Clinical trial NCT01441206: Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants
Official title: Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Infection
Keywords: rifampin
infants
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2011-09-27
Enrollment: 2
Sex: ALL
Maximum age (years): 121
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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: 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

Primary outcomes:
measure: Area under the plasma concentration versus time curve 0-24 hours for rifampin
timeFrame: 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
measure: Peak plasma concentration of rifampin
timeFrame: 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
measure: Clearance of rifampin
timeFrame: 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
measure: Volume of distribution at steady state
timeFrame: 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
measure: Half life of rifampin
timeFrame: 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
Secondary outcomes:
measure: Number of subjects with adverse events as a measure of safety and tolerability.
timeFrame: 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.
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Matthew M. Laughon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: