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[Synercid emergency prescription program. The French experience]
1Service Réanimation et surveillance continue, médico-chirurgical polyvalent, CH du pays d'Aix, Avenue Tamaris, F13616 Aix-en-Provence.
Objective:
An emergency-use program forof Synercid (quinupristin/dalfopristin, Q/D) has been set up following the occurrence of Gram-positive infections with no therapeutic alternatives to the available antibiotic arsenal.
Methods:
The experience in France is based on a collective of 88 infections analysed in 74 patients. The most frequent clinical indications were: central catheter-related bacteremia, bone and joint infection, endocarditis and, intraabdominal infection. The most frequently causative pathogens were: S. aureus (n = 26, including 24/26 meticillin-resistant), coagulase negative staphylococci (n = 28, including 24/28 meticillin-resistant), enterococci (n = 15), and others (n = 5). Q/D was administered most frequently by central venous infusion, 3 times a day (68/74 patients); the mean and median dose per infusion was 7.4 mg/kg and the mean duration of treatment was 15.6 days. A combined antibiotic therapy was used in 70/74 patients (a glycopeptide in 41/54 staphylococcal infections).
Results:
A Clinical success at the end of treatment was obtained in 40/74 patients (54%; CI 42.1%-65.7%) [the analysis included 25 patients (34%) with an indeterminate clinical response, categorized as failures] et and 39/73 patients (53%) at the follow-up [including 22 deaths (30%), categorized as failure at the follow-up]. The end-of-treatment success rate in patients with staphylococcal and enterococcal infections was respectively 30/54 (56%) and 8/15 (53%). The safety analysis indicated that 24/74 patients presented at least one treatment-related intercurrent event (possible or probable relationship), the most frequent ones being digestive disordersturbances, signs of venous intolerance, or diffuse or muscular pain.
Conclusion:
Q/D has demonstrated a therapeutic potential in a variety of Gram-positive infections (staphylococcal and enterococcal) in patients with no therapeutic antibiotic alternative, and the type of the intercurrent events reported was consistent with those expected ones in this population of seriously ill patients.
Insights
Synercid (quinupristin/dalfopristin) showed therapeutic potential for Gram-positive infections when no other options existed. This emergency use program treated serious staphylococcal and enterococcal infections, with manageable side effects.
Area of Science:
- Infectious Diseases
- Pharmacology
- Clinical Medicine
Background:
- The emergence of antibiotic-resistant Gram-positive pathogens necessitates novel therapeutic strategies.
- Synercid (quinupristin/dalfopristin) offers a potential treatment option for infections with limited alternatives.
Purpose of the Study:
- To evaluate the efficacy and safety of Synercid (quinupristin/dalfopristin) in an emergency-use program for Gram-positive infections in France.
- To analyze clinical outcomes and adverse events in patients with limited therapeutic options.
Main Methods:
- Retrospective analysis of 74 patients with 88 Gram-positive infections treated with Synercid (quinupristin/dalfopristin).
- Common indications included catheter-related bacteremia, bone and joint infections, endocarditis, and intra-abdominal infections.
- Pathogens included methicillin-resistant Staphylococcus aureus, coagulase-negative staphylococci, and enterococci. Treatment involved central venous infusion, often with combined antibiotic therapy.
Main Results:
- Clinical success at end-of-treatment was 54% (40/74 patients), with 34% categorized as failures.
- Follow-up success rate was 53% (39/73 patients), including 30% deaths.
- Success rates for staphylococcal and enterococcal infections were 56% and 53%, respectively.
- 24/74 patients experienced treatment-related adverse events, primarily gastrointestinal issues, venous intolerance, or pain.
Conclusions:
- Synercid (quinupristin/dalfopristin) demonstrates therapeutic potential for serious Gram-positive infections, particularly staphylococcal and enterococcal, in patients lacking alternative treatments.
- Reported adverse events were consistent with known side effect profiles for Synercid in critically ill patients.