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

NCT01602614 | Completed Results DMC

• 1 other identifier: F21116007
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 15

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.

Conditions

Cytomegalovirus Infections

Outcome Measures

Primary Outcomes (1)

• 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 (14)

• 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

Study Arms (4)

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.

Eligibility Criteria

• Age: 1 Day - 180 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Premature infants who receive intravenous ganciclovir as part of clinical care

You may qualify if:

• Signed informed consent from parent(s) or legal guardian(s)
• Confirmation of CMV infection from urine, blood, or saliva by culture, shell vial, or PCR tests (local lab)
• Receiving intravenous ganciclovir, prescribed by the patient's physician
• \< 32 weeks gestational age at birth
• ≥ 500 grams at study enrollment

You may not qualify if:

• Imminent demise
• Current receipt of valganciclovir or foscarnet
• Receiving breast milk from a mother who is being treated with ganciclovir or valganciclovir
• Current receipt of other investigational drugs
• Major congenital anomaly that in the site investigator's opinion may impact drug metabolism or the patient's volume of distribution

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (15)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72202, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

University of South Florida School of Medicine

St. Petersburg, Florida, 33701, United States

Location

Louisiana State University Health Science Center - Shreveport

Shreveport, Louisiana, 71103, United States

Location

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21287, United States

Location

Washington University in St Louis School of Medicine

St Louis, Missouri, 63110, United States

Location

Steven & Alexandra Cohen Children's Medical Center of New York (CCMC)

Manhasset, New York, 11030, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Carolinas Medical Center - Charlotte

Charlotte, North Carolina, 28203, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Nationwide Childrens Hospital

Columbus, Ohio, 43205, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: David Kimberlin, MD
• Organization: University of Alabama at Birmingham

Dkimberlin@peds.uab.edu

205 934-2424

Study Officials

• David Kimberlin, MD

  University of Birmingham at Alabama

  PRINCIPAL INVESTIGATOR

• Richard Whitley, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Protocol Principal and Lead Investigator

Study Record Dates

• First Submitted: May 17, 2012
• First Posted: May 21, 2012
• Study Start: April 1, 2013
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: June 2, 2020
• Results First Posted: May 19, 2020

Record last verified: 2020-05

Locations

US (15)