CLINICAL TRIAL
CLINICAL TRIAL, PHASE III
CONTROLLED CLINICAL TRIAL
ENGLISH ABSTRACT
JOURNAL ARTICLE
MULTICENTER STUDY
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[The first clinical experiences in Hungary with a new effective antibiotic (linezolid) effective against Gram-positive infections].

Orvosi Hetilap 2003 January 6
INTRODUCTION: The occurrence of gram-positive infections caused by multiresistant organisms has increased significantly in general, particularly among the surgical patients, and only a few effective antibiotics are available. A new and effective, synthetic antibiotic, against gram-positives is the oxazolidinon group, that electively inhibits bacterial protein synthesis in the early phase. Linezolid, the first member of this group to be used in clinical practice is the linezolid was studied.

AIMS: The purpose of this study was to evaluate the effectiveness and safety of linezolid in the gram-positive infections of surgical patients.

METHODS: A 3rd phase, clinical trial was conducted at the Semmelweis University Ist Surgical Department in the period of 1999-2001. Twenty-one patients with gram-positive infections were enrolled to this study. The mean of age was 57 years. Patients were selected for linezolid treatment in whom the conventional anti-gram-positive antibiotic therapy caused difficulties.

RESULTS: Sixteen patients out of 21 recovered, one patient was cured clinically, but not microbiologically, and one case showed microbiological cure with clinical failure. In one case the methicillin resistant Staphylococcus aureus carriership was cured. Two cases had a fatal outcome. The causes of death were mediastinitis plus pneumonia in one case, and diffuse peritonitis with renal insufficiency in the other. Withdrawal from the study occurred in one case, due to drug intolerance.

CONCLUSIONS: The linezolid administration proved to be safe and effective even in those cases, in which either hypacusis or decreased renal function persisted, or oral intake was advantagous. Contraindication of linezolid therapy did not occur. Few side effects were observed. If the infection was polymicrobial, the linezolid could be combined with other antibiotics. Further investigations are mandatory to evaluate the role of linezolid in the treatment of methicillin resistant Staphylococcus aureus carriership.

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