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Efficacy and safety of tigecycline monotherapy compared with vancomycin plus aztreonam in patients with complicated skin and skin structure infections: Results from a phase 3, randomized, double-blind trial.
Int J Infect Dis. 2005 Sep; 9(5):251-61.IJ

Abstract

OBJECTIVES

To compare the effect of tigecycline monotherapy, a first-in-class, expanded broad spectrum glycylcycline, with the combination of vancomycin and aztreonam (V + A) in the treatment of complicated skin and skin structure infections (cSSSI).

METHODS

A phase 3, double-blind study conducted in 8 countries enrolled adults with cSSSI who required intravenous (IV) antibiotic therapy for > or =5 days. Patients were randomly assigned (1:1) to receive either tigecycline or V + A for up to 14 days. Primary endpoint was the clinical cure rate at the test-of-cure visit. Secondary endpoints included microbiologic efficacy and in vitro susceptibility to tigecycline of bacteria that cause cSSSI. Safety was assessed by physical examination, laboratory analyses, and adverse event reporting.

RESULTS

A total of 596 patients were screened for enrollment, 573 were analyzed for safety, 537 were included in the clinical modified intent-to-treat (c-mITT) population, 397 were clinically evaluable (CE), and 228 were microbiologically evaluable (ME). At test-of-cure, cure rates were similar between tigecycline and V + A groups in the CE population (82.9% versus 82.3%, respectively) and in the c-mITT population (75.5% versus 76.9%, respectively). Microbiologic eradication rates (subject level) at test-of-cure in the ME population were also similar between tigecycline and V + A. Frequency of adverse events was similar between groups, although patients receiving tigecycline had higher incidence of nausea, vomiting, dyspepsia, and anorexia, while increased ALT/SGPT, pruritus, and rash occurred significantly more often in V + A-treated patients.

CONCLUSIONS

This study demonstrates that the efficacy of tigecycline monotherapy for the treatment of patients with cSSSI is statistically noninferior to the combination of V + A.

Authors+Show Affiliations

Victoria Hospital, Bangalore Medical College, Fort, Bangalore, India. sacchi1260@yahoo.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16099700

Citation

Sacchidanand, Sarvajna, et al. "Efficacy and Safety of Tigecycline Monotherapy Compared With Vancomycin Plus Aztreonam in Patients With Complicated Skin and Skin Structure Infections: Results From a Phase 3, Randomized, Double-blind Trial." International Journal of Infectious Diseases : IJID : Official Publication of the International Society for Infectious Diseases, vol. 9, no. 5, 2005, pp. 251-61.
Sacchidanand S, Penn RL, Embil JM, et al. Efficacy and safety of tigecycline monotherapy compared with vancomycin plus aztreonam in patients with complicated skin and skin structure infections: Results from a phase 3, randomized, double-blind trial. Int J Infect Dis. 2005;9(5):251-61.
Sacchidanand, S., Penn, R. L., Embil, J. M., Campos, M. E., Curcio, D., Ellis-Grosse, E., Loh, E., & Rose, G. (2005). Efficacy and safety of tigecycline monotherapy compared with vancomycin plus aztreonam in patients with complicated skin and skin structure infections: Results from a phase 3, randomized, double-blind trial. International Journal of Infectious Diseases : IJID : Official Publication of the International Society for Infectious Diseases, 9(5), 251-61.
Sacchidanand S, et al. Efficacy and Safety of Tigecycline Monotherapy Compared With Vancomycin Plus Aztreonam in Patients With Complicated Skin and Skin Structure Infections: Results From a Phase 3, Randomized, Double-blind Trial. Int J Infect Dis. 2005;9(5):251-61. PubMed PMID: 16099700.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of tigecycline monotherapy compared with vancomycin plus aztreonam in patients with complicated skin and skin structure infections: Results from a phase 3, randomized, double-blind trial. AU - Sacchidanand,Sarvajna, AU - Penn,Robert L, AU - Embil,John M, AU - Campos,Maria E, AU - Curcio,Daniel, AU - Ellis-Grosse,Evelyn, AU - Loh,Evan, AU - Rose,Gilbert, PY - 2005/01/17/received PY - 2005/05/19/revised PY - 2005/05/23/accepted PY - 2005/8/16/pubmed PY - 2005/11/4/medline PY - 2005/8/16/entrez SP - 251 EP - 61 JF - International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases JO - Int J Infect Dis VL - 9 IS - 5 N2 - OBJECTIVES: To compare the effect of tigecycline monotherapy, a first-in-class, expanded broad spectrum glycylcycline, with the combination of vancomycin and aztreonam (V + A) in the treatment of complicated skin and skin structure infections (cSSSI). METHODS: A phase 3, double-blind study conducted in 8 countries enrolled adults with cSSSI who required intravenous (IV) antibiotic therapy for > or =5 days. Patients were randomly assigned (1:1) to receive either tigecycline or V + A for up to 14 days. Primary endpoint was the clinical cure rate at the test-of-cure visit. Secondary endpoints included microbiologic efficacy and in vitro susceptibility to tigecycline of bacteria that cause cSSSI. Safety was assessed by physical examination, laboratory analyses, and adverse event reporting. RESULTS: A total of 596 patients were screened for enrollment, 573 were analyzed for safety, 537 were included in the clinical modified intent-to-treat (c-mITT) population, 397 were clinically evaluable (CE), and 228 were microbiologically evaluable (ME). At test-of-cure, cure rates were similar between tigecycline and V + A groups in the CE population (82.9% versus 82.3%, respectively) and in the c-mITT population (75.5% versus 76.9%, respectively). Microbiologic eradication rates (subject level) at test-of-cure in the ME population were also similar between tigecycline and V + A. Frequency of adverse events was similar between groups, although patients receiving tigecycline had higher incidence of nausea, vomiting, dyspepsia, and anorexia, while increased ALT/SGPT, pruritus, and rash occurred significantly more often in V + A-treated patients. CONCLUSIONS: This study demonstrates that the efficacy of tigecycline monotherapy for the treatment of patients with cSSSI is statistically noninferior to the combination of V + A. SN - 1201-9712 UR - https://www.unboundmedicine.com/medline/citation/16099700/Efficacy_and_safety_of_tigecycline_monotherapy_compared_with_vancomycin_plus_aztreonam_in_patients_with_complicated_skin_and_skin_structure_infections:_Results_from_a_phase_3_randomized_double_blind_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1201-9712(05)00098-6 DB - PRIME DP - Unbound Medicine ER -