CompletedPhase 2

Determine the PK and Safety and Tolerability of ATM-AVI for the Treatment of cIAIs in Hospitalized Adults (REJUVENATE)

France, Germany, Spain40 participantsStarted 2016-05-19

Plain-language summary

Determine the PK and safety and tolerability of aztreonam-avibactam (ATM-AVI) in the treatment of hospitalized adults with cIAI

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Provision of informed consent
✓. Male or female from 18 to 90 years
✓. Female patients are authorized to participate in this clinical study if criteria concerning pregnancy avoidance stated in the protocol are met
✓. Diagnosis of cIAI
✓. Patients who failed prior antibacterial treatment for their current cIAI can be enrolled but must:
✓. Patient must have or will have a surgical intervention within 24 hours (before or after) the administration of the first dose of study drug

Exclusion criteria

✕. Involvement in the planning and/or conduct of the study
✕. Patient has been previously enrolled in this study, previously treated with ATM-AVI or previously participated in an investigational study containing AVI
✕. Patient has participated or intends to participate in any other clinical study that involves the administration of a study drug during the course of the study, or during the 30 days prior to study start.
✕. History of serious allergy, hypersensitivity (eg, anaphylaxis), or any serious reaction to aztreonam, carbapenem,monobactam or other β-lactam antibiotics, avibactam, nitroimidazoles or metronidazole, or any of the excipients of the study drugs
✕. Diagnosis of abdominal wall abscess; small bowel obstruction or ischemic bowel disease without perforation; traumatic bowel perforation with surgery within 12 hours of diagnosis; perforation of gastroduodenal ulcer with surgery within 24 hours of diagnosis primary etiology is not likely to be infectious
✕. Simple cholecystitis, gangrenous cholecystitis without rupture, simple appendicitis, acute suppurative cholangitis, infected necrotizing pancreatitis, pancreatic abscess or ischaemic/necrotic intestine without perforation
✕. Staged abdominal repair (STAR), open abdomen technique or where infection source control is not likely to be achieved; unlikely to solely respond to antimicrobial therapy
✕. Infection due to a pathogen that is unlikely to respond to ATM-AVI plus metronidazole

What they're measuring

Plasma Concentration of Aztreonam (ATM): Sparse Sampling at Day 1, 0 hr

Timeframe: Predose (0 hr) on Day 1

Plasma Concentration of Aztreonam (ATM): Sparse Sampling at Day 1, 0.42 hr

Timeframe: 0.42 hr Post dose on Day 1

Plasma Concentrations of Aztreonam (ATM): Sparse Sampling at Day 1, 3.25 hr

Timeframe: 3.25 hr Post dose on Day 1

Plasma Concentrations of Aztreonam (ATM): Sparse Sampling at Day 1, 5 hr

Timeframe: 5 hr Post dose on Day 1

Plasma Concentration of Avibactam (AVI): Sparse Sampling at Day 1, 0 hr

Timeframe: Predose (0 hr) on Day 1

Plasma Concentration of Avibactam (AVI): Sparse Sampling at Day 1, 0.42 hr

Timeframe: 0.42 hr Post dose on Day 1

Plasma Concentration of Avibactam (AVI): Sparse Sampling at Day 1, 3.25 hr

Timeframe: 3.25 hr Post dose on Day 1

Plasma Concentration of Avibactam (AVI): Sparse Sampling at Day 1, 5 hr

Trial details

NCT IDNCT02655419

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-10-26

Results submitted2018-10-24

View on ClinicalTrials.gov More Complicated Intra-Abdominal Infections, cIAIs trials

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Provision of informed consent
✓. Male or female from 18 to 90 years
✓. Female patients are authorized to participate in this clinical study if criteria concerning pregnancy avoidance stated in the protocol are met
✓. Diagnosis of cIAI
✓. Patients who failed prior antibacterial treatment for their current cIAI can be enrolled but must:
✓. Patient must have or will have a surgical intervention within 24 hours (before or after) the administration of the first dose of study drug

Exclusion criteria

✕. Involvement in the planning and/or conduct of the study
✕. Patient has been previously enrolled in this study, previously treated with ATM-AVI or previously participated in an investigational study containing AVI
✕. Patient has participated or intends to participate in any other clinical study that involves the administration of a study drug during the course of the study, or during the 30 days prior to study start.
✕. History of serious allergy, hypersensitivity (eg, anaphylaxis), or any serious reaction to aztreonam, carbapenem,monobactam or other β-lactam antibiotics, avibactam, nitroimidazoles or metronidazole, or any of the excipients of the study drugs
✕. Diagnosis of abdominal wall abscess; small bowel obstruction or ischemic bowel disease without perforation; traumatic bowel perforation with surgery within 12 hours of diagnosis; perforation of gastroduodenal ulcer with surgery within 24 hours of diagnosis primary etiology is not likely to be infectious
✕. Simple cholecystitis, gangrenous cholecystitis without rupture, simple appendicitis, acute suppurative cholangitis, infected necrotizing pancreatitis, pancreatic abscess or ischaemic/necrotic intestine without perforation
✕. Staged abdominal repair (STAR), open abdomen technique or where infection source control is not likely to be achieved; unlikely to solely respond to antimicrobial therapy
✕. Infection due to a pathogen that is unlikely to respond to ATM-AVI plus metronidazole

What they're measuring

Plasma Concentration of Aztreonam (ATM): Sparse Sampling at Day 1, 0 hr

Timeframe: Predose (0 hr) on Day 1

Plasma Concentration of Aztreonam (ATM): Sparse Sampling at Day 1, 0.42 hr

Timeframe: 0.42 hr Post dose on Day 1

Plasma Concentrations of Aztreonam (ATM): Sparse Sampling at Day 1, 3.25 hr

Timeframe: 3.25 hr Post dose on Day 1

Plasma Concentrations of Aztreonam (ATM): Sparse Sampling at Day 1, 5 hr

Timeframe: 5 hr Post dose on Day 1

Plasma Concentration of Avibactam (AVI): Sparse Sampling at Day 1, 0 hr

Timeframe: Predose (0 hr) on Day 1

Plasma Concentration of Avibactam (AVI): Sparse Sampling at Day 1, 0.42 hr

Timeframe: 0.42 hr Post dose on Day 1

Plasma Concentration of Avibactam (AVI): Sparse Sampling at Day 1, 3.25 hr

Timeframe: 3.25 hr Post dose on Day 1

Plasma Concentration of Avibactam (AVI): Sparse Sampling at Day 1, 5 hr