Evaluation of the Pharmacokinetics (PK) and Pharmacodymam... | NCT01602614

NCT01602614

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Detailed Description

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, or 8 of intravenous ganciclovir. Specimens will be shipped for processing at that time. The pharmacokinetic data will then be provided to the study site, including the area under curve (AUC) and clearance (CL) values for information purposes.

Duration of intravenous ganciclovir therapy is at the discretion of the treating physician and will not be dictated by the research protocol. Both whole blood for CMV polymerase chain reaction (PCR) and urine for CMV detection will be obtained once in each study period as long as the subject is receiving intravenous ganciclovir therapy. These specimens will be used to determine blood viral load and ganciclovir resistance. Since ganciclovir is a renally excreted drug, serum creatinine will be drawn for the research protocol on the day that the ganciclovir pharmacokinetic specimens are obtained in order to calculate creatinine clearance using a method such as the modified Schwartz formula, and thus correlate ganciclovir clearance with renal function. Otherwise, data from hematology assessments (WBC count and differential, hemoglobin, platelet count) and from chemistry labs (serum creatinine, aspartate aminotransferase (AST) , and alanine aminotransferase (ALT) will be recorded on the study case report forms during each study period if they are being obtained for clinical reasons, but will not be drawn only for the purposes of the study. Ganciclovir dosing information (mg/dose, dosing interval, and patient weight) will be recorded on the day of the pharmacokinetic blood draws, and weekly from Period 1 through Period 7 as long as the subject is receiving intravenous ganciclovir therapy.

If the patient continues to receive intravenous ganciclovir from Study Assessment Day 18 through Study Assessment Day 24 (Period 4), a second PK assessment may be performed at the request of the treating physician if the subject weighs 575 grams or more at the time of specimen collection.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		≤ 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.
Group 2		≤ 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.
Group 3		≥ 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.
Group 4		≥ 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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
Plasma Pharmacokinetics Parameters for Ganciclovir, Including Maximum Serum Concentration (Cmax mg/L).	Looking at the Pharmacokinetics (PK) parameters for Ganciclovir (GCV). A series of blood samples was 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.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
David Kimberlin, MD	University of Birmingham at Alabama	Principal Investigator
Richard Whitley, MD	University of Alabama at Birmingham	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35233	United States
University of Arkansas for Medical Sciences

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Group 1	≤ 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.
FG001	Group 2

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 14, 2015	Mar 23, 2020

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

No data available

No data is available for this block.

Group 1 and Group 4 did not enroll subjects.

Arm/Group Information

ID	Title	Description
BG000	Group 1	≤ 27 weeks 6 days gestational age at birth and ≤ 30 days chronologic age at study enrollment
BG001	Group 2	≤ 27 weeks 6 days gestational age at birth and > 30 days chronologic age at study enrollment
BG002	Group 3	≥ 28 weeks 0 days gestational age at birth and ≤ 30 days chronologic age at study enrollment
BG003	Group 4	≥ 28 weeks 0 days gestational age at birth and > 30 days chronologic age at study enrollment
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG0000 BG00110 BG0028 BG0030 BG00418

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Mean

Standard Deviation

days

Title

Denominators

Categories

Age (days)

Title	Measurements
	BG00163.2± 18.0 BG00216.5± 7.4 BG00442.4± 27.6

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0012 BG0021 BG004

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Race

Title	Measurements
Asian	BG0011 BG0020 BG004

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00110 BG0028 BG004

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full panel therefore no pk analyzed.

Posted

Mean

Standard Error

mgxh/L

within 12 hours after dose administration

ID	Title	Description
OG000	Group 1	≤ 27 weeks 6 days gestational age at birth and ≤ 30 days chronologic age at study enrollment
OG001	Group 2	≤ 27 weeks 6 days gestational age at birth and > 30 days chronologic age at study enrollment
OG002	Group 3	≥ 28 weeks 0 days gestational age at birth and ≤ 30 days chronologic age at study enrollment
OG003	Group 4	≥ 28 weeks 0 days gestational age at birth and > 30 days chronologic age at study enrollment

Units	Counts
Participants	OG0000 OG00110 OG0027 OG003

Title

Denominators

Categories

Title	Measurements
	OG00147.2± 21.5 OG00276.8± 39.6

Secondary

Plasma Pharmacokinetics Parameters for Ganciclovir, Including Maximum Serum Concentration (Cmax mg/L).

Looking at the Pharmacokinetics (PK) parameters for Ganciclovir (GCV). A series of blood samples was 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.

No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full panel therefore no pk analyzed.

Posted

Mean

Standard Error

mg/L

within 12 hours after dose administration

ID	Title	Description
OG000	Group 1	≤ 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.
OG001	Group 2	≤ 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.
OG002	Group 3

Secondary

Plasma Pharmacokinetics Parameters for Ganciclovir for Half-life (T1/2 hr).

No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full panel therefore no pk analyzed.

Posted

Mean

Standard Error

within 12 hours after dose administration

ID	Title	Description
OG000	Group 1	≤ 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.
OG001	Group 2	≤ 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.
OG002	Group 3

Secondary

Plasma Pharmacokinetics Parameters for Ganciclovir for Clearance (Cl L/hr/kg).

No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full panel therefore no pk analyzed.

Posted

Mean

Standard Error

L/hr/kg

within 12 hours after dose administration

ID	Title	Description
OG000	Group 1	≤ 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.
OG001	Group 2	≤ 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.
OG002	Group 3

Secondary

Plasma Pharmacokinetics Parameters for Ganciclovir for Volume of Distribution (Vd L).

No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full panel therefore no pk analyzed.

Posted

Mean

Standard Error

within 12 hours after dose administration

ID	Title	Description
OG000	Group 1	≤ 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.
OG001	Group 2	≤ 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.
OG002	Group 3

Secondary

Correlation of Ganciclovir Plasma Pharmacokinetics (Clearance (CL) With Whole Blood Cytomegalovirus (CMV) Viral Load.

Comparing the GCV PK clearance (CL L/hr/kg) results to the whole blood CMV viral load data.

No subjects were enrolled in Group 1 and Group 4. Four (4) Group 2 subjects and two (2) Group 3 subjects did not have viral loads for at least two (2) time points, therefore correlation could not be performed.

Posted

Mean

Standard Deviation

L/hr/kg

6 weeks

ID	Title	Description
OG000	Group 1	≤ 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.
OG001	Group 2	≤ 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.
OG002	Group 3	≥ 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.

Secondary

Correlation of Ganciclovir Plasma Pharmacokinetics Maximum Serum Concentration (Cmax) With Whole Blood Cytomegalovirus (CMV) Viral Load.

Comparing the GCV PK results maximum serum concentration (Cmax) to the CMV viral load data.

Posted

Mean

Standard Deviation

mg/L

6 weeks

ID	Title	Description
OG000	Group 1	≤ 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.
OG001	Group 2	≤ 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.
OG002	Group 3	≥ 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.

Secondary

Correlation of Ganciclovir Plasma Pharmacokinetics Area Under the Curve (AUC12) With Whole Blood Cytomegalovirus (CMV) Viral Load.

Comparing the GCV PK results area under the curve (AUC12-mgxh/L) to the whole blood CMV viral load data.

Posted

Mean

Standard Deviation

mgxh/L

6 weeks

ID	Title	Description
OG000	Group 1	≤ 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.
OG001	Group 2	≤ 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.
OG002	Group 3	≥ 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.

Secondary

Correlation of Ganciclovir Plasma Pharmacokinetics Half-life (T1/2) With Whole Blood Cytomegalovirus (CMV) Viral Load.

Comparing the GCV PK results half-life (T1/2 hr) to the whole blood CMV viral load data.

Posted

Mean

Standard Deviation

6 weeks

ID	Title	Description
OG000	Group 1	≤ 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.
OG001	Group 2	≤ 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.
OG002	Group 3	≥ 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.

Secondary

Correlation of Ganciclovir Plasma Pharmacokinetics Volume of Distribution (Vd) With Whole Blood Cytomegalovirus (CMV) Viral Load.

Comparing the GCV PK results volume of distribution (Vd L) to the whole blood CMV viral load data.

Posted

Mean

Standard Deviation

6 weeks

ID	Title	Description
OG000	Group 1	≤ 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.
OG001	Group 2	≤ 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.
OG002	Group 3	≥ 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.

Secondary

Correlation of Ganciclovir Plasma Pharmacokinetics Clearance (Cl) With Clearance of CMV in Urine

Comparing the GCV PK results clearance (Cl L/hr/kg) to the clearance of CMV in the urine samples

Posted

Mean

Standard Deviation

L/hr/kg

6 weeks

ID	Title	Description
OG000	Group 1	≤ 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.
OG001	Group 2	≤ 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.
OG002	Group 3	≥ 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.

Secondary

Correlation of Ganciclovir Plasma Pharmacokinetics Maximum Serum Concentration (Cmax) With Clearance of CMV in Urine.

Comparing the GCV PK results to the Cmax with clearance of CMV in the urine samples

Posted

Mean

Standard Deviation

mg/L

6 weeks

ID	Title	Description
OG000	Group 1	≤ 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.
OG001	Group 2	≤ 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.
OG002	Group 3	≥ 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.

Secondary

Correlation of Ganciclovir Plasma Pharmacokinetics Area Under the Curve (AUC) With Clearance of CMV in Urine.

Comparing the GCV PK AUC results to the clearance of CMV in the urine samples.

Posted

Mean

Standard Deviation

mgxhr/L

6 weeks

ID	Title	Description
OG000	Group 1	≤ 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.
OG001	Group 2	≤ 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.
OG002	Group 3	≥ 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.

Secondary

Correlation of Ganciclovir Plasma Pharmacokinetics Maximum Serum Half Life (T1/2) With Clearance of CMV in Urine.

Comparing the GCV PK half-life results to the clearance of CMV in the urine samples.

Posted

Mean

Standard Deviation

6 weeks

ID	Title	Description
OG000	Group 1	≤ 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.
OG001	Group 2	≤ 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.
OG002	Group 3	≥ 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.

Secondary

Correlation of Ganciclovir Plasma Pharmacokinetics Volume of Distribution (Vd) With Clearance of CMV in Urine.

Comparing the GCV PK Vd results to the clearance of CMV in the urine samples

Posted

Mean

Standard Deviation

6 weeks

ID	Title	Description
OG000	Group 1	≤ 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.
OG001	Group 2	≤ 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.
OG002	Group 3	≥ 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.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (At Risk)
EG000	Group 1	≤ 27 weeks 6 days gestational age at birth and ≤ 30 days chronologic age at study enrollment	0	0	0
EG001	Group 2	≤ 27 weeks 6 days gestational age at birth and > 30 days chronologic age at study enrollment	10	10	10
EG002	Group 3	≥ 28 weeks 0 days gestational age at birth and ≤ 30 days chronologic age at study enrollment	8	8	8
EG003	Group 4	≥ 28 weeks 0 days gestational age at birth and > 30 days chronologic age at study enrollment	0	0	0

ID	Term
D003586	Cytomegalovirus Infections

≥ 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.

ID	Term
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections