This study will evaluate the acceptability and safety of famciclovir in infants with herpes simplex infection
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Administered orally as a single individualized dose between 25-200 mg based on body weight.
Pediatric Infectious Disease Of University of Alabama
Birmingham, Alabama, United States
Children's Memorial Hospital Chicago
Chicago, Illinois, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Archana Chatterjee
Omaha, Nebraska, United States
Pharmacokinetics of Single Dose - Tmax
Measured by Tmax - The time after administration of a drug when the maximum plasma concentration is reached.
Time frame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.
Pharmacokinetics of Single Dose - Cmax
Measured by Cmax - The maximum plasma concentration of study medication
Time frame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.
Pharmacokinetics of Single Dose - AUC(0-tlast)
Measured by AUC(0-tlast) - Area under the plasma concentration time curve from time zero to the last quantifiable concentration-timepoint.
Time frame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.
Pharmacokinetics of Single Dose - AUC(0-6h)
Measured by AUC(0-6h) - Area under the plasma concentration time curve from time zero up to 6 hours post dose (i.e. the time of the last sample).
Time frame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.
Safety Assessed by AEs, SAEs
AEs and SAEs were collected during patient's stay in the clinic for PK sampling up to Hour 8, then at day 2 visit, 8 days(safety follow-up call) and 38 days (safety follow-up call) post dose.
Time frame: 38 days
Safety Assessed by Labs
Samples for safety labs were obtained at baseline and Day 2 visit and samples were analyzed by local accredited laboratory.
Time frame: 2 days
Tolerability of of the Famciclovir Pediatric Formulation as Assessed by Study Personnel.
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University Hospital Cased Medical Center Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Tolerability was assessed by the study personnel 30 minutes after dosing using the following scale: 1. Significant emesis occurred, 2. Infant spit out most of the dose ingesting less than half of what was administered, 3. Infant spit out some of the dose, but ingested at least 50% of what was administered, 4. Infant was able to ingest and retain the dose administered
Time frame: 30 minutes after dosing
Acceptability of the Famciclovir Pediatric Formulation as Assessed by the Patient's Caregiver
Assessed by the caregiver using a 5-point scale immediately after dosing: 1. Very badly accepted/unacceptable: infant showed great displeasure, compromising use of formulation 2. Badly but accepted: infant showed displeasure with dosing but could be coaxed to take complete dose 3. Neither good nor bad: infant showed no apparent displeasure and with little effort was coaxed to take complete dose 4. Well accepted: infant appeared to enjoy the formulation and with little coaxing ingested most of dose 5. Very well accepted: infant appeared eager and ingested most of dose without special coaxing
Time frame: Immediately after dosing
Acceptability of the Famciclovir Pediatric Formulation as Assessed by Study Personnel
Assessed by the study personnel using a 5-point scale after dosing: 1. Very badly accepted/unacceptable: infant showed great displeasure, compromising use of formulation 2. Badly but accepted: infant showed displeasure with dosing but could be coaxed to take complete dose 3. Neither good nor bad: infant showed no apparent displeasure and with little effort was coaxed to take complete dose 4. Well accepted: infant appeared to enjoy the formulation and with little coaxing ingested most of dose 5. Very well accepted: infant appeared eager and ingested most of dose without special coaxing
Time frame: Immediately after dosing