Pharmacokinetics (PK) of Antistaphylococcal Antibiotics in Infants (NICHD-2012-02-Staph Trio)
NCT ID: NCT01728363
Last Updated: 2023-07-27
Study Results
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Basic Information
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COMPLETED
PHASE1
63 participants
INTERVENTIONAL
2013-01-31
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Suspected systemic infection or receiving 1 of the study drugs per standard of care
* informed consent from legal guardian
Exclusion Criteria
* 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
14 Days
32 Weeks
ALL
No
Sponsors
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Phillip Brian Smith
OTHER
Responsible Party
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Phillip Brian Smith
Principal Investigator
Principal Investigators
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Philip B Smith, MD
Role: PRINCIPAL_INVESTIGATOR
Duke Clinical Research Institute and DUMC
Locations
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University of FL
Gainesville, Florida, United States
UFL Health and Baptist
Jacksonville, Florida, United States
Emory University
Atlanta, Georgia, United States
Indiana University
Indianapolis, Indiana, United States
Wesley Medical
Wichita, Kansas, United States
University of Louisville
Louisville, Kentucky, 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 Texas Children's Hospital
Galveston, Texas, United States
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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Pro00037820
Identifier Type: -
Identifier Source: org_study_id
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