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A Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants (PTN_Acyclo)

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ClinicalTrials.gov Identifier: NCT00942084
Recruitment Status : Completed
First Posted : July 20, 2009
Results First Posted : January 8, 2014
Last Update Posted : January 8, 2014
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Phillip Brian Smith, Duke University

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Herpes Simplex Virus
Neonatal Sepsis
Intervention: Drug: Acyclovir

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Total enrollment is 32. 32 for safety analysis and 30 in PK population (28 included in final PK analysis).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Acyclovir Study Enrollment Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).

Participant Flow:   Overall Study
    Acyclovir Study Enrollment
STARTED   32 
COMPLETED   30 [1] 
NOT COMPLETED   2 
Death                2 
[1] There were 2 infant deaths. None determined to be related to study drug.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Acyclovir Study Design Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).

Baseline Measures
   Acyclovir Study Design 
Overall Participants Analyzed 
[Units: Participants]
 32 
Age 
[Units: Days]
Median (Full Range)
 
Postnatal Age (days)   3.0 
 (0.0 to 30.0) 
Age 
[Units: Weeks]
Median (Full Range)
 
Gestational Age (weeks)   30.5 
 (23.0 to 40.0) 
Gender 
[Units: Participants]
 
Female   17 
Male   15 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   4 
Not Hispanic or Latino   28 
Unknown or Not Reported   0 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   1 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   11 
White   20 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   32 
Birthweight 
[Units: Grams]
Median (Full Range)
 1295 
 (420 to 4840) 


  Outcome Measures

1.  Primary:   Clearance (CL)   [ Time Frame: V1:0-5 min,2-4 hrs,6-8 hrs post Doses 1&5-15;prior to doses 5-15; V2:0-15 min post doses 1&5-15; within 30 min prior to doses 2&5-15; 2-3 hrs post doses 5-15; 15-18 hrs post last dose ]

2.  Primary:   Volume of Distribution (V)   [ Time Frame: up to 3 days of study drug administration and 10 days of safety monitoring ]

3.  Primary:   Half-life (T1/2)   [ Time Frame: up to 3 days of study drug administration and 10 days of safety monitoring ]

4.  Primary:   Maximum Steady State Concentration (Cmaxss)   [ Time Frame: up to 3 dasy of study drug administration and 10 days of safety monitoring ]

5.  Primary:   Steady State Concentration at 50% of the Dosing Interval (C50ss)   [ Time Frame: up to 3 days of study drug administration and 10 days of safety monitoring ]

6.  Primary:   Minimum Steady State Concentration (Cminss)   [ Time Frame: up to 3 days of study drug administration and 10 days of safety monitoring ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: P. Brian Smith, MD MPH MHS
Organization: Duke Clinical Research Institute
phone: 919-668-8951
e-mail: brian.smith@duke.edu


Publications of Results:
Other Publications:
Pickering LK. Red Book. 28th ed. Elk Grove Village, Illinois: American Academy of Pediatrics; 2009.


Responsible Party: Phillip Brian Smith, Duke University
ClinicalTrials.gov Identifier: NCT00942084     History of Changes
Other Study ID Numbers: Pro00028772
First Submitted: July 17, 2009
First Posted: July 20, 2009
Results First Submitted: August 27, 2013
Results First Posted: January 8, 2014
Last Update Posted: January 8, 2014