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

July 25, 2023 updated by: Phillip Brian Smith

Pharmacokinetics of Antistaphylococcal Antibiotics in Infants

Multiple center, open-label, PK study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Gainesville, Florida, United States, 32610
        • University of FL
      • Jacksonville, Florida, United States, 32209
        • UFL Health and Baptist
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Wesley Medical
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • New York
      • Brooklyn, New York, United States, 11203
        • Kings County Hospital Center
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University
    • Texas
      • Galveston, Texas, United States, 77555
        • University of Texas Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks to 7 months (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ticarcillin-clavulanate 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.

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.
Other Names:
  • Ticarcillin-clavulanate generic; Brand Timentin
  • Rifampin generic; Brand Rifadin, Rimatane
  • Clindamycin generic; Brand Cleocin
Experimental: Rifampin generic 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.

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.
Other Names:
  • Ticarcillin-clavulanate generic; Brand Timentin
  • Rifampin generic; Brand Rifadin, Rimatane
  • Clindamycin generic; Brand Cleocin
Experimental: Clindamycin Generic 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.

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.
Other Names:
  • Ticarcillin-clavulanate generic; Brand Timentin
  • Rifampin generic; Brand Rifadin, Rimatane
  • Clindamycin generic; Brand Cleocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohort 1: Area under the curve infinity (AUCinfinity) for rifampin
Time Frame: 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)
72 hours
Cohort 1: Maximum concentration (Cmax) of rifampin
Time Frame: 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)
72 hours
Cohort 1: Clearance (CL) of rifampin
Time Frame: 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)
72 hours
Cohort 1: Volume of distribution at steady state (Vss) of rifampin
Time Frame: 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)
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohort 1: Adverse events for participants receiving rifampin
Time Frame: 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
7 days after last study dose
Cohort 1 participants: serious adverse events for participants receiving rifampin
Time Frame: 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
7 days after last study dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Philip B Smith, MD, Duke Clinical Research Institute and DUMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

November 9, 2012

First Submitted That Met QC Criteria

November 14, 2012

First Posted (Estimated)

November 19, 2012

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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