- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01728363
Pharmacokinetics (PK) of Antistaphylococcal Antibiotics in Infants (NICHD-2012-02-Staph Trio) (Staph)
Pharmacokinetics of Antistaphylococcal Antibiotics in Infants
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Florida
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Gainesville, Florida, United States, 32610
- University of FL
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Jacksonville, Florida, United States, 32209
- UFL Health and Baptist
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University
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Kansas
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Wichita, Kansas, United States, 67214
- Wesley Medical
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Kentucky
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Louisville, Kentucky, United States, 40202
- University of Louisville
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Tufts Medical Center
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New York
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Brooklyn, New York, United States, 11203
- Kings County Hospital Center
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North Carolina
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Durham, North Carolina, United States, 27705
- Duke University
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Texas
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Galveston, Texas, United States, 77555
- University of Texas Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
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:
|
Experimental: Rifampin generic antibiotic
Cohort GA PNA Dose
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:
|
Experimental: Clindamycin Generic Antibiotic
Cohort GA PNA Dose
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:
|
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
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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)
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72 hours
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Cohort 1: Maximum concentration (Cmax) of rifampin
Time Frame: 72 hours
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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)
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72 hours
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Cohort 1: Clearance (CL) of rifampin
Time Frame: 72 hours
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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)
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72 hours
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Cohort 1: Volume of distribution at steady state (Vss) of rifampin
Time Frame: 72 hours
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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)
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72 hours
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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
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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
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7 days after last study dose
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Cohort 1 participants: serious adverse events for participants receiving rifampin
Time Frame: 7 days after last study dose
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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
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7 days after last study dose
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philip B Smith, MD, Duke Clinical Research Institute and DUMC
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Systemic Inflammatory Response Syndrome
- Inflammation
- Sepsis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Leprostatic Agents
- Protein Synthesis Inhibitors
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Antitubercular Agents
- Antibiotics, Antitubercular
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C8 Inducers
- Cytochrome P-450 CYP2C19 Inducers
- Cytochrome P-450 CYP2C9 Inducers
- beta-Lactamase Inhibitors
- Anti-Bacterial Agents
- Rifampin
- Clindamycin
- Clavulanic Acid
- Ticarcillin
- Ticarcillin-clavulanic acid
Other Study ID Numbers
- Pro00037820
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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