deltatrials
Terminated PHASE3 INTERVENTIONAL 2-arm NCT03580044

Efficacy, Safety, and Tolerability of ATM-AVI in the Treatment of Serious Infection Due to MBL-producing Gram-negative Bacteria

A PROSPECTIVE, RANDOMIZED,OPEN-LABEL, COMPARATIVE STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF AZTREONAM- AVIBACTAM (ATM-AVI) AND BEST AVAILABLE THERAPY FOR THE TREATMENT OF SERIOUS INFECTIONS DUE TO MULTI-DRUG RESISTANT GRAM- NEGATIVE BACTERIA PRODUCING METALLO -Β-LACTAMASE (MBL)

Sponsor: Allergan

Conditions Serious Bacterial Infection
Interventions ATM-AVI BAT
Updated 40 times since 2018 Last updated: Jan 8, 2024 Started: Dec 25, 2020 Primary completion: Jan 23, 2023 Completion: Jan 23, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Recruitment of patients with serious infections caused by gram-negative bacteria producing MBL has been challenging. Date study terminated: 16-Dec-2022.

Other terminated trials from Allergan

See all terminations from Allergan

This PHASE3 trial investigates Serious Bacterial Infection and is currently terminated or withdrawn. Allergan leads this study, which shows 40 recorded versions since 2020 — indicating substantial longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Oct 2018 · 30 days · monthly snapshot~Oct 2018 – ~Dec 2018 · 2 months · monthly snapshot~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Mar 2019 · 59 days · monthly snapshot~Mar 2019 – ~May 2019 · 2 months · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Nov 2019 · 3 months · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Jun 2020 · 5 months · monthly snapshot~Jun 2020 – ~Sep 2020 · 3 months · monthly snapshot~Sep 2020 – ~Nov 2020 · 2 months · monthly snapshot~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Apr 2021 · 59 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~Jan 2022 · 2 months · monthly snapshot~Jan 2022 – ~Feb 2022 · 31 days · monthly snapshot~Feb 2022 – ~Apr 2022 · 59 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Sep 2022 · 3 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Apr 2023 · 59 days · monthly snapshot~Apr 2023 – ~Mar 2024 · 11 months · monthly snapshot~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

40 versions recorded

  1. Sep 2025 — Present [monthly]

    Terminated PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  4. Mar 2024 — Jul 2024 [monthly]

    Terminated PHASE3

  5. Apr 2023 — Mar 2024 [monthly]

    Terminated PHASE3

    Status: Active Not Recruiting → Terminated

▶ Show 35 earlier versions

  1. Feb 2023 — Apr 2023 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  2. Jan 2023 — Feb 2023 [monthly]

    Recruiting PHASE3

  3. Dec 2022 — Jan 2023 [monthly]

    Recruiting PHASE3

  4. Nov 2022 — Dec 2022 [monthly]

    Recruiting PHASE3

  5. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE3

  6. Jun 2022 — Sep 2022 [monthly]

    Recruiting PHASE3

  7. May 2022 — Jun 2022 [monthly]

    Recruiting PHASE3

  8. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE3

  9. Feb 2022 — Apr 2022 [monthly]

    Recruiting PHASE3

  10. Jan 2022 — Feb 2022 [monthly]

    Recruiting PHASE3

  11. Nov 2021 — Jan 2022 [monthly]

    Recruiting PHASE3

  12. Oct 2021 — Nov 2021 [monthly]

    Recruiting PHASE3

  13. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE3

  14. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

  15. May 2021 — Jun 2021 [monthly]

    Recruiting PHASE3

  16. Apr 2021 — May 2021 [monthly]

    Recruiting PHASE3

  17. Feb 2021 — Apr 2021 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  18. Jan 2021 — Feb 2021 [monthly]

    Not Yet Recruiting PHASE3

  19. Dec 2020 — Jan 2021 [monthly]

    Not Yet Recruiting PHASE3

  20. Nov 2020 — Dec 2020 [monthly]

    Not Yet Recruiting PHASE3

  21. Sep 2020 — Nov 2020 [monthly]

    Not Yet Recruiting PHASE3

  22. Jun 2020 — Sep 2020 [monthly]

    Not Yet Recruiting PHASE3

  23. Jan 2020 — Jun 2020 [monthly]

    Not Yet Recruiting PHASE3

  24. Dec 2019 — Jan 2020 [monthly]

    Not Yet Recruiting PHASE3

  25. Nov 2019 — Dec 2019 [monthly]

    Not Yet Recruiting PHASE3

  26. Aug 2019 — Nov 2019 [monthly]

    Not Yet Recruiting PHASE3

  27. Jul 2019 — Aug 2019 [monthly]

    Not Yet Recruiting PHASE3

  28. Jun 2019 — Jul 2019 [monthly]

    Not Yet Recruiting PHASE3

  29. May 2019 — Jun 2019 [monthly]

    Not Yet Recruiting PHASE3

  30. Mar 2019 — May 2019 [monthly]

    Not Yet Recruiting PHASE3

  31. Jan 2019 — Mar 2019 [monthly]

    Not Yet Recruiting PHASE3

  32. Dec 2018 — Jan 2019 [monthly]

    Not Yet Recruiting PHASE3

  33. Oct 2018 — Dec 2018 [monthly]

    Not Yet Recruiting PHASE3

  34. Sep 2018 — Oct 2018 [monthly]

    Not Yet Recruiting PHASE3

  35. Aug 2018 — Sep 2018 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Allergan
  • Pfizer
Data source: Pfizer

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Athens, Greece , Bangalore, India , Bangkoknoi, Thailand , Baotou, China , Bucharest, Romania , Changsha, China , Chennai, India , Cluj-Napoca, Romania , Córdoba, Argentina , Davao City, Philippines and 22 more locations