Empiric treatment with once-daily cefonicid and gentamicin for febrile non-neutropenic pediatric cancer patients with indwelling central venous catheters.

SUMMARY: The approach to treating febrile non-neutropenic hematooncologic patients with central venous catheters varies. We recently introduced once-daily administration of cefonicid and gentamicin for such children who were in good clinical condition and without focal signs of infection. Our 2-year experience of 125 episodes in 54 children is hereby reported. Absolute neutrophil counts were 550 to 16,700/mm. Bacteremia occurred in 6.4% episodes: only in patients with Hickman/Broviac catheters and not in those with port-a-caths [8/37 (21.6%) vs. 0/17 patients, P=0.046; 8/86 (9.3%) vs. 0/39 episodes, P=0.056]. The pathogens were coagulase-negative staphylococci (3), Streptococcus pneumoniae (2), Pseudomonas aeruginosa and Klebsiella pneumoniae (1), methicillin-sensitive Staphylococcus aureus (1), and Streptococcus milleri (1). All patients remained in stable clinical condition and all, except for 2 who became neutropenic and 1 with S. aureus bacteremia who developed cellulitis, defervesced while on the empiric therapy. Three episodes could not be managed as outpatients. No adverse effects were observed. We conclude that our approach is efficacious and safe and, furthermore, that empiric antibiotic therapy may not be indicated for selected patients with port-a-caths. Future study of children with Hickman/Broviac catheters will evaluate the use of cefonicid alone.

Influence of the ischaemic tourniquet in antibiotic prophylaxis in total knee replacement.

OBJECTIVE: There is level iv evidence that the preoperative administration of antibiotics helps in the prevention of prosthetic infection. There is controversy on whether the ischemia applied during surgery may affect the minimum inhibitory concentration of the antibiotic in the peri-prosthetic tissues. The aim of this study is to review this phenomenon through the determination of antibiotic concentration in the synovial tissue. MATERIAL AND METHOD: A prospective observational clinical study was conducted on 32 patients undergoing total knee replacement. Cefonicid 2g was administered as prophylaxis, with a tourniquet used for all patients. The antibiotic concentration was quantified by high performance liquid chromatography in samples of synovial tissue collected at the beginning and at the end of the intervention. RESULTS: The mean concentration of antibiotic was 23.16 µg/g (95% CI 19.19 to 27.13) in the samples at the beginning of the intervention and 15.45 µg/g (95% CI 13.20 to 17.69) in the final samples, being higher than the minimum inhibitory concentration of cefonicid, set at 8 µg/g. These results were statistically significant for both concentrations (P<.00001). DISCUSSION: The antibiotic concentration throughout the standard total knee prosthesis surgery performed with tourniquet gradually decreases throughout the intervention. The concentration determined at the end of the intervention was higher than the minimum inhibitory concentration required for the antibiotic studied. In conclusion, the use of a tourniquet does not increase the risk of infection.

Postoperative mediastinitis: a comparison of two electrocautery techniques on presternal soft tissues.

Postoperative mediastinitis remains a serious surgical problem, complicating 0.4% to 5% of all cases. In an experiment designed to address this problem, 36 mongrel dogs underwent a median sternotomy incision. In group I (n = 18) all layers to the sternum were opened by a scalpel, and electrocautery was used only for pinpoint hemostasis. In group II (n = 18) the skin was opened by a scalpel and the remaining layers to the sternum were opened by electrocautery. Total kilojoules of electrical energy delivered to the tissues was 9.4 +/- 5.7 for group I and 44.1 +/- 7.0 for group II (p less than 0.001). Each group was randomly divided into three subgroups (n = 6): Ia and IIa were noninoculated controls; Ib and IIb were inoculated just before skin closure; Ic and IIc were inoculated and given one preoperative dose of cefonicid. The inoculum contained Staphylococcus intermedius in a 0.5 ml suspension of 10(8) organisms. Each animal was observed and the wounds were scored daily until death or until all survivors were put to death on the eighth postoperative day. Pleural fluid was cultured at autopsy. Ten dogs died of mediastinitis (four in IIa and six in IIb), but none from group I (p less than 0.01). Positive cultures from pleural fluid in matching subgroups (n = 6) occurred as follows: one in Ia and five in IIa (p less than 0.05); one in Ib and six in IIb (p less than 0.01); zero in Ic and two in IIc. We conclude that pinpoint hemostasis on the soft tissues of the sternotomy incision significantly reduces the severity and frequency of penetrating mediastinitis.

Preventive antibiotic usage in traumatic thoracic injuries requiring closed tube thoracostomy.

OBJECTIVE: To evaluate the safety and effectiveness of antibiotics in reducing the infectious complications following closed tube thoracostomy for isolated chest trauma. DESIGN: Double-blind, randomized clinical trial. SETTING: Medical school affiliated large urban teaching hospital and trauma center. PATIENTS: One hundred nineteen of 159 patients over 18 years old presenting to the emergency department requiring closed tube thoracostomy for isolated chest injuries (113 penetrating, 6 blunt). INTERVENTION: Patients received either placebo or 1 g cefonicid daily intravenously started at chest tube insertion and stopped within 24 h of removal. MEASUREMENTS AND RESULTS: The development of wound infections, pneumonia (CDC criteria), or empyema; the incidence of adverse events; length of hospitalization. One nonspecific infection was seen in the cefonicid group (1.6 percent) and six respiratory tract infections (10.7 percent) in the placebo group (three empyema, one empyema with pneumonia, two pneumonia) (p = 0.0505; p = 0.0094 [excluding nonspecific infection]). No significant differences with antibiotic use were seen in the duration of chest tube use (p = 0.766), peak WBC counts (p = 0.108), lower peak temperatures (p = 0.063), or length of hospitalization (p = 0.165). Patients who developed infectious complications averaged approximately 8 days longer hospitalization than those without (p < 0.0001). CONCLUSION: This study showed that patients receiving antibiotics had a significantly reduced rate of infection than did patients administered placebo. No significant adverse events were seen in either group.

Single-dose antibiotic prophylaxis in patients at high risk for infection in biliary surgery: a prospective and randomized study comparing cefonicid with mezlocillin.

The usefulness of antibiotic prophylaxis in biliary surgery is well established. When antibiotic prophylaxis is not used, wound infection rates after biliary surgery range from 10% to 25%. With antibiotic prophylaxis, the rates can be reduced to less than 5%. Three questions are still controversial: Do all patients undergoing biliary surgery require antibiotic prophylaxis? What is the ideal antibiotic for use in biliary surgery? What should be the duration of antibiotic prophylaxis? In this study we prospectively evaluated the efficacy of a single dose of antibiotic prophylaxis in biliary surgery, administered to patients at high risk for infection, in a trial comparing cefonicid (a cephalosporin with a long half-life) with mezlocillin (a broad-spectrum ureidopenicillin).

Cefamandole versus cefonicid prophylaxis in cardiovascular surgery: a prospective study.

We randomized 400 patients who were scheduled for an elective cardiovascular operation involving median sternotomy to receive cefamandole nafate or cefonicid in a prospective double-blind study. Three hundred fifty-seven patients were evaluable for prophylactic efficacy. Chest wound and donor site infections and early prosthetic valve endocarditis occurred more frequently with cefonicid (11 patients, 6.3%) than with cefamandole (4 patients, 2.2%) (p = 0.05). Three patients, all in the cefonicid group, required sternal debridement to control postoperative deep wound infections. Twenty-five miscellaneous postoperative infections (urinary tract infection, pneumonia, intravenous site infection, bacteremia, sepsis, Clostridium difficile diarrhea) occurred in 16 patients (9.19%) in the cefonicid group and four in 4 patients (2.19%) in the cefamandole group (p = 0.003). These data indicate that cefamandole is superior to cefonicid in preventing both surgical wound infections and miscellaneous nonsurgical infections after cardiovascular operations.

Comparative clinical study of cefonicid, chloramphenicol, and penicillin in community-acquired pneumonia.

Community-acquired pneumonia is one of the most common infectious conditions that require hospitalization. When intravenous treatment is indicated, cefonicid is usually the drug of choice. The aim of this study was to find out if chloramphenicol, which is superior to the standard drugs from a financial point of view, could serve as an equally efficient treatment, especially in the elderly. The outcomes of 3 pneumonia patient groups who were either treated with cefonicid, chloramphenicol or penicillin-G (n = 59, 17, 24, respectively) were retrospectively compared. Data about demographic characteristics of the patients, clinical outcomes, rehospitalization rates, duration of improvement/treatment/ hospitalization and clinical laboratory tests were obtained from each patient's medical records. Only minor differences (even though occasionally significant) were found with respect to rehospitalization and improvement rates, duration of hospitalization, treatment and improvement, death rates and clinical laboratory tests. However, chloramphenicol patients were found to be significantly older than cefonicid patients. Moreover, no bone-marrow suppression was associated with chloramphenicol treatment. All 3 drugs tested seem to have the same efficacy. We conclude that since chloramphenicol is as safe as, and much cheaper than cefonicid, this antibiotic agent is not inferior to the others, its usage in older patients with pneumonia should be considered.

Prophylaxis against infection. Single-dose cefonicid compared with multiple-dose cefamandole.

A total of 1489 patients were included in a prospective, randomized study that compared the efficacy of a single dose of cefonicid in 474 patients (Group I) with that of three doses of cefamandole in 510 patients (Group II) and five doses of cefamandole in 505 patients (Group III), for prophylaxis against infection after an operation on bone. The operations involved the insertion of a Moore prosthesis, an Ender and Küntscher nail, a bone-plate, or another device for internal fixation. Patients who had an open fracture or a total joint replacement were not included in the study. The three groups were similar with regard to mean age, sex ratio, duration of preoperative hospitalization, underlying risk factors, and type of operation. The rates of wound infection were not significantly different in the three groups (p = 0.8) or when the rates were stratified according to the type of operation (p greater than 0.3). Staphylococcus aureus and gram-negative bacilli were the most common infecting microorganisms. The rate of mortality related to infection was similar in all three groups (p = 0.2). No adverse side-effects of drugs were encountered. A single preoperative dose of cefonicid, three doses of cefamandole, and five doses of cefamandole were equally effective prophylaxis against infection of the wound in these patients.

Clindamycin/cefonicid in head and neck oncologic surgery: one-day prophylaxis is as effective as a three-day schedule.

The aim of our study was to evaluate the optimal duration of antibiotic prophylaxis in major oncologic surgery of the head and neck using a novel broad spectrum drug combination: clindamycin and cefonicid. A prospective randomized study was carried out on 126 evaluable patients undergoing clean-contaminated (skin to mucosa) surgery for cancer of larynx, pharynx or oral cavity. Cases at high surgical risk (because of need of pedicled or microvascular free flaps reconstruction), were excluded from the study. Within 20 days after surgery, only one case of wound infection was recorded among the 62 patients treated with the one-day schedule, versus three cases registered among the 64 subjects receiving three-day chemoprophylaxis. Episodes of systemic infections and eventual wound complications occurring in the first 20 days after surgery have also been recorded. The role of potential risk factors for postoperative complications has been evaluated. According to our findings, a three-day antibiotic regimen is not more effective than a short-term (one-day) schedule in preventing wound or systemic infection in clean-contaminated head and neck cancer surgery without flap reconstruction.

Management of low velocity gunshot-induced fractures.

Bullets fired from civilian weapons are usually of low velocity, resulting in minimal tissue cavitation as compared to high-velocity weapons. A prospective protocol was initiated for patients sustaining a low-velocity gunshot to the extremity resulting in a stable, nonoperative fracture configuration. Treatment consisted of local irrigation and débridement, tetanus prophylaxis as required, a long acting cephalosporin intramuscularly, and splinting or casting of the fractured extremity. Twenty-five patients were managed by this protocol. This patient population was compared to a random retrospective sample of 25 patients with similar ballistic induced fractures and wounds managed by local débridement and 48 h of intravenous antibiotics. One infection occurred in each group, requiring further therapy. We conclude that the patient with a low-velocity gunshot induced fracture can be managed without the use of short-term intravenous antibiotics with no increased risk of infection.

Antibiotic for cesarean section: the case for 'true' prophylaxis.

OBJECTIVES: To assess prospectively the efficiency and safety of two extended spectrum cephalosporins used as pre-operative prophylaxis in nonelective cesarean sections, and compare the results to those of a third group of patients that received cefamezine post cord clamping. METHODS: Two hundred and forty one patients undergoing a nonscheduled cesarean section were assigned to receive either cefonicid or ceftriaxone prior to skin incision. These patients were followed prospectively for infectious and fetal complications. The outcome of these patients was also compared with another group of 194 patients that received cefamezine prophylaxis post cord clamping, and whose data were collected retrospectively. Chi-square analysis of variance were performed with P < 0.05 considered significant. RESULTS: There were no significant differences in the febrile complications among the two groups of patients that received pre-operative prophylaxis. However, these patients had significantly less wound infections (P = 0.008) and a significantly shorter hospital stay (P < 0.001) than the patients who received their prophylactic antibiotics post cord clamping. CONCLUSIONS: Extended-spectrum cephalosporins, when given pre-operatively, are both effective and safe, and may have an advantage over intra-operative first generation cephalosporins in the reduction of post cesarean section infectious morbidity.

The clinical significance of suction drainage cultures.

A prospective study of 72 operations in which one or more suction drains were inserted, showed that cultures of the drains did not have any predictive value for the development of signs of infection. Protracted suction drainage could, however, increase the risk of postoperative infection.

[Prophylactic antibiotic therapy in extracorporeal shock-wave lithotripsy: prospective, randomized study]. / Antibioterapia profiláctica en la litotricia extracorpórea por ondas de choque (LEOC): estudio prospectivo y randomizado.

Two hundred patients that underwent ESWL were randomized into 4 groups in order to determine the benefits of antibiotic prophylaxis. All comparisons among groups were not statistically significant. Neither cephalosporin nor quinolone prophylaxis impacted significantly on bacteriuria rate after ESWL. Thus, in patients without infected stones, urinary tract obstruction and ancillary procedures ESWL could be performed without prophylactic antibiotic regimes.

Characteristics of microorganisms cultured from infected wounds post-hysterectomy.

OBJECTIVE: To characterize organisms causing wound infection following abdominal hysterectomy. STUDY DESIGN: All patients who underwent an abdominal hysterectomy (December 2002-January 2006) and developed abdominal wall wound infection proven by a positive culture were included in the study. Patient information was collected from the computerized files. The isolated microorganisms were characterized for antibiotics susceptibility. RESULTS: Sixty-eight (68/620, 10.96%) patients had positive wound cultures. Of 100 isolated microorganisms, 44 were resistant to cefonicid (prophylactic treatment) and 15 were resistant to combined ampicillin, gentamicin and metronidazole (empirical treatment). Major co-morbidities (including diabetes mellitus, hypertension, past malignancies, renal, cardiovascular and pulmonary diseases, hypothyroidism or anemia), were found to be significantly associated with pseudomonal infection (P<.008). CONCLUSION: A significant portion of pathogens causing post-hysterectomy abdominal wall wound infection are resistant to the prophylactic treatment, and some are resistant to the empirical treatment. Further studies are necessary to evaluate the effectiveness of various prophylactic regimens with better coverage of Enterococcus fecalis, as well as the effectiveness of empirical treatment active against the resistant Enterobacteriaceae group.

Influencia del manguito de isquemia en la profilaxis antibiótica en prótesis total de rodilla / Influence of the ischaemic tourniquet in antibiotic prophylaxis in total knee replacement

Objetivo. Existe evidencia científica grado iv de la importancia que el antibiótico administrado preoperatoriamente tiene en la prevención de la infección protésica. Hay controversia en si la isquemia aplicada en la cirugía de estos pacientes puede afectar a la concentración mínima inhibitoria del antibiótico en los tejidos periprotésicos. Para estudiar este fenómeno hemos diseñado un estudio basado en la determinación de la concentración de antibiótico en el tejido sinovial. Material y método. Estudio clínico prospectivo observacional de 32 pacientes intervenidos de prótesis total de rodilla. Se administró 2 g de cefonicid como profilaxis y se utilizó el manguito de isquemia en todos los pacientes, cuantificándose la concentración antibiótica mediante la cromatografía líquida de alta resolución en muestras de tejido sinovial del inicio y del final de la intervención. Resultados. La concentración media de antibiótico fue de 23,16 μg/g (IC del 95%, 19,19-27,13) en las muestras del inicio de la intervención y de 15,45 μg/g (IC del 95%, 13,20-17,69) en las muestras del final, mostrándose superiores a la concentración mínima inhibitoria del cefonicid, establecida en 8 μg/g, siendo estos resultados estadísticamente significativos para ambas concentraciones (p < 0,00001). Discusión. La concentración de antibiótico a lo largo de una intervención estándar de prótesis total de rodilla realizada con isquemia preventiva varía a lo largo de la intervención sufriendo un descenso paulatino. Aun así, la concentración determinada al final de la intervención no fue inferior a la concentración mínima inhibitoria del antibiótico estudiado. Como conclusión, la utilización del manguito de isquemia no aumenta el riesgo de infección (AU)

Objective. There is level iv evidence that the preoperative administration of antibiotics helps in the prevention of prosthetic infection. There is controversy on whether the ischemia applied during surgery may affect the minimum inhibitory concentration of the antibiotic in the peri-prosthetic tissues. The aim of this study is to review this phenomenon through the determination of antibiotic concentration in the synovial tissue. Material and method. A prospective observational clinical study was conducted on 32 patients undergoing total knee replacement. Cefonicid 2 g was administered as prophylaxis, with a tourniquet used for all patients. The antibiotic concentration was quantified by high performance liquid chromatography in samples of synovial tissue collected at the beginning and at the end of the intervention. Results. The mean concentration of antibiotic was 23.16 μg/g (95% CI 19.19 to 27.13) in the samples at the beginning of the intervention and 15.45 μg/g (95% CI 13.20 to 17.69) in the final samples, being higher than the minimum inhibitory concentration of cefonicid, set at 8 μg/g. These results were statistically significant for both concentrations (P<.00001). Discussion. The antibiotic concentration throughout the standard total knee prosthesis surgery performed with tourniquet gradually decreases throughout the intervention. The concentration determined at the end of the intervention was higher than the minimum inhibitory concentration required for the antibiotic studied. In conclusion, the use of a tourniquet does not increase the risk of infection (AU)

Influencing prescribing behavior by adapting computerized order-entry pathways.

A program is described in which informational text was inserted into a computerized drug order-entry pathway to alter prescribing patterns and contain costs. In April 1986 the pharmacy and therapeutics committee at a 700-bed teaching hospital recommended that cefonicid be used instead of cefuroxime to treat adult patients with community-acquired pneumonia in which infection with Haemophilus influenzae or gram-negative enteric rods was suspected; substantial cost savings were projected. A paragraph recommending cefonicid was inserted into the cefuroxime order-entry screen in November 1986. In February 1987 the screen was further modified to allow the physician to select the cefonicid alternative without returning to the drug index. A final change was made in November 1987 to allow the physician to select ampicillin or erythromycin directly from the cefuroxime screen as well. The cost and relative use of cefonicid and cefuroxime were examined in specific patients with pneumonia--those assigned to diagnosis-related group 89--for whom either drug was prescribed. From January 1986 to December 1987, the percentage of these patients who were prescribed cefuroxime decreased from 100% to 22%, while the percentage of patients receiving cefonicid increased from 0% to 78%. The average acquisition cost of the two antibiotics per patient decreased from $123 to $48. Although other variables may have affected prescribing patterns and this method of drug therapy intervention has some disadvantages, such as the need for physician cooperation, the concept warrants further attention. Adaptation of computerized order-entry pathways may increase the ability of pharmacy to influence prescribing behavior and control costs.

Comparison of single-dose antibiotic prophylaxis in uncomplicated transurethral resection of the prostate.

We evaluated the necessity for antibiotic prophylaxis in uncomplicated transurethral resection of the prostate. A total of 107 patients was entered into a double-blind, prospective, placebo-controlled, randomized trial. Only 7 patients were excluded because they had positive preoperative urine cultures. All patients received a single dose of either 1 gm. cefonicid or saline placebo intramuscularly before surgery. No further antibiotics were administered. Urine cultures were obtained intraoperatively, daily while hospitalized, and at 2 and 4 weeks postoperatively. A growth of 10(4) organisms constituted a positive urine culture. Postoperative infection rates were statistically significant with 12% (6 of 51) in the cefonicid group and 37% (18 of 49) in the placebo group (p = 0.003). During the initial 2 days postoperatively there were no infections in the cefonicid treated patients as opposed to 8 in the placebo group (p = 0.003). Our study demonstrated the need for antibiotic prophylaxis to prevent infection after uncomplicated transurethral resection of the prostate. This can be accomplished by using a single dose, broad-spectrum cephalosporin (cefonicid). This procedure simplifies the implementation and decreases the cost of prophylaxis for transurethral resection of the prostate.

A trial using early preoperative administration of cefonicid for antimicrobial prophylaxis with hysterectomies.

A single dose of cefonicid given 3.5-5.0 hours or 0.5-1.0 hour preoperatively was compared with cefoxitin given as five doses beginning 0.5-1.0 hour preoperatively for prophylaxis of infection in 202 patients undergoing vaginal or abdominal hysterectomy. The administration of cefonicid 3.5-5.0 hours preoperatively was intended to simulate situations where surgery may be delayed or prolonged. The trial was double-blind, and patients were randomized to one of the three regimens. Operative site infections were noted in 6.2 percent of patients (7/113) who received cefonicid 3.5-5.0 hours preoperatively, in 7.0 percent of patients (3/43) who received cefonicid 0.5-1.0 hour preoperatively, and in 4.3 percent of patients (2/46) who received cefoxitin (p greater than 0.05). Enterococci were isolated most frequently from operative-site infections. When administered 3.5-5.0 hours preoperatively, cefonicid was as effective as more traditional regimens.

Comparison of cefonicid and cefazolin prophylaxis in abdominal hysterectomy.

One hundred and sixty-four patients undergoing abdominal hysterectomy for benign diseases were prospectively evaluated. The efficacy and safety of surgical prophylaxis with a single dose of the long-acting cefonicid was compared to the standard three dose regimen of cefazolin. Prophylaxis was successful in 82 of 85 (96.5%) patients receiving cefonicid and in 77 of 79 (97.5%) patients receiving cefazolin. No serious adverse effects were encountered with both drugs. It is concluded that single dose intravenous cefonicid, when given preoperatively, is as safe and effective as the standard multiple dose regimen of cefazolin in patients undergoing elective abdominal hysterectomy.