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New treatment option for Gram-negative Bacterial Infection
Official title A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted in Hospitals With Bacterial Infection (CHERISH)
ClinicalTrials.gov ID: NCT06462235
What this study is testing
What is Part A: ATM-AVI Single Dose, Cohorts 1-4?
Part A: ATM-AVI Single Dose, Cohorts 1-4 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gram-negative bacterial infection.
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 learn about the safety and effects of ATM-AVI for the possible treatment of infections caused by a type of bacteria called gram-negative bacteria. The study medicine is a combination of an antibiotic, aztreonam (ATM), and another medicine, avibactam (AVI), which is used to help stop bacteria from being resistant to antibiotics.
- 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 up to 39
You may be able to join if
- Participants must meet the following key to be eligible for enrollment into the study:
- Hospitalized with age from birth \<9 months, including preterm birth
- Part A: Receiving IV antibiotics for treatment of suspected or confirmed bacterial infection, including but not limited to cIAI, cUTI, HAP/VAP, BSI...
- Part B: Suspected or confirmed gram-negative bacterial infection requiring IV antibiotics, including but not limited to cIAI, cUTI, HAP/VAP, BSI, or...
- Received any other investigational medicinal product within the longer of 30 days or 5 half-lives before enrollment.
See the full eligibility criteria
- Participants must meet the following key to be eligible for enrollment into the study:
- Hospitalized with age from birth \<9 months, including preterm birth
- Part A: Receiving IV antibiotics for treatment of suspected or confirmed bacterial infection, including but not limited to cIAI, cUTI, HAP/VAP, BSI, or sepsis.
- Part B: Suspected or confirmed gram-negative bacterial infection requiring IV antibiotics, including but not limited to cIAI, cUTI, HAP/VAP, BSI, or sepsis. Participants with any of the following...
- Received any other investigational medicinal product within the longer of 30 days or 5 half-lives before enrollment.
- Any medical or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Severe renal impairment or known significant renal disease, as evidenced by elevated serum creatinine at screening, or urinary output \<0.5 mL/kg/h for 6 consecutive hours or requirement for dialysis.
- Part B Only: Received \>24 hours of systemic antibiotic treatment for gram-negative organisms at time of enrollment, unless documented treatment failure or lack of improvement in at least one objective sign or symptom...
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
- Aurora, Colorado, United States
- Indianapolis, Indiana, United States
- Louisville, Kentucky, United States
- Boston, Massachusetts, United States
- Durham, North Carolina, United States
- Houston, Texas, United States
- Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
- Mar del Plata, Buenos Aires, Argentina
- Córdoba, Córdoba Province, Argentina
- San Miguel de Tucumán, Tucumán Province, Argentina
- Surat, Gujarat, India
- Bengaluru, Karnataka, India
- Pune, Maharashtra, India
- Lucknow, Uttar Pradesh, India
- Kolkata, West Bengal, India
- Petah Tikva, Central District, Israel
- Haifa, Northern District, Israel
- Hsinchu, Hsinchu, Taiwan
- Hualien City, Hualien, Taiwan
+ 2 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, up to 39 weeks. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States; Aurora, Colorado, United States; Indianapolis, Indiana, United States; Louisville, Kentucky, United States; Boston, Massachusetts, United States; Durham, North Carolina, United States and 16 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.