Safety and Efficacy Study to Compare IV CXA 101/Tazobactam and Metronidazole With Meropenem in Complicated Intraabdominal Infections



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 90
Updated:10/27/2018
Start Date:June 25, 2010
End Date:March 25, 2011

Use our guide to learn which trials are right for you!

A Multicenter, Double-Blind, Randomized, Phase 2 Study to Compare the Safety and Efficacy of Intravenous CXA 101/ Tazobactam and Metronidazole With That of Meropenem in Complicated Intraabdominal Infections

A Phase 2, multicenter, prospective, randomized, double-blind study of CXA-101/ tazobactam
(1000/500 mg q8h) and metronidazole (500 mg q8h) IV infusion vs. meropenem IV infusion (1000
mg q8h) and a matching saline placebo (q8h) in the treatment of cIAI in adult subjects. Dose
adjustments for subjects with mild renal impairment are not necessary and subjects with more
severe degrees of renal failure are excluded.


Inclusion Criteria:

- Male or female, from 18 to 90 years of age, inclusive

- One of the following diagnoses (in which there is evidence of intraperitoneal
infection) including:(a) Cholecystitis (including gangrenous cholecystitis) with
rupture, perforation, or progression of the infection beyond the gallbladder
wall;(b)Diverticular disease with perforation or abscess; (c) Appendiceal perforation
or periappendiceal abscess; (d) Acute gastric or duodenal perforation, only if
operated on >24 hours after perforation occurs; (e) Traumatic perforation of the
intestine, only if operated on > 12 hours after perforation occurs; (f) Peritonitis
due to perforated viscus, postoperative or spread from other focus of infection (but
not spontaneous [primary] bacterial peritonitis or peritonitis associated with
cirrhosis and chronic ascites).Subjects with inflammatory bowel disease or ischemic
bowel disease are eligible provided there is bowel perforation; or (g) Intraabdominal
abscess (including liver and spleen).

- Subject requires surgical intervention (e.g. laparotomy, laparoscopic surgery, or
percutaneous draining of an abscess) within 24 hours of (before or after) the first
dose of study drug

- If subject is to be enrolled preoperatively, the subject must have radiographic
evidence of bowel perforation or intraabdominal abscess

- Subjects who failed prior antibacterial treatment for the current cIAI can be enrolled
but must: (a) have a positive culture (from an intraabdominal site) and (b) require
surgical intervention. Such subjects can be enrolled before the results of the culture
are known; however, if the culture is negative, study drug administration must be
discontinued.

- Willing and able to comply with all study procedures and restrictions

- Willing and able to provide written informed consent

Exclusion Criteria:

- Women who are pregnant, nursing, or - if of child bearing potential - not using a
medically accepted, effective method of birth control (e.g. condom, oral
contraceptive, indwelling intrauterine device, or sexual abstinence)

- Diagnosis of abdominal wall abscess; small bowel obstruction or ischemic bowel disease
without perforation; traumatic bowel perforation with surgery within 12 hours;
perforation of gastroduodenal ulcer with surgery within 24 hours (these are considered
situations of peritoneal soiling before infection has become established); another
intraabdominal process in which the primary etiology is not likely to be infectious.

- Simple cholecystitis, gangrenous cholecystitis without rupture, simple appendicitis,
acute suppurative cholangitis, infected, necrotizing pancreatitis, or pancreatic
abscess

- cIAI managed by staged abdominal repair (STAR), open abdomen technique or any
situation where infection source control is not likely to be achieved

- Known prior to randomization to have an IAI or postoperative infection caused by
pathogen(s) resistant to meropenem

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

- Any rapidly-progressing disease or immediately life-threatening illness (including
acute hepatic failure, respiratory failure and septic shock)

- The need for concomitant systemic antibacterial agents (other than vancomycin or
linezolid) in addition to study drug(s)

- Moderate or severe impairment of renal function (estimated CrCl < 50 mL/min), or
requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria (< 20
mL/h urine output over 24 hours)

- The presence of hepatic disease defined as: (a) ALT or AST > 4 x ULN; (b)Total
bilirubin >2 x ULN, unrelated to cholecystitis (c) Alkaline phosphatase >4 x ULN.
Subjects with a value >4 x ULN and <5 x ULN are eligible if this value is historically
stable.

- Subjects with acute hepatic failure or acute decompensation of chronic hepatic failure

- Hematocrit < 25% or hemoglobin < 8 gm/dL

- Neutropenia with absolute neutrophil count < 1000/mm3

- Platelet count < 75,000 /mm3. Subjects with a platelet count as low as 50,000 /mm3 are
permitted if the reduction is historically stable.

- Immunocompromising illness, including known human immunodeficiency virus (HIV)
positivity or AIDS, organ (including bone marrow) transplant recipients, and
hematological malignancy. Immunosuppressive therapy, including use of high-dose
corticosteroid therapy (e.g. >40 mg prednisone or equivalent per day for greater than
2 weeks).

- History of hypersensitivity reactions to cephalosporins, carbapenems, penicillins,
ß-lactamase inhibitors, metronidazole, or nitroimidazole derivatives. Subjects with a
history of mild skin rash, not documented to be caused by previous ß-lactam use, may
be enrolled.

- Any condition or circumstance that, in the opinion of the Investigator, would
compromise the safety of the subject or the quality of study data

- Clinically significant abnormality in baseline electrocardiogram (ECG)

- Participation in any investigational drug or device study within 30 days prior to
study entry

- Use of systemic antibiotic therapy for IAI for 24 or more hours in the 48-hour period
prior to the first dose of study drug, unless there is a documented treatment failure
with such therapy

- More than one dose of an active non-study antibacterial regimen was given
postoperatively. For subjects enrolled preoperatively, no postoperative non-study
antibacterial therapy is allowed

- who previously participated in a study with CXA-101

- Subjects who previously received imipenem, meropenem, doripenem or cefepime for the
current intraabdominal infection

- Subjects who have received disulfiram in the past 14 days or who are currently
receiving probenecid.
We found this trial at
12
sites
12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Cleveland, Ohio 44109
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Newark, Delaware 19713
?
mi
from
Newark, DE
Click here to add this to my saved trials
940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Orange, CA
Click here to add this to my saved trials
Paraná, Entre Ríos
?
mi
from
Paraná,
Click here to add this to my saved trials
Pensacola, Florida 32504
?
mi
from
Pensacola, FL
Click here to add this to my saved trials
Somers Point, New Jersey 08244
?
mi
from
Somers Point, NJ
Click here to add this to my saved trials
?
mi
from
Torrance, CA
Click here to add this to my saved trials