Clinical trial NCT01728363: Pharmacokinetics (PK) of Antistaphylococcal Antibiotics in Infants (NICHD-2012-02-Staph Trio)
Official title: Pharmacokinetics of Antistaphylococcal Antibiotics in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Systemic Infection
Keywords: Staphylococcal
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2012-11-19
Enrollment: 63
Sex: ALL
Minimum age (years): 14
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cohort 1: Area under the curve infinity (AUCinfinity) for rifampin
timeFrame: 72 hours
measure: Cohort 1: Maximum concentration (Cmax) of rifampin
timeFrame: 72 hours
measure: Cohort 1: Clearance (CL) of rifampin
timeFrame: 72 hours
measure: Cohort 1: Volume of distribution at steady state (Vss) of rifampin
timeFrame: 72 hours
Secondary outcomes:
measure: Cohort 1: Adverse events for participants receiving rifampin
timeFrame: 7 days after last study dose
measure: Cohort 1 participants: serious adverse events for participants receiving rifampin
timeFrame: 7 days after last study dose
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of FL
state: Florida
city: Jacksonville
country: United States
facility: UFL Health and Baptist
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Wichita
country: United States
facility: Wesley Medical
state: Kansas
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Brooklyn
country: United States
facility: Kings County Hospital Center
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Galveston
country: United States
facility: University of Texas Children's Hospital
state: Texas
Study officials:
affiliation: Duke Clinical Research Institute and DUMC
name: Philip B Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maharaj AR, Gonzalez D, Cohen-Wolkowiez M, Hornik CP, Edginton AN. Improving Pediatric Protein Binding Estimates: An Evaluation of alpha1-Acid Glycoprotein Maturation in Healthy and Infected Subjects. Clin Pharmacokinet. 2018 May;57(5):577-589. doi: 10.1007/s40262-017-0576-7.
citation: Gonzalez D, Delmore P, Bloom BT, Cotten CM, Poindexter BB, McGowan E, Shattuck K, Bradford KK, Smith PB, Cohen-Wolkowiez M, Morris M, Yin W, Benjamin DK Jr, Laughon MM. Clindamycin Pharmacokinetics and Safety in Preterm and Term Infants. Antimicrob Agents Chemother. 2016 Apr 22;60(5):2888-94. doi: 10.1128/AAC.03086-15. Print 2016 May.
citation: Smith PB, Cotten CM, Hudak ML, Sullivan JE, Poindexter BB, Cohen-Wolkowiez M, Boakye-Agyeman F, Lewandowski A, Anand R, Benjamin DK Jr, Laughon MM; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Rifampin Pharmacokinetics and Safety in Preterm and Term Infants. Antimicrob Agents Chemother. 2019 May 24;63(6):e00284-19. doi: 10.1128/AAC.00284-19. Print 2019 Jun.
citation: Watt KM, Hornik CP, Balevic SJ, Mundakel G, Cotten CM, Harper B, Benjamin DK Jr, Anand R, Laughon M, Smith PB, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act - Pediatric Trials Network Steering Committee. Pharmacokinetics of ticarcillin-clavulanate in premature infants. Br J Clin Pharmacol. 2019 May;85(5):1021-1027. doi: 10.1111/bcp.13882. Epub 2019 Mar 6.
citation: Smith MJ, Gonzalez D, Goldman JL, Yogev R, Sullivan JE, Reed MD, Anand R, Martz K, Berezny K, Benjamin DK Jr, Smith PB, Cohen-Wolkowiez M, Watt K; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Pharmacokinetics of Clindamycin in Obese and Nonobese Children. Antimicrob Agents Chemother. 2017 Mar 24;61(4):e02014-16. doi: 10.1128/AAC.02014-16. Print 2017 Apr.