A Phase 2/3 interventional study of Meropenem in Carbapenem-Resistant Enterobacteriaceae Infection and Bloodstream Infection, sponsored by Hospital de Clinicas de Porto Alegre. Terminated at 2 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-03.
Sponsored by Hospital de Clinicas de Porto Alegre · Phase 2/3, Interventional, and Treatment
Enterobacterales resistant to carbapenem are cause of severe concern in hospital-acquired infections since therapeutic options are limited. Recently approved drugs, such as bela-lactam/beta-lactamase inhibitor, have been the drug of choice. However, its use is limited in low- and middle-income countries. Thus, therapy of these infections mostly relies on polymyxins and other old drugs.
The role of adjuvant carbapenem therapy in combination with polymyxins, aminoglycosides and other drugs is under investigation. From a pharmacokinetic/pharmacodynamic (PK/PD), there is an elevated probability that high-dose, extended infusion administered meropenem reach the PK/PD target of 40% above the minimal inhibitory concentration (MIC) of the pathogen when the MIC is 32mg/L or lower (non-susceptible isolates have MICs of 4mg/L or higher). However, the MIC is not routinely determined in clinical laboratories. In addition, high-level (above 32mg/L) resistance to carbapenems have been reported in many studies.
This open-label, randomized clinical trial aim to assess if the addition of meropenem to the best available therapy can increase the number of days alive and free of hospitalization in patients with bloodstream infections by Enterobacterales with MIC of meropenem above 32mg/L.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 13 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Hospital de Clinicas de Porto Alegre is the lead sponsor of 450 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
Meropenem 2g every 8 hours combined with the best available therapy (BAT). BAT will be defined according to the susceptibility profile and decision of the assistant team before randomization and should include at least one of the antimicrobials that, usually, have in vitro activity against carbapenem-resistant Enterobacterales isolates. 1. Polymyxin B or colistimethate; 2. Amikacin or gentamicin; 3. Tigecycline; 4. Another antimicrobial with in vitro susceptibility. Doses will be defined by the assistant team.
Drug: Meropenem
The best available therapy will be defined according to the susceptibility profile and decision of the assistant team before randomization and should include at least one of the antimicrobials that, usually, have in vitro activity against carbapenem-resistant Enterobacterales isolates. 1. Polymyxin B or colistimethate; 2. Amikacin or gentamicin; 3. Tigecycline; 4. Another antimicrobial with in vitro susceptibility. Doses will be defined by the assistant team.
Meropenem 2g every 8h for patients with glomerular filtration rate (GFR) equal or higher that 50 mL/min. Dose adjustment is recommended for patients with GFR \< 50mL/min.
Days alive and free of hospitalization
Number of days in which patients are alive and out of the hospital
Time frame: 60 days
Overall mortality
Death for any cause
Time frame: 14, 28 and 60 days after randomization
Antimicrobial-free days
Number of days in which patients are alive and without use of antimicrobial drugs
Time frame: 60 days after randomization
Relapse of infection
Presence of infection with isolation of the same bacteria between 14 and 60 days after randomization.
Time frame: 60 days after randomization
Clostridioides difficile infection
Incidence of Clostridioides difficile infection
Time frame: 60 days after randomization
Acute Kidney Injury
Incidence of Acute Kidney Injury, according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Time frame: 14 days after randomization
Meropenem-related adverse effects
Incidence of adverse effects related to meropenem, such as neurological toxicity and hypersensitivity reactions
Time frame: 14 days after randomization
This study is terminated, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Hospital de Clinicas de Porto Alegre