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Synercid (Quinupristin / Dalfopristin Injection) - Summary

 
 



One of Synercid 's approved indications is for the treatment of patients with serious or life-threatening infections associated with vancomycin-resistant Enterococcus faecium (VREF) bacteremia. Synercid has been approved for marketing in the United States for this indication under FDA's accelerated approval regulations that allow marketing of products for use in life-threatening conditions when other therapies are not available. Approval of drugs for marketing under these regulations is based upon a demonstrated effect on a surrogate endpoint that is likely to predict clinical benefit.

Approval of this indication is based upon Synercid 's ability to clear VREF from the bloodstream, with clearance of bacteremia considered to be a surrogate endpoint. There are no results from well-controlled clinical studies that confirm the validity of this surrogate marker. However, a study to verify the clinical benefit of therapy with Synercid on traditional clinical endpoints (such as cure of the underlying infection) is presently underway.

 

SYNERCID SUMMARY

Synercid® I.V.
(quinupristin and dalfopristin for injection)

Synercid ® (quinupristin and dalfopristin powder for injection) I.V., a streptogramin antibacterial agent for intravenous administration, is a sterile lyophilized formulation of two semisynthetic pristinamycin derivatives, quinupristin (derived from pristinamycin I) and dalfopristin (derived from pristinamycin IIA) in the ratio of 30:70 (w/w).

Synercid is indicated in adults for the treatment of the following infections when caused by susceptible strains of the designated microorganisms.

Vancomycin-resistant Enterococcus faecium (VREF)

Synercid is indicated for the treatment of patients with serious or life-threatening infections associated with vancomycin-resistant Enterococcus faecium (VREF) bacteremia. (See Clinical Studies.)

One of Synercid's approved indications is for the treatment of patients with serious or life-threatening infections associated with vancomycin-resistant Enterococcus faecium (VREF) bacteremia. Synercid has been approved for marketing in the United States for this indication under FDA's accelerated approval regulations that allow marketing of products for use in life-threatening conditions when other therapies are not available. Approval of drugs for marketing under these regulations is based upon a demonstrated effect on a surrogate endpoint that is likely to predict clinical benefit.

Approval of this indication is based upon Synercid's ability to clear VREF from the bloodstream, with clearance of bacteremia considered to be a surrogate endpoint. There are no results from well-controlled clinical studies that confirm the validity of this surrogate marker. However, a study to verify the clinical benefit of therapy with Synercid on traditional clinical endpoints (such as cure of the underlying infection) is presently underway.

Complicated skin and skin structure infections caused by Staphylococcus aureus (methicillin susceptible) or Streptococcus pyogenes. (See CLINICAL STUDIES.)


See all Synercid indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Synercid (Quinupristin / Dalfopristin)

Prospective, randomized study comparing quinupristin-dalfopristin with linezolid in the treatment of vancomycin-resistant Enterococcus faecium infections. [2004.04]
OBJECTIVES: Quinupristin-dalfopristin and linezolid have been shown to be efficacious in the treatment of vancomycin-resistant Enterococcus faecium (VREF) infections. However, the two antibiotics have not been compared in terms of safety and efficacy in a prospective randomized study. The objective of this study was to compare the safety and efficacy of the two drugs in the treatment of VREF infections in cancer patients... CONCLUSION: In cancer patients, quinupristin-dalfopristin treatment is associated with a relatively high frequency of myalgias/arthralgias; however, profound thrombocytopenia might limit the choice of linezolid in a subpopulation of cancer patients.

Impact of quinupristin/dalfopristin (RP59500) on the faecal microflora in healthy volunteers. [2002.01]
The effect of 5 days' administration of quinupristin/dalfopristin (RP59500) on the faecal microflora was evaluated in healthy volunteers. Twenty healthy volunteers received 7.5 mg/kg of quinupristin/dalfopristin infused over 1 h twice daily for 5 days and four received a matched placebo... However, no decrease in colonization resistance towards exogenous potentially pathogenic bacteria was observed and the observed modifications disappeared within 12 weeks after the end of quinupristin/dalfopristin administration.

Treatment of gram-positive nosocomial pneumonia. Prospective randomized comparison of quinupristin/dalfopristin versus vancomycin. Nosocomial Pneumonia Group. [2000.03]
Nosocomial pneumonia is a frequent complication in hospitalized patients...

Treatment of hospitalized patients with complicated gram-positive skin and skin structure infections: two randomized, multicentre studies of quinupristin/dalfopristin versus cefazolin, oxacillin or vancomycin. Synercid Skin and Skin Structure Infection Group. [1999.08]
Quinupristin/dalfopristin (Synercid), the first injectable streptogramin antibiotic available for the treatment of complicated gram-positive skin and skin structure infections, was compared with standard comparators (cefazolin, oxacillin or vancomycin) in one USA and one international trial...

Prospective, randomized dose-ranging open phase II pilot study of quinupristin/dalfopristin versus vancomycin in the treatment of catheter-related staphylococcal bacteremia. [1999.03]
Two different doses of quinupristin/dalfopristin were compared with intravenous vancomycin with regard to the efficacy and safety in the treatment of catheter-related staphylococcal bacteremia. A total of 39 patients were enrolled from 13 centers.However, larger prospective randomized trials are required.

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Clinical Trials Related to Synercid (Quinupristin / Dalfopristin)

Open-Label, Multiple-Dose, Phase III Study of the Population Pharmacokinetics of I.V. Synercid in 75 Pediatric Patients [Terminated]

more trials >>


Page last updated: 2006-01-31

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