A Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants (PTN_Acyclo)
Herpes Simplex Virus, Neonatal Sepsis
About this trial
This is an interventional treatment trial for Herpes Simplex Virus focused on measuring HSV, Acyclovir, Pharmacokinetics, Neonate, Premature, Sepsis
Eligibility Criteria
The investigator or other study site personnel will document in the source documents (e.g., the hospital chart) that informed consent was obtained. Laboratory tests or non-pharmacologic treatment procedures that were performed as standard of care within 72 hours prior to first dose of study drug may be used for screening procedures and recorded in the CRF.
Inclusion Criteria
- < 45 days of age at the time of initial study drug administration.
- Sufficient venous access to permit administration of study medication.
- Availability and willingness of the parent/legal guardian to provide written informed consent.
Suspected HSV sepsis OR At least two (2) of the following
- Signs of sepsis AND negative blood cultures for >24 hours7
- Respiratory distress8
- Lethargy8
- Fever ≥ 38.0°C7
- Skin lesions7,8
- Seizures (clinical OR EEG confirmed)7
- Irritability7
- AST OR ALT >2 X upper limit of normal7,8
- >20 WBCs/µL or >500 RBCs/µL7
Exclusion Criteria
- History of anaphylaxis attributed to acyclovir.
- Serum creatinine >1.7 mg/dL.
- Urine output <0.5 mL/kg/hour over the previous 12 hours
- Previous participation in the study.
- Concomitant condition, which in the opinion of the investigator would preclude a participant's participation in the study
Sites / Locations
- Wesely Medical Center
- Tulane School of Medicine
- Duke University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Other
Protocol V2&up-Grp1-Acyclo10 mg/kg IVq12
Protocol V2&up-Grp2_Acyclo20 mg/kg IVq12
Protocol V2&up-Grp3-Acyclo20 mg/kg IVq8
Protocol V1-Grps1-4-Acyclo 500 mg/m2 IVq8h
Gestational Age 23-29 weeks Postnatal Age < 14 days Dosage 10 mg/kg IV q12 Number of Infants 8
Gestational Age 23-29 weeks Postnatal Age 14-44 days Dosage 20 mg/kg IV q12 Number of Infants 8
Gestational Age 30-34 weeks Postnatal Age <45 days Dosage 20 mg/kg IV q8 Number of Infants 4
All patients in protocol V1 were to be dosed with 500 mg/m2 IV q8h. Protocol V1 Group 1: Gestational Age: 23-29 Weeks; PNA: <14 days; Protocol V1 Group 2: Gestational Age: 30-42 Weeks; PNA: <14 days; Protocol V1 Group 3: Gestational Age: 23-29 Weeks; PNA: 14-60 days; Protocol V1 Group 4: Gestational Age: 30-42 Weeks; PNA: 14-60 days