Evaluation of the PK and PD of Ganciclovir (GCV) in Premature Infants Receiving Treatment for CMV Infection



Status:Recruiting
Conditions:Infectious Disease, Hospital
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:Any
Updated:10/28/2018
Start Date:April 2013
End Date:April 2019
Contact:Jill Bailey-Griffin, RN, MSN
Email:jgriffin@peds.uab.edu
Phone:205-996-7698

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

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.

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 AUC and 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 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, AST, and 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.

Inclusion Criteria:

1. Signed informed consent from parent(s) or legal guardian(s)

2. Confirmation of CMV infection from urine, blood, or saliva by culture, shell vial, or
PCR tests (local lab)

3. Receiving intravenous ganciclovir, prescribed by the patient's physician

4. < 32 weeks gestational age at birth

5. ≥ 500 grams at study enrollment

Exclusion Criteria:

1. Imminent demise

2. Current receipt of valganciclovir or foscarnet

3. Receiving breast milk from a mother who is being treated with ganciclovir or
valganciclovir

4. Current receipt of other investigational drugs

5. Major congenital anomaly that in the site investigator's opinion may impact drug
metabolism or the patient's volume of distribution
We found this trial at
15
sites
529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
Principal Investigator: Jose Romero, MD
Phone: 501-364-1416
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Phone: 877-975-7280
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Pablo Sanchez, MD
Phone: 614-355-6638
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Columbus, OH
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Gregory Wilson, MD
Phone: 615-343-5731
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Principal Investigator: Marian J Michaels, MD, MPH
Phone: 412-692-6786
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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Pittsburgh, PA
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Penelope Dennehy, MD
Phone: 401-444-8360
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Providence, RI
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Mary Caserta, MD
Phone: 585-275-9613
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Baltimore, Maryland 21287
Principal Investigator: Ravit Boger, MD
Phone: 410-614-3917
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Charlotte, North Carolina 28203
Principal Investigator: Amina Ahmed, MD, BS
Phone: 704-381-6870
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Charlotte, NC
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2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
Principal Investigator: Nazha F Abughali, MD
Phone: 216-778-3402
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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Manhasset, New York 11030
Principal Investigator: Sunil Sood, MD
Phone: 516-562-3957
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Saint Louis, Missouri 63110
Principal Investigator: Gregory Storch, MD
Phone: 314-454-6079
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Saint Petersburg, Florida 33701
Principal Investigator: Carina Rodriguez, MD
Phone: 727-553-3526
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Shreveport, Louisiana 71130
Principal Investigator: John Vanchiere, MD, PhD
Phone: 318-675-7877
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Principal Investigator: Roberta L DeBiasi, MD
Phone: 202-476-5051
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Washington,
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