Reply Burkholderia pseudomallei Infections

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Jul 13, 2011 - selected patients, was on balance of no advantage for the study population. In view of the higher cost of sparfloxacin and the risk of emergence ...

CID 2000;30 (January)

Correspondence

James R. Johnson Infectious Diseases Section, Minneapolis Veterans Affairs Medical Center, and Department of Medicine, University of Minnesota, Minneapolis, Minnesota

References 1. Aubier M, Verster R, Regamey C, Geslin P, Vercken J-B, the Sparfloxacin European Study Group. Once-daily sparfloxacin versus high-dosage amoxicillin in the treatment of community-acquired, suspected pneumococcal pneumonia in adults. Clin Infect Dis 1998; 26:1312–20. 2. Young LS. Editorial response: a new fluoroquinolone for community-acquired pneumonia. Clin Infect Dis 1998; 26:1322–3. Reprints or correspondence: Dr. James R. Johnson, Infectious Diseases Section (111F), Minneapolis Veterans Affairs Medical Center, 1 Veterans Drive, Minneapolis, MN 55417 ([email protected]). Clinical Infectious Diseases 2000; 30:234–5 q 2000 by the Infectious Diseases Society of America. All rights reserved. 1058-4838/2000/3001-0057$03.00

Reply SIR—The points raised by Johnson are well taken and supplement rather than conflict with my comments [1]. I hope that he did not interpret my views as advocating the use of the new fluoroquinolones for treatment of community-acquired pneumonia in preference to more traditional therapies. The issue of pharmaceutical industry sponsorship of clinical trials involves most medical specialties. It is simply a fact of life that studies of new therapeutic agents have some component of industrial sponsorship or involvement, and Clinical Infectious Diseases and other specialty journals reflect this. Lowell S. Young Kuzell Institute for Arthritis and Infectious Diseases, San Francisco, California

References 1. Young LS. Editorial response: a new fluoroquinolone for community-acquired pneumonia. Clin Infect Dis 1998; 26:1322–3. Reprints or correspondence: Dr. Lowell S. Young, Kuzell Institute for Arthritis and Infectious Diseases, 2200 Webster Street, Suite 305, San Francisco, CA 94115. Clinical Infectious Diseases 2000; 30:235 q 2000 by the Infectious Diseases Society of America. All rights reserved. 1058-4838/2000/01-0058$03.00

Burkholderia pseudomallei Infections SIR—I am always pleased to see anything that may heighten physicians’ awareness of melioidosis and Burkholderia pseudomallei, such as the 2 articles recently published in Clinical Infectious Diseases [1, 2]. However, I would like to add a few comments to these reports. Dorman et al. [1] incorrectly claim that our study from northeast Thailand [3] supports the use of ceftazidime plus trimethoprim-sulfamethoxazole to treat severe melioidosis. In fact, ceftazidime monotherapy was used in this study partly because of concern about bactericidal antagonism between ceftazidime and trimethoprim-sulfamethoxazole [4]. Cefixime has not been evaluated for use in the treatment of melioidosis, despite evidence of in vitro activity, and for children aged 11 years, I would advocate the use of amoxicillin/clavulanate treatment for 20 weeks [5]. In their table 1, Dorman et al. [1] usefully summarize confirmed cases of melioidosis apparently indigenous to the Americas and the Caribbean. I can also provide independent confirmation of the identity of the isolate from Guadeloupe that was reported by Pe´rez et al. [6]. Using biochemical testing and the antibiogram at the Central Public Health Laboratory (Colindale, UK), we found it to be indistinguishable from clinical isolates of B. pseudomallei from Southeast Asia and northern Australia. Clearly, further studies

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selected patients, was on balance of no advantage for the study population. In view of the higher cost of sparfloxacin and the risk of emergence of fluoroquinolone-resistant organisms with more widespread use of these compounds, the observed therapeutic equivalence should be taken as an argument for preferring amoxicillin over sparfloxacin, rather than the reverse, so long as sparfloxacin offers no clear safety advantage. Yet in their study, Aubier et al. found that sparfloxacin apparently did not offer a safety advantage, in spite of their misleading emphasis on the higher incidence of gastrointestinal side effects associated with amoxicillin. Close reading of the text reveals that discontinuation of the study drug for adverse effects was twice as common with sparfloxacin as with amoxicillin, and that one-half of the discontinuations involving sparfloxacin (but none involving amoxicillin) were for gastrointestinal symptoms. Therefore, this study can be legitimately interpreted as providing reassurance that even in locales where historically the prevalence of penicillin-resistant pneumococci is high, high doses of amoxicillin remain an effective and well-tolerated regimen for mild to moderately severe presumed pneumococcal pneumonia in otherwise healthy adults and that newer, extended-spectrum agents are not necessary in this context. It should be noted that the study was funded by Rhoˆne DPC (Antony, France), the manufacturer of sparfloxacin, who would stand to benefit from the authors’ quite different conclusions. The infectious diseases community and the general public are not well served by recommendations to use newer, more expensive agents on the basis merely of demonstrated equivalence with traditional regimens. This disservice is all the greater when study results are presented in an unbalanced fashion that favors the sponsor’s product. It is disappointing that the author of the editorial response to this study did not comment on these issues [2].

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are indicated to determine the true incidence of melioidosis in Central America, South America, and the Caribbean. Finally, I must correct some factual inaccuracies. First, the patient originally described by Whitmore and Krishnaswami [7] was 40 years old, not 10 years old as stated by Dorman et al. [1]. Second, the longest incubation period for melioidosis has recently been increased to 29 years [8]. Last, the case reported by Lee et al. [2] is not, as they state, the first reported case of mycotic aneurysm caused by B. pseudomallei; an earlier case was reported in 1996 [9]. D. A. B. Dance Plymouth Public Health Laboratory, Derriford Hospital, Plymouth, United Kingdom

References

Reprints or correspondence: Dr. D. A. B. Dance, Plymouth Public Health Laboratory, Derriford Hospital, Plymouth, Devon PL6 8DH, United Kingdom ([email protected]). Clinical Infectious Diseases 2000; 30:235–6 q 2000 by the Infectious Diseases Society of America. All rights reserved. 1058-4838/2000/3001-0059$03.00

randomized, controlled trials for assessing comparative antifungal efficacy. We participated in 2 randomized, controlled trials of ABLC therapy for neutropenic patients that were not mentioned in this report. The first trial was a randomized study comparing the efficacy and safety of ABLC and fluconazole as prophylaxis for fungal infections in bone marrow transplant recipients. Unfortunately, this trial was prematurely discontinued because of unacceptable nephrotoxicity when ABLC prophylaxis was used for patients receiving cyclosporine treatment. Patients who received ABLC prophylaxis also had frequent chills and fever; these toxicities were not observed in patients who received fluconazole prophylaxis. In a second multicenter, randomized trial, ABLC was compared with amphotericin B as empirical antifungal therapy for febrile neutropenic patients. Despite objections from investigators, this trial was also prematurely discontinued by the study sponsor, the Liposome Company. Nonetheless, analysis of patients from our center who participated in this trial showed that the incidence of nephrotoxicity (defined as doubling of the baseline serum creatinine level) and fever or chills among ABLC recipients was not different from the incidence among amphotericin B recipients. The rates of clinical response to amphotericin B and ABLC were similar. Randomized, double-blind, controlled trials evaluating the efficacy and safety of other lipid-associated formulations of amphotericin B as empirical antifungal therapy have also been performed. The efficacy of amphotericin B colloidal dispersion (ABCD) was found to be comparable with the efficacy of amphotericin B as empirical antifungal therapy for febrile neutropenic patients [2]. ABCD was associated with less renal dysfunction but more infusion-related hypoxia and chills. Similarly, liposomal amphotericin B (AmBisome; Vestar, San Dimas, CA) and amphotericin B were equally effective as empirical antifungal treatment of persistently febrile neutropenic patients [3]. However, nephrotoxicity, fever, chills, and cardiopulmonary events were less frequently associated with liposomal amphotericin B. Therefore, when choosing an agent for antifungal therapy for neutropenic patients, physicians will need to consider not only the difference in toxicity between the lipid-associated formulations and amphotericin B, but also possible differences in the toxicity of the different lipid-associated preparations of amphotericin B. Drew J. Winston and Gary J. Schiller Division of Hematology-Oncology, Department of Medicine, UCLA Center for the Health Sciences, Los Angeles, California

Controlled Trials of Amphotericin B Lipid Complex and Other Lipid-Associated Formulations

References

SIR—In their report of an uncontrolled study of amphotericin B lipid complex (ABLC; Liposome, Princeton, NJ) for invasive fungal infections, Walsh et al. [1] emphasize the importance of

1. Walsh RJ, Hiemenz JW, Seibel NL, et al. Amphotericin B lipid complex for invasive fungal infections: analysis of safety and efficacy in 556 cases. Clin Infect Dis 1998; 26:1383–96. 2. White MH, Bowden RA, Sandler ES, et al. Randomized, double-blind clinical

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1. Dorman SE, Gill VJ, Gallin JI, Holland SM. Burkholderia pseudomallei infection in a Puerto Rican patient with chronic granulomatous disease: case report and review of occurrences in the Americas. Clin Infect Dis 1998; 26: 889–94. 2. Lee SS-J, Liu Y-C, Wang J-H, Wann S-R. Mycotic aneurysm due to Burkholderia pseudomallei. Clin Infect Dis 1998; 26:1013–4. 3. White NJ, Dance DAB, Chaowagul W, Wattanagoon Y, Wuthiekanun V, Pitakwatchera N. Halving of mortality in severe melioidosis by ceftazidime. Lancet 1989; 2:697–701. 4. Dance DAB, Wuthiekanun V, Chaowagul W, White NJ. Interactions in vitro between agents used to treat melioidosis. J Antimicrob Chemother 1989; 24:311–6. 5. Rajchanuvong A, Chaowagul W, Suputtamongkol Y, Smith MD, Dance DAB, White NJ. A prospective comparison of co-amoxiclav and the combination of chloramphenicol, doxycycline, and co-trimoxazole for the oral maintenance treatment of melioidosis. Trans R Soc Trop Med Hyg 1995; 89: 546–9. 6. Pe´rez J-M, Petiot A, Adjide´ C, Gerry F, Goursaud R, Juminer B. First case report of melioidosis in Guadeloupe, a French West Indies archipelago. Clin Infect Dis 1997; 25:164–5. 7. Whitmore A, Krishnaswami CS. An account of the discovery of a hitherto undescribed infective disease occurring among the population of Rangoon. Indian Medical Gazette 1912; 47:262–7. 8. Chodimella U, Hoppes WL, Whalen S, Ognibene AJ, Rutecki GW. Septicemia and suppuration in a Vietnam veteran. Hosp Pract 1997; 32:219–21. 9. Steinmetz I, Stosiek P, Hergenrother D, Bal W. Melioidosis causing a mycotic aneurysm. Lancet 1996; 347:1564–5.

CID 2000;30 (January)