Clinical Trial: Evaluation of the PK and PD of Ganciclovir in Premature Infants Receiving Treatment for CMV Infection

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Evaluation of the Pharmacokinetics and Pharmacodynamics of Ganciclovir in Premature Infants Receiving Treatment for Cytomegalovirus Infection

Brief Summary: 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.

Detailed Summary:

This is an open-label, multi-center, clinical sampling study to assess ganciclovir pharmacokinetics and pharmacodynamics in premature infants. Only those subjects who receive ganciclovir for clinical reasons will be enrolled. The decision to initiate ganciclovir therapy will be made by the attending physician based upon his/her clinical decision to treat virologically-confirmed CMV infection; infants receiving such therapy and meeting entry criteria will then be eligible for this study. Therefore, ganciclovir will not provided under this protocol.

Subjects meeting enrollment criteria will be entered into this clinical trial. Subjects will be stratified by gestational age and by chronologic age as follows: 1) ≤ 27 weeks 6 days gestational age at birth and ≤ 30 days chronologic age at study enrollment; 2) ≤ 27 weeks 6 days gestational age at birth and > 30 days chronologic age at study enrollment; 3) ≥ 28 weeks 0 days gestational age at birth and ≤ 30 days chronologic age at study enrollment; 4) ≥ 28 weeks 0 days gestational age at birth and > 30 days chronologic age at study enrollment. Eight subjects will enroll in each of the four groups, for a total sample size of 32 subjects. Subjects in each cohort with inadequate pharmacokinetic data for analysis (e.g., due to dropping out of the study before PK assessments are performed, or blood sampling obtained but is inadequate for analysis) will be replaced and will not count toward the total of eight subjects in each of the four groups. Additionally, enrollment of an additional 2-3 subjects may be allowed for operational reasons.

A full pharmacokinetic profile will be obtained with one of the ganciclovir doses received after enrollment. PK assessments will be obtained after the subject has received study assessment dose 3, 4, 5, 6, 7, o
Sponsor: University of Alabama at Birmingham

Current Primary Outcome: Plasma pharmacokinetics parameters for ganciclovir Area Under the Curve at 12 hours (AUC12) [ Time Frame: within 12 hours after dose administration ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Plasma pharmacokinetics parameters for ganciclovir, including maximum serum concentration (Cmax), half-life (T1/2), CL, and Vd [ Time Frame: within 12 hours after dose administration ]
  • Correlation of ganciclovir plasma concentrations with CMV whole blood viral load [ Time Frame: 6 weeks ]
  • Correlation of ganciclovir plasma concentrations with clearance of CMV in urine [ Time Frame: 6 weeks ]
  • Correlation of ganciclovir plasma concentrations with neutropenia [ Time Frame: 6 weeks ]
  • Detection of resistance to ganciclovir [ Time Frame: 6 weeks ]


Original Secondary Outcome: Same as current

Information By: University of Alabama at Birmingham

Dates:
Date Received: May 17, 2012
Date Started: April 2013
Date Completion: July 2018
Last Updated: December 14, 2016
Last Verified: December 2016