NCT06651047

Brief Summary

A multicenter, national, prospective, observational pharmacological study of patients with difficult-to-treat Gram-negative infections treated with ceftazidime/avibactam (CAZ/AVI) or cefiderocol (CEF) monotherapy or combination therapy with ceftazidime/avibactam associated with fosfomycin (FOS) or cefiderocol associated with fosfomycin.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 21, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

October 21, 2024

Status Verified

October 1, 2024

Enrollment Period

1.2 years

First QC Date

October 15, 2024

Last Update Submit

October 18, 2024

Conditions

Gram Negative InfectionAntimicrobial Resistance (AMR)

Keywords

Gram-negative infectionCeftazidime/AvibactamCefiderocolFosfomycinPharmacokinetics/Pharmacodynamics targetsCarbapenem-resistant Enterobacterales (CRE)

Outcome Measures

Primary Outcomes (1)

  • PK/PD efficacy targets for study drugs

    Primary endpoint will be the proportion of patients achieving the PK/PD efficacy target. Since these drugs are widely used in clinical practice, safety is not evaluated in this study

    From enrollment (treatment onset) to the end of treatment (up to 7 days)

Secondary Outcomes (6)

  • Difference in SOFA score

    From day 0 (day of index positive culture) and day 7

  • Difference in C-Reactive Protein (CRP), Procalcitonin (PCT) and Interleukin-6 (IL-6)

    From day 0 (day of index positive culture) and day 7

  • Identification of new protein-based biomarkers

    From enrollment to the end of treatment (up to 7 days)

  • Microbiological eradication

    From day 0 (day of index positive culture) and day 7

  • Relapse and/or reinfection

    From enrollment to the end of the follow-up at three months

  • +1 more secondary outcomes

Study Arms (1)

Patients with difficult-to-treat gram-negative infection treated with CAZ/AVI or CEF, ± FOS

All patients (any age) with infection due to a difficult-to-treat Gram-negative bacteria treated with CAZ/AVI alone, CEF alone, CAZ/AVI plus FOS, or CEF plus FOS

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with infection due to a difficult-to-treat Gram-negative bacteria, treated with CAZ/AVI alone, CEF alone, CAZ/AVI plus FOS, or CEF plus FOS (any age), hospitalized during the study period in the participating centers, will be screened for inclusion

You may qualify if:

  • Patients with infection due to a difficult-to-treat Gram-negative bacteria treated with CAZ/AVI alone, CEF alone, CAZ/AVI plus FOS, or CEF plus FOS (any age)
  • Signature of the informed consent (for pediatric patients: parents or guardians able to provide consent)

You may not qualify if:

  • Premature newborns
  • Polymicrobial/mixed infections with the exception of cases with multiple Gram-negative bacteria susceptible to study drugs
  • Continuous renal replacement therapy (CRRT) applications
  • Age ≥18 years
  • Signature of the informed consent
  • \- Any known clinically relevant health problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Irccs Aoubo

Bologna, 40138, Italy

RECRUITING

Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione (ARNAS) Garibaldi

Catania, 95124, Italy

NOT YET RECRUITING

ASST-FBF-Sacco

Milan, 20157, Italy

NOT YET RECRUITING

Azienda Ospedale - Università Padova

Padua, 35128, Italy

NOT YET RECRUITING

Istituto mediterraneo per i trapianti e terapie ad alta specializzazione (ISMETT)

Palermo, 90127, Italy

NOT YET RECRUITING

Policlinico Umberto I

Rome, 00100, Italy

NOT YET RECRUITING

Policlinico Universitario Campus Bio-Medico

Rome, 00128, Italy

NOT YET RECRUITING

Ospedale Pediatrico Bambin Gesù

Rome, 00165, Italy

NOT YET RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

NOT YET RECRUITING

Azienda Ospedaliero Universitaria Senese

Siena, 53100, Italy

NOT YET RECRUITING

Città della salute e della Scienza, Molinette

Turin, 10126, Italy

NOT YET RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Serum samples for PK/PD analysis * Serum samples for identification of new biomarkers * Isolated bacterial strains

Central Study Contacts

Maddalena Giannella, MD PhD

CONTACT

+39 0512143199maddalena.giannella@unibo.it

Natascia Caroccia, PhD

CONTACT

+39 0512143595natascia.caroccia@unibo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 15, 2024

First Posted

October 21, 2024

Study Start

July 9, 2024

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

October 21, 2024

Record last verified: 2024-10

Locations

IT(11)