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Combination Product

ATM-AVI for Bacterial Infection

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

Study Summary

This trial is testing a new drug to see if it is better than current best available therapy for treating various infections.

Eligible Conditions
  • Bacterial Infection

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Clinical Cure at the Test of Cure (TOC) Visit -Microbiological Intent to Treat (Micro-ITT) Analysis Set
Secondary outcome measures
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 2017 Phase 2 trial • 40 Patients • NCT02655419
44%
Hepatic enzyme increased
13%
Diarrhoea
6%
Confusional state
6%
Hallucination, visual
6%
Back pain
6%
Hyperuricaemia
6%
Rash
6%
Sepsis
6%
Abdominal wall infection
6%
Acute respiratory distress syndrome
6%
Respiratory distress
6%
Anaemia
6%
Thrombocytosis
6%
Cardiac failure congestive
6%
Paraesthesia oral
6%
Generalised oedema
6%
Drug-induced liver injury
6%
Chronic hepatitis C
6%
Skin exfoliation
6%
Testicular swelling
6%
Colon cancer
6%
Tooth abscess
100%
80%
60%
40%
20%
0%
Study treatment Arm
ATM-AVI+ Metronidazole: Low AVI Dose Cohort
ATM-AVI + Metronidazole: High AVI Dose Cohort

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
4,567 Previous Clinical Trials
10,911,858 Total Patients Enrolled
AllerganIndustry Sponsor
781 Previous Clinical Trials
276,554 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,093,026 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the benefits of ATM-AVI for patients?

"ATM-AVI is a medication that's frequently used to treat septicemia, but can also be helpful in combating febrile neutropenia, urinary tract infection, and gram-negative bacterial infections."

Answered by AI

How many people are included in this research project?

"That is correct, the listed clinical trial on clinicaltrials.gov has an open call for 60 patients from 4 different sites. The study was first posted on December 25th, 2020 with the 10/27/2022 update being the most recent change."

Answered by AI

Are there any current openings for participants in this trial?

"The clinical trial is recruiting patients at this time, according to the website clinicaltrials.gov. The study was first posted on December 25th 2020 and has been updated as recently as October 27th 2022."

Answered by AI

Does previous research exist on the ATM-AVI drug combination?

"ATM-AVI was first studied in 2020 at Hsinchu Mackay Memorial Hospital. As of now, a total of 53 studies have been completed with 4 clinical trials still ongoing. The majority of these remaining trials are taking place in Tucson, Arizona."

Answered by AI

Does this research stand alone or has it been done before?

"ATM-AVI has been the subject of 4 active studies since 2020, with 53 trials completed to date. These 84 cities and 16 countries. The earliest trial for ATM-AVI was run in 2020. The study, sponsored by Pfizer, involved 48 participants and completed its Phase 2 drug approval stage."

Answered by AI

What are the risks associated with ATM-AVI treatments?

"ATM-AVI's safety is commonly estimated to be a 3. This is because it has advanced to Phase 3 clinical trials, where there is some data supporting efficacy as well as multiple rounds of data collected for safety analysis."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Efficacy, Safety, and Tolerability of ATM-AVI in the Treatment of Serious Infection Due to MBL-producing Gram-negative Bacteria
2020. "Efficacy, Safety, and Tolerability of ATM-AVI in the Treatment of Serious Infection Due to MBL-producing Gram-negative Bacteria". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03580044.
~4 spots leftby Apr 2025
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