Pharmacokinetics (PK) of Antistaphylococcal Antibiotics in Infants (NICHD-2012-02-Staph Trio)

Phillip Brian Smith63 enrolled

Overview

Multiple center, open-label, PK study

Pharmacokinetics of rifampin, ticarcillin-clavulanate, and clindamycin antibiotics in hospitalized infants with suspected systemic infection or receiving one of the study drugs per local standard of care. Number of participants are 16-32 evaluable per each study drug of rifampin, ticarcillin-clavulanate, and clindamycin antibiotics.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Systemic Infection

Interventions

AntibioticDRUG

Ticarcillin-clavulanate/Timentin is an antibiotic used to treat a wide variety of bacterial infections. Rifampin/Rifadin/Rimatane is an antibiotic and first line antituberculotic. Clindamycin/Cleocin is an antibiotic used to treat a wide variety of bacterial infections and serious bacterial infections.

Eligibility

Sex: ALLMin age: 14 DaysMax age: 32 Weeks

Medical Language ↔ Plain English

Inclusion Criteria: * Sufficient intravascular access * Suspected systemic infection or receiving 1 of the study drugs per standard of care * informed consent from legal guardian Exclusion Criteria: * history of allergic reaction to study drugs * urine output \<0.5 mL/hr/kg over the prior 24 hours * serum creatinine \>1.7 mg/dl * Any condition in investigator judgment precludes participation because it could affect participant safety

Locations (10)

University of FL

Gainesville, Florida, United States

UFL Health and Baptist

Jacksonville, Florida, United States

Emory University

Atlanta, Georgia, United States

Indiana University

Outcomes

Primary Outcomes

Cohort 1: Area under the curve infinity (AUCinfinity) for rifampin

Pharmacometric analysis of area under the curve at steady state for cohort 1 participants who were dosed with rifampin 10mg/kg Q 24 hours x 4 doses (GA \< 32 weeks, PNA \< 14 days)

Time frame: 72 hours

Cohort 1: Maximum concentration (Cmax) of rifampin

Pharmacometric analysis of maximum concentration after first dose for cohort 1 participants who were dosed with rifampin 10 mg/kg Q 24 hours x 4 doses (GA \< 32 weeks, PNA \< 14 days)

Time frame: 72 hours

Cohort 1: Clearance (CL) of rifampin

Pharmacometric analysis of the clearance for cohort 1 participants who were dosed with rifampin 10 mg/kg Q 24 hours x 4 doses (GA \< 32 weeks, PNA \< 14 days)

Time frame: 72 hours

Cohort 1: Volume of distribution at steady state (Vss) of rifampin

Pharmacometric analysis of volume of distribution at steady state for cohort 1 participants who were dosed with rifampin 10 mg/kg Q 24 hours x 4 doses (GA \< 32 weeks, PNA \< 14 days)

Time frame: 72 hours

Secondary Outcomes

Cohort 1: Adverse events for participants receiving rifampin

Adverse events experienced by cohort 1 participants receiving rifampin 10 mg/kg Q 24 hours x 4 doses (GA \< 32 weeks, PNA \> 14 days). An adverse event is any untoward medical occurrence in humans, whether or not considered drug-related, that occurs during the conduct of a clinical trial. Any change in clinical status (routine labs, physical examinations, etc.) that is considered clinically significant

Time frame: 7 days after last study dose

Cohort 1 participants: serious adverse events for participants receiving rifampin

Data from ClinicalTrials.gov

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