Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants

Stopped early · Phase 1

Conditions studied: Infection

In brief

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

Key facts

Study ID

NCT01441206

Run by

University of North Carolina, Chapel Hill

People needed

2

Starts

2011-09-01

Expected to finish

2012-04-01

Last updated by the study team

2012-09-14

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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

Where it is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.