Effect of ganciclovir therapy on hearing in symptomatic congenital cytomegalovirus disease involving the central nervous system: a randomized, controlled trial∗☆
Section snippets
Study population
Neonates with symptomatic (clinically apparent disease in the newborn period) congenital CMV disease involving the CNS were eligible for enrollment into this trial. All study subjects had confirmed isolation of CMV from a urine specimen obtained before study enrollment and within the first month of life,15 and all had evidence of CNS disease, such as (1) microcephaly; (2) intracranial calcifications; (3) abnormal cerebrospinal fluid (CSF) for age; (4) chorioretinitis; and/or (5) hearing
Population characteristics
From 1991 through 1999, 100 patients from 18 CASG sites enrolled patients in this clinical trial. These sites and their corresponding enrollment numbers were University of Alabama at Birmingham, 15 subjects; University of Texas Southwestern Medical Center and University of Florida at Gainesville, 13 subjects each; Baylor College of Medicine, 11 subjects; University of Arkansas, 9 subjects; University of California at San Diego, 7 subjects; University of Alberta and Cook Fort Worth Children's
Discussion
Six weeks of intravenous ganciclovir therapy prevents best-ear hearing deterioration at 6 months for patients with symptomatic congenital CMV disease involving the CNS. Ganciclovir therapy also may prevent best-ear hearing deterioration at or beyond 1 year. Although an understanding of the full clinical relevance of this audiologic effect awaits further long-term follow-up of these patients, the ability to prevent a patient from worsening from one level of hearing impairment (eg, mild) to
Acknowledgements
This study is dedicated to Charles A. Alford, Jr, MD, whose vision and leadership were instrumental to this endeavor.
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Supported under contract with the Virology Branch, Division of Microbiology and Infectious Diseases of the National Institute of Allergy and Infectious Diseases (NIAID), NO1-AI-15113 and NO1-AI-62554, and by grants from the General Clinical Research Center Program (RR-032) and the State of Alabama.
Presented at the 40th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), Toronto, Ontario, Canada; 2000; Abstract 1942. Recipient of the ICAAC Program Committee Award in the area of Therapy of Microbial Diseases.
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Committee membership of the National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group is listed at http://www.casg.uab.edu.