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• W1985547745 abstract "SIR-We read with attention the article by Winston et al. [1] that described a clinical trial in which sulbactam/cefoperazone was compared with imipenem in patients with febrile granulocytopenia. We would like to comment on some aspects of the design and conduct of the trial. First, in reference to selection criteria, both fever and neutropenia are not in agreement with the Guidelines for the Evaluation of New Anti-Infective Drugs for the Treatment of Febrile Episodes in Neutropenic Patients [2]. In addition, it is not mentioned if measurement of temperature was oral or axillary. It seems evident that oral measurement is the commonly accepted method [2-4]. Another point is that patients were not stratified as recommended in the guidelines [2]. Although the study results show homogenous groups, we believe that a priori stratification of the patients according to type of tumor and bone marrow transplant is advisable [5, 6]. The report does not specify if patients with septic shock, CNS infections, or HIV infection, or those receiving previous systemic antibiotics were excluded, as seems logical and was contemplated by other investigators [5, 7]. With respect to the patients' treatment, the estimated duration of treatment was not specified in the Patients and Methods section. Although the period of patient's inclusion is also not indicated in the article, this point is clearly explained according to neutrophil count, duration of fever, and risk factors, in the 1997 Guidelines from the Infectious Diseases Society of America [4]. With reference to the classification of the response to therapy, it is not clear what is meant by overall clinical improvement. In this sense, the Guidelines [2] and other investigators [5] require resolution of clinical signs of infection (whenever present). Furthermore, a period of maintenance of a normal temperature and a period in which primary infection must not recur are required [2, 5]. Finally, the policy for treatment modification is not mentioned in the Patients and Methods section. Because it is commonly accepted that investigations must be reproducible, we believe that the previously mentioned points should be clearly specified in the methodology of published clinical trials." @default.
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• W1985547745 date "1999-02-01" @default.
• W1985547745 modified "2023-10-15" @default.
• W1985547745 title "Comparison of Sulbactam/Cefoperazone with Imipenem as Empirical Monotherapy for Febrile Granulocytopenic Patients" @default.
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• W1985547745 doi "https://doi.org/10.1086/515109" @default.
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