A Multicentre, Open label, Randomized, Comparative, Parallel Group, Active-controlled, Phase III Clinical Trial to Evaluate Safety and Efficacy of Arbekacin Sulphate Injection versus Vancomycin Injection in Patients Diagnosed with MRSA Infection.
J Assoc Physicians India
; 66(12): 47-50, 2018 Dec.
Article
em En
| MEDLINE
| ID: mdl-31313549
ABSTRACT
BACKGROUND:
Increasing resistance to currently available antimicrobials has led to the development of new agents. Arbekacin is aminoglycoside antibiotic currently used in Japan and Korea for the treatment of infections caused by multi-resistant bacteria including MRSA. Currently there is no published data available for use of Arbekacin in Indian patient population, thus the present study was conducted to evaluate the safety and efficacy of Arbekacin in Indian population. MATERIAL ANDMETHODS:
The study was a phase III, multi-centre, open-label, randomised comparative, active control study. Subjects with microbiologically confirmed MRSA infection were randomized in the study to receive either Arbekacin sulphate 200 mg OD or Vancomycin hydrochloride 1000 mg BD for a period of 7 to 14 days. The primary endpoint was to evaluate the overall cure rate i.e. Clinical and microbiological cure during the study.RESULTS:
A total of 162 patients were randomized in 2 treatment groups (i.e. 81 patients in each group). Out of these microbiologically confirmed MRSA patients, 153 patients were admitted for SSTI while 9 patients were admitted for CAP. Overall cure rate of MRSA infection (clinical as well as microbiological cure) was comparable in both the treatment groups i.e. 97.5% (79/81) in Arbekacin group and 100 % (79/79) in Vancomycin group (p value 0.159). Both Arbekacin and Vancomycin were well tolerated by the patients during the study period.CONCLUSION:
Arbekacin can be considered as safe and effective alternative to vancomycin in the management of MRSA infections.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Contexto em Saúde:
1_ASSA2030
Problema de saúde:
1_doencas_transmissiveis
Assunto principal:
Infecções Estafilocócicas
/
Dibecacina
/
Vancomicina
/
Staphylococcus aureus Resistente à Meticilina
/
Antibacterianos
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
Limite:
Humans
País/Região como assunto:
Asia
Idioma:
En
Revista:
J Assoc Physicians India
Ano de publicação:
2018
Tipo de documento:
Article