Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants

Infection Clinical Trial

Official title:

Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01441206
• Other study ID #: 10-2314
• Secondary ID: 1K23HD068497-01
• Status: Terminated
• Phase: Phase 1
• First received: September 19, 2011
• Last updated: September 13, 2012
• Start date: September 2011
• Est. completion date: April 2012

Study information

• Verified date: September 2012
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

Pharmacokinetics and safety of rifampin will be studied in term and preterm infants who are receiving rifampin per standard of care.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 121 Days

Eligibility

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:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Infection

Intervention

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

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration versus time curve 0-24 hours for rifampin		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	No
Primary	Peak plasma concentration of rifampin		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	No
Primary	Clearance of rifampin		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	No
Primary	Volume of distribution at steady state		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	No
Primary	Half life of rifampin		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	No
Secondary	Number of subjects with adverse events as a measure of safety and tolerability.		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.	Yes