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Completed

NCT Number: NCT01728363

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

Multiple center, open-label, PK study

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Key information

Conditions

Systemic Infection Infections Toxemia

Age range

14 day–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of FL, Gainesville, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antibiotic

Drug

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

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Phillip Brian Smith

Other

Registry information

Official study title

Pharmacokinetics of Antistaphylococcal Antibiotics in Infants

Acronym: Staph

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 19, 2012
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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