N/A N=18

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

Cytomegalovirus Infections

Bottom Line

View on ClinicalTrials.gov: NCT01602614 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2020

Primary outcome: Primary: Plasma Pharmacokinetics Parameters for Ganciclovir Area Under the Curve at 12 Hours (AUC12mgxh/L) — 47.2; 76.8 mgxh/L

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: University of Alabama at Birmingham
Primary completion: Mar 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Plasma Pharmacokinetics Parameters for Ganciclovir Area Under the Curve at 12 Hours (AUC12mgxh/L)	47.2; 76.8	—
SECONDARY Plasma Pharmacokinetics Parameters for Ganciclovir, Including Maximum Serum Concentration (Cmax mg/L).	7.9; 10.0	—
SECONDARY Plasma Pharmacokinetics Parameters for Ganciclovir for Half-life (T1/2 hr).	5.0; 7.2	—
SECONDARY Plasma Pharmacokinetics Parameters for Ganciclovir for Clearance (Cl L/hr/kg).	0.1; 0.1	—
SECONDARY Plasma Pharmacokinetics Parameters for Ganciclovir for Volume of Distribution (Vd L).	1.4; 1.1	—
SECONDARY Correlation of Ganciclovir Plasma Pharmacokinetics (Clearance (CL) With Whole Blood Cytomegalovirus (CMV) Viral Load.	0.13667; 0.08000	0.3117
SECONDARY Correlation of Ganciclovir Plasma Pharmacokinetics Maximum Serum Concentration (Cmax) With Whole Blood Cytomegalovirus (CMV) Viral Load.	7.99833; 10.22500	0.6175
SECONDARY Correlation of Ganciclovir Plasma Pharmacokinetics Area Under the Curve (AUC12) With Whole Blood Cytomegalovirus (CMV) Viral Load.	50.77167; 79.58833	0.7129
SECONDARY Correlation of Ganciclovir Plasma Pharmacokinetics Half-life (T1/2) With Whole Blood Cytomegalovirus (CMV) Viral Load.	5.37333; 7.36167	0.9828
SECONDARY Correlation of Ganciclovir Plasma Pharmacokinetics Volume of Distribution (Vd) With Whole Blood Cytomegalovirus (CMV) Viral Load.	1.36333; 1.06000	0.9656
SECONDARY Correlation of Ganciclovir Plasma Pharmacokinetics Clearance (Cl) With Clearance of CMV in Urine	0.12000; 0.07667	0.5113
SECONDARY Correlation of Ganciclovir Plasma Pharmacokinetics Maximum Serum Concentration (Cmax) With Clearance of CMV in Urine.	8.93000; 10.58667	0.2170
SECONDARY Correlation of Ganciclovir Plasma Pharmacokinetics Area Under the Curve (AUC) With Clearance of CMV in Urine.	55.23667; 81.46333	0.4299
SECONDARY Correlation of Ganciclovir Plasma Pharmacokinetics Maximum Serum Half Life (T1/2) With Clearance of CMV in Urine.	6.25000; 7.39667	0.8629
SECONDARY Correlation of Ganciclovir Plasma Pharmacokinetics Volume of Distribution (Vd) With Clearance of CMV in Urine.	1.35000; 0.97333	0.5717

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01602614). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.