CID 1992;15 (August)

Correspondence

Antiendotoxin Monoclonal Antibodies for Gram-Negative Sepsis

Correspondence: Dr. Herman Chmel, Department of Medicine, St. Francis Medical Center, 601 Hamilton Avenue, Trenton, New Jersey 086291986.

Clinical Infectious Diseases

1992;15:371

© 1992 by The University of Chicago. All rights reserved. 1058-4838/92/1502-0021$02.00

Reply SIR-We appreciate the effort ofChmel and Emmanuel to clarify our analysis of the published data on E5 and HA-IA that we Correspondence: Dr. Richard P. Wenzel, Department of Internal Medicine, The University of Iowa College of Medicine, Iowa City, Iowa 52242.

Clinical Infectious Diseases

1992;15:371-2

© 1992 by The University of Chicago. All rights reserved. 1058-4838/92/1502-0022$02.00

Table 2. Treatment of gram-negative sepsis with antiendotoxin monoclonal antibodies. Result with monoclonal antibody Parameter Efficacy in indicated patient group All enrolled Without gram-negative sepsis With gram-negative sepsis All Shock (refractory) With bacteremia Without bacteremia Without shock With bacteremia Without bacteremia Bacteremia Shock Without shock Without bacteremia Shock Without shock No. (%) of patients with allergic reactions

E5

HA-IA

No No

No No

No No No No Yes Yes Yes

No

4/246 (1.6)

Yes Yes Yes No No No 2/286 (0.7)

elusively prove that these agents reduce overall mortality. However, on the basis of the two published trials, these antibodies do appear to offer a clinical benefit to a subset of patients with suspected gram-negative sepsis. In closing, we believe that clinicians should be guided by established criteria not unlike those used in the clinical trials and as outlined in the paper by Wenzel et al. [I] so as to provide a favorable and hopefully cost-effective outcome.

Herman Chmel and George Emmanuel Department of Medicine, St. Francis Medical Center, Trenton, New Jersey; and Pulmonary Section, Veterans Medical Center, Bay Pines, Florida

Reference 1. Wenzel RP, Andriole YT, Bartlett JG, et al. Antiendotoxin monoclonal antibodies for gram-negative sepsis: guidelines for the IDSA. Clin Infect Dis 1992;14:973-6.

used in putting forth our guidelines for the use of antiendotoxin monoclonal antibodies for suspected gram-negative sepsis. All of the patients in both trials had clinical characteristics suggestive of the sepsis syndrome; our analysis separated out those individuals with demonstrated bacteremia from those without, but simple addition of the adjacent rows would yield the total number of patients that they would prefer to see in table 1. The crucial point in evaluating efficacy is in prospectively knowing that patients who meet the clinical criteria for use of the agent will benefit from its use. In our table 2 and in that of

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SIR-The article by Wenzel et al. [1] is timely. We support our colleagues' beliefs that it is extremely important to review the indications for the current use ofantiendotoxin monoclonal antibodies for gram-negative sepsis and to establish guidelines for their use clinically. However, the body of the text of the article by Wenzel et al. does not coincide with the data presented in the various tables. In table 1, the number ofpatients with gram-negative sepsis in either trial is wrong (that for E5 should read 316, not 145, and that for HA-IA should be 401, not 201). Also, the overall mortality in the E5 trial should be by day 30 and that in the HA-IA trial, by day 28. In our opinion, table 2 is inappropriately constructed on the basis of data from the two published studies and can be misleading. Concerning efficacy, the E5 trial prospectively defined patient groups for analysis in terms of shock, while the HA-l A trial prospectively defined patients for analysis in terms of gram-negative bacteremia. We believe that the following version of table 2 would be more appropriate. Table 3 implies that patients could be enrolled in the HA-IA trial without having a suspected or documented gram-negative infection. We also disagree with the authors' statements concerning the total population of patients and the data presented. In the E5 trial, 242 patients received active drug; of these patients, 164 had documented gram-negative sepsis, and 74 of these also had no refractory shock. These 74 patients (31% of 242) benefited. Seventy-four patients with gram-negative sepsis and no refractory shock (45% of 164) mayor may not represent "a minority of the total population of patients treated." In the HA-l A trial, 262 patients received active drug. However, the number of treated patients who had gram-negative infection is not stated in the HA-l A article, but ofa total of 200 bacteremic patients, 105 received active drug. One hundred five patients with documented gram-negative bacteremia (40% of 262) may or may not represent "a minority of the total population of patients treated." We do agree that the data published to date concerning the efficacy of antiendotoxin monoclonal antibodies may not con-

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Antiendotoxin monoclonal antibodies for gram-negative sepsis.

CID 1992;15 (August) Correspondence Antiendotoxin Monoclonal Antibodies for Gram-Negative Sepsis Correspondence: Dr. Herman Chmel, Department of Me...
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