A Meta-analysis Using Patient-level Data
- Author
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Jessica E. Ericson, Paresh Pandit, Natalie Neu, Michael J. Smith, Agnes Perenyi, Margarita Bidegain, Anand Kantak, Catherine M. Bendel, Robert L. Schelonka, Mark L. Hudak, Brenda B. Poindexter, Stephen D. Kicklighter, Shahnaz Duara, Dan L. Stewart, Antonio Arrieta, Karen E. Shattuck, Jamie Gao, David Burchfield, Roger Kim, Scott Macgilvray, Michael Cohen-Wolkowiez, Mohan Pammi, Edmund V. Capparelli, Rune Toms, Jatinder Bhatia, Katherine Y. Berezny, Jonathan Nedrelow, Traci Clemons, Barry R. Bloom, Phillip Gordon, David A. Siegel, Ravinder Anand, Gregory L. Kearns, Kelly C. Wade, Gratias Mundakel, Matthew M. Laughon, Pablo J. Sánchez, Echezona E. Ezeanolue, David A. Kaufman, Perdita Taylor-Zapata, Seetha Shankaran, Zhaoxia Ren, Ramasubbareddy Dhanireddy, John N. van den Anker, Kathleen A. Kennedy, Ashley Ross, Robert D. White, Ian M. Paul, Daniel K. Benjamin, Anne Zajicek, Alice Pagan, Kristi Prather, Daniela Testoni, Ekaterini Tsilou, Neil Finer, P. Brian Smith, and Gina A. Simone
- Subjects
Male ,Microbiology (medical) ,medicine.medical_specialty ,Antifungal Agents ,Placebo ,Infant, Newborn, Diseases ,03 medical and health sciences ,0302 clinical medicine ,030225 pediatrics ,Internal medicine ,medicine ,Humans ,Candidiasis, Invasive ,030212 general & internal medicine ,Antibiotic prophylaxis ,Adverse effect ,Fluconazole ,Articles and Commentaries ,Randomized Controlled Trials as Topic ,business.industry ,Incidence (epidemiology) ,Infant, Newborn ,Odds ratio ,Antibiotic Prophylaxis ,United States ,Confidence interval ,Low birth weight ,Infectious Diseases ,Female ,medicine.symptom ,business ,Infant, Premature ,medicine.drug - Abstract
Background Invasive candidiasis (IC) is an important cause of sepsis in premature infants and is associated with a high risk of death and neurodevelopmental impairment. Prevention of IC has become a major focus in very low birth weight infants, with fluconazole increasingly used as prophylaxis. Methods We identified all randomized, placebo-controlled trials evaluating fluconazole prophylaxis in premature infants conducted in the United States. We obtained patient-level data from the study investigators and performed an aggregated analysis. The occurrence of each endpoint in infants who received prophylaxis with fluconazole vs placebo was compared. Endpoints evaluated were IC or death, IC, death, Candida colonization, and fluconazole resistance among tested isolates. Safety endpoints evaluated included clinical and laboratory parameters. Results Fluconazole prophylaxis reduced the odds of IC or death, IC, and Candida colonization during the drug exposure period compared with infants given placebo: odds ratios of 0.48 (95% confidence interval [CI], .30-.78), 0.20 (95% CI, .08-.51), and 0.28 (95% CI, .18-.41), respectively. The incidence of clinical and laboratory adverse events was similar for infants who received fluconazole compared with placebo. There was no statistically significant difference in the proportion of tested isolates that were resistant to fluconazole between the fluconazole and placebo groups. Conclusions Fluconazole prophylaxis is effective and safe in reducing IC and Candida colonization in premature infants, and has no impact on resistance.
- Published
- 2016
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