Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants

• Status: Terminated
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Rifampin

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