A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted in Hospitals With Bacterial Infection (CHERISH)

Study acronym: CHERISH
StatusRecruiting
PhasePhase 2
SponsorPfizer
Started

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Record History

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  1. Study sites: 30 to 32
  2. Primary endpoints: details revised at 1 of 10 entries Show 4 more changesShow less
    • Trial sites expanded: 26 → 30 locations
    • Eligibility criteria shortened, about 8 words
    • Secondary endpoints: details revised at 5 of 7 entries
    • Study description revised
  3. Study sites: 27 to 26v30
  4. Study sites: 29 to 27v29
  5. Site details revised at 1 of 29 sitesv28
  6. Re-verified, no change to tracked fieldsv27
  7. Primary and study completion moved earlier from Dec 2, 2027 to Apr 25, 2027
    • Study sites: 30 to 29
    v26
  8. Re-verified, no change to tracked fieldsv25
  9. Study sites: 28 to 30v24
  10. Site details revised at 1 of 28 sitesv23
  11. Study sites: 27 to 28v22
  12. Study sites: 26 to 27v21
  13. Study sites: 25 to 26
    • Primary and study completion dates: Jul 31, 2028 to Dec 2, 2027
    v20
  14. Study sites: 23 to 25v19
  15. Study sites: 21 to 23v18
  16. Study sites: 20 to 21v17
  17. Study sites: 19 to 20v16
  18. Study sites revised (19)v15
  19. 2 versions Re-verified since Jul 7, 2025, no change to tracked fieldsv13-v14
  20. Primary and study completion dates: Sep 27, 2027 to Jul 31, 2028v12
  21. Re-verified, no change to tracked fieldsv11
  22. Study sites: 18 to 19v10
  23. Study sites: 16 to 18v9
  24. Study sites: 13 to 16v8
  25. Re-verified, no change to tracked fieldsv7
  26. Study sites: 10 to 13v6
  27. Site details revised at 1 of 10 sitesv5
  28. Start date changed from estimate of Sep 16, 2024 to Sep 25, 2024
    • Site details revised at 4 of 10 sites
    v4
  29. Study sites: 5 to 10v3
  30. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 5
    v2
  31. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Pfizer
438 trials monitored
See 32 trials at risk
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. Antibiotics are medicines that fights bacteria and infections. The study will include newborns and infants up to 9 months of age who are admitted in the hospital. The study is conducted in 2 parts: Part A and Part B. In Part A, all participants will receive a single intravenous (injected directly into a vein) infusion of ATM-AVI. This is to study the safety and effects of a single amount. In Part B, all participants will receive multiple intravenous infusions of ATM-AVI as treatment for a possible or confirmed infection with gram-negative bacteria.
Trial Details
NCT Number NCT06462235
Lead Sponsor Pfizer
Collaborators: AbbVie
Conditions
(from sponsor)		 Gram-negative Bacterial Infection
Related terms Gram-Negative Bacterial Infections
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov