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A Study of Aztreonam-Avibactam (ATM-AVI) Compared to Best Available Therapy in Pediatric Participants with Serious Gram-Negative Bacterial Complicated Intra-abdominal, Complicated Urinary Tract, Blood Stream Infections, and Hospital Acquired and Ventilator Associated Pneumonia
EU CTIS ID: 2022-501575-12-00
What this study is testing
Evaluate the PK of ATM-AVI for the treatment of serious gram-negative bacterial infections in participants 9 months to <18 years of age. Evaluate the safety, and tolerability of ATM-AVI and BAT for the treatment of serious gram-negative bacterial infections in participants 9 months to <18 years of age.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants ≥9 months to <18 years of age at Screening; Female (post-menarchal) participants must have a negative serum/urine pregnancy test (βhCG sensitivity ≥25 mIU/mL).
- Suspected/confirmed cIAI, cUTI, HAP/VAP, or BSI with gram-negative pathogens.
- Require hospitalization and IV antibiotic treatment.
You likely can't join if
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
- Previous enrollment in the study
- Gram-negative species not expected to respond to ATM-AVI ≤14 days.
- Pregnant or breastfeeding; fertile male/female unwilling/unable to use effective contraception for at ≥7 days (males) or ≥28 days (females) after last ATM-AVI infusion.
- (HAP/VAP only): Microbiologically known or high likelihood of monomicrobial infection with a gram-positive organism, lung abscess, pleural empyema, or postobstructive pneumonia, lung or heart transplant.
- Received >24 hours of systemic antibiotics during the 48 hours before randomization unless participant has documented treatment failure after at least 48 hours of antibiotic therapy.
See the full eligibility criteria
- Participants ≥9 months to <18 years of age at Screening; Female (post-menarchal) participants must have a negative serum/urine pregnancy test (βhCG sensitivity ≥25 mIU/mL).
- Suspected/confirmed cIAI, cUTI, HAP/VAP, or BSI with gram-negative pathogens.
- Require hospitalization and IV antibiotic treatment.
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
- Previous enrollment in the study
- Gram-negative species not expected to respond to ATM-AVI ≤14 days.
- Pregnant or breastfeeding; fertile male/female unwilling/unable to use effective contraception for at ≥7 days (males) or ≥28 days (females) after last ATM-AVI infusion.
- (HAP/VAP only): Microbiologically known or high likelihood of monomicrobial infection with a gram-positive organism, lung abscess, pleural empyema, or postobstructive pneumonia, lung or heart transplant.
- Received >24 hours of systemic antibiotics during the 48 hours before randomization unless participant has documented treatment failure after at least 48 hours of antibiotic therapy.
- Current use of any prohibited concomitant medication(s) or unwilling/unable (Cockayne Syndrome patients with cIAI are excluded) to use MTZ or having received previous investigational drug(s) or vaccine ≤30 days or 5 half-lives before randomization (whichever is longer).
- CrCL ≤15 mL/min/1.73 m2 (eCrCl or eGFR calculation based on age).
- Non-infectious related screening ALT or AST >3 x ULN, ALP >3 x ULN and/or TBili >2 x ULN (> 3 x ULN for Gilbert’s syndrome).
- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
The study team makes the final eligibility decision.
Where it's taking place
- India
- China
- United States
- Taiwan
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include India; China; United States; Taiwan; Turkey. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.