Status:
TERMINATED
Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Infection
Eligibility:
All Genders
Up to 121 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to learn more about the safety and dosing of rifampin in infants.
Detailed Description
Pharmacokinetics and safety of rifampin will be studied in term and preterm infants who are receiving rifampin per standard of care.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01441206
Start Date
September 1 2011
End Date
April 1 2012
Last Update
September 14 2012
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7596