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

Systemic Infection Clinical Trial

— Staph  

Official title:

Pharmacokinetics of Antistaphylococcal Antibiotics in Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01728363
• Other study ID #: Pro00037820
• Status: Completed
• Phase: Phase 1
• Start date: January 2013
• Est. completion date: May 2015

Study information

• Verified date: July 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Multiple center, open-label, PK study

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 information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Days to 32 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Systemic Infection

Intervention

Drug:
• Antibiotic
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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Tufts Medical Center	Boston	Massachusetts
United States	Kings County Hospital Center	Brooklyn	New York
United States	Duke University	Durham	North Carolina
United States	University of FL	Gainesville	Florida
United States	University of Texas Children's Hospital	Galveston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	UFL Health and Baptist	Jacksonville	Florida
United States	University of Louisville	Louisville	Kentucky
United States	Wesley Medical	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Phillip Brian Smith

Country where clinical trial is conducted

United States, 

References & Publications (5)

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 — View 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. — View 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 Clind — View 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 Pharmacokinetic — View 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-clavulan — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	72 hours
Primary	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)	72 hours
Primary	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)	72 hours
Primary	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)	72 hours
Secondary	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	7 days after last study dose
Secondary	Cohort 1 participants: serious adverse events for participants receiving rifampin	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	7 days after last study dose