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Completed

NCT Number: NCT03840148

Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections

This study will assess the safety and efficacy of cefepime/VNRX-5133 compared with meropenem in both eradication of bacteria and in symptomatic response in patients with cUTIs.

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Key information

Conditions

Urinary Tract Infections Acute Pyelonephritis Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site 103203, Córdoba, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult male and female
  • Documented diagnosis of pyuria
  • Documented diagnosis of cUTI or Acute Pyelonephritis (AP)

Exclusion criteria

  • Receipt of effective antibacterial drug therapy for cUTI for more than 24 hours during the previous 72 hours prior to randomization
  • A urine culture result is resistant to meropenem or a gram negative pathogen is not identified or more than 2 microorganisms are isolated or a confirmed fungal UTI is identified
  • Required use of nonstudy systemic bacterial therapy
  • Suspected or confirmed prostatitis or urinary tract symptoms attributable to sexually transmitted disease
  • Patients with perinephric or renal abscess
  • Patients with renal transplantation or receiving hemodialysis or peritoneal dialysis
  • Abnormal labs

Treatment and study plan

Cefepime/VNRX-5133 (taniborbactam)

Drug

Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.

Meropenem

Drug

Meropenem will be administered q8h IV over 30 minutes for 7 days (up to 14 days for patients with bacteremia). Patients will also receive cefepime/VNRX-5133 placebo administered via IV over a 2-hour period.

Primary outcomes

  1. Composite Success at Test of Cure (TOC) in the Microbiological Intent-to-treat (microITT) Population

    Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)

    Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

Secondary outcomes

  1. Microbiologic Success at Test of Cure (TOC) in the microITT Population

    Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)

    Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL.

  2. Clinical Success at Test of Cure (TOC) in the microITT Population

    Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)

    Symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

  3. Composite Success at Test of Cure (TOC) in the Extended Microbiological Intent-to-treat (emicroITT) Population

    Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)

    Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

  4. Composite Success at End of Treatment (EOT) in the microITT Population

    Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)

    Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

  5. Microbiological Success at End of Treatment (EOT) in the microITT Population

    Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)

    Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL.

  6. Clinical Success at End of Treatment (EOT) in the microITT Population

    Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)

    Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

  7. Composite Success at Late Follow Up (LFU) in the microITT Population

    Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)

    Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

  8. Microbiological Success at Late Follow Up (LFU) in the microITT Population

    Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)

    Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL.

  9. Clinical Success at Late Follow Up (LFU) in the microITT Population

    Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)

    Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

  10. Investigator Opinion of Clinical Success at Test of Cure (TOC) in the microITT Population

    Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)

    The proportion of patients with clinical success based on investigator opinion at TOC.

  11. Composite Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population

    Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)

    Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

  12. Microbiologic Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population

    Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)

    Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL.

  13. Clinical Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population

    Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)

    Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

  14. Composite Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population

    Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)

    Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

  15. Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population

    Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)

    Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL.

  16. Clinical Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population

    Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)

    Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

  17. Composite Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population

    Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)

    Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

  18. Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population

    Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)

    Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL.

  19. Clinical Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population

    Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)

    Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

  20. Composite Success at End of Treatment (EOT) in the Microbiologically-Evaluable (ME) Population

    Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)

    Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

  21. Microbiologic Success at End of Treatment (EOT) in the ME Population

    Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)

    Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL.

  22. Composite Success at Test of Cure (TOC) in the ME Population

    Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)

    Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

  23. Microbiologic Success at Test of Cure (TOC) in the ME Population

    Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)

    Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL.

  24. Composite Success at Late Follow Up (LFU) in the ME Population

    Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)

    Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

  25. Microbiologic Success at Late Follow Up (LFU) in the ME Population

    Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)

    Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL.

  26. Composite Success in Patients With Cefepime-Resistant Pathogens at the End of Treatment (EOT) in the ME Population

    Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)

    Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

  27. Microbiologic Success in Patients With Cefepime-Resistant Pathogens at the End of Treatment (EOT) in the ME Population

    Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)

    Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL.

  28. Composite Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the ME Population

    Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)

    Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

  29. Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the ME Population

    Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)

    Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL.

  30. Composite Success in Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population

    Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)

    Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

  31. Microbiologic Success in Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population

    Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)

    Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL.

  32. Clinical Success at End of Treatment (EOT) in the Clinically Evaluable (CE) Population

    Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)

    Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

  33. Clinical Success at Test of Cure (TOC) in the CE Population

    Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)

    Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

  34. Clinical Success at Late Follow Up (LFU) in the CE Population

    Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)

    Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

  35. Clinical Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the CE Population

    Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)

    Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

  36. Clinical Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the CE Population

    Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)

    Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

  37. Clinical Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the CE Population

    Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)

    Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

  38. Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population

    Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)

    Per-pathogen eradication by baseline gram-negative pathogens. The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.

  39. Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population

    Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)

    Per-pathogen eradication by baseline gram-negative pathogens. The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.

  40. Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population

    Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)

    Per-pathogen eradication by baseline gram-negative pathogens. The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.

  41. Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population

    Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)

    Per-pathogen eradication by baseline gram-negative pathogens (only pathogens identified 10 or more times are reported). The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.

  42. Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population

    Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)

    Per-pathogen eradication by baseline gram-negative pathogens (only pathogens identified 10 or more times are reported). The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.

  43. Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population

    Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)

    Per-pathogen eradication by baseline gram-negative pathogens (only pathogens identified 10 or more times are reported). The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.

  44. Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population

    Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)

    Per-pathogen eradication by baseline gram-negative pathogens. The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.

  45. Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population

    Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)

    Per-pathogen eradication by baseline gram-negative pathogens. The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.

  46. Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population

    Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)

    Per-pathogen eradication by baseline gram-negative pathogens. The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.

  47. Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the ME Population

    Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)

    Per-pathogen eradication by baseline gram-negative pathogens (only pathogens identified 10 or more times are reported). The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.

  48. Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure TOC in the ME Population

    Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)

    Per-pathogen eradication by baseline gram-negative pathogens (only pathogens identified 10 or more times are reported). The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.

  49. Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population

    Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)

    Per-pathogen eradication by baseline gram-negative pathogens (only pathogens identified 10 or more times are reported). The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.

Other outcomes

  1. Number of Patients With Treatment-Emergent Adverse Events

    Time frame: Study Days 1 to 35

    Percent of participants experiencing Treatment Emergent Adverse Events (TEAE). Treatment emergent is defined as any event that starts or worsens during or after treatment.

  2. Number of Patients With Serious Adverse Events

    Time frame: Study Days 1 to 35

    Percent of participants experiencing treatment emergent Serious Adverse Events (SAE).

Sponsors and collaborators

Lead sponsor

Venatorx Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Phase 3, Randomized, Double-blind, Active Controlled Noninferiority Study Evaluating the Efficacy, Safety, and Tolerability of Cefepime/VNRX-5133 in Adults With Complicated Urinary Tract Infections (cUTI), Including Acute Pyelonephritis

Acronym: CERTAIN-1

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 15, 2019
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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