Clinical trial
Randomised Controlled Trial of Temocillin vs Meropenem for the Targeted Treatment of Bacteraemia Due to Enterobacteriaceae Showing Resistance to Third Generation Cephalosporins
Name
ASTARTÉ
Description
A Phase 3, Multicenter, Randomised, Controlled, Open-Label Study to demonstrate noninferiority of temocillin (unauthorized investigational medicinal product IMP in Spain, but authorized in Belgium and UK) vs a carbapenem antibiotic (meropenem) in adults with bacteraemia due to third-generation cephalosporin-resistant Enterobacteriaceae.
The duration of treatment will be between 7 and 14 days. From the 5th day of intravenous treatment, the sequential oral treatment is permitted if the patient meets appropriate conditions.
Trial arms
Trial start
2020-12-15
Estimated PCD
2023-09-01
Trial end
2023-09-01
Status
Recruiting
Phase
Early phase I
Treatment
Temocillin
The intervention of experimental arm will be Intravenous administration of temocillin.
Arms:
Temocillin
Meropenem
The intervention of comparator arm will be intravenous administration of meropenem.
Arms:
Meropenem
Size
334
Primary endpoint
Number of participants with a "success" at the test of cure (TOC)
Up to 7-10 days after the last day of antibiotic therapy
Survival at day 28
At day 28.
Number of patients who do not need to stop or change the assigned drug
Up to 7-14 days after the last day of antibiotic therapy
Number of patients who do not need to prolong therapy beyond 14 days
Up to 7-14 days after the last day of antibiotic therapy
Not recurrence until day 28
At day 28.
Eligibility criteria
Inclusion Criteria:
* Adult patients with monomicrobial bacteremia due to Enterobacteriaceae showing resistance to cefotaxime, ceftriaxone (MIC \>2 mg/L) and/or ceftazidime (MIC \>4 mg/L), and sensible to temocillin (MIC ≤8 mg/L, except in bacteremia only of urinary origin, for which the criterion is MIC ≤16 mg/L ) and meropenem (MIC ≤2 mg/L).
* Duration of intravenous treatment is planned to be at least 4 days.
* The patient signed informed consent form.
Exclusion Criteria:
* \<18 years
* Pregnancy
* Breastfeeding
* Palliative care
* Allergy to betalactams
* Polymicrobial bacteraemia
* Infections typically needing prolonged \>14 days of therapy (e.g., endocarditis, prosthetic joint infection, vascular graft infection, empyema, chronic prostatitis) or meningitis
* Active empirical treatment\> 96 hours after initial blood culture extraction
* Delay in inclusion\> 48 h
* Recruited in another clinical trial with active treatment
* Peritoneal dialysis or continuous hemofiltration
* extreme gravity or imminent death
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized 1.1 to temocillin: meropenem', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 334, 'type': 'ESTIMATED'}}
Updated at
2023-05-03
1 organization
2 products
1 indication
Product
TemocillinIndication
BacteremiaProduct
Meropenem