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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
No Placebo-Only Group
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to day 50
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to day 50
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Apparent Clearance (CL)
Area under the Concentration-Time Curve (AUC) of ATM-AVI
Maximum Predicted Plasma Concentration (Cmax) of ATM and AVI
+7 moreSecondary study objectives
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 moreSide effects data
From 2023 Phase 3 trial • 422 Patients • NCT033290927%
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.
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
4,660 Previous Clinical Trials
17,877,307 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,545 Previous Clinical Trials
14,918,472 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is very low.I am not currently taking any prohibited medications and have not participated in another drug study within the last 30 days or 5 half-lives.I have an infection suspected to be caused by gram-negative bacteria.My infection is not expected to respond to specific antibiotics within 14 days.I am between 9 months and 18 years old.I cannot or will not use birth control for the required time after my last treatment.I am a woman and my pregnancy test was negative.I've had over 24 hours of antibiotics in the last 2 days unless it was for a failed treatment.I have a lung or heart infection likely caused by a single type of bacteria.I need to be hospitalized for IV antibiotic treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Best available therapy (BAT)
- Group 2: ATM-AVI
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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