Randomised comparison of oral ofloxacin alone with combination of parenteral antibiotics in neutropenic febrile patients
Prompt treatment with empirical antibiotics in neutropenic febrile patients reduces morbidity and mortality. Most patients have been treated with parenteral combination antibiotics, but newer antibiotics with broad-spectrum bactericidal activity have made monotherapy feasible. Ofloxacin, a broad-spe...
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Published in | The Lancet (British edition) Vol. 339; no. 8801; pp. 1092 - 1096 |
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Main Authors | , , |
Format | Journal Article |
Language | English |
Published |
London
Elsevier Ltd
02.05.1992
Lancet Elsevier Limited |
Subjects | |
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Abstract | Prompt treatment with empirical antibiotics in neutropenic febrile patients reduces morbidity and mortality. Most patients have been treated with parenteral combination antibiotics, but newer antibiotics with broad-spectrum bactericidal activity have made monotherapy feasible. Ofloxacin, a broad-spectrum fluoroquinolone, has the additional advantage that bactericidal concentrations can be achieved with oral administration. We have compared ofloxacin as an oral single agent with standard parenteral combination antibiotics for the management of neutropenic febrile patients in a prospective, randomised trial. Patients with severe neutropenia (absolute neutrophil count ≤0·5 × 10
9/l), fever above 38°C, and ability to take drugs by mouth were eligible for the study. After initial investigations, 60 patients were randomly assigned to oral ofloxacin 400 mg twice daily and 62 to parenteral combination antibiotic therapy (amikacin 15 mg/kg daily, plus, at various times in the trial, carbenicillin, cloxacillin, or piperacillin). Patients were examined 72 h and 7 days after the start of treatment and when neutropenia resolved. 24 (40%) ofloxacin-treated and 26 (42%) combination-treated patients had pyrexia of unknown origin (PUO). In both treatment groups, the treatment success rate was higher for such patients than for those with clinically or microbiologically documented infections (92% vs 67% [p<0·05] for ofloxacin; 85% vs 64% for combination). There were no significant differences in success rates of ofloxacin and combination treatment for these subgroups or overall (77%
vs 73%). Patients with neutropenia for less than 1 week had better responses to both treatments than patients with longer-lasting neutropenia. There were 4 (7%) deaths in the ofloxacin group and 6 (10%) in the combination group. Both regimens were well tolerated. We conclude that oral single-agent ofloxacin is as effective as parenteral combination antibiotic therapy in neutropenic febrile patients, especially those expected to have short durations of neutropenia.
Lancet 1992;
339: 1092-96. |
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AbstractList | Prompt treatment with empirical antibiotics in neutropenic febrile patients reduces morbidity and mortality. Most patients have been treated with parenteral combination antibiotics, but newer antibiotics with broad-spectrum bactericidal activity have made monotherapy feasible. Ofloxacin, a broad-spectrum fluoroquinolone, has the additional advantage that bactericidal concentrations can be achieved with oral administration. We have compared ofloxacin as an oral single agent with standard parenteral combination antibiotics for the management of neutropenic febrile patients in a prospective, randomised trial. Patients with severe neutropenia (absolute neutrophil count less than or equal to 0.5 x 10(9)/l), fever above 38 degrees C, and ability to take drugs by mouth were eligible for the study. After initial investigations, 60 patients were randomly assigned to oral ofloxacin 400 mg twice daily and 62 to parenteral combination antibiotic therapy (amikacin 15 mg/kg daily, plus, at various times in the trial, carbenicillin, cloxacillin, or piperacillin). Patients were examined 72 h and 7 days after the start of treatment and when neutropenia resolved. 24 (40%) ofloxacin-treated and 26 (42%) combination-treated patients had pyrexia of unknown origin (PUO). In both treatment groups, the treatment success rate was higher for such patients than for those with clinically or microbiologically documented infections (92% vs 67% [p less than 0.05] for ofloxacin; 85% vs 64% for combination). There were no significant differences in success rates of ofloxacin and combination treatment for these subgroups or overall (77% vs 73%). Patients with neutropenia for less than 1 week had better responses to both treatments than patients with longer-lasting neutropenia. There were 4 (7%) deaths in the ofloxacin group and 6 (10%) in the combination group. Both regimens were well tolerated. We conclude that oral single-agent ofloxacin is as effective as parenteral combination antibiotic therapy in neutropenic febrile patients, especially those expected to have short durations of neutropenia. Prompt treatment with empirical antibiotics in neutropenic febrile patients reduces morbidity and mortality. Most patients have been treated with parenteral combination antibiotics, but newer antibiotics with broad-spectrum bactericidal activity have made monotherapy feasible. Ofloxacin, a broad-spectrum fluoroquinolone, has the additional advantage that bactericidal concentrations can be achieved with oral administration. We have compared ofloxacin as an oral single agent with standard parenteral combination antibiotics for the management of neutropenic febrile patients in a prospective, randomised trial. Patients with severe neutropenia (absolute neutrophil count ≤0·5 × 10 9/l), fever above 38°C, and ability to take drugs by mouth were eligible for the study. After initial investigations, 60 patients were randomly assigned to oral ofloxacin 400 mg twice daily and 62 to parenteral combination antibiotic therapy (amikacin 15 mg/kg daily, plus, at various times in the trial, carbenicillin, cloxacillin, or piperacillin). Patients were examined 72 h and 7 days after the start of treatment and when neutropenia resolved. 24 (40%) ofloxacin-treated and 26 (42%) combination-treated patients had pyrexia of unknown origin (PUO). In both treatment groups, the treatment success rate was higher for such patients than for those with clinically or microbiologically documented infections (92% vs 67% [p<0·05] for ofloxacin; 85% vs 64% for combination). There were no significant differences in success rates of ofloxacin and combination treatment for these subgroups or overall (77% vs 73%). Patients with neutropenia for less than 1 week had better responses to both treatments than patients with longer-lasting neutropenia. There were 4 (7%) deaths in the ofloxacin group and 6 (10%) in the combination group. Both regimens were well tolerated. We conclude that oral single-agent ofloxacin is as effective as parenteral combination antibiotic therapy in neutropenic febrile patients, especially those expected to have short durations of neutropenia. Lancet 1992; 339: 1092-96. |
Author | Abbas, Z Malik, I.A Karim, M |
Author_xml | – sequence: 1 givenname: I.A surname: Malik fullname: Malik, I.A organization: Department of Medicine, Aga Khan University Hospital, Karachi, Pakistan – sequence: 2 givenname: Z surname: Abbas fullname: Abbas, Z organization: Department of Medicine, Aga Khan University Hospital, Karachi, Pakistan – sequence: 3 givenname: M surname: Karim fullname: Karim, M organization: Department of Medicine, Aga Khan University Hospital, Karachi, Pakistan – sequence: 4 givenname: I.A surname: Malik fullname: Malik, I.A organization: Division of Hematology-Oncology, Department of Medicine, University of California Irvine Medical Center, California, U.S.A |
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Keywords | Human Antibiotic Chemotherapy Treatment Oral administration Hemopathy Comparative study Fever Parenteral administration Neutropenia |
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References | De Jongh, Joshi, Newman (BIB5) 1986; 80 Wade, Schimpff, Newman, Fortner, Standiford, Wiernik (BIB29) 1981; 71 Chan, Oppenheim, Anderson, Swindell, Scarffe (BIB25) 1989; 33 Flaherty, Waitley, Edlin (BIB26) 1989; 87 Fainstein, Bodey, Elting (BIB20) 1983; 12 Hathorn, Rubin, Pizzo (BIB2) 1987; 31 Elliot, Pater (BIB27) 1988; 11 Sanders (BIB9) 1988; 10 Pater, Weir (BIB12) 1986; 4 Sander, Sander, Goenng (BIB16) 1982; 21 Rubin (BIB1) 1988; 108 Wade, Schimpff (BIB6) 1982 Kelsey, Wood, Shaw, Newland (BIB22) 1989; 87 Klastersky, Cappel, Daneau (BIB3) 1972; 2 Karim, Khan, Farooqi, Malik (BIB10) 1991; 41 Morgan, Duerden, Lilleyman (BIB19) 1983; 12 Kibbler, Pomeroy, Sage, Mannan, Noone, Prentice (BIB30) 11-14 May, 1987 Bodey, Buckley, Sathe, Freireich (BIB13) 1966; 64 EORTC International Antimicrobial Therapy Project Group (BIB14) 1978; 137 Piccart, Klastersky, Meunier, Lagast, Van Laethem, Weerts (BIB17) 1984; 26 Issell, Bodey (BIB24) 1980; 17 EORTC International Antimicrobial Therapy Project Group (BIB28) 1978; 137 Anderson, Young, Hewitt (BIB4) 1978; 24 Wade, Standiford, Drusano (BIB18) 1985; 78 Wade, Johnson, Bustamante (BIB7) 1986; 80 Wade, Schimpff, Newman, Wiernick (BIB15) 1982; 97 Van Laethem, Lagast, Klastersky (BIB8) 1983; 23 Pizzo, Hathorn, Hiemenz (BIB11) 1986; 315 Reilly, Brada, Bellingham, Hart, Bennet (BIB21) 1983; 12 Bayston, Want, Cohen (BIB23) June, 1988 Lancet 1992 Jul 11;340(8811):128 Wade (10.1016/0140-6736(92)90674-R_BIB18) 1985; 78 Elliot (10.1016/0140-6736(92)90674-R_BIB27) 1988; 11 Karim (10.1016/0140-6736(92)90674-R_BIB10) 1991; 41 Wade (10.1016/0140-6736(92)90674-R_BIB7) 1986; 80 Pizzo (10.1016/0140-6736(92)90674-R_BIB11) 1986; 315 Wade (10.1016/0140-6736(92)90674-R_BIB6) 1982 Hathorn (10.1016/0140-6736(92)90674-R_BIB2) 1987; 31 Piccart (10.1016/0140-6736(92)90674-R_BIB17) 1984; 26 Fainstein (10.1016/0140-6736(92)90674-R_BIB20) 1983; 12 Wade (10.1016/0140-6736(92)90674-R_BIB15) 1982; 97 EORTC International Antimicrobial Therapy Project Group (10.1016/0140-6736(92)90674-R_BIB28) 1978; 137 Sanders (10.1016/0140-6736(92)90674-R_BIB9) 1988; 10 Pater (10.1016/0140-6736(92)90674-R_BIB12) 1986; 4 Wade (10.1016/0140-6736(92)90674-R_BIB29) 1981; 71 Flaherty (10.1016/0140-6736(92)90674-R_BIB26) 1989; 87 Rubin (10.1016/0140-6736(92)90674-R_BIB1) 1988; 108 EORTC International Antimicrobial Therapy Project Group (10.1016/0140-6736(92)90674-R_BIB14) 1978; 137 Van Laethem (10.1016/0140-6736(92)90674-R_BIB8) 1983; 23 De Jongh (10.1016/0140-6736(92)90674-R_BIB5) 1986; 80 Bodey (10.1016/0140-6736(92)90674-R_BIB13) 1966; 64 Reilly (10.1016/0140-6736(92)90674-R_BIB21) 1983; 12 Bayston (10.1016/0140-6736(92)90674-R_BIB23) 1988 Issell (10.1016/0140-6736(92)90674-R_BIB24) 1980; 17 Kelsey (10.1016/0140-6736(92)90674-R_BIB22) 1989; 87 Morgan (10.1016/0140-6736(92)90674-R_BIB19) 1983; 12 Sander (10.1016/0140-6736(92)90674-R_BIB16) 1982; 21 Klastersky (10.1016/0140-6736(92)90674-R_BIB3) 1972; 2 Anderson (10.1016/0140-6736(92)90674-R_BIB4) 1978; 24 Chan (10.1016/0140-6736(92)90674-R_BIB25) 1989; 33 Kibbler (10.1016/0140-6736(92)90674-R_BIB30) 1987 |
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granulocytopenic cancer patients publication-title: Am J Med contributor: fullname: Wade – volume: 137 start-page: 14 year: 1978 ident: 10.1016/0140-6736(92)90674-R_BIB28 article-title: Three antibiotic regimens in the treatment of infection in granulocytopenic patients with cancer publication-title: J Infect Dis doi: 10.1093/infdis/137.1.14 contributor: fullname: EORTC International Antimicrobial Therapy Project Group – volume: 64 start-page: 328 year: 1966 ident: 10.1016/0140-6736(92)90674-R_BIB13 article-title: Quantitative relationships between circulating leukocytes and infection in patients with acute leukemia publication-title: Ann Intern Med doi: 10.7326/0003-4819-64-2-328 contributor: fullname: Bodey – volume: 12 start-page: 101 issue: suppl A year: 1983 ident: 10.1016/0140-6736(92)90674-R_BIB20 article-title: A randomized study of ceftazidime compared to ceftazidime and tobramycin for the treatment of infections in cancer patients publication-title: J Antimicrob Chemother 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– volume: 12 start-page: 89 issue: suppl A year: 1983 ident: 10.1016/0140-6736(92)90674-R_BIB21 article-title: Cefatizidime compared to tobramycin and ticarcillin in immunocompromised hematological patients publication-title: J Antimicrob Chemother doi: 10.1093/jac/12.suppl_A.89 contributor: fullname: Reilly – volume: 33 start-page: 87 year: 1989 ident: 10.1016/0140-6736(92)90674-R_BIB25 article-title: Randomized trial comparing ciprofloxacin plus netilmicin versus piperacillin plus netilmicin for empiric treatment of fever of neutropenic patients publication-title: Antimicrob Agents Chemother doi: 10.1128/AAC.33.1.87 contributor: fullname: Chan – volume: 87 start-page: 274S issue: suppl 5A year: 1989 ident: 10.1016/0140-6736(92)90674-R_BIB22 article-title: Intravenous ciprofloxacin as empirical treatment of febrile neutropenic patients publication-title: Am J Med doi: 10.1016/0002-9343(89)90079-X contributor: fullname: Kelsey – volume: 315 start-page: 552 year: 1986 ident: 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10.1016/0140-6736(92)90674-R_BIB29 article-title: Piperacillin or ticarcillin plus amikacin: a double-blind prospective comparison of empiric antibiotic therapy for febrile granulocytopenic cancer patients publication-title: Am J Med doi: 10.1016/0002-9343(81)90324-7 contributor: fullname: Wade |
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Snippet | Prompt treatment with empirical antibiotics in neutropenic febrile patients reduces morbidity and mortality. Most patients have been treated with parenteral... |
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SubjectTerms | Administration, Oral Adult Amikacin - therapeutic use Anti-Bacterial Agents - therapeutic use Antibiotics Biological and medical sciences Blood Carbenicillin - therapeutic use Cloxacillin - therapeutic use Drug Therapy, Combination Drugs Female Fever - drug therapy Gram-Negative Bacteria - drug effects Gram-Negative Bacteria - isolation & purification Gram-Positive Bacteria - drug effects Gram-Positive Bacteria - isolation & purification Hematologic and hematopoietic diseases Humans Male Medical disorders Medical research Medical sciences Neutropenia - drug therapy Neutropenia - microbiology Neutropenia - mortality Ofloxacin - administration & dosage Piperacillin - therapeutic use Prospective Studies |
Title | Randomised comparison of oral ofloxacin alone with combination of parenteral antibiotics in neutropenic febrile patients |
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