Who is sponsoring NCT05258851?

NCT05258851 is sponsored by King Faisal Specialist Hospital & Research Center.

What drugs are being tested in NCT05258851?

Interventions in NCT05258851: Ceftazidime-avibactam, Colistin.

What condition does NCT05258851 study?

NCT05258851 studies Carbapenem-Resistant Enterobacteriaceae Infection.

Is NCT05258851 still recruiting?

NCT05258851 is currently terminated. Last updated 14 June 2024.

Last reviewed 2024-06-14 · How we verify

NCT05258851: AVI-ICU

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Ceftazidime-Avibactam Use in Critically Ill Patients With Carbapenem-Resistant Enterobacteriaceae Infections

Terminated Phase 3 Last updated 14 June 2024

What this trial tests

Phase 3 trial testing Ceftazidime-avibactam in Carbapenem-Resistant Enterobacteriaceae Infection in 29 participants. Terminated before completion.

Timeline

1 June 2022

Primary endpoint
12 April 2023

28 January 2024

Quick facts

Lead sponsor	King Faisal Specialist Hospital & Research Center
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	29
Start date	1 June 2022
Primary completion	12 April 2023
Estimated completion	28 January 2024
Sites	1 location across Saudi Arabia

Drugs / interventions tested

Ceftazidime-avibactam — full drug profile →
Colistin (COLISTIN) — full drug profile →

Conditions studied

Carbapenem-Resistant Enterobacteriaceae Infection — all drugs for Carbapenem-Resistant Enterobacteriaceae Infection →

Sponsor

King Faisal Specialist Hospital & Research Center

Who can join

Adults 18 to 85, any sex, with Carbapenem-Resistant Enterobacteriaceae Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Carbapenem-Resistant Enterobacteriaceae (CRE) infections are a growing national and international challenge in healthcare settings. This is not only due to the rapid spread of resistance and paucity of options of targeted-antimicrobial agents, but also owing to the high mortality of patients infected with CRE reaching up to 50% as per the Centers of Disease Control and Prevention. Colistin-based combination regimens have been the mainstay for treating CRE-related infections. Ceftazidime-avibactam is a beta-lactamase inhibitor combination, a novel antibiotic, which recently showed a better clinical and microbiological cure against CRE along with the potential to reduce mortality and nephrotoxicity in comparison to colistin-based regimens in observational studies. However, randomized clinical trials are lacking. This non-inferiority randomized controlled study aims to assess the efficacy and safety of ceftazidime-avibactam-based regimens in critically ill patients with CRE infections in comparison to colistin-based regimens.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Polymyxins: recent advances and challenges.
Yang S, Wang H, Zhao D, Zhang S, et al · · 2024 · cited 20× · PMID 38974043 · DOI 10.3389/fphar.2024.1424765
An Update on Recent Clinical Trial Data in Bloodstream Infection.
Stewart AG, Simos P, Sivabalan P, Escolà-Vergé L, et al · · 2024 · cited 5× · PMID 39596730 · DOI 10.3390/antibiotics13111035
Small-molecule inhibitors of bacterial-producing metallo-β-lactamases: insights into their resistance mechanisms and biochemical analyses of their activities.
Ayipo YO, Chong CF, Mordi MN. · · 2023 · cited 4× · PMID 37360393 · DOI 10.1039/d3md00036b

Verify or expand the search:

Other trials of Ceftazidime-avibactam

Trials testing the same drug.

NCT07004049 — Optimising TREATment for Severe Gram-Negative Bacterial Infections · Phase 4 · recruiting
NCT06818565 — Comparison of Efficacy and Safety of Ceftazidime Avibactam Versus Extended Infusions of High Dose Meropenem in Patients · NA · not yet recruiting
NCT06633718 — Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in CIAI · Phase 3 · not yet recruiting
NCT05413343 — Clinical Study on Monitoring the Plasma Concentration of Ceftazidime-Avibactam in Critically Ill Patients · active not recruiting
NCT04628572 — Retrospective Analysis of Real World Use of Ceftazidime-avibactam in the Management of Gram Negative Infections · completed

Other recruiting trials for Carbapenem-Resistant Enterobacteriaceae Infection

Currently open trials in the same condition.

NCT05979545 — EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics · Phase 4 · recruiting
NCT06051513 — Efficacy and Safety of Colistimethate Sodium for Injection in The Treatment of Carbapenem-Resistant Enterobacteriaceae I · NA · recruiting
NCT07086391 — Different Methods of Aerosolized Polymyxin B Inhalation for Treating Carbapenem-Resistant Gram-Negative Bacterial Pneumo · recruiting
NCT05871476 — Interventions to Decrease CRE Colonization and Transmission Between Hospitals, Households, Communities and Domesticated · NA · recruiting
NCT04535661 — Risk Factors for Colonization or Infection With Carbapenem-Resistant Enterobacteriaceae in Children · recruiting

Other King Faisal Specialist Hospital & Research Center trials

Trials by the same sponsor.

NCT07429929 — Saudi Emergency Laparotomy Audit · not yet recruiting
NCT07324174 — A Randomized Controlled Trial on the Effectiveness of Early Versus Conservative Rehabilitation Following Rotator Cuff Re · NA · not yet recruiting
NCT07316777 — Saudi CABG Audit and Registry · not yet recruiting
NCT07318571 — AI-Assisted Skin Assessment for Pressure Injury Prevention in Critical Care Nurses · NA · recruiting
NCT07243041 — Code Status Discussions in Muslim ICU Patients: Insights Into Physician-Family Communication · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05258851 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by King Faisal Specialist Hospital & Research Center
Last refreshed: 14 June 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05258851.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing