Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants

This study has been terminated.
(Study to be redesigned.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01441206
First received: September 19, 2011
Last updated: September 13, 2012
Last verified: September 2012
  Purpose

The purpose of this study is to learn more about the safety and dosing of rifampin in infants.


Condition Intervention Phase
Infection
Drug: rifampin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Area under the plasma concentration versus time curve 0-24 hours for rifampin [ Time Frame: Sampling for 24 hr dosing:Dose 1:0-15min,30-60min,1-3hr,3-6hr, 6-12hr,12-18hr. Dose 2,3 or 4:<15min prior to dose, 48-72hrs. Sampling for 12 hr dosing:Dose 1: 0-15min, 0.5-1hr, 1-2hr, 2-4hr, 5-8hr, 8-10 hr. Dose 2, 3 or 4:<15min prior to dose, 24-36hr ] [ Designated as safety issue: No ]
  • Peak plasma concentration of rifampin [ Time Frame: Sampling for 24 hr dosing:Dose 1:0-15min,30-60min,1-3hr,3-6hr, 6-12hr,12-18hr. Dose 2,3 or 4:<15min prior to dose, 48-72hrs. Sampling for 12 hr dosing:Dose 1: 0-15min, 0.5-1hr, 1-2hr, 2-4hr, 5-8hr, 8-10 hr. Dose 2, 3 or 4:<15min prior to dose, 24-36hr ] [ Designated as safety issue: No ]
  • Clearance of rifampin [ Time Frame: Sampling for 24 hr dosing:Dose 1:0-15min,30-60min,1-3hr,3-6hr, 6-12hr,12-18hr. Dose 2,3 or 4:<15min prior to dose, 48-72hrs. Sampling for 12 hr dosing:Dose 1: 0-15min, 0.5-1hr, 1-2hr, 2-4hr, 5-8hr, 8-10 hr. Dose 2, 3 or 4:<15min prior to dose, 24-36hr ] [ Designated as safety issue: No ]
  • Volume of distribution at steady state [ Time Frame: Sampling for 24 hr dosing:Dose 1:0-15min,30-60min,1-3hr,3-6hr, 6-12hr,12-18hr. Dose 2,3 or 4:<15min prior to dose, 48-72hrs. Sampling for 12 hr dosing:Dose 1: 0-15min, 0.5-1hr, 1-2hr, 2-4hr, 5-8hr, 8-10 hr. Dose 2, 3 or 4:<15min prior to dose, 24-36hr ] [ Designated as safety issue: No ]
  • Half life of rifampin [ Time Frame: Sampling for 24 hr dosing:Dose 1:0-15min,30-60min,1-3hr,3-6hr, 6-12hr,12-18hr. Dose 2,3 or 4:<15min prior to dose, 48-72hrs. Sampling for 12 hr dosing:Dose 1: 0-15min, 0.5-1hr, 1-2hr, 2-4hr, 5-8hr, 8-10 hr. Dose 2, 3 or 4:<15min prior to dose, 24-36hr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of subjects with adverse events as a measure of safety and tolerability. [ Time Frame: From the time of the first dose to 3 days after the last dose; serious adverse events will be collected from the first dose of rifampin to 7 days after the last dose of rifampin. ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: September 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
rifampin
Cohort 1 will include infants who will be receiving up to 4 doses rifampin per study protocol.
Drug: rifampin

Infants who will be receiving up to 4 doses of rifampin per protocol(Cohort 1)

Cohort 1:

Dosing will be as follows:

GA at birth < 32 weeks - PNA < 14 days: 10 mg/kg QD GA at birth < 32 weeks - PNA ≥ 14 days: 15 mg/kg QD GA at birth ≥ 32 weeks - PNA < 14 days: 15 mg/kg QD GA at birth ≥ 32 weeks - PNA ≥ 14 days: 20 mg/kg QD

No Intervention: rifampin per standard of care
Cohort 2: Receiving rifampin per standard of care

Detailed Description:

Pharmacokinetics and safety of rifampin will be studied in term and preterm infants who are receiving rifampin per standard of care.

  Eligibility

Ages Eligible for Study:   up to 121 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Cohort 1:

  • Suspected systemic infection
  • Infant < 121 days of age at the time of 1st dose of rifampin administration
  • Sufficient intravascular access (either peripheral or central) to receive rifampin.

Cohort 2:

  • Receiving rifampin per local standard of care.
  • Infant < 121 days of age at the time of 1st dose of rifampin administration

Exclusion Criteria:

Cohort 1:

  • History of allergic reactions to rifampin
  • Aspartate aminotransferase (AST) greater than 3 times upper limit of normal
  • Alanine aminotransferase (ALT) greater than 3 times upper limit of normal
  • Serum creatinine greater than 1.7 mg.dL
  • Urine output < 0.5 mL/hr/kg over the prior 24 hours
  • Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study

Cohort 2:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441206

Locations
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7596
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Matthew M. Laughon, MD, MPH University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01441206     History of Changes
Other Study ID Numbers: 10-2314, 1K23HD068497-01
Study First Received: September 19, 2011
Last Updated: September 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of North Carolina, Chapel Hill:
rifampin
infants

Additional relevant MeSH terms:
Rifampin
Antibiotics, Antitubercular
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014