Study of Ceftolozane/Tazobactam (MK-7625A) in Combination With Metronidazole in Japanese Participants With Complicated Intra-abdominal Infection (MK-7625A-013)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02739997
• Date of registration: 30/03/2016
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp.
• Public title: Study of Ceftolozane/Tazobactam (MK-7625A) in Combination With Metronidazole in Japanese Participants With Complicated Intra-abdominal Infection (MK-7625A-013)
• Scientific title: A Multicenter, Open-label, Noncomparative, Japanese Phase III Study to Assess the Efficacy and Safety of Ceftolozane/Tazobactam (MK-7625A) Used in Combination With Metronidazole in Japanese Patients With Complicated Intra-abdominal Infection.
• Date of first enrolment: April 8, 2016
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02739997
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Japan

Contacts

• Name: Medical Director
• Affiliation: Merck Sharp & Dohme Corp.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Has one of the following diagnoses with evidence of intra-peritoneal infection:
cholecystitis (including gangrenous cholecystitis) with rupture, perforation, or
progression of the infection beyond the gallbladder wall; diverticular disease with
perforation or abscess; appendiceal perforation or periappendiceal abscess; acute
gastric or duodenal perforation, traumatic perforation of the intestine; peritonitis
due to perforated viscus or following a prior operative procedure; or Intra-abdominal
abscess (including liver and spleen).

- Has evidence of systemic infection

- Had or has plans to have surgical intervention within 24 hours of the first dose of
study drug

- Has radiographic evidence of perforation or abscess if enrolled preoperatively

- Is able to have intra-abdominal specimen taken at baseline for the microbiological
assessment

- Female participants of child bearing potential must not be pregnant (negative human
chorionic gonadotropin test) or breastfeeding and must agree to use adequate
contraception for the duration of the study and up to 35 days after the last dose of
study drug

- Male participants must agree to use adequate contraception for the duration of the
study and up to 75 days after the last dose of study drug

Exclusion Criteria:

- Has simple appendicitis; abdominal wall abscess; small bowel obstruction or ischemic
bowel disease without perforation; spontaneous bacterial peritonitis associated with
cirrhosis and chronic ascites; acute suppurative cholangitis; infected necrotizing
pancreatitis; pancreatic abscess; infectious mononucleosis; cystic fibrosis; or pelvic
infections

- Has complicated intra-abdominal infection managed by staged abdominal repair (STAR) or
open abdomen drainage

- Has had acute gastric or duodenal perforation (= 24 hours after) or traumatic
perforation of the intestine (= 12 hours after) operated on after the perforation
occurred

- Is expected to be cured by only surgical intervention without use of systemic
antibacterial therapy

- Has used systemic antibacterial therapy for intra-abdominal infection for more than 24
hours prior to the first dose of study drug, unless there is a documented treatment
failure with such therapy

- Has severe impairment of renal function (estimated CrCl < 30 mL/minute), or
requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria (< 20
mL/hour urine output over 24 hours)

- Has a concomitant infection at the time of randomization, which requires non-study
systemic antibacterial therapy in addition to study drug with the exception of an
antibacterial with Gram-positive activity only (vancomycin, teicoplanin, linezolid and
daptomycin)

- Has used any postoperative non-study antibacterial therapy if enrolled preoperatively

- Has used more than 1 dose of non-study antibacterial therapy following surgery if
enrolled postoperatively

- Has hepatic disease

- Is unlikely to survive the 4 to 5 week study period

- Has organic brain or spinal cord disease

- Has any rapidly-progressing disease or immediately life-threatening illness

- Has an immunocompromising condition (i.e., AIDS, hematological malignancy, or bone
marrow transplantation, or immunosuppressive therapy) or is receiving = 40 mg of
prednisone per day administered continuously for > 14 days prior to study start

- Has a history of any moderate or severe hypersensitivity or allergic reaction to any
beta-lactam (ß-lactam) antibacterial, including cephalosporins, carbapenems,
penicillins, or ß-lactamase inhibitors, or metronidazole, or nitroimidazole
derivatives

- Is receiving or has received disulfiram within 14 days before receiving study drug or
who is currently receiving probenecid

- Has participated in any clinical study of an investigational product within 30 days
prior to the first dose of study drug

- Has previously participated in any study of ceftolozane or MK-7625A.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Complicated Intra-abdominal Infection

Intra-abdominal Infection

Intervention(s)

Drug: metronidazole 500 mg

Drug: MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g)

Primary Outcome(s)

Percentage of Participants With Adverse Events (AEs) [Time Frame: Up to Day 42 (up to 28 days after completing study therapy)]

Percentage of Participants Discontinuing Study Drug Due to AEs [Time Frame: Up to Day 14]

Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at Test of Cure (TOC) [Time Frame: Day 28 (28 days after initiating study therapy)]

Secondary Outcome(s)

Percentage of Participants With Microbiological Response (Eradication, Persistence, or Indeterminate) at EOT [Time Frame: Up to Day 14]

Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at Late Follow-Up (LFU) [Time Frame: Up to Day 42 (28 days after completing study therapy)]

Percentage of Participants With Microbiological Response (Eradication, Persistence, or Indeterminate) by Pathogen at EOT [Time Frame: Up to Day 14]

Percentage of Participants With Microbiological Response (Eradication, Persistence, or Indeterminate) by Pathogen at TOC [Time Frame: Day 28 (28 days after initiating study therapy)]

Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at End Of Therapy (EOT) [Time Frame: Up to Day 14]

Percentage of Participants With Microbiological Response (Eradication, Persistence, or Indeterminate) at TOC [Time Frame: Day 28 (28 days after initiating study therapy)]

Secondary ID(s)

163275

7625A-013

MK-7625A-013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/07/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02739997