A randomized open-lable Phase 3 study performed at multiple study sites to evaluate the safety, efficacy and tolerability of the combinational product Carbavance (Meropenem/RPX7009) in comparison to best available therapy to treat patients with selected serious urinary infections, bacterial pneumonia infections and/or blood infections known or suspected to be caused by carbapenem-resistant Enterobacteriaceae.
- Conditions
- serious infections, specifically complicated urinary tract infection (cUTI) or acute pyelonephritis (AP), complicated intra-abdominal infections (cIAI), hospital acquired bacterial pneumonia (HABP), ventilator associated bacterial pneumonia (VABP), and/or bacteremia, known or suspected to be caused by carbapenem-resistant Enterobacteriaceae (CRE)MedDRA version: 18.0 Level: LLT Classification code 10003999 Term: Bacteremia System Organ Class: 100000004862MedDRA version: 18.0 Level: LLT Classification code 10001032 Term: Acute pyelonephritis System Organ Class: 100000004862MedDRA version: 18.0 Level: LLT Classification code 10056570 Term: Intra-abdominal infection System Organ Class: 100000004862MedDRA version: 18.0 Level: LLT Classification code 10004051 Term: Bacterial pneumonia, unspecified System Organ Class: 100000004862MedDRA version: 18.0 Level: HLT Classification code 10046577 Term: Urinary tract infections System Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2014-000546-30-GB
- Lead Sponsor
- Rempex Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
1.Willingness to comply with all study activities and procedures and to provide signed, written informed consent prior to any study procedures. If a subject is unable to provide informed consent due to their medical condition, the subject's legal representative will be provided with study information in order for consent to be obtained.
2.Hospitalized male or female, >/=18 years of age.
3.Weight 4.Have a confirmed diagnosis of a serious infection, specifically cUTI or AP, cIAI, HABP, VABP, and/or bacteremia, requiring administration of IV antibacterial therapy (See inclusion number 7 for criteria for all indications).
5.The following must be satisfied:
For known CRE infection:
-Have a known CRE infection based on evidence from CRE culture or other phenotypic or molecular testing within 72 hours prior to Day 1, alone or as a single isolate of a polymicrobial infection;
-Have received no more than 24 hours of an antimicrobial agent to which the known CRE is susceptible prior to enrollment,
OR
-Have documented clinical evidence of failure (i.e., clinical deterioration or failure to improve) after at least 48 hours of treatment with an antimicrobial agent to which the known CRE is susceptible.
For suspected CRE infection:
-Have a suspected CRE infection based on evidence from CRE culture (KPC producing, if known) or other phenotypic or molecular testing, alone or as a single isolate of a polymicrobial infection, from any source within 90 days prior to Day 1;
-Have received no more than 24 hours of empiric antimicrobial therapy for gram negative organisms prior to enrollment.
6.Expectation, in the opinion of the Investigator, that the subject's infection will require treatment with IV antibiotics for a minimum of 7days.
7.Expectation that subjects with an estimated creatinine clearance <10 ml/min Cockcroft-Gault) will receive hemodialysis at least 2 times per week.
8. Diagnosis with either cUTI or AP, cIAI, HABP, VABP, and/or bacteremia asdefined per protocol.
9.Female subjects of child-bearing potential, including those who are less than 2 years post-menopausal, must agree to, and comply with,using 2 highly effective methods of birth control (i.e., condom plus spermicide, combined oral contraceptive, implant, injectable, indwelling intrauterine device, sexual abstinence, or a vasectomized partner) while participating in this study. In addition, all women of childbearing potential must agree to continue to use 2 forms of birth control throughout the study and for at least 30 days after administration of the
last dose of study drug.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90
1.History of any significant hypersensitivity or severe allergic reaction to any beta lactam antibiotics (e.g., cephalosporins, penicillins, carbapenems, or monobactams).
2.Known or suspected likely infection with New Delhi metallo- (NDM), Verona integron encoded metallo- (VIM), or IMP-metallo-betalactamases or oxacillinase- (OXA) beta lactamases (i.e., Class B or Class D beta lactamases).
3.For subjects to be enrolled with the primary indication of cUTI or AP, any of the following urologic conditions:
Likely to receive ongoing antibacterial drug prophylaxis after treatment of cUTI (e.g., subjects with vesico-ureteral reflux);
Suspected or confirmed prostatitis;
Requirement for bladder irrigation with antibiotics or for antibiotics to be administered directly via urinary catheter;
Previous or planned cystectomy or ileal loop surgery;
Uncomplicated urinary tract infection (for example, female subjects with urinary frequency, urgency or pain or discomfort without systemic symptoms or signs of infection);
Complete, permanent obstruction of the urinary tract;
Suspected or confirmed perinephric or renal corticomedullary abscess;
Polycystic kidney disease; or
Any recent history of trauma to the pelvis or urinary tract.
4.For subjects to be enrolled with the primary indication of cIAI, any of the following conditions:
a.Incomplete drainage of suspected or known intra-abdominal source;
b.Likely to receive ongoing antibacterial drug prophylaxis or chronic
suppressive therapy after intravenous treatment of cIAI;
c.Source of infection thought to be related to or involving a nonremovable prosthesis (e.g. intra-abdominal mesh) or implantable device, line (e.g. peritoneal catheter) or stent (e.g. biliary stent);
d.Uncomplicated intra-abdominal infection, such as simple appendicitis,simple cholecystitis or gangrenous cholecystitis without rupture;
e.Patients with infected necrotizing pancreatitis or pancreatic abscess;
f.Patients whose surgery will include staged abdominal repair or open abdomen technique, or marsupialization (i.e. patients who undergo a surgical procedure where facial closure is performed are eligible. The skin incision may be left open for purposes of wound management as long as fascial closure is accomplished);
g.Patients in whom the intra-abdominal process is deemed not likely to be infectious in origin (e.g. bowel obstruction, ischemic bowel without perforation, traumatic bowel perforation within past 12 hours,perforated gastroduodenal ulcer within 24 hours); or
h.Non-intra-abdominal infection (e.g. infection or abscess of the
abdominal wall without extension into the intra-abdominal cavity)
5.For subjects to be enrolled with the primary indication of HABP or VABP, any of the following conditions:
Diagnosis of ventilator-associated tracheobronchitis
Inability to obtain proper respiratory specimens for culture
6.For subjects to be enrolled with the indication of bacteremia unrelated to cUTI or AP, cIAI, HABP, and VABP, any of the following:
Unverified CRE infect
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method