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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antitubercular
Antitubercular Agents
Enzyme Inhibitors
Leprostatic Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014