Systemic Infection
Conditions
Keywords
Staphylococcal
Brief summary
Multiple center, open-label, PK study
Detailed description
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.
Interventions
DRUGAntibiotic
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.
Sponsors
Phillip Brian Smith
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Days to 32 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1: Area under the curve infinity (AUCinfinity) for rifampin | 72 hours | 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) |
| Cohort 1: Maximum concentration (Cmax) of rifampin | 72 hours | 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) |
| Cohort 1: Clearance (CL) of rifampin | 72 hours | 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) |
| Cohort 1: Volume of distribution at steady state (Vss) of rifampin | 72 hours | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1: Adverse events for participants receiving rifampin | 7 days after last study dose | 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 |
| Cohort 1 participants: serious adverse events for participants receiving rifampin | 7 days after last study dose | Serious adverse events experienced by cohort 1 participants receiving rifampin 10 mg/kg Q 24 hours x 4 doses(GA \< 32 weeks, PNA \> 14 days)Any event that results in any of the following outcomes: death, life-threatening adverse vent, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, inpatient hospitalization or prolongation of existing hospitalization, or important medical event that may jeopardize the health of the study participant or require medical or surgical intervention to prevent another outcome listed above |
Countries
United States
Outcome results
None listed