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Beta-lactamase inhibitor

ATM-AVI for Bacterial Infections

Phase 2
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to day 50
Awards & highlights

Study Summary

This trial is studying the safety/effectiveness of ATM/AVI as a treatment for children with serious infections. They will be given an intravenous dose based on weight/kidney function, and may be switched to oral therapy.

Who is the study for?
This trial is for hospitalized children aged 9 months to less than 18 years with suspected or confirmed serious gram-negative infections, requiring IV antibiotics. It's not for those unlikely to respond to the study drugs within 14 days, pregnant/breastfeeding individuals without effective contraception, or those with certain medical conditions.Check my eligibility
What is being tested?
The trial compares Aztreonam and Avibactam (ATM-AVI) combination against the best available therapy (BAT) in treating complicated infections like abdominal, urinary tract, bloodstream, and lung infections. ATM-AVI dosage depends on weight and kidney function; treatment lasts up to 14 days with possible switch to oral therapy.See study design
What are the potential side effects?
Potential side effects may include reactions at the infusion site, allergic responses specific to antibiotic use such as rashes or gastrointestinal issues like nausea and diarrhea. Kidney function might be affected due to medication processing requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to day 50
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to day 50 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Apparent Clearance (CL)
Area under the Concentration-Time Curve (AUC) of ATM-AVI
Maximum Predicted Plasma Concentration (Cmax) of ATM and AVI
+7 more
Secondary outcome measures
Percentage of Participants With Favorable Clinical Response (CR) at End of Treatment (EOT)
Percentage of Participants With Favorable Clinical Response (CR) at Test of Cure (TOC)
Percentage of Participants with Favorable Microbiological Response at End of Treatment (EOT)
+3 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-AVIExperimental Treatment1 Intervention
ATM-AVI administered iv every 6 or 8 hours and dosed according to participant's weight and kidney function for up to 14 days depending on response. At the investigator's discretion, the participant may be switched to oral therapy after 3 days of iv ATM-AVI therapy
Group II: Best available therapy (BAT)Active Control1 Intervention
BAT will be selected by the investigator and administered iv. At the investigator's discretion, the participant may be switched to oral therapy after 3 days of iv BAT
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
4,570 Previous Clinical Trials
10,915,958 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,476 Previous Clinical Trials
8,092,173 Total Patients Enrolled

Media Library

Avibactam (Beta-lactamase inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05639647 — Phase 2
Bacterial Infection Research Study Groups: ATM-AVI, Best available therapy (BAT)
Bacterial Infection Clinical Trial 2023: Avibactam Highlights & Side Effects. Trial Name: NCT05639647 — Phase 2
Avibactam (Beta-lactamase inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05639647 — Phase 2

Frequently Asked Questions

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

Are people younger than forty years of age able to participate in this clinical study?

"This clinical study requires participants to be aged between 9 Months and 17 years old, per the pre-defined inclusion criteria."

Answered by AI

Are applications currently being taken for this experiment?

"According to clinicaltrials.gov, this trial is not actively recruiting at present as it was last updated on November 28th 2022 and initially posted on January 23rd 2023. Nonetheless, 801 additional medical studies are still in need of participants for their research."

Answered by AI

Has the FDA approved ATM-AVI for medical use?

"Our research team at Power has rated the safety of ATM-AVI as a 2, since it is only in phase 2 and lacks evidence for efficacy but does have some data backing its safe usage."

Answered by AI

What are the foremost goals of this experimental research?

"This medical trial will assess the proportion of participants that suffer from liver injury and acute kidney injury when compared to best available therapy (BAT). Additionally, it will measure the percentage of patients with a favorable microbiological response at end-of-iv study drug treatment, end of treatment in those switched to oral therapy, and test of cure. All outcomes are expected within 50 days following baseline measurements."

Answered by AI

Is there a specific demographic that is favored for participation in this investigation?

"This clinical trial requires 48 participants aged from 9 months to 17 years who are hospitalized and diagnosed with gram-negative bacterial infections, such as cIAI, cUTI, HAP/VAP or BSI."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections
2023. "Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05639647.
~30 spots leftby Feb 2026
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