Dose-finding, Pharmacokinetics, and Safety of VABOMERE in Pediatric Subjects With Bacterial Infections



Status:Recruiting
Conditions:Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any - 17
Updated:11/4/2018
Start Date:July 2016
End Date:September 2019
Contact:Karen Fusaro
Email:kfusaro@melinta.com

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An Open Label, Dose-finding, Pharmacokinetics, Safety, and Tolerability Study of a Single Dose Infusion of VABOMERE (Meropenem-Vaborbactam) in Pediatric Subjects From Birth to Less Than 18 Years of Age With Serious Bacterial Infections

A single dose infusion of Vabomere (meropenem-vaborbactam) is being tested for dose-finding,
pharmacokinetics, safety, and tolerability in pediatric subjects from birth to less than 18
years of age with serious bacterial infections

In the current era of increased resistance to extended spectrum cephalosporins, carbapenem
antimicrobial agents are frequently the antibiotics of "last defense" for the most resistant
pathogens in serious infections, including those found in complicated Urinary Tract
Infections (cUTI). The recent dissemination of serine carbapenemases (e.g. KPC) in
Enterobacteriaceae in many hospitals worldwide now poses a considerable threat to the
carbapenems and other members of the beta-lactam class of antimicrobial agents.

Rempex developed meropenem-vaborbactam administered as a fixed combination by IV infusion, to
treat serious Gram-negative infections, such as cUTIs, including those infections caused by
bacteria resistant to currently available carbapenems.

This study is an open label, dose-finding, pharmacokinetics, safety, and tolerability study
of a single dose infusion of meropenem-vaborbactam in pediatric subjects from birth to less
than 18 years of age with serious bacterial infections

Inclusion Criteria:

1. A signed and dated written informed consent from the parent or legal representative
and a subject assent (according to local IRB requirements);

2. Male or female from birth to < 18 years of age;

3. Are hospitalized, in stable condition, and receiving systemic antibiotics for a known
or suspected bacterial infection; or subjects receiving peri-operative prophylactic
use of antibiotics;

4. The subject will be observed in the hospital for at least 6 hours after the study drug
is administered;

5. If female and has reached menarche, or has reached Tanner Stage 3 breast development
(even if not having reached menarche), the subject is practicing appropriate birth
control or is sexually abstinent;

6. Sufficient intravascular access (peripheral or central) to receive study drug.

Subjects will be excluded from the study if any of the following exclusion criteria apply
prior to randomization:

1. Signs of severe sepsis including:

1. Shock or profound hypotension that is not responsive to fluid challenge;

2. Hypothermia (core temperature < 35.6 ºC or 96.1 ºF);

3. Disseminated intravascular coagulation as evidenced by prothrombin time or
partial thromboplastin time ≥ 2X the ULN or platelets < 50% of the lower limit of
normal;

2. Any surgical or medical condition which, in the opinion of the investigator, would put
the subject at increased risk or is likely to interfere with study procedures or PK of
the study drug;

3. Females who are of childbearing potential and unwilling to practice abstinence or use
at least two methods of contraception (oral contraceptives, barrier methods, approved
contraceptive implant) during the entire study period;

4. Female adolescent subjects who are pregnant or breastfeeding or have a positive serum
β-hCG pregnancy test at screening and at pre-dose Day 1;

5. Males who are unwilling to practice abstinence or use an acceptable method of broth
control during the entire study period (i.e. condom with spermicide);

6. Renal function at screening as estimated by creatinine clearance < 50 mL/min using the
Cockcroft-Gault formula;

7. Treatment within 30 days prior to enrollment with valproic acid;

8. Treatment within 30 days prior to enrollment with probenecid;

9. Evidence of significant hepatic disease or dysfunction, including known acute viral
hepatitis or hepatic encephalopathy;

10. Neutropenia with absolute neutrophil count (ANC) < 500 cells/mm3;

11. Aspartate aminotransferase or alanine aminotransferase ≥ 3X ULN or total bilirubin ≥
1.5X ULN;

12. Receipt of any investigational medication or investigational device within 30 days
prior to enrollment;

13. Prior exposure to vaborbactam or Vabomere;

14. Use of meropenem within 48 hours of administration of study drug or 12 hours after
study drug administration;

15. Known significant hypersensitivity to any beta-lactam antibiotic;

16. Unable or unwilling in the judgment of the Investigator, to comply with the protocol;

17. An employee of the Investigator or study center with direct involvement in the
proposed study or other studies under the direction of that Investigator or study
center, as well as a family member of the employee or the Investigator;

18. BMI outside the range (below the 5th percentile or above the 95th percentile) for
height, age and weight except for children < 2 years of age.)
We found this trial at
10
sites
225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Principal Investigator: William Muller, M.D.
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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11100 Euclid Avenue
Cleveland, Ohio 44106
(216) 844-1000
Principal Investigator: David Speicher
Phone: 216-844-5112
Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
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Cleveland, OH
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Principal Investigator: Antonio Arrieta, MD
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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3020 Childrens way
San Diego, California 92123
(858) 576-1700
Principal Investigator: John Bradley, MD
Phone: 858-966-8381
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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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Principal Investigator: Jose R. Romero, MD
Phone: 501-364-1542
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Little Rock, AR
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Los Angeles, California 90095
Principal Investigator: Jaime Deville, MD
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Los Angeles, CA
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New Brunswick, New Jersey 08901
Principal Investigator: Sunanda Gaur, MD
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New Brunswick, NJ
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Kari Simonsen, MD
Phone: 402-559-2977
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Omaha, NE
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Toledo, Ohio 43606
Principal Investigator: Jeffrey Blumer, MD
Phone: 419-291-2949
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Toledo, OH
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Torrance, California 90502
Principal Investigator: John McKinnell, MD
Phone: 424-571-9745
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Torrance, CA
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