A Phase IIa prospective, open-label, multicenter study to determine the pharmacokinetics (PK) and safety and tolerability of aztreonam-avibactam (ATM-AVI) for the treatment of complicated Intra-Abdominal Infections (cIAIs) in hospitalized adults - REJUVENATE

AstraZeneca AB0 sites40 target enrollmentFebruary 3, 2016

ConditionsComplicated Intra-Abdominal Infections (cIAIs) in hospitalized adults Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

DrugsAZACTAM 1 g vial Metronidazole 500 mg/ 100 ml intravenous infusion AZACTAM 2 g AZACTAM 1 g Aztreonam

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Complicated Intra-Abdominal Infections (cIAIs) in hospitalized adults
Sponsor: AstraZeneca AB
Enrollment: 40
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 3, 2016

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

AstraZeneca AB

Eligibility Criteria

Inclusion Criteria

•1\. Provision of informed consent prior to any study\-specific procedures.
•2\. Male or female from 18 to 90 years of age inclusive.
•3\. Female patients are authorized to participate in this clinical study if criteria concerning pregnancy avoidance stated in the protocol are met
•4\. Diagnosis of cIAI
•Intra\-operative/postoperative enrolment with visual confirmation (presence of pus within the abdominal cavity) of an intra\-abdominal infection associated with peritonitis. Surgical intervention includes open laparotomy, percutaneous drainage of an abscess, or laparoscopic surgery. Specimens from the surgical intervention must be sent for culture. Patients who undergo a surgical procedure with complete fascial closure are appropriate for the trial. The skin incision may be left open for purposes of wound management as long as complete fascial closure is accomplished. The patient has at least 1 of the following diagnosed during the surgical intervention:
•(a)Cholecystitis with gangrenous rupture or perforation or progression of the infection beyond the gallbladder wall
•(b)Diverticular disease with perforation or abscess
•(c)Appendiceal perforation or peri\-appendiceal abscess
•(d)Acute gastric or duodenal perforations, only if operated on \>24 hours after perforation occurs
•(e)Traumatic perforation of the intestines, only if operated on \>12 hours after perforation occurs

Exclusion Criteria

•1\.Involvement in the planning and/or conduct of the study
•2\.Patient has been previously enrolled in this study, previously treated with ATM\-AVI or previously participated in an investigation study containing AVI
•3\.Patient has participated or intends to participate in any other clinical study that involves the administration of an investigational medication at the time of presentation, during the course of the study, or during the 30 days prior to study start.
•4\.Patient has a history of serious allergy, hypersensitivity (eg, anaphylaxis), or any serious reaction to aztreonam, carbapenem, monobactam or other ?\-lactam antibiotics, avibactam, nitroimidazoles or metronidazole, or any of the excipients of the respective (investigational) medicinal products to be administered during the study
•5\.Patient has a 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 intra\-abdominal process in which the primary etiology is not likely to be infectious
•6\.Patient has a simple cholecystitis, gangrenous cholecystitis without rupture, simple appendicitis, acute suppurative cholangitis, infected necrotizing pancreatitis, pancreatic abscess or ischaemic/necrotic intestine without perforation
•7\.Patient has a cIAI managed by staged abdominal repair (STAR), open abdomen technique or any situation where infection source control is not likely to be achieved or in whom the abdomen is left open, particularly those for whom re\-operation is planned, or those unlikely to solely respond to antimicrobial therapy
•8\.At screening, if it is known the patient has an infection due to a pathogen that is unlikely to respond to ATM\-AVI plus metronidazole treatment
•9\.Patient has a rapidly progressive (expected to die in \<30 days) or terminal illness, including acute hepatic failure, respiratory failure or septic shock with a high risk of mortality due to other causes than cIAI
•10\.Patient has received systemic antibacterial agents within the 48\-hour period prior to study entry, unless either of the following pertains: