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Background: Therapy with an aminoglycoside and a beta-lactam remains common empirical therapy for febrile neutropenic patients. Concerns of aminoglycoside-induced ototoxicity and nephrotoxicity have led to studies of alternate regimens. Objective: To determine whether ciprofloxacin-piperacillin is equivalent to tobramycin-piperacillin as empirical therapy for neutropenic fever. Design: Randomized, double-blind multicenter trial. Setting: Seven U.S. university-affiliated hospitals and one private research center. Patients: Febrile (temperature greater than or equal to 38 deg C), neutropenic (neutrophil level less than 1 x 10(super 9) cells/L) hospitalized patients who had leukemia, lymphoma, or solid tumors, or were undergoing bone marrow transplantation. Interventions: Patients received piperacillin, 50 mg/kg of body weight intravenously every 4 hours, and ciprofloxacin, 400 mg intravenously every 8 hours, or tobramycin, 2 mg/kg intravenously every 8 hours. Measurements: Success was defined as resolution of infection and previously positive cultures without the need to give additional antimicrobial agents. Results: 543 febrile episodes were evaluated, of which 471 were clinically evaluable (234 in the ciprofloxacin-piperacillin group and 237 in the tobramycin-piperacillin group). Success rates in the ciprofloxacin-piperacillin group (63 of 234 febrile episodes) and tobramycin-piperacillin group (52 of 237 episodes) were similar (27% vs. 22%, respectively; difference, 5.0 percentage points [95% CI, -2.3 to 12.8 percentage points]), as was survival (96.2% of patients receiving ciprofloxacin-piperacillin versus 94.1% of patients receiving tobramycin-piperacillin; difference, 2.1 percentage points [CI, -2.2 to 6.4 percentage points]). Additions to the initial antimicrobial regimen were the most common reason for treatment failure in both groups (accounting for 67% of failures in the ciprofloxacin-piperacillin group and 72% in the tobramycin-piperacillin group; difference 5.0 percentage points [CI, -13.8 to 3.7 percentage points]). Fevers resolved faster in patients receiving ciprofloxacin-piperacillin than in patients receiving tobramycin-piperacillin (mean, 5 vs. 6 days) (P = 0.005). No significant differences in adverse events or toxicity were noted (P = 0.083). Conclusion: Ciprofloxacin-piperacillin is as safe and effective as tobramycin-piperacillin for empirical therapy of neutropenic fever.

Background: Cholangitis does not often occur after endoscopic retrograde cholangiopancreatography (ERCP), but it can be a serious complication of this procedure. Antibiotic prophylaxis is therefore frequently used in patients having (ERCP), but existing data are insufficient to allow evaluation of the effectiveness of this practice. Objective. To determine the efficacy of single-dose anti@ prophylaxis with piperacillin for ERCP-induced cholangitis. Design: Randomized, double-blind, placebo-controlled clinical trial. Setting: Tertiary referral center for ERCP. Patients: Patients who had ERCP for suspected biliary tract stones or distal common bile duct stricture were eligible. Major exclusion criteria were previous ERCP within 7 days, biliary endoprosthesis in situ, and use of antimicrobial agents or presence of fever within 7 days before the procedure. Intervention: Piperacillin, 4 g, or placebo was given intravenously approximately 30 minutes before ERCP. Measurements: Duration of follow-up was l week. Acute cholangitis was diagnosed if a patient had a body temper@ greater than 38 [degrees]C, a clinically apparent need for antibiotic treatment, and no symptoms indicating infection outside of the biliary tree. Results: 551 consecutive patients were enrolled. During ERCP, stones were found in 147 patients, malignant distal strictures were found in 203 patients, other pathologic findings were seen in 88 patients, and normal biliary tracts were seen in 113 patients. Seventeen of the 281 patients who received placebo (6.%) and 12 of the 270 patients who received piperacillin (4.4%) developed acute cholangitis (relative risk, 0.73 [95% CI, 0.36 to 1.5]). The absolute risk reduction was 1.6% (CI, - 5.3% to 2.1%]). All cases of cholangitis (with the exception of one case seen in a patient in the piperacillin group@ were mild or moderate in severity. Conclusion: Single-dose prophylaxis with piperacillin is not associated with a clinically significant reduction in the incidence of acute cholangitis after ERCP in patients suspected of having biliary tract stones or distal common bile duct stricture., Routine preventive antibiotic treatment with piperacillin before endoscopic retrograde cholangiopancreatography (ERCP) does not seem to be effective in reducing the risk for an inflamed bile duct. ERCP is a technique to visualize the bile duct's vessel structure using a dye injection. Five hundred fifty-one patients scheduled for ERCP received either piperacillin or placebo a half an hour before the procedure. Six percent of the piperacillin group and 4.4% of the placebo group developed an inflamed bile duct within one week of the ERCP. Most of the inflammations were not serious.

* Objective: To compare piperacillin and tobramycin with ceftazidime alone for the empiric treatment of fever in the neutropenic patient without evidence of skin infections or anaerobic infections. * Design: A multicenter, randomized, controlled trial. * Patients: 876 febrile, neutropenic episodes in 696 patients (83% acute leukemia or bone marrow transplantation); 92 episodes were excluded from analysis because of protocol violation. * Interventions: Patients received either intravenous ceftazidime (2 g every 8 h) or piperacillin (12 to 18 g/d in 4 to 6 divided doses plus tobramycin (1.7 to 2.0 mg/kg body weight every 8 h). Treatment could be modified at any time at the discretion of the investigator. * Measurements: Percentage of satisfactory response, eradication of the infecting organism, development of superinfections, and occurrence of adverse events. * Results: As a single agent, ceftazidime was as effective as the combination of piperacillin and tobramycin (62.7% satisfactory responses compared with 61.1%; odds ratio, 1.07; 95% CI, 0.79 to 1.44; P > 0.2). Equivalent responses were also obtained in episodes of profound neutropenia (odds ratio, 0.76; CI, 0.43 to 1.33; P > 0.2). Infectious mortality was 6% for ceftazidime and 8% for the combination therapy. Eradication of the infecting organisms was achieved in 79% of bacteremic episodes treated with ceftazidime compared with 68% of the episodes treated with the combination therapy (odds ratio, 1.76; CI, 0.92 to 3.38; P = 0.08), and rates for gram-negative rod bacteremia were also similar (95% compared with 77%; odds ratio, 5.25; CI, 1.0 to 27.5; P = 0.03). Superinfections developed in 38 episodes in each group. An adverse event occurred in 8% of episodes treated with ceftazidime compared with 20% of episodes treated with combination therapy P < 0.001). * Conclusion: Ceftazidime alone was as effective but safer than the combination of piperacillin and tobramycin for the empiric treatment of febrile, neutropenic patients, even those with profound and prolonged granulocytopenia., Ceftazidime has been shown to be safer than and just as effective as the combination of piperacillin and tobramycin in treating cancer patients with fever and neutropenia who do not have a staphylococcal or anaerobic infection. Neutropenia is a reduced level of white blood cells that is also known as granulocytopenia and agranulocytosis. Most of the 696 patients studied had acute leukemia or a bone marrow transplant. The combination of piperacillin and tobramycin had a much higher rate of toxicity than did ceftazidime, especially on kidney function. Resistance to ceftazidime developed in only 3% of the patients. An adverse event occurred in 8% of the cases in which ceftazidime was used, as opposed to 20% of the cases with piperacillin and tobramycin therapy.

Granulocytopenia, the depletion of granulocyte white blood cells, places patients at grave risk from infection. Nowadays, this condition occurs quite frequently, often as a side effect of chemotherapy or other immunosuppressive therapies. Aggressive antibiotic treatment is necessary to prevent any bacterial infection from attaining life-threatening magnitude, and therefore indications of infection such as fever are treated without necessarily waiting for laboratory confirmation of the type of bacteria and the antibiotic sensitivity of the bacteria. Many of the patients experiencing granulocytopenia are already receiving drugs which are toxic to the kidneys. Therefore, the use of additional drugs which are also toxic to the kidneys is probably unwise; unfortunately, this rules out the aminoglycosides, an important group of antibiotics. (Streptomycin and gentamicin are examples of aminoglycosides.) To make matters worse, chemotherapy seems to increase the toxicity of aminoglycosides. A study was conducted to evaluate three antibiotic regimens for the treatment of granulocytopenic patients with fever; 429 patients were entered into the study, but 26 were excluded from analysis for a variety of reasons, including infections which turned out to be viral rather than bacterial. The patients were randomly assigned to receive cefoperazone with piperacillin, ceftazidime with piperacillin, or imipenem alone. Complications were not common, but included seizures in six patients and diarrhea in 83. The lower dose of imipenem tested, 2 g per day, was found to be just as effective as the regimens containing two antibiotics. Imipenem is less costly than the other antibiotic treatments, and the results of this study provide no reason for using the more expensive combination therapy in the treatment of granulocytopenic patients with fever. (Consumer Summary produced by Reliance Medical Information, Inc.)

Many women develop a wound infection or an infection inside the uterus, endometritis, after cesarean section. The chances of endometritis developing are greater if the membranes that surround the fetus have been ruptured for six hours or longer before delivery. The risk of infection is increased from obesity, chronic disease and vaginitis. Poor surgical technique and pre-hospitalization are also risk factors for infection. Studies indicate that the bacteria commonly isolated in infections after cesarean sections are the same organisms normally involved in causing infections in the vagina. Prophylactic antibiotic treatment can reduce the incidence of postcesarean section infection. The effectiveness of seven antibiotics, given in 10 different treatment regimens, was studied among 1,580 women who underwent cesarean section. The four most effective antibiotics in preventing endometritis were a single dose of ampicillin (2 grams), cefazolin (2 g), piperacillin (4 g) and cefotetan (1 g). The lowest infection rate was seen after prophylactic administration of cefotetan (6.1 percent) and piperacillin (8.4 percent). Women experiencing premature rupture of the membranes surrounding the fetus or those requiring internal fetal monitoring and cesarean section delivery should be given a single dose antibiotic to prevent postcesarean section infection. (Consumer Summary produced by Reliance Medical Information, Inc.)

Treating cancer patients who have fever and low white blood cell counts with two different types of antibiotics may be effective in treating their bacterial infection without increasing the risk that the bacteria will become resistant to the antibiotics. A study published in 2002 showed that the combination of ciprofloxacin and piperacillin was as effective in treating patients as the combination of tobramycin and piperacillin.

The antibiotics piperacillin and ciprofloxacin or piperacillin and tobramycin are equally effective for treating cancer patients who have fever and low white blood cell counts. This was the conclusion of a study of 485 cancer patients who received one of the two drug combinations.