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PubMed1996

Imipenem or cefoperazone-sulbactam combined with vancomycin for therapy of presumed or proven infection in neutropenic cancer patients.

The purpose of this prospective randomized study was to compare the efficacy and safety of imipenem and cefoperazone-sulbactam combined with vancomycin for the treatment of fever in neutropenic cancer patients. Patients were assigned to either imipenem 500 mg/m2 (500 mg for bone marrow transplant recipients) every 6 h or cefoperazone (2 g)-sulbactam (1 g) every 8 h All patients received vancomycin 1 g every 12 h. A total of 457 febrile or infectious episodes occurring in 407 patients were entered in the study. The response rate was 73% for imipenem plus vancomycin and 74% for cefoperazone-sulbactam plus vancomycin among the 369 episodes that could be evaluated. Response rates were comparable for the two regimens with regard to infecting organism, administration of antimicrobial prophylaxis, and neutrophil count and trend. The frequency of side-effects was significantly higher for imipenem plus vancomycin (11% vs.5%, p = 0.02), due to therapy-associated nausea and vomiting (5.3% vs. 0%, p = 0.0004). The overall frequency of superinfections was similar with both regimens, but Clostridium difficile colitis occurred significantly more often in patients receiving imipenem plus vancomycin (5 vs. 0, p = 0.02). In this study cefoperazone-sulbactam plus vancomycin was an effective alternative to imipenem plus vancomycin for initial therapy of fever in neutropenic patients.

Adolescent↗
PubMed1983

Treatment of gram-negative bacillary septicemia with cefoperazone.

Cefoperazone, a new broad-spectrum cephalosporin, was administered by continuous infusion or intermittent injection to 20 and 25 patients respectively with gram-negative bacillary septicemia most of whom had severe underlying disease. No difference was observed in the clinical response of the two groups. The overall rate of favourable response was 76%. Of the 40 non-neutropenic patients treated three died of infection despite sensitivity of the organism, three improved temporarily and three died as the result of superinfection. Three of the five neutropenic patients treated failed to respond to cefoperazone therapy, despite adequate serum bactericidal activity. Tolerance to cefoperazone was satisfactory. Emergence of cefoperazone-resistant strains leading to relapse or superinfection was not a major cause of failure.

Adult↗
PubMed1988

Cefoperazone plus mezlocillin for empiric therapy of febrile cancer patients.

Two dosing regimens of cefoperazone plus mezlocillin were compared in a prospective, randomized trial for therapy of febrile cancer patients. The two regimens were 5 g mezlocillin plus 2 g cefoperazone intravenously every four hours (higher dose) or 3 g mezlocillin plus 1 g cefoperazone intravenously every four hours (lower dose). Although the overall response rate was higher with the higher dose regimen (78 percent versus 66 percent, p = 0.04), the two regimens were comparable in patients with documented infections (72 percent versus 68 percent). Likewise, the two regimens were equally effective against those infections in which the pathogen could be determined (82 percent versus 82 percent). Serum bactericidal titers of at least 1:32 against a known pathogen were associated with a higher response rate than were titers of less than 1:32, but the higher dose regimen did not result in higher serum bactericidal titers. Hypoprothrombinemia was a side effect, especially with the higher dose regimen, before prophylactic vitamin K was routinely administered to patients. Since there were no major benefits with the use of the higher dose regimen of mezlocillin plus cefoperazone, the lower dose regimen is more appropriate for routine usage.

Adolescent↗
PubMed1988

Comparison of cefoperazone and mezlocillin with imipenem as empiric therapy in febrile neutropenic cancer patients.

Seventy-eight patients with cancer experienced 88 episodes of fever while neutropenic and were randomly assigned to receive empiric antibiotic therapy with cefoperazone 2 g intravenously every 12 hours and mezlocillin 4 g intravenously every six hours or imipenem/cilastatin 500 mg intravenously over 30 to 60 minutes every six hours. Within 96 hours of starting antibiotic treatment, 24 patients (57 percent) treated with cefoperazone and mezlocillin and 34 patients (74 percent) receiving imipenem/cilastatin became afebrile. One half of the patients in each arm required changes in the antibiotic regimen because of side effects, persistent fever with a site suspicious for infection, resistant organisms, or breakthrough bacteremias. Forty patients (95 percent) receiving cefoperazone and mezlocillin and 43 patients (93 percent) receiving imipenem/cilastatin recovered from the neutropenic episode. Two patients in each regimen group died of their underlying disease. One patient in the imipenem/cilastatin arm died of Pseudomonas aeruginosa sepsis. Although the two regimens are comparable in efficacy, the incidence of side effects favored the cefoperazone and mezlocillin group. No seizures or bleeding were seen in either arm; however, 19 patients (41 percent) receiving imipenem/cilastatin required pretreatment antiemetic drugs for nausea.

Adult↗
PubMed1988

Cefoperazone versus ceftazidime monotherapy of nosocomial pneumonia.

Cefoperazone and ceftazidime monotherapy were compared in a randomized, prospective evaluation of patients with nosocomial pneumonia. These antibiotics were equally effective, with an overall successful treatment rate of 45 of 62 (73 percent) for cefoperazone-treated patients and 50 of 63 (79 percent) for ceftazidime-treated patients (p = 0.41). There was no difference in the incidence of side effects (including hypoprothrombinemia), superinfections, or colonization of the oropharynx with yeast, enterococcus, Staphylococcus aureus, or resistant gram-negative bacilli. When antibiotic administration, and laboratory costs are considered, cefoperazone is less expensive than ceftazidime. Both cefoperazone and ceftazidime are effective therapy for nosocomial pneumonia.

Bacteria↗
PubMed1994

First and second derivative spectrophotometric determination of cefoperazone and sulbactam in injections.

A simple, spectrophotometric assay to measure the concentrations of cefoperazone and sulbactam in injectable formulations is described. Since zero-order spectra are subject to interference, derivative spectrophotometry was used to enhance the spectral details. A linear relationship between derivative amplitudes and the concentrations of the compounds was found. Beer's law is obeyed up to 75 and 80 micrograms ml-1 of cefoperazone in the first and second derivative modes, respectively, and up to 75 micrograms ml-1 of sulbactam in the second derivative mode. Detection limits were 0.64 and 0.88 microgram ml-1, respectively for cefoperazone in the first and second derivative modes and 0.30 micrograms ml-1 for sulbactam in the second derivative mode. The method is rapid, simple, does not require a separation step and has successfully been applied to the assay of commercial injections containing cefoperazone and sulbactam.

Anti-Infective Agents, Urinary↗
PubMedDate not supplied

In vitro assessment of sulbactam plus cefoperazone in the treatment of bacteria isolated from cancer patients.

Cefoperazone is a broad-spectrum cephalosporin that has been used extensively to treat infections in cancer patients. A recent survey demonstrated only a 6% resistance to this drug among Gram-negative bacteria. The combination of cefoperazone plus sulbactam was studied in vitro against consecutive isolates causing bacteremia in cancer patients as well as those selected for resistance to cefoperazone. Both a fixed ratio of sulbactam/cefoperazone (2:1 w/w) and selected concentrations of sulbactam (2, 4, 8, and 16 micrograms/ml) were studied. Sulbactam was shown to increase the susceptibility of various unselected Gram-negative bacilli; this effect increased with larger concentrations of sulbactam. The addition of sulbactam at optimum concentration levels made 29 of 65 cefoperazone-resistant Gram-negative bacilli susceptible. This effect was seen most markedly for Acinetobacter spp.

Bacterial Infections↗
PubMedDate not supplied

Comparative in vitro activity of cefoperazone and various combinations of cefoperazone/sulbactam.

Cefoperazone with 2 and 4 micrograms/ml of sulbactam and in a 2:1 ratio was tested against 1258 clinical isolates of Gram-positive and Gram-negative bacteria, as well as against Gram-negative bacilli that had stably derepressed Type I beta-lactamase or that were hyperproductive of non-Type I beta-lactamases. The 2:1 cefoperazone/sulbactam combination was the most potent combination tested. With this combination cefoperazone minimum inhibitory concentrations (MICs) of 27 of 40 (67%) of the clinical isolates of Pseudomonas species and 64 of 67 (95%) of clinical isolates of the Enterobacteriaceae were reduced from greater than or equal to 64 micrograms/ml by at least two-fold. In contrast, cefoperazone MICs of greater than or equal to 64 micrograms/ml remained unchanged for 26 (65%) and 24 (60%) of Pseudomonas species and 35 (52%) and 30 (45%) of the Enterobacteriaceae in the presence of 2 and 4 micrograms/ml of sulbactam, respectively. Cefoperazone/sulbactam in the 2:1 ratio was also the most active combination against the mutants derepressed for Type I beta-lactamase. Although the 2:1 combination of cefoperazone/sulbactam had the greatest potency in vitro, it remains to be seen whether this combination is predictive of clinical outcome from treatment of cefoperazone-resistant Gram-negative bacilli with cefoperazone/sulbactam.

Bacteria↗
PubMed2006

Voltammetric studies on the antibiotic drug cefoperazone quantification and pharmacokinetic studies.

A fully validated simple, sensitive and selective square-wave stripping voltammetry procedure was described for the trace quantification of cefoperazone in bulk form, formulations and human serum/plasma. The procedure was based on reduction of the adsorbed drug onto a hanging mercury drop electrode. The procedural conditions were optimized as: frequency=60Hz, scan increment=8mV, pulse amplitude=25mV, preconcentration potential=-0.3V (versus Ag/Ag/KCl(s)), preconcentration duration=60-150s and an acetate buffer of pH 4.2 as a supporting electrolyte. A limit of detection of 4.5x10(-10)M and a limit of quantitation of 1.5x10(-9)M bulk cefoperazone were achieved following preconcentration of the drug onto the hanging mercury drop electrode for 150s. The proposed square-wave adsorptive cathodic stripping voltammetric procedure was successfully applied for trace quantification of cefoperazone in human serum and plasma. The achieved limits of detection and quantitation of the drug in human serum were 6x10(-10)M (0.375ngml(-1)) and 2x10(-9)M (1.250ngml(-1)), respectively. The pharmacokinetic parameters of cefoperazone in plasma of hospitalized volunteers were successfully estimated.

Anti-Bacterial Agents↗
PubMed1984

Multicenter clinical trial of cefoperazone sodium in the United States.

A total of 187 physician investigators throughout the United States participated in a multicenter trial to evaluate the safety and efficacy of a twice daily dosage of cefoperazone sodium; 91 percent of patients received a dosage of 4 g or less of cefoperazone per day. A total of 455 patients were included in the evaluation of efficacy: 100 patients with lower respiratory tract infection; 146 patients with skin and soft tissue infection; 14 patients with osteomyelitis; 18 patients with obstetric and gynecologic infections; 84 patients with urinary tract infection; and 44 patients with bacteremia. Overall, treatment achieved a satisfactory clinical outcome in 95.3 percent of these patients. Side effects of cefoperazone were evaluated in 659 patients. Prothrombin time increased during therapy in 4 percent of patients, all but one of whom was more than 65 years old. Prothrombin time became normal with the administration of vitamin K. Diarrhea (4 or more loose stools a day) was observed in 3 percent of patients. Other adverse reactions including leukopenia, elevation of serum liver enzyme levels, and eosinophilia were mild, reversible, and typical of beta-lactam antibiotics. These results suggest that (1) twice daily administration of cefoperazone sodium can be used to treat a variety of bacterial infections caused by susceptible pathogens; (2) the adverse reactions associated with this agent at the dosage schedule employed in this trial (2 g twice a day) are predictable and limited; (3) multicenter trials of this type allow for rapid collection of data regarding safety and efficacy of new antibiotics.

Aged↗
PubMed2001

Randomized, double-blind, controlled study of cefoperazone-sulbactam plus cotrimoxazole versus ceftazidime plus cotrimoxazole for the treatment of severe melioidosis.

We conducted a prospective randomized, double-blind, controlled study of cefoperazone-sulbactam (ratio, 1:1; cefoperazone 25 mg/kg/day) plus cotrimoxazole (trimethoprim-sulfamethoxazole [TMP-SMZ] at a ratio of 80:400; TMP, 8 mg/kg/day) versus ceftazidime (100 mg/kg/day) plus cotrimoxazole (TMP, 8 mg/kg/day) for the treatment of severe melioidosis. Of 219 patients enrolled in the study, 102 (47%) had culture-proven melioidosis. These patients were assigned randomly to 2 treatment groups, each with 50 patients (2 patients were excluded). Mortality rates were not significantly different between the 2 groups: 18% in the cefoperazone-sulbactam group versus 14% in the ceftazidime group. The crude difference in the mortality rate was 4%, but when adjusted for type of infection the difference was 0.9% (95% confidence interval, -3.6% to 5.4%; P = .696). The duration of defervescence and the bacteriological response of successfully treated patients were similar in both groups, and both treatment regimens were well tolerated. Cefoperazone-sulbactam plus cotrimoxazole might be used as an alternative to ceftazidime plus cotrimoxazole as treatment for severe melioidosis.

Adult↗
PubMedDate not supplied

Cefoperazone therapy for obstetric and gynecologic infections.

The safety and clinical efficacy of cefoperazone therapy for obstetric and gynecologic infections have been evaluated in clinical trials involving 107 women hospitalized at nine medical centers. The indications for cefoperazone therapy have included post-partum and postoperative uterine infections, pelvic inflammatory disease, postoperative pelvic infections, and miscellaneous pelvic infections. A variety of aerobic and anaerobic bacteria, including members of the genera Staphylococcus, Streptococcus, Escherichia, Klebsiella, Proteus, Neisseria, Bacteroides, Peptococcus, and Peptostreptococcus, were isolated from these patients. More than 80% of these isolates were inhibited in vitro by cefoperazone concentrations less than or equal to 2.0 micrograms/ml. Symptomatic cures were achieved in 91% of patients, and 96% of isolated pathogens were eradicated during therapy. Adverse drug-related reactions occurred in only 4% of patients. Follow-up laboratory evaluations demonstrated only minor abnormalities that affected a small number of patients. These results indicate that cefoperazone offers safe and effective therapy for common obstetric and gynecologic infections.

Adolescent↗
PubMed1986

Typhoid fever: successful therapy with cefoperazone.

We compared cefoperazone with chloramphenicol in a randomized trial involving the treatment of 25 children with severe typhoid fever. The clinical characteristics of the two treatment groups were comparable on entry into the study. Four patients died (three receiving chloramphenicol, one cefoperazone), and an additional two patients received dexamethasone (one per group). Excluding these six patients, the response of the cefoperazone group was comparable or superior to that of the chloramphenicol group in terms of the number of days from initiation of therapy to becoming afebrile (P less than .055) and the number of days until negative blood cultures were obtained (P less than .19). There were no relapses or treatment failures in either group. We conclude that cefoperazone is as effective as chloramphenicol in the treatment of severe typhoid fever.

Adolescent↗
PubMed1983

Cefoperazone against carbenicillin-resistant isolates of Pseudomonas aeruginosa: comparison with other newer cephalosporins and N-formimidoyl thienamycin.

The in-vitro activities of cefoperazone, cefotaxime, ceftriaxone, latamoxef (moxalactam), ceftazidime and N-formimidoyl-thienamycin (N-f-thienamycin) were compared against clinical isolates of Pseudomonas aeruginosa that were resistant to carbenicillin and gentamicin, or against those which were susceptible. N-f-thienamycin and ceftazidime were more active than cefotaxime, ceftriaxone and latamoxef only against carbenicillin-susceptible isolates: isolates resistant to carbenicillin exhibited markedly increased resistance to cefoperazone, but not to N-f-thienamycin or ceftazidime. A partial cross-resistance was observed between carbenicillin and cefoperazone. This was due to the presence in these Pseudomonas isolates of a plasmid-mediated beta-lactamase which was active against carbenicillin and cefoperazone but not against cefotaxime, ceftriazone and latamoxef.

Carbenicillin↗
PubMed1983

Pharmacokinetics of cefoperazone in normal subjects and patients with hepatosplenic schistosomiasis.

The pharmacokinetics of cefoperazone were studied and compared in four normal subjects and six patients with hepatosplenic schistosomiasis (HSS) with mild liver disease but marked portal hypertension. All subjects received a 2 g intravenous infusion of cefoperazone over 15 min. Although most pharmacokinetic parameters did not differ significantly between normal subjects and patients with HSS, the serum beta half-life of cefoperazone was longer in patients with HSS compared to normal subjects (3.0 h vs. 1.7 h). This demonstrates only mild impairment of excretion of cefoperazone in patients with HSS.

Adult↗
PubMed1990

The effect of obstruction on the biliary excretion of cefoperazone and ceftazidime.

The biliary excretion of cefoperazone and ceftazidime was studied by endoscopic cannulation of the common bile duct, in patients with complete biliary obstruction and in an unobstructed control group. Patients were given each drug prophylactically for 24 h before endoscopy and as a single dose at the time of cannulation. In unobstructed patients biliary excretion of ceftazidime was passive. At the time of cannulation bile contained 10% of the peak serum concentration, rising to 20% 90 min later. Cefoperazone excretion was active. At cannulation biliary concentrations were 200% of the serum peak, 900% at 60 min and 700% at 90 min. In obstructed patients, bile sampled immediately at decompression contained neither antibiotic. Passive excretion of both drugs occurred rapidly after relief of obstruction and biliary concentrations were 20% of maximum serum levels at 60 min. Twenty-four hours later passive excretion had further improved, but the active excretion mechanism of cefoperazone had still not recovered. We conclude that obstruction impairs active as well as passive biliary excretion of antibiotics, that drainage is essential for the control of sepsis in obstructed cholangitis, and that both cefoperazone and ceftazidime achieve similar and therapeutic concentrations in bile during the 24 h after decompression.

Adult↗
PubMed1992

Multicentre study on antibiotic susceptibilities of anaerobic bacteria to cefoperazone-sulbactam and other antimicrobial agents.

The antibiotic susceptibilities of 241 anaerobic bacteria recovered from six geographic sites in North America were tested by agar dilution to cefoperazone-sulbactam and other drugs. Of the 189 Bacteroides fragilis group isolates, only one was resistant to cefoperazone-sulbactam (0.5%) or ampicillin-sulbactam (0.5%), and none was resistant to ticarcillin-clavulanate or chloramphenicol. No resistance to cefoperazone-sulbactam was observed among the other Bacteroides spp., Clostridium spp., or Peptostreptococcus spp. Resistance to cefoperazone-sulbactam is not commonly observed against anaerobic bacteria recovered from different geographical sites across North America.

Anti-Bacterial Agents↗
PubMed1993

Efficacy of cefoperazone in combination with sulbactam in experimental Staphylococcus aureus endocarditis in rabbits.

The activity of cefoperazone with and without sulbactam was studied in vitro and in vivo against strains of methicillin-resistant and methicillin-susceptible Staphylococcus aureus. Cefoperazone with or without sulbactam was inactive in vitro against the methicillin-resistant strain and was bound by penicillin-binding protein 2a with an IC50 of 190 mg/L (the concentration that reduced radio-labelling with 3H-penicillin by 50%). Cefoperazone was hydrolysed by beta-lactamase in vitro but sulbactam improved cefoperazone activity in a rabbit model of aortic valve endocarditis caused by a beta-lactamase producing methicillin-susceptible strain.

Animals↗