Double-blind randomized study of prophylactic trimethoprim/sulfamethoxazole in granulocytopenic patients with hematologic malignancies

Gualtieri, Richard J.; Donowitz, Gerald R.; Kaiser, Donald L.; Hess, Charles E.; Sande, Merle A.

doi:10.1016/0002-9343(83)90785-4

Cited by 103 publications

(18 citation statements)

References 17 publications

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“…In that study, TMP-SMX was found to be superior for infection prophylaxis (35). Nalidixic acid was administered in doses of 8 g daily, and TMP-SMX was given in a dose 50% higher than in previously reported studies (5,9,10,18 …”

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confidence: 87%

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Selective gut decontamination with nalidixic acid or trimethoprim-sulfamethoxazole for infection prophylaxis in neutropenic cancer patients: relationship of efficacy to antimicrobial spectrum and timing of administration

Bow¹,

Rayner²,

Scott³

et al. 1987

Antimicrob Agents Chemother

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Eighty-four cancer patients at risk of infection because of neutropenia were randomized to receive nalidixic acid as an alternative to trimethoprim-sulfamethoxazole (TMP-SMX) for infection prophylaxis. Infections were documented significantly earlier and more often among patients who entered the trial with neutrophil counts of less than 0.1 X 10(9)/liter. TMP-SMX recipients experienced fewer microbiologically documented infections and bacteremias and were free of infection for a higher proportion of days with severe neutropenia (less than 0.1 X 10(9)/liter) than nalidixic acid recipients. Gram-negative bacillary and Staphylococcus aureus infections accounted for the major differences. Although the majority of aerobic gram-negative bacilli were eliminated from the feces after 1 week of prophylaxis with either agent, TMP-SMX was proved superior to nalidixic acid in this regard and was associated with acquired drug resistance by gram-negative bacilli less frequently. Both agents selected for colonization and subsequent infection by gram-positive cocci. Our data suggest that prophylaxis is most likely to be effective if administered to patients for at least 1 week before they become severely neutropenic. Nalidixic acid used as a single agent in doses of 4 g daily, however, cannot be recommended as an alternative to TMP-SMX for infection prophylaxis in neutropenic cancer patients.

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confidence: 87%

“…More recently, enthusiasm for the use of this agent for infection prophylaxis has been dampened by reports that TMP-SMX may select for antibiotic-resistant aerobic gram-negative bacilli (GNB) (8,10,18,21,23,26,28,39) and for colonization by fungi (5,15,18,24). Furthermore, myelosuppression associated with the use of this combination (5,10,29) is of concern.…”

mentioning

confidence: 99%

Selective gut decontamination with nalidixic acid or trimethoprim-sulfamethoxazole for infection prophylaxis in neutropenic cancer patients: relationship of efficacy to antimicrobial spectrum and timing of administration

Bow¹,

Rayner²,

Scott³

et al. 1987

Antimicrob Agents Chemother

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“…Most of these studies were performed in patients with acute leukaemia. Some of these trials also included patients with other [29] rwith [30] ijfer [26] Weiser [31] Dekker [32] Guiot [27] Kauffman [33] Gualtieri [34] de Jongh [35] Estey [36] EORTC [37] Henry [38] Karp [39] Hartlapp [40] Table 2. The interpretation and comparison of the data of these studies are rather difficult, since these studies differed in the selection of patients, in the antibacterial and antifungal regimens, and in the definitions of fever episodes and infections.…”

Section: Clinical Trials Of Selective Decontaminationmentioning

confidence: 99%

“…In all other trials fixed drug regimens were studied. Trimethoprim-sulphamethoxazole was applied in ten studies [29][30][31][32][33][34][35][36][37][38]. Six of these studies showed a significant reduction of the risk of all infections and fever episodes to 38-63% as compared to the control groups.…”

Section: Clinical Trials Of Selective Decontaminationmentioning

confidence: 99%

“…In the trial of the EORTC a significant reduction of infection could not be demonstrated in patients with acute non-lymphocytic leukaemia but could with other diseases [37]. In three studies SD failed to reduce the overall incidence of febrile episodes but reduced significantly the incidence of Gram-negative [33], of clinically documented [38] or of microbiologically documented infections [34]. One trial of trimethoprim-sulphamethoxazole failed to show the efficacy of SD using this agent [31].…”

Section: Clinical Trials Of Selective Decontaminationmentioning

confidence: 99%

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Selective decontamination in neutropenic patients

1992

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It is well known that severe neutropenia, as usually seen in patients with acute leukaemia, aplastic anaemia or secondary to aggressive chemotherapy, predisposes to infections with Gram-negative enteric bacilli,Pseudomonas aeruginosa, Staphylococcus aureus, and to fungal infections. Infection with anaerobes, in contrast, is rare in patients with haematologic malignancy [1]. The spectrum of bacterial pathogens in this patient population has recently broadened, and now includes coagulase-negative staphylococci, viridans group streptococci, and, occasionally, coryneforms and other rather unusual opportunistic organisms. All these microorganisms originate either from the patient's own microflora, especially from the digestive tract, or from the hospital environment after having colonized the patient during the hospital stay [2]. Studies have shown that the incidence of fever during periods of severe neutropenia approaches 100%, and most of these fever episodes actually represent bacterial infection. For more than 20 years, methods for the prevention of bacterial and fungal infections have been under investigation in patients with profound neutropenia. These included decontamination trails, oral or systemic antimicrobial prophylaxis, strict reverse isolation and maintenance of germ-free conditions [3–8], prophylactic granulocyte transfusions [9], and, more recently, the application of haemopoietic growth factors [10, 11]. The method which remains the most widely used is oral antimicrobial prophylaxis, especially with agents for so-called selective decontamination of the intestinal tract.

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Selective discharge of patients with acute myeloid leukemia during chemotherapy-induced neutropenia

1996

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Purpose. it is common practice for patients with acute myeloid leukemia (AML) to be observed in hospital during the entire nadir after intensive chemotherapy. in an attempt to lessen the likelihood of developing infections with hospital acquired pathogens, we usually discharge patients upon completion of chemotherapy and follow them as outpatients. They are readmitted if fever develops. We evaluated the feasibility and safety of this practice. Patients and Methods. We studied 29 patients with AML (median age 40 years, range 16-63) who were treated with intensive remission-induction and consolidation chemother-apy. Afebriie patients not receiving antibiotics were discharged immediately following chemotherapy and were followed every 3-4 days at the day care unit. Patients were instructed to return immediately if fever rose to 38.2"C or a fever of 38°C persisted for 2 hr. The 29 patlents received a total of 86 courses. Following 50 courses, patients were discharged. These 50 ambulatory nadir periods (ANPs) were monitored. Results. Median WBC and platelet counts on discharge were 2,900 per cubic millimeter (range 3004,300) and 137,000 per cubic millimeter (range 17,000-61 8,000), respectively. Mean traveling time from the hospital by car was 1.6 hr (range 15 min-3 hr). In three of the 50 ANPs (So/.), patients were not readmitted during their entire nadir. During 47 of the ANPs, patients returned to the hospital (because of fever in 44 cases), a mean of 7.2 days (range 1.0-12.7 days) after discharge. In 45 ANPs, patients were readmitted in good general condition. Four patients had iife-threatening complications. Two patients were admitted in septic shock due to delay in seeking admission, but rapidly recovered. Two other patients died, one of cardiogenic shock within 24 hr of readmission and one 24 days later. Only one of the 11 gram negative bacteria cultured was resistant to mezlocillin and gentamlcin. After 45 ANPs, patients were discharged a mean of 12.2 days (range 5-42 days) foilowing readmission. We estimate that approximately 383 hospital days were saved by this policy, a mean of 7.6 days per patient, representing 16% of total inpatient hospital days. Conclusions. For AML patients who are reliable and without complicating medical conditions, selected discharge following chemotherapy is a low-risk practice and may reduce the incidence of infection with resistant hospital-acquired pathogens.

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Double-blind randomized study of prophylactic trimethoprim/sulfamethoxazole in granulocytopenic patients with hematologic malignancies

Cited by 103 publications

References 17 publications

Selective gut decontamination with nalidixic acid or trimethoprim-sulfamethoxazole for infection prophylaxis in neutropenic cancer patients: relationship of efficacy to antimicrobial spectrum and timing of administration

Selective gut decontamination with nalidixic acid or trimethoprim-sulfamethoxazole for infection prophylaxis in neutropenic cancer patients: relationship of efficacy to antimicrobial spectrum and timing of administration

Selective decontamination in neutropenic patients

Selective discharge of patients with acute myeloid leukemia during chemotherapy-induced neutropenia

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