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Systemic InfectionPhase 1StaphNCT01728363

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

A Phase 1 study testing Antibiotic in people with Systemic Infection, run by Phillip Brian Smith at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Multiple center, open-label, PK study Read more about this study

Who is it for?
Ages 14 days to 32 weeks
Conditions the study is for
Systemic Infection
What is being tested?
Antibiotic
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
10 sitesUnited States
Study dates
Jan 2013to May 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 days to 32 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Sufficient intravascular access
  • Suspected systemic infection or receiving 1 of the study drugs per standard of care
  • informed consent from legal guardian

Who cannot join

  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Emory University

    Atlanta, Georgia, 30322

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Kings County Hospital Center

    Brooklyn, New York, 11203

  • Duke University

    Durham, North Carolina, 27705

  • University of FL

    Gainesville, Florida, 32610

  • University of Texas Children's Hospital

    Galveston, Texas, 77555

  • Indiana University

    Indianapolis, Indiana, 46202

  • UFL Health and Baptist

    Jacksonville, Florida, 32209

  • University of Louisville

    Louisville, Kentucky, 40202

  • Wesley Medical

    Wichita, Kansas, 67214

Other trials in United States

About this study

Official title: Pharmacokinetics of Antistaphylococcal Antibiotics in Infants

Multiple center, open-label, PK study

Read the 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.

Being tested
Antibiotic
Keywords
Staphylococcal
Medical subject headings
Toxemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AntibioticDrug

    Also called Ticarcillin-clavulanate generic; Brand Timentin, Rifampin generic; Brand Rifadin, Rimatane, Clindamycin generic; Brand Cleocin

    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.

Study groups in NCT01728363
Study groupRoleWhat they receive
Ticarcillin-clavulanate antibioticExperimentalCohort 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.
Receives: Drug: Antibiotic
Rifampin generic antibioticExperimentalCohort 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.
Receives: Drug: Antibiotic
Clindamycin Generic AntibioticExperimentalCohort 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.
Receives: Drug: Antibiotic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 72 hours

  2. 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)

    Measured: 72 hours

  3. 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)

    Measured: 72 hours

  4. 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)

    Measured: 72 hours

Secondary outcomes (2)

  1. 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

    Measured: 7 days after last study dose

  2. 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

    Measured: 7 days after last study dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2012 (estimated)
  2. Study startJan 2013
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01728363
Sponsor's protocol ID
Pro00037820
Acronym
Staph
Status last verified
Jul 2023
First submitted
9 Nov 2012
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28779462

  • 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.

    PubMed 26926644

  • 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.

    PubMed 30910891

  • 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.

    PubMed 30710387

  • 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.

    PubMed 28137820

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Antibiotic in people with Systemic Infection, run by Phillip Brian Smith at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort 1: Area under the curve infinity (AUCinfinity) for rifampin (time frame: 72 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01728363, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.

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