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Combination Product

ATM-AVI for Sepsis

Phase 3
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (last non-missing value observed before start of treatment on day 1), eot (up to 24 hours after the last infusion on day 14), toc (day 28)
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial tests a new drug combination, aztreonam-avibactam, in hospitalized adults with tough-to-treat infections. The drug works by killing bacteria and preventing them from neutralizing the antibiotic. It aims to help patients with infections that don't respond to usual treatments. Aztreonam-avibactam is being developed for treating infections caused by specific bacteria, leveraging aztreonam's stability against these enzymes and avibactam's broad coverage against other enzymes.

Eligible Conditions
  • Sepsis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 hours after the last infusion on day 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours after the last infusion on day 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With Clinical Cure at the Test of Cure (TOC) Visit -Microbiological Intent to Treat (Micro-ITT) Analysis Set
Secondary study objectives
Number of Participants With Abnormal Physical Examination Findings
Number of Participants With Clinically Significant Abnormalities in Clinical Chemistry Assessments
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)
+16 more

Side effects data

From 2023 Phase 3 trial • 422 Patients • NCT03329092
7%
Anaemia
7%
Alanine aminotransferase increased
6%
Diarrhoea
6%
Hypokalaemia
5%
Pyrexia
5%
Aspartate aminotransferase increased
4%
Nausea
4%
Vomiting
4%
Hepatic function abnormal
3%
Constipation
3%
Pleural effusion
3%
Rash
2%
Abdominal distension
2%
Abdominal pain
2%
Atrial fibrillation
2%
Hypertransaminasaemia
2%
Decubitus ulcer
2%
Hypertension
2%
Phlebitis
1%
Septic shock
1%
Wound dehiscence
1%
Pneumonia
1%
Cardiac arrest
1%
COVID-19 pneumonia
1%
Sepsis
1%
COVID-19
1%
Abdominal abscess
1%
Pulmonary embolism
1%
Respiratory failure
1%
Circulatory collapse
100%
80%
60%
40%
20%
0%
Study treatment Arm
Aztreonam-avibactam ± Metronidazole
Meropenem± Colistimethate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ATM- AVI Aztreonam- Avibactam (ATM-AVI) Active Treatment ArmExperimental Treatment1 Intervention
Group II: Best Available Therapy (BAT) Comparator Treatment ArmActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ATM-AVI
2018
Completed Phase 3
~470

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,661 Previous Clinical Trials
17,844,974 Total Patients Enrolled
12 Trials studying Sepsis
38,344 Patients Enrolled for Sepsis
AllerganIndustry Sponsor
781 Previous Clinical Trials
276,639 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,546 Previous Clinical Trials
14,886,130 Total Patients Enrolled
3 Trials studying Sepsis
32,939 Patients Enrolled for Sepsis
~3 spots leftby Dec 2025
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