An interventional study of Clinical Stability-Driven Antibiotic Discontinuation Strategy and Standard of Care Antibiotic Duration in Bloodstream Infection, Gram Negative Infections and Bacteraemia Caused by Gram-Negative Bacteria, sponsored by Valeria Cento. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Valeria Cento · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if a personalized duration of antibiotic therapy, based on clinical stability, is as effective as a standard duration of at least 10 days in hospitalized patients with hematologic malignancies (such as leukemia or lymphoma) who develop febrile neutropenia and Gram-negative bacteraemia.
The main questions it aims to answer are:
Researchers will compare:
Participants will:
This is a multicenter, open-label, randomized controlled trial. Upon confirmation of Gram-negative bacteraemia, eligible patients are randomized 1:1 to one of two treatment strategies:
In parallel, a prospective observational microbiological sub-study will utilize Shotgun Metagenomic Next-Generation Sequencing (mNGS) to analyze the evolution of the intestinal and blood microbiota. The goal is to compare the rate of MDR organism colonization and the reconstitution of the healthy microbiome between the two antibiotic duration strategies.
All participants will undergo clinical monitoring until day 28. For those enrolled in the sub-study, biological samples (stool, rectal swabs, and blood) will be collected at baseline (V1), at the end of treatment (V4), and at the end of the study (V5). These samples will be analyzed to identify clinically significant bacteria and antibiotic-resistance genes.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 172 is above the median of 102 across 1,165 interventional studies indexed under Sepsis.
Browse Sepsis studies →This is the only study on the registry with Valeria Cento as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard of care antibiotic therapy with a suggested minimum duration of 10 days.
Other: Standard of Care Antibiotic Duration
Patients in this arm will receive antibiotic therapy for a duration guided by clinical stability. Antibiotics will be discontinued after 72 consecutive hours of clinical stability, defined as apyrexia (Tc \< 38°C) for at least 48 hours and stable or improved qSOFA score.
Other: Clinical Stability-Driven Antibiotic Discontinuation Strategy
A therapeutic strategy where the duration of antibiotic treatment for Gram-negative bacteraemia is determined by the achievement of clinical stability (defined as apyrexia for 48h and stable/improved qSOFA score) maintained for 72 consecutive hours
Also known as: A
This intervention follows the standard clinical practice for treating Gram-negative bacteraemia in hematological patients. The duration of therapy is not fixed by a stability-driven rule but is based on the treating physician's decision, with a suggested minimum of 10 days.
Also known as: B
Days Free from Anti-Gram-Negative Antibiotic Therapy within 28 days
Number of days that the participant is alive and free from any anti-Gram-negative antibiotic therapy, calculated from the date of the index blood culture collection (onset of infection) up to Day 28. Antibiotics active exclusively on Gram-positive bacteria (e.g., glycopeptides, daptomycin) and fluoroquinolone prophylaxis are excluded from this calculation.
Time frame: From the date of index blood culture collection (Day 0) up to Day 28
Incidence of New Fever Episodes
Number of participants experiencing a new episode of fever (Tc ≥ 38.3°C) occurring after a period of apyrexia of at least 72 hours
Time frame: From the end of antibiotic therapy up to Day 28
28-day All-cause Mortality
Number of participants who died from any cause within 28 days from the onset of the index infection (date of first positive blood culture)
Time frame: Up to Day 28
Relapse of Bloodstream Infection (BSI) by the Same Pathogen
Number of participants with a new positive blood culture for the same Gram-negative pathogen identified in the index episode
Time frame: From the end of antibiotic therapy up to Day 28
Recurrent BSI by Gram-negative Bacteria
Number of participants experiencing a new episode of bloodstream infection caused by any Gram-negative bacteria different from the index pathogen
Time frame: From the end of antibiotic therapy up to Day 28
Emergence of Multi-Drug Resistant Organisms (MDRO)
Number of participants with isolation of a new MDRO from recurrent positive blood cultures, or evidence of a worsened resistance profile compared to the index isolate
Time frame: Within 90 days from the index blood culture collection
Incidence of Clostridioides difficile Infection (CDI)
Number of participants with a laboratory-confirmed diagnosis of Clostridioides difficile infection
Time frame: Up to Day 28
Incidence of Antibiotic-Related Adverse Events
Number of participants experiencing adverse events (AE) judged by the investigator to be related to the antibiotic therapy (e.g., allergic reactions, renal toxicity)
Time frame: Up to Day 28
Started Feb 2026 (actual). Primary completion is estimated for Feb 2028, 24 months after the start.
Of 301 non-industry interventional studies with no phase under Sepsis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 24 months is close to that.
Counting every sponsor, half of 324 studies reached it within 22 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
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