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Beta-lactamase inhibitor

ATM-AVI for Bacterial Pneumonia (REVISIT Trial)

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 test of cure (toc) visit, day 28 +/- 3 days

Awards & highlights

REVISIT Trial Summary

This trial is testing a new combination drug against a standard drug to see if it is better at treating serious infections caused by gram-negative bacteria.

Eligible Conditions

Bacterial Pneumonia
Intraabdominal Infections
Pneumonia

REVISIT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout study to late follow up visit (day 45 +/- 3 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout study to late follow up visit (day 45 +/- 3 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout study to late follow up visit (day 45 +/- 3 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of subjects with clinical cure in the ITT and CE analysis sets

Secondary outcome measures

Description of safety in terms of adverse events

PK of ATM

PK of AVI

+7 more

Other outcome measures

Health resource utilization in terms of duration of mechanical ventilation

Health resource utilization in terms of length of ICU stay

Health resource utilization in terms of length of hospital stay

+13 more

Side effects data

From 2017 Phase 2 trial • 40 Patients • NCT02655419

44%

Hepatic enzyme increased

13%

Diarrhoea

Confusional state

Hallucination, visual

Back pain

Hyperuricaemia

Rash

Sepsis

Abdominal wall infection

Acute respiratory distress syndrome

Respiratory distress

Anaemia

Thrombocytosis

Cardiac failure congestive

Paraesthesia oral

Generalised oedema

Drug-induced liver injury

Chronic hepatitis C

Skin exfoliation

Testicular swelling

Colon cancer

Tooth abscess

100%

80%

60%

40%

20%

Study treatment Arm

ATM-AVI+ Metronidazole: Low AVI Dose Cohort

ATM-AVI + Metronidazole: High AVI Dose Cohort

REVISIT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Aztreonam-Avibactam ± MetronidazoleExperimental Treatment2 Interventions

All patients randomised to this arm will receive ATM-AVI; all patients with cIAI will receive MTZ for anaerobic cover

Group II: Meropenem ± ColistinActive Control2 Interventions

All patients randomised to this arm will receive MER; addition of COL will be at investigator's discretion in line with local practice

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MTZ

2018

Completed Phase 3

~430

ATM-AVI

2018

Completed Phase 3

~470

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Biomedical Advanced Research and Development AuthorityFED

83 Previous Clinical Trials

909,382 Total Patients Enrolled

PfizerLead Sponsor

4,573 Previous Clinical Trials

10,922,929 Total Patients Enrolled

Innovative Medicines Initiative (IMI) COMBACTE-CARE (EU)UNKNOWN

Frequently Asked Questions

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

What are the short-term and long-term effects of ATM-AVI use?

"There is some clinical data supporting ATM-AVI's efficacy, and it has undergone multiple rounds of safety testing--giving it a score of 3."

Answered by AI

Are there any patients currently enrolling in this trial?

"That is correct. The information available on clinicaltrials.gov reveals that this study has not yet reached its full patient quota. This particular trial was first advertised on April 5th, 2018 and was last updated on October 26th, 2020. There are still 425 spots open at 10 different medical facilities."

Answered by AI

Could you inform me as to how many people have signed up for this research project?

"In order to successfully run this study, the sponsor - Pfizer - needs to enrol 425 patients that meet the inclusion criteria. This will take place at various sites including O'Donoghue Research Building in Torrance, California and University of Oklahoma Health Sciences Center in Springfield, Illinois."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Determine the Efficacy, Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) Versus Meropenem (MER) ± Colistin (COL) for the Treatment of Serious Infections Due to Gram Negative Bacteria.

2018. "A Study to Determine the Efficacy, Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) Versus Meropenem (MER) ± Colistin (COL) for the Treatment of Serious Infections Due to Gram Negative Bacteria.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03329092.