MK-7625A Plus Metronidazole Versus Meropenem in Pediatric Participants With Complicated Intra-Abdominal Infection (cIAI) (MK-7625A-035)

Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Age Range:Any - 17
Start Date:April 3, 2018
End Date:September 6, 2020
Contact:Toll Free Number

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A Phase 2, Randomized, Active Comparator-Controlled, Multicenter, Double-Blind Clinical Trial to Study the Safety and Efficacy of Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem in Pediatric Subjects With Complicated Intra-Abdominal Infection

This study aims to evaluate the safety and tolerability of MK-7625A (ceftolozane/tazobactam)
plus metronidazole, compared with that of meropenem in pediatric participants with cIAI.

Inclusion Criteria:

- Has a legal representative who provides written informed consent on the participant's
behalf and provides age-appropriate written informed assent (as applicable) for the

- Aged from birth (defined as >32 weeks gestational age and ≥7 days postnatal) to <18
years of age.

- Require IV antibacterial therapy for the treatment of presumed or documented cIAI.

- Has an operative procedure for the current diagnosis and management of cIAI planned or
completed within 24 hours of the first dose of an antibacterial drug.

- Has in compliance baseline intra-abdominal specimen collection.

- Is not of reproductive potential; but if of reproductive potential agrees to avoid
becoming pregnant or impregnating a partner during screening, while receiving study
treatment and for at least 30 days after the last dose of study treatment.

- Female of reproductive potential is not pregnant, and not planning to become pregnant
within 30 days of the last day of treatment administration; and is nonlactating.

Exclusion Criteria:

- Is currently participating in or has participated in an interventional clinical trial
with an investigational compound or device within 30 days prior to the first dose of
study treatment in this current trial.

- Has previously participated in any trial of ceftolozane or ceftolozane/tazobactam or
has enrolled previously in the current trial and been discontinued.

- Has a history of any moderate or severe hypersensitivity (eg, anaphylaxis), allergic
reaction, or other contraindication to any of the following: β-lactam antibiotics (eg,
penicillins, cephalosporins, and carbapenems), β-lactamase inhibitors (eg, tazobactam,
sulbactam, clavulanic acid, avibactam), or metronidazole.

- Has an IAI within the past 1 year prior to randomization known to be caused by a
pathogen resistant to either IV study treatment.

- Has a concomitant infection at the time of randomization that requires nonstudy
systemic antibacterial therapy in addition to IV study treatment or oral step-down

- Has received potentially therapeutic antibacterial therapy for a duration more than 24
hours during the 48 hours preceding the first dose of study treatment, unless is
considered to be failing antibiotic therapy for cIAI.

- Has any of the following: a) intractable cIAI that the investigator anticipates would
require more than 14 days of study treatment; b) abdominal wall abscess; c) small
bowel obstruction; d) ischemic bowel disease without perforation; e) traumatic bowel
perforation with surgery within 12 hours of perforation; f) perforation of
gastroduodenal ulcers requiring surgery within 24 hours of perforation; g) suspected
uncomplicated intra-abdominal infection (eg, cholecystitis without rupture or
extension beyond the gallbladder wall); h) acute suppurative cholangitis; i) infected
necrotizing pancreatitis; j) pancreatic abscess.

- Has severe impairment of renal function.

- Has a seizure disorder or is anticipated to be treated with divalproex sodium or
valproic acid during the course of study treatment.

- Is receiving, or is expected to receive, any prohibited medications.

- Has any rapidly progressing disease or immediately life-threatening illness, including
acute hepatic failure, respiratory failure, or septic shock.

- Has an immunocompromising condition.

- Has a history of malignancy ≤5 years prior to signing informed consent.

- Is planning to receive suppressive/prophylactic antibiotics with gram-negative
activity after completion of study treatment.
We found this trial at
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...
San Diego, CA
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Phone: 323-361-5047
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
Los Angeles, CA
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Phone: 714-509-4791
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
Orange, CA
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750 E Adams St
Syracuse, New York 13210
(315) 464-5540
Phone: 315-464-7353
SUNY Upstate Medical University Hospital SUNY Upstate Medical University in Syracuse, NY, is the only...
Syracuse, NY
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Boston, Massachusetts 02111
Phone: 617-636-5025
Boston, MA
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Jacksonville, Florida 32207
Phone: 904-244-5331
Jacksonville, FL
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Recife, Pernambuco 50070
Phone: +558121224792
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Saint Louis, Missouri 63110
Phone: 314-747-5128
Saint Louis, MO
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Salt Lake City, Utah 84143
Phone: 801-587-0694
Salt Lake City, UT
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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...
Seattle, WA
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