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Journal of Antimicrobial Chemotherapy (1992) 30, 203-214
© 1992 The British Society for Antimicrobial Chemotherapy

research-article

A randomized trial of high-dose ciprofloxacin versus azlocillin and netilmicin in the empirical therapy of febrile neutropenic patients

P. R. E. Johnsona, J. A. Lin Yina and J. A. Toothb

aDepartment of Clinical Haematology Oxford Road, Manchester M13 9WL, UK bDepartment of Microbiology, Manchester Royal Infirmary Oxford Road, Manchester M13 9WL, UK

Received 27 September 1991; returned 3 April 1992; accepted 3 April 1992

A prospective, randomized trial comparing monotherapy with high-dose ciprofloxacin versus a standard combination regimen of aziocillin and netilmicin in the empirical treatment of febrile episodes in neutropenic patients was performed. One hundred and forty-six patient episodes were randomized, but ten (seven ciprofloxacin and three aziocilhin/netilmicin) were considered unevaluable for efficacy, and three episodes were withdrawn due to incorrect randomization or non-neutropenia. Of the remaining 133 episodes, infections resolved without modification of therapy in 25/66(38%) versus 28/67(42%) of ciprofloxacin and azlocillin/netilmicin treated groups respectively (P=0·72). Considering all randomized episodes, therapy was modified in 46/73(63%) episodes with ciprofloxacin and 39/70(56%) with aziocillin/netilmicin (P=0·40). Of 73 patient episodes randomized to ciprofloxacin, 25 (34%) received oral follow-on therapy after a median of three days of intravenous therapy. Infections were microbiologically documented in 31/73 (42%;) ciprofloxacin and 32/70 (46%) azlocillin/netilmicin, of which 8/27 (30%) and 14/31 (45%) of evaluable episodes resolved without modification of therapy respectively (P=0·28). Gram-positive organisms accounted for 78% of all organisms cultured with 36% coagulase-negative staphylococci. Bacteriological eradication was recorded in 18/24 (75%) and 26/29 (90%) evaluable patient episodes treated with ciprofloxacin and azlocillin/netilmicin respectively (P=0·27). Superinfections were seen in 14% of episodes in both groups, and subsequent infections in 12% ciprofloxacin and 14% aziocillin/netilmicin treated patients. Two patients (one ciprofloxacin and one azlocillin/netilmicin) died within 48 h of randomization, and a further 13 patients (four ciprofloxacin and nine azlocillin/netilmicin) died before resolution of neutropenia. Adverse events were recorded in 9% and 15% of ciprofloxacin and azlocilhin/netilmicin treated patients respectively, with skin rash (five ciprofloxacin and four azlocillin/netilmicin), nephrotoxicity (two azlocillin/netilmicin), abnormal liver function tests (two azlocillin/netihnicin), ototoxicity (one azlocilhin/netilmicin) and nausea (one ciprofloxacin) being the major events recorded. It was concluded that monotherapy with ciprofloxacin at this dosage is a safe alternative to combination therapy with azjocillin/netilmicin, and has the advantages of twice daily administration, iv and oral presentations, no cross allergy in ß-lactam-hypersensitive patients, and no nephro or oto-toxicity.


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