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Compares treatment options for Gram-negative Bacterial Infections
Official title Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections
ClinicalTrials.gov ID: NCT05639647
What this study is testing
What is ATM-AVI?
ATM-AVI is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gram-negative bacterial infections.
Also referred to as aztreonam plus avibactam.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate how Aztreonam (ATM) and Avibactam (AVI) are processed in pediatric participants. This study also aims to understand participant safety and effects in pediatric participants.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 9 to 17
You may be able to join if
- Participants must meet the following key to be eligible for enrollment into the study:
- Participants ≥9 months to \<18 years of age at Screening; Female (post-menarchal) participants must have a negative serum/urine pregnancy test (β hCG...
- Suspected/confirmed cIAI, cUTI, HAP/VAP, or BSI with gram-negative pathogens.
- Require hospitalization and IV antibiotic treatment.
You likely can't join if
- Participants with any of the following characteristics/conditions will be excluded:
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that...
- 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...
- Microbiologically known or high likelihood of monomicrobial infection with a gram-positive organism, lung abscess, pleural empyema, or...
- Received \>24 hours of systemic antibiotics during the 48 hours before randomization unless participant has documented treatment failure after at...
See the full eligibility criteria
- Participants must meet the following key to be eligible for enrollment into the study:
- Participants ≥9 months to \<18 years of age at Screening; Female (post-menarchal) participants must have a negative serum/urine pregnancy test (β hCG sensitivity ≥25 mIU/mL).
- Suspected/confirmed cIAI, cUTI, HAP/VAP, or BSI with gram-negative pathogens.
- Require hospitalization and IV antibiotic treatment.
- Participants with any of the following characteristics/conditions will be excluded:
- 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...
- 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 post-obstructive 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- New York, New York, United States
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Shanghai, China
- Heraklion, Irakleío, Greece
- Thessaloniki, Kentrikí Makedonía, Greece
- Budapest, Hungary
- Bangalore, Karnataka, India
- Lucknow, Uttar Pradesh, India
- Kolkata, West Bengal, India
- Badalona, Barcelona [barcelona], Spain
- Esplugues de Llobregat, Barcelona [barcelona], Spain
- Madrid, Madrid, Comunidad de, Spain
- Barcelona, Spain
- Madrid, Spain
- Hsinchu, Hsinchu, Taiwan
- Taipei, Taiwan
- Taoyuan, Taiwan
- Sarçam, Adana, Turkey (Türkiye)
+ 1 more site(s).
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, 9 months to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States; New York, New York, United States; Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Shanghai, China; Heraklion, Irakleío, Greece and 15 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.