Pharmacokinetics (PK) of Antistaphylococcal Antibiotics in Infants (NICHD-2012-02-Staph Trio)
- Registration Number
- NCT01728363
- Lead Sponsor
- Phillip Brian Smith
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
- Sufficient intravascular access
- Suspected systemic infection or receiving 1 of the study drugs per standard of care
- informed consent from legal guardian
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ticarcillin-clavulanate antibiotic Antibiotic Cohort Gestational Age (GA) Postnatal Age (PNA) Dose 1. \<30 weeks \<14 days: 75 mg/kg Q12 hrs x 6 doses 2. \<30 weeks ≥14 days-45 days 75 mg/kg Q 8 hours x 6 doses 3. \<30 weeks \>45 days-90 days 75 mg/kg Q 6 hours x 6 doses Brand name is Timentin. This drug is an antibiotic used to treat a wide variety of bacterial infections. It is a combination of two drugs \& both treat bacterial infections. Ticarcillin is a penicillin-type antibiotic that stops bacterial growth \& clavulanate potassium is an enzyme inhibitor that helps the ticarcillin work better. Rifampin generic antibiotic Antibiotic Cohort GA PNA Dose 1. \<32 weeks \<14 days 10 mg/kg Q 24 hours x 4 doses 2. \<32 weeks ≥14 days-120 days 15 mg/kg Q 24 hours x 4 doses 3. ≥32 weeks \<14 days 15 mg/kg Q 24 hours x 4 doses 4. ≥32 weeks ≥14 days-120 days 20 mg/kg Q 24 hours x 4 doses The brand name is Rifadin, Rimatane. This drug is an antibiotic and a first line antituberculotic and unlabeled use for infections caused by staphylococcus aureus \& staphylococcus epidermis. Clindamycin Generic Antibiotic Antibiotic Cohort GA PNA Dose 1. \<30 weeks \<14 days 10 mg/kg Q 12 hours x 6 doses 2. \<30 weeks ≥14 days-45 days 10 mg/kg Q 8 hours x 6 doses 3. \<30 weeks \>45 days-120 days 10 mg/kg Q 6 hours x 6 doses The brand name is Cleocin. This drug is an antibiotic used to treat a wide variety of bacterial infections and serious infections.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (10)
University of Louisville
🇺🇸Louisville, Kentucky, United States
Duke University
🇺🇸Durham, North Carolina, United States
Kings County Hospital Center
🇺🇸Brooklyn, New York, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
University of FL
🇺🇸Gainesville, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
University of Texas Children's Hospital
🇺🇸Galveston, Texas, United States
UFL Health and Baptist
🇺🇸Jacksonville, Florida, United States
Wesley Medical
🇺🇸Wichita, Kansas, United States