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

Completed

Conditions studied: Cytomegalovirus Infections

In brief

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.

Key facts

Study ID

NCT01602614

Run by

University of Alabama at Birmingham

People needed

18

Starts

2013-04-01

Expected to finish

2019-03-01

Last updated by the study team

2020-06-02

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• University of South Florida School of Medicine — St. Petersburg, Florida, United States
• Louisiana State University Health Science Center - Shreveport — Shreveport, Louisiana, United States
• Johns Hopkins Medical Institutions — Baltimore, Maryland, United States
• Washington University in St Louis School of Medicine — St Louis, Missouri, United States
• Steven & Alexandra Cohen Children's Medical Center of New York (CCMC) — Manhasset, New York, United States
• University of Rochester — Rochester, New York, United States
• Carolinas Medical Center - Charlotte — Charlotte, North Carolina, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Nationwide Childrens Hospital — Columbus, Ohio, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.