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 range

18 Years – 90 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

18 Years – 90 Years

Sex

ALL

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

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