Research Topics
| Jack D SobelSummaryAffiliation: Wayne State University Country: USA Publications
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Publications
Recurrent group A streptococcal vulvovaginitis in adult women: family epidemiologyJack D Sobel
Division of Infectious Diseases, Wayne State University School of Medicine, Detroit, MI, USA
Clin Infect Dis 44:e43-5. 2007..These cases reiterate the necessity for adequate screening of the patient's family and contacts in cases of recurrent GAS infection by culturing all potential areas of GAS carriage...- Vulvovaginal candidosisJack D Sobel
Department of Medicine, Wayne State University School of Medicine, Detroit, MI, USA
Lancet 369:1961-71. 2007..I review the epidemiology and pathogenesis of this infection, and also discuss management strategies... - Boric acid addition to suppressive antimicrobial therapy for recurrent bacterial vaginosisOrna Reichman
Division of Infectious Disease, Department of Medicine, Wayne State University School of Medicine, Detroit, Michigan, USA
Sex Transm Dis 36:732-4. 2009..Accordingly, topical boric acid (BA) aimed at biofilm removal was added to nitroimidazole induction and maintenance therapy creating a triple phase regimen to reduce symptomatic recurrence of BV in high-risk patients... - Effect of pH on In Vitro Susceptibility of Candida glabrata and Candida albicans to 11 Antifungal Agents and Implications for Clinical UseClaire S Danby
Address correspondence to J D Sobel
Antimicrob Agents Chemother 56:1403-6. 2012..In selecting agents for treatment of recurrent C. glabrata vaginitis, clinicians should recognize the limitations of in vitro susceptibility testing utilizing pH 7.0... - Maintenance fluconazole therapy for recurrent vulvovaginal candidiasisJack D Sobel
Division of Infectious Diseases, Wayne State University School of Medicine, Detroit, USA
N Engl J Med 351:876-83. 2004..No safe and convenient regimen has proved to be effective for the management of recurrent vulvovaginal candidiasis... - Caspofungin in the treatment of symptomatic candiduriaJack D Sobel
Department of Medicine, Wayne State University School of Medicine, Detroit, MI, USA
Clin Infect Dis 44:e46-9. 2007..Because the urine concentrations achieved by echinocandin antifungal agents are low, drugs from this class are excluded from consideration when candiduria treatment is selected... - Prognosis and treatment of desquamative inflammatory vaginitisJack D Sobel
Division of Infectious Diseases, Department of Medicine, Wayne State University School of Medicine, Detroit, Michigan, USA
Obstet Gynecol 117:850-5. 2011..We describe patient outcomes and treatment at follow-up in a case series of 98 women diagnosed with this syndrome... - What's new in bacterial vaginosis and trichomoniasis?Jack D Sobel
Harper University Hospital, Division of Infectious Diseases, 3990 John R 5 Hudson, Detroit, MI 48201, USA
Infect Dis Clin North Am 19:387-406. 2005..New diagnostic tests may soon be available that will allow women to test self-obtained specimens. Treatment of BV has lagged, although innovative methods appear to be helpful in managing recurrent diseases... - Candida urinary tract infections--epidemiologyJack D Sobel
Division of Infectious Diseases, Wayne State University School of Medicine, Detroit, Michigan, USA
Clin Infect Dis 52:S433-6. 2011..In ICU patients, although candiduria is a marker for increased mortality, it is only rarely attributable to Candida urinary tract infection... - A randomized study of the use of fluconazole in continuous versus episodic therapy in patients with advanced HIV infection and a history of oropharyngeal candidiasis: AIDS Clinical Trials Group Study 323/Mycoses Study Group Study 40Mitchell Goldman
Indiana University School of Medicine, Division of Infectious Diseases, Wishard Memorial Hospital, Indianapolis, IN 46202, USA
Clin Infect Dis 41:1473-80. 2005..However, concerns exist with regard to the use of fluconazole prophylaxis and the risk of development of fluconazole treatment-refractory infections... - Fungicidal activity of fluconazole against Candida albicans in a synthetic vagina-simulative mediumMahomed-Yunus S Moosa
Division of Infectious Diseases, Department of Internal Medicine, Wayne State University School of Medicine, Detroit, Michigan 48201, USA
Antimicrob Agents Chemother 48:161-7. 2004..Elucidating the mechanism by which FLZ and acetate interact may disclose vulnerable pathways that could be exploited in drug development... - Reduced fluconazole susceptibility of Candida albicans isolates in women with recurrent vulvovaginal candidiasis: effects of long-term fluconazole therapyZainab Shahid
Detroit Medical Center, Wayne State University, MI, USA
Diagn Microbiol Infect Dis 64:354-6. 2009..Accordingly, in patients with refractory vaginitis or breakthrough infections due to Candida albicans, in vitro susceptibility testing is essential to optimally manage vaginitis... - Longitudinal study of mucosal Candida species colonization and candidiasis among human immunodeficiency virus (HIV)-seropositive and at-risk HIV-seronegative womenSuzanne E Ohmit
Wayne State University School of Medicine, Detroit, Michigan, USA
J Infect Dis 188:118-27. 2003..In HIV-seropositive women, mucosal candidiasis is the consequence of multiple interacting factors... - Use of terbinafine in rare and refractory mycosesSanjay G Revankar
Wayne State University, Division of Infectious Diseases, Harper University Hospital, 3990 John R St, 5 Hudson Detroit, MI 48201, USA
Future Microbiol 3:9-17. 2008..We review the current literature with regard to in vitro data and clinical experience with terbinafine in the treatment of rare and refractory mycoses... - Clinical practice guidelines for the management of candidiasis: 2009 update by the Infectious Diseases Society of AmericaPeter G Pappas
Department of Medicine, Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, Alabama 35294 0006, USA
Clin Infect Dis 48:503-35. 2009..This new information is incorporated into this revised document... - Suppressive antibacterial therapy with 0.75% metronidazole vaginal gel to prevent recurrent bacterial vaginosisJack D Sobel
Department of Medicine, Wayne State University School of Medicine, Detroit, MI, USA
Am J Obstet Gynecol 194:1283-9. 2006..02). CONCLUSION: Suppressive therapy with twice-weekly metronidazole gel achieves a significant reduction in the recurrence rate of bacterial vaginosis; however, secondary vaginal candidiasis is common... - Treatment of vaginal Candida infectionsJack D Sobel
Division of Infectious Diseases, Wayne State University School of Medicine, Detroit, MI, USA
Expert Opin Pharmacother 3:1059-65. 2002..In spite of the wide array of antifungal agents currently available, considerable limitations in available therapy exist in the effective management of complicated vaginitis... - Candida urinary tract infections--diagnosisCarol A Kauffman
Division of Infectious Diseases, Department of Internal Medicine, University of Michigan, Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, Michigan, USA
Clin Infect Dis 52:S452-6. 2011.... - A case of high-level metronidazole-resistant trichomoniasis in pregnancy successfully treatedChithra Subramanian
Division of Infectious Diseases, Wayne State University, Detroit, MI, USA
J Low Genit Tract Dis 15:248-9. 2011..We report a case of metronidazole-resistant trichomoniasis in pregnancy, successfully treated with a high dose of tinidazole... - Mucosal candidiasisJose A Vazquez
Division of Infectious Diseases, School of Medicine, Wayne State University, 3990 John R, 4 Brush Center, Detroit, MI 48201, USA
Infect Dis Clin North Am 16:793-820, v. 2002..Such issues as pathogenesis and host defenses, clinical manifestations, diagnosis, and treatment are discussed... - Anidulafungin: a novel echinocandinJose A Vazquez
Division of Infectious Diseases, Henry Ford Hospital, Wayne State University School of Medicine, Detroit, Michigan 48202, USA
Clin Infect Dis 43:215-22. 2006..To date, anidulafungin appears to have an excellent safety profile. On the basis of early clinical experience, it appears that anidulafungin will be a valuable asset in the management of serious and difficult-to-treat fungal infections... - Management of patients with recurrent vulvovaginal candidiasisJack D Sobel
Division of Infectious Diseases, Department of Internal Medicine, Wayne State University School of Medicine, Detroit, Michigan, USA
Drugs 63:1059-66. 2003..Maintenance suppressive azole antifungal regimens are highly effective in controlling symptoms, although cure is less common. Further advances in achieving higher cure rates await the availability of non-azole fungicidal agents... - Improvement of a clinical prediction rule for clinical trials on prophylaxis for invasive candidiasis in the intensive care unitLuis Ostrosky-Zeichner
Division of Infectious Diseases, University of Texas Medical School at Houston, Houston, TX 77030, USA
Mycoses 54:46-51. 2011..Modification of our original rule resulted in a more inclusive rule for studies... - Tinidazole for the treatment of vaginal infectionsMichael D Nailor
Detroit Receiving Hospital, Department of Pharmacy, Detroit, MI, USA
Expert Opin Investig Drugs 16:743-51. 2007..Although uncommon, high-level trichomonal metronidazole resistance can be reliably cured by using tinidazole, which is an invaluable advantage... - Use of the VS-sense swab in diagnosing vulvovaginitisJack D Sobel
Department of Internal Medicine, Wayne State University, Detroit, Michigan, USA
J Womens Health (Larchmt) 18:1467-70. 2009..The purpose of this study was to determine the performance characteristics of the VS-Sense (pH test) swab (Common Sense, Ltd., Caesarea, Israel) in augmenting the diagnosis of vaginitis... - Fluconazole for the treatment of candidiasis: 15 years experienceRaymond Cha
Eugene Applebaum College of Pharmacy and Health Sciences, School of Medicine, AntiInfective Research Laboratory, Wayne State University, Detroit, Michigan 48201, USA
Expert Rev Anti Infect Ther 2:357-66. 2004..This review will examine the contributions and limitations of fluconazole in the treatment of superficial and invasive candidiasis syndromes... - Treatment of vaginitis caused by Candida glabrata: use of topical boric acid and flucytosineJack D Sobel
Division of Infectious Diseases, Wayne State University School of Medicine, Harper Hospital, 3990 John R, Detroit, MI 48201, USA
Am J Obstet Gynecol 189:1297-300. 2003..The purpose of this study was to review the treatment outcome and safety of topical therapy with boric acid and flucytosine in women with Candida glabrata vaginitis... - Tinidazole for bacterial vaginosisMichael D Nailor
Wayne State University School of Medicine, Detroit Receiving Hospital, Department of Pharmacy, Detroit, MI 48201, USA
Expert Rev Anti Infect Ther 5:343-8. 2007..These studies should establish the role of tinidazole in the treatment of BV; however, cure rates are unlikely to be significantly different... - Effect of antibiotics on vulvovaginal candidiasis: a MetroNet studyJinping Xu
Department of Family Medicine and Public Health Sciences, Division of Practice Based Research, Wayne State University School of Medicine, Detroit, Michigan, USA
J Am Board Fam Med 21:261-8. 2008..Vulvovaginal candidiasis (VVC) is believed common after systemic antibiotic therapy, yet few studies demonstrate this association. In this pilot study, we evaluate the effect of short-course oral antibiotic use on VVC... - High-throughput identification and quantification of Candida species using high resolution derivative melt analysis of panfungal ampliconsTasneem Mandviwala
Department of Biochemistry and Molecular Biology, Wayne State University School of Medicine, Detroit, Michigan, USA
J Mol Diagn 12:91-101. 2010..This tool can potentially detect, count, and identify fungi in hundreds of samples per day without further manipulation, costs, or delays, offering a major step forward in fungal molecular diagnostics... - Design of clinical trials of empiric antifungal therapy in patients with persistent febrile neutropenia: considerations and critiquesJack D Sobel
Wayne State University School of Medicine, and the Division of Infectious Disease, Detroit Medical Center, Detroit, Michigan, USA
Pharmacotherapy 26:47S-54S. 2006.... - Guidelines for treatment of candidiasisPeter G Pappas
Division of Infectious Diseases, University of Alabama at Birmingham, Alabama 35294-0006, USA
Clin Infect Dis 38:161-89. 2004 - Vulvovaginal trichosporonosisPaul Makela
Department of Obstetrics and Gynecology, Wayne State University School of Medicine, Detroit, MI, USA
Infect Dis Obstet Gynecol 11:131-3. 2003..Isolation of Trichosporon species from vaginal secretions is a rare event, and no data are available on its pathogenic role. A case series is presented to determine the pathogenic role of Trichosporon species in vulvovaginal infections... - Selecting antifungal agents for the treatment of invasive fungal infections in patients with renal failureVarsha V Moudgal
Division of Infectious Diseases, Harper Hospital, 3990 John R, 4 Brush Center, Detroit, MI 48201, USA
Curr Opin Investig Drugs 5:873-8. 2004..This review will focus on the currently available data on this subject, providing guidelines for the use of antifungals in patients with renal failure... - Antibiotics for gram-positive bacterial infections: vancomycin, teicoplanin, quinupristin/dalfopristin, oxazolidinones, daptomycin, dalbavancin, and telavancinMichael D Nailor
Department of Internal Medicine, Wayne State University, Detroit, MI 48201, USA
Infect Dis Clin North Am 23:965-82, ix. 2009..Newer antimicrobial agents that have activity against vancomycin-resistant organisms are now available and play a critical role in the treatment of life-threatening infections... - Shuttle vectors for Candida albicans: control of plasmid copy number and elevated expression of cloned genesWenjin Du
Department of Biochemistry and Molecular Biology, Wayne State University School of Medicine, Detroit, MI 48201, USA
Curr Genet 45:390-8. 2004..These shuttle vectors should facilitate global genomics approaches in C. albicans that have been hampered by its diploid genome... - Genital malodor in women: a modern reappraisalChithra Subramanian
Division of Infectious Diseases, Detroit Medical Center, Detroit, MI, USA
J Low Genit Tract Dis 16:49-55. 2012..We also provide an algorithm for the management of this symptom beyond vaginal infections... - Vaginitis due to Candida krusei: epidemiology, clinical aspects, and therapyShivani Singh
Division of Infectious Diseases, Wayne State University School of Medicine, Detroit, MI 48201, USA
Clin Infect Dis 35:1066-70. 2002..C. krusei is a rare but important cause of refractory vaginitis and is unique because of its intrinsic resistance to fluconazole... - Candida kefyr endocarditis in a patient with hypertrophic obstructive cardiomyopathyTeena Chopra
Wayne State University, Detroit, Michigan 48201, USA
Am J Med Sci 339:188-9. 2010..Repeat echocardiogram showed small vegetation, preserved leaflet mobility and mild regurgitation. Patient received 10 days of micafungin, followed by 6 weeks of fluconazole... - Valvular perforation in left-sided native valve infective endocarditisKhaled Bachour
Division of Cardiology, Wayne State University, Detroit, Michigan, USA
Clin Cardiol 32:E55-62. 2009..Left-sided native valve infective endocarditis (LNVIE) can result in mitral (MP) and aortic (AP) valve perforation, the prognostic significance of which remains poorly defined... - Current trends and challenges in candidiasisJack D Sobel
Wayne State University, School of Medicine, Detroit, Michigan, USA
Oncology (Williston Park) 18:7-8. 2004 - Combination therapy for invasive mycoses: evaluation of past clinical trial designsJack D Sobel
Department of Internal Medicine, Division of Infectious Diseases, Wayne State University School of Medicine, Detroit, Michigan, USA
Clin Infect Dis 39:S224-7. 2004..Combination therapy offers potentially higher cure rates, especially for resistant organisms. In vitro studies and experimental animal models have provided conflicting data... - A case of Conidiobolus coronatus in the vaginaChithra Subramanian
Division of Infectious Diseases, Wayne State University, Detroit, Michigan 48201, USA
Med Mycol 49:427-9. 2011..Infections are reported mostly from West Africa and South East Asia. Vaginal involvement in humans has not been described before. We report a case of C. coronatus infection involving the vagina that was successfully treated... - Non-albicans Candida infections in patients with hematologic malignanciesMahomed-Yunus S Moosa
Division of Infectious Diseases, Department of Internal Medicine, Wayne State University School of Medicine, Detroit, MI 48201, USA
Semin Respir Infect 17:91-8. 2002..This article addresses the biology, epidemiology, prognostic factors, and management of an emerging group of pathogens such as non-albicans Candida... - Emerging azole antifungalsAnne Chen
Wayne State University, Detroit Medical Center, 3990 Harper Street, 5 Hudson, Detroit, MI 48201, USA
Expert Opin Emerg Drugs 10:21-33. 2005..This review highlights the emerging azole antifungals, both those available and in clinical development, and discusses their prospects for the future... - Chronic vulvar fissure--a rare manifestation of mycosis fungoidesOrna Reichman
Division of Infectious Diseases, Wayne State University School of Medicine, Detroit, MI, USA
J Low Genit Tract Dis 14:65-7. 2010..Mycosis fungoides, the dominant component of cutaneous T-cell lymphoma, rarely present as fissures. We report a case of a chronic vulvar fissure due to mycosis fungoides... - Antifungal drugs in pregnancy: a reviewVarsha V Moudgal
Division of Infectious Diseases, Harper Hospital, 3990 John R, 4 Brush Center, Detroit, MI 48201, USA
Expert Opin Drug Saf 2:475-83. 2003..These drugs are contraindicated in pregnancy. There are insufficient data regarding the use of caspofungin in pregnancy. This article will review available data regarding the safety of antifungal drug use in pregnant women... - Vulvovaginal pellagra and lichen sclerosus complicating carcinoid syndromeOrna Reichman
Division of Infectious Diseases, Wayne State University School of Medicine, Detroit, Michigan, USA
Obstet Gynecol 113:543-5. 2009..Pellagra is a rare clinical syndrome caused by niacin deficiency, and although most commonly nutritional in origin, may be secondary to carcinoid syndrome... - Miconazole mucoadhesive tablets: a novel delivery systemJose A Vazquez
Department of Medicine, Division of Infectious Diseases, Henry Ford Hospital
Clin Infect Dis 54:1480-4. 2012..MBT, although more expensive, offers an effective, safe, and well-tolerated topical treatment option for OPC that is administered as a convenient once-daily dose... - Treatment of abnormal vaginal flora in early pregnancy with clindamycin for the prevention of spontaneous preterm birth: a systematic review and metaanalysisRonald F Lamont
Perinatology Research Branch, NICHD, NIH, DHHS, Bethesda, MD, USA
Am J Obstet Gynecol 205:177-90. 2011..However, a deeper understanding of the vaginal microbiome, mucosal immunity, and the biology of BV will be needed to inform the design of such trials... - CAN-296-P is effective against cutaneous candidiasis in guinea pigsAvital M Ben-Josef
Division of Infectious Diseases, Department of Medicine, Wayne State University, 427 Lande Building, 505E Canfield, Detroit, MI 48201, USA
Int J Antimicrob Agents 22:168-71. 2003..Effectiveness in eradicating candidiasis with CAN-296-P was concentration-dependent and free of local adverse effects. Can-296-P is a novel, highly active topical fungicidal agent, with broad potential for clinical use... - Clinical practice guidelines for the management of cryptococcal disease: 2010 update by the infectious diseases society of americaJohn R Perfect
Division of Infectious Diseases, Duke University Medical Center, Durham, North Carolina 27710, USA
Clin Infect Dis 50:291-322. 2010..However, if the diagnosis is made early, if clinicians adhere to the basic principles of these guidelines, and if the underlying disease is controlled, then cryptococcosis can be managed successfully in the vast majority of patients... - Onset of vulvodynia in a woman ultimately diagnosed with Creutzfeldt-Jakob diseaseOrna Reichman
Division of Infectious Diseases, Department of Neurology, Wayne State University School of Medicine, Detroit, Michigan, USA
Obstet Gynecol 115:423-5. 2010..Vulvodynia, defined as vulvar pain or burning in the presence of normal vulvar appearance, is common and is associated with chronic pain syndromes and psychiatric disorders... - Prevalence and risk factors for vaginal Candida colonization in women with type 1 and type 2 diabetesElla M de Leon
Epidemiology, University of Michigan School of Public Health, Ann Arbor, MI, USA
BMC Infect Dis 2:1. 2002..Diabetes mellitus increases the rate of vaginal colonization and infection with Candida species.. - Sepsis associated with a new Atopobium species, provisionally named Atopobium detroiti: case report and review of the current status of the species AtopobiumHossein Salimnia
Department of Pathology, Wayne State University School of Medicine, Detroit, MI 48201, USA
Scand J Infect Dis 40:679-81. 2008.... - Guidelines for the treatment of bacterial vaginosis: focus on tinidazoleLaura J Dickey
Department of Pharmacy Services, Detroit Receiving Hospital, Detroit, MI, USA
Ther Clin Risk Manag 5:485-9. 2009..Available data suggest tinidazole has a role in special populations particularly for refractory or relapsing BV... - Over-the-counter antifungal drug misuse associated with patient-diagnosed vulvovaginal candidiasisDaron G Ferris
Department of Family Medicine, Medical College of Georgia, Augusta, Georgia 30912, USA
Obstet Gynecol 99:419-25. 2002..To estimate what proportion of symptomatic women purchasing over-the-counter antifungal products for immediate treatment of presumed vulvovaginal candidiasis have vulvovaginal candidiasis or other genitourinary conditions... - Vulvovaginal candidiasis: a comparison of HIV-positive and -negative womenJack D Sobel
Int J STD AIDS 13:358-62. 2002..Ongoing concerns include vaginal acquisition of non-albicans Candida species and the development of antimycotic drug resistance in C. albicans vaginal isolates... - Desquamative inflammatory vaginitis: an exploratory case-control studyE Claire Newbern
Department of Epidemiology, University of Michigan School of Public Health, Ann Arbor, MI 48109-2029, USA
Ann Epidemiol 12:346-52. 2002.... - Incident and persistent vulvovaginal candidiasis among human immunodeficiency virus-infected women: Risk factors and severityAnn Duerr
National Center for Chronic Disease Prevention and Health Promotion, Division of Reproductive Health HIV Section, Centers for Disease Control and Prevention, Mailstop K 34, 4770 Buford Highway NE, Atlanta, GA 30341 3717, USA
Obstet Gynecol 101:548-56. 2003..To examine risk factors for vulvovaginal candidiasis among women with or at risk for human immunodeficiency virus (HIV) infection... - Changing epidemiology of invasive candidiasis in intensive care units--much ado about nothing?Jack D Sobel
Crit Care Med 36:2188-9. 2008 - Empirical fluconazole versus placebo for intensive care unit patients: a randomized trialMindy G Schuster
University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104, USA
Ann Intern Med 149:83-90. 2008..Invasive infection with Candida species is an important cause of morbidity and mortality in intensive care unit (ICU) patients. Optimal preventive strategies have not been clearly defined... - The VI-SENSE-vaginal discharge self-test to facilitate management of vaginal symptomsAdam Geva
SBC Women's Health Centers of Lin, Israel
Am J Obstet Gynecol 195:1351-6. 2006..CONCLUSION: The VI-SENSE test was found to be superior to traditional individual tests in facilitating preliminary diagnosis of vaginal infections... - Risk factors for recurrent vulvovaginal candidiasis in women receiving maintenance antifungal therapy: results of a prospective cohort studyDivya A Patel
Department of Epidemiology, University of Michigan School of Public Health, Ann Arbor, Mich, USA
Am J Obstet Gynecol 190:644-53. 2004.... - Vulvovaginal candidiasisPaul Nyirjesy
Department of Obstetrics and Gynecology, Drexel University College of Medicine, Philadelphia, PA, USA
Obstet Gynecol Clin North Am 30:671-84. 2003..Future advances, particularly in the area of home diagnostics, may help to optimize use of currently available medicines... - Echinocandins--first-choice or first-line therapy for invasive candidiasis?Jack D Sobel
N Engl J Med 356:2525-6. 2007 - Influence of sex hormones, HIV status, and concomitant sexually transmitted infection on cervicovaginal inflammationKhalil G Ghanem
Johns Hopkins University School of Medicine, Baltimore, Maryland 21224, USA
J Infect Dis 191:358-66. 2005..Progesterone-based contraceptives, younger age, and race have an independent effect on cervicovaginal inflammatory cells... - Failure of nitazoxanide to cure trichomoniasis in three womenMichael Dan
Infectious Diseases Unit, E Wolfson Hospital, Holon, Israel
Sex Transm Dis 34:813-4. 2007 - Revised definitions of invasive fungal disease from the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) CBen de Pauw
Department of Blood Transfusion Service and Transplant Immunology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
Clin Infect Dis 46:1813-21. 2008..Clarity and uniformity in defining these infections are important factors in improving the quality of clinical studies. A standard set of definitions strengthens the consistency and reproducibility of such studies...