A Pharmacokinetics Study of MK-7655A in Pediatric Participants With Gram-negative Infections (MK-7655A-020)



Status:Recruiting
Conditions:Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any - 17
Updated:1/30/2019
Start Date:November 6, 2017
End Date:August 13, 2020
Contact:Toll Free Number
Email:Trialsites@merck.com
Phone:1-888-577-8839

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A Phase 1b, Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of MK-7655A in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed or Suspected Gram-negative Infections

This study aims to obtain plasma pharmacokinetic (PK) data and characterize the PK profile of
imipenem (IMI), cilastatin (CIL), and relebactam (REL) following administration of a single
intravenous (IV) dose of MK-7655A (a fixed ratio combination of
imipenem/cilastatin/relebactam), hereafter referred to as IMI/REL.


Inclusion Criteria:

- Has a parent or legally acceptable representative (LAR) who provides written informed
consent for the trial on the participant's behalf.

- Aged from birth to <18 years old; or was born at or after 37 weeks of gestation.

- Is hospitalized, currently receiving antibacterial treatment for confirmed or
suspected Gram-negative bacterial infection, and expected to require hospitalization
until at least 24 hours after completion of study drug administration.

- Is not of reproductive potential; but if of reproductive potential, agrees to avoid
becoming pregnant or impregnating a partner from the time of consent through 24 hours
after completion of study drug administration.

- Has clinically stable renal function at the time of screening that is judged to be
within acceptable ranges.

- Has sufficient intravascular access to receive study drug through an existing
peripheral or central line.

Exclusion Criteria:

- Has a personal history of hypersensitivity to imipenem/cilastatin (IMI) or to any of
the following: any carbapenem, cephalosporin, penicillin, or other β-lactam agent; or
other β-lactamase inhibitors (BLIs) e.g. tazobactam, sulbactam, clavulanic acid,
avibactam.

- Female is currently pregnant or breast feeding or has a positive serum β-human
chorionic gonadotropin (β-hCG) pregnancy test.

- Has a history of a seizure disorder requiring ongoing treatment with anti-convulsive
therapy or prior treatment with anti-convulsive therapy within the last 3 years.

- Has used or plans to use valproic acid or divalproex sodium within 2 weeks prior to
screening or at any point between screening and 24 hours after the completion of study
drug infusion.

- Has received treatment or plans to receive treatment with any carbapenem antibiotic
within 48 hours prior to initiation of study drug infusion or at any point between
administration of study drug and the last PK sample collection.

- Has used or plans to use any of the following medications, which are organic anion
transporter (OAT) 1 or OAT3 inhibitors, within 1 week prior to screening or at any
point between screening and the last PK sample collection: cimetidine, probenecid,
indomethacin,mefenamic acid, furosemide or other loop diuretics (eg, bumetanide,
torsemide, ethacrynic acid), angiotensin receptor blockers (eg, valsartan), and
ketorolac.

- Is currently participating in or has participated in an interventional clinical trial
with an investigational compound or device within 30 days prior to screening.

- Has enrolled previously in the current trial and been discontinued, or has received
REL for any other reason.

- Has a current diagnosis of cystic fibrosis, meningitis, or severe sepsis.

- Is expected to survive less than 72 hours after completion of study drug
administration.

- Has a history of clinically significant renal, hepatic, or hemodynamic instability.

- Plans to use cardiopulmonary bypass, extracorporeal membrane oxygenation,
hemodialysis, or peritoneal dialysis during the study.

- For participants that are 2 to 17 years of age only: weighs outside of the 5th to 95th
percentile based on age.

- Is, at the time of signing informed consent, a user of recreational or illicit drugs
or has had a recent history (within the last year) of drug or alcohol abuse or
dependence.

- Has a planned blood transfusion within 24 hours of study drug administration or
expected before the end of the PK sampling.

- Has had significant blood loss (≥5% of total blood volume) within 4 weeks before the
screening visit.
We found this trial at
8
sites
1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Phone: 501-364-1416
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Phone: 714-509-4064
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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Orange, CA
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Phone: 215-590-4024
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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3020 Childrens way
San Diego, California 92123
(858) 576-1700
Phone: 858-966-7785
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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San Diego, CA
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Baton Rouge, Louisiana 70808
Phone: 225-765-5956
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Cali, Valle Del Cauca 760032
Phone: +57233190904022
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Cali,
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Phone: 919-681-1504
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Phone: 206-884-5086
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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Seattle, WA
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