Status:
COMPLETED
A Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants (PTN_Acyclo)
Lead Sponsor:
Phillip Brian Smith
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Herpes Simplex Virus
Neonatal Sepsis
Eligibility:
All Genders
Up to 45 years
Phase:
PHASE1
Brief Summary
Acyclovir is a drug used to treat herpes simplex virus (HSV) infections in babies. Appropriate dosing of acyclovir is known for adults and children but acyclovir has not been adequately studied in ful...
Detailed Description
Neonatal herpes infection carries a major risk of death if untreated. Prognosis is related to disease extent and timing of therapy, making early diagnosis crucial. Mortality in the pre-antiviral era w...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00942084
Start Date
September 1 2011
End Date
June 1 2012
Last Update
January 8 2019
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Wesely Medical Center
Wichita, Kansas, United States, 67214-4976
2
Tulane School of Medicine
New Orleans, Louisiana, United States, 70112
3
Duke University
Durham, North Carolina, United States, 27713