NCT01602614|CompletedResultsDMC
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Sponsor study identifier
observational
18
1 country
15
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2019
Actual (reported)Study Completion
March 2019
Actual (reported)This is a clinical sampling study, and no study drugs will be administered under this protocol. Premature infants who receive intravenous ganciclovir as part of clinical care will be eligible for participation in this study. Intravenous ganciclovir will not be provided under this protocol.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 17, 2012
Actual (reported)May 21, 2012
Actual (reported)April 2013
Date type not reportedThis date has not been verified as actual or estimated.
March 2019
Actual (reported)March 2019
Actual (reported)May 19, 2020
Actual (reported)Plasma Pharmacokinetics Parameters for Ganciclovir Area Under the Curve at 12 Hours (AUC12mgxh/L)
A series of blood samples will be collected to assess the ganciclovir levels in the blood at the following time points: 0 hour (immediately prior to intravenous (IV) ganciclovir dose; within 15 min prior to dose), 1 hour (immediately after the end of the IV ganciclovir dose; within 15 min after dose), 2-3 hour, 5-7 hour, and 10-12 hour; required amount of whole blood for plasma ganciclovir determination at each time point is at least 0.2 mL
within 12 hours after dose administration
Plasma Pharmacokinetics Parameters for Ganciclovir, Including Maximum Serum Concentration (Cmax mg/L).
within 12 hours after dose administration
Plasma Pharmacokinetics Parameters for Ganciclovir for Half-life (T1/2 hr).
within 12 hours after dose administration
Plasma Pharmacokinetics Parameters for Ganciclovir for Clearance (Cl L/hr/kg).
within 12 hours after dose administration
Plasma Pharmacokinetics Parameters for Ganciclovir for Volume of Distribution (Vd L).
within 12 hours after dose administration
Correlation of Ganciclovir Plasma Pharmacokinetics (Clearance (CL) With Whole Blood Cytomegalovirus (CMV) Viral Load.
6 weeks
≤ 27 weeks 6 days gestational age at birth and ≤ 30 days chronologic age at study enrollment. Dose and duration of intravenous ganciclovir therapy is at the discretion of the treating physician and will not be dictated by the research protocol.
≤ 27 weeks 6 days gestational age at birth and \> 30 days chronologic age at study enrollment. Dose and duration of intravenous ganciclovir therapy is at the discretion of the treating physician and will not be dictated by the research protocol.
≥ 28 weeks 0 days gestational age at birth and ≤ 30 days chronologic age at study enrollment. Dose and duration of intravenous ganciclovir therapy is at the discretion of the treating physician and will not be dictated by the research protocol.
≥ 28 weeks 0 days gestational age at birth and \> 30 days chronologic age at study enrollment. Dose and duration of intravenous ganciclovir therapy is at the discretion of the treating physician and will not be dictated by the research protocol.
Premature infants who receive intravenous ganciclovir as part of clinical care
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72202, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
University of South Florida School of Medicine
St. Petersburg, Florida, 33701, United States
Louisiana State University Health Science Center - Shreveport
Shreveport, Louisiana, 71103, United States
Johns Hopkins Medical Institutions
Baltimore, Maryland, 21287, United States
Washington University in St Louis School of Medicine
Remnant blood will be retained for future cytomegalovirus (CMV) studies if subjects/subject families consent to future use. Institutional Review Board (IRB) approval for any future studies of remnant specimens will be required.
David Kimberlin, MD
University of Birmingham at Alabama
Richard Whitley, MD
University of Alabama at Birmingham
18 participants (actual enrollment reported by the registry).
First Submitted
May 17, 2012
First Posted
May 21, 2012
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
St Louis, Missouri, 63110, United States
Steven & Alexandra Cohen Children's Medical Center of New York (CCMC)
Manhasset, New York, 11030, United States
University of Rochester
Rochester, New York, 14642, United States
Carolinas Medical Center - Charlotte
Charlotte, North Carolina, 28203, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Nationwide Childrens Hospital
Columbus, Ohio, 43205, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Primary Completion
March 2019
Actual (reported)Study Completion
March 2019
Actual (reported)Last Updated
June 2, 2020
Results First Posted
May 19, 2020
Record last verified: 2020-05
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Source: ClinicalTrials.gov.
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