Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants

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

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

Official Title
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Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants

Conditions
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Infection

Intervention / Treatment
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* Drug: rifampin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 121 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: rifampin<br>Cohort 1 will include infants who will be receiving up to 4 doses rifampin per study protocol. | Drug: rifampin<br>* 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<br>|
| No Intervention: rifampin per standard of care<br>Cohort 2: Receiving rifampin per standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rifampin, infants