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PubMed1988

New sensitive bioassay for sulbactam in bovine tissues.

A quantitative cylinder plate bioassay for sulbactam has been developed which can detect concentrations as low as 0.01 microgram/g in bovine muscle, fat, kidney, and liver tissues. This procedure may also be applicable to human tissues and fluids. In addition to the improved sensitivity, this method differs from all previously described systems because it is based on inhibition by sulbactam of a cell-free beta-lactamase incorporated in the assay agar. The assay is unaffected by the presence of ampicillin even at concentrations 10 times that of the sulbactam concentration. This report describes the analytical technique as well as the accuracy and precision of the method. The assay can be applied to tissue depletion studies.

Adipose Tissue↗
PubMed1990

Ceftriaxone-sulbactam combination in rabbit endocarditis caused by a strain of Klebsiella pneumoniae producing extended-broad-spectrum TEM-3 beta-lactamase.

We studied the activity of the combination of sulbactam and ceftriaxone against a Klebsiella pneumoniae strain producing TEM-3, a new extended-broad-spectrum beta-lactamase, in an endocarditis model. In vitro, ceftriaxone was strongly inactivated in the presence of TEM-3 (MBC, 128 micrograms/ml with an inoculum of 5 x 10(5) CFU/ml). A marked inoculum effect was demonstrated with sulbactam: effective concentrations of inhibitor needed to reduce the MIC and MBC of ceftriaxone to similar levels increased from 1 microgram/ml in the presence of an inoculum of 5 x 10(5) CFU/ml to 20 micrograms/ml in the presence of an inoculum of 1 x 10(7) CFU/ml. In vivo, sulbactam given at 200 mg/kg of body weight every 12 h, a dosage higher than that previously reported to be effective against rabbit endocarditis caused by other microorganisms, was not sufficient to restore the complete activity of ceftriaxone given at 30 mg/kg once daily for 4 days. This insufficient activity may be correlated with the presence of a high level of beta-lactamase inside the vegetations, as indicated by a quantitative in vitro assay of beta-lactamase activity in the cardiac vegetation, suggesting an insufficient inactivation of the extended-broad-spectrum beta-lactamase in vivo.

Animals↗
PubMed1990

In vitro activities of cefoperazone and sulbactam singly and in combination against cefoperazone-resistant members of the family Enterobacteriaceae and nonfermenters.

Among 28,000 isolates of the family Enterobacteriaceae and nonfermenters isolated at multiple medical centers, 1,084 (4%) were resistant to cefoperazone (MIC, greater than or equal to 64 micrograms/ml) and 1,711 (6%) exhibited cefoperazone MICs of 2 to 32 micrograms/ml. Ninety-six percent of these 2,795 isolates produced beta-lactamase, as determined by the nitrocefin test. Sulbactam alone (8 micrograms/ml) was inactive against 99.6% of the isolates other than Acinetobacter calcoaceticus and Pseudomonas cepacia. Sulbactam enhanced the activity of cefoperazone against 56% of the isolates of the family Enterobacteriaceae and 44% of the nonfermenters. In the presence of sulbactam concentrations of less than or equal to 8 micrograms/ml, 65% of the cefoperazone-resistant isolates had reductions in cefoperazone MICs of greater than or equal to 2 log2 dilution steps and were susceptible to less than or equal to 32 micrograms/ml. Antagonism was not observed.

Bacteria↗
PubMed1996

Efficacy of sulbactam-ampicillin for the treatment of severe diabetic foot infections.

Diabetic foot infections, a frequent and serious cause of morbidity in patients with diabetes mellitus, are caused by anaerobic and aerobic bacteria. Given the fact that seriously impaired host defense factors are almost always present in these patients, bactericidal agents with a broad spectrum of antimicrobial activity are required for their treatment. Seventy-four patients with diabetic foot infections were treated with parenteral sulbactam-ampicillin (1.5 g, q.i.d.). All patients were followed-up prospectively in order to determine the efficacy and safety of sulbactam-ampicillin. The mean duration (+/- SD) of treatment in patients with osteomyelitis (n = 49) and soft tissue infections (n = 25) was 41 +/- 5 and 14 +/- 3 days, respectively. Infected limbs were amputated at various levels in 14 patients (19%). Clinical cure rates were 86% and 100% in patients with osteomyelitis and with soft tissue infection, respectively. The most frequent side effect was diarrhea and observed in 10 patients (14%). The results of the present study indicate that sulbactam-ampicillin is safe and effective in the treatment of diabetic foot infections.

Adult↗
PubMed1996

In vitro activity of ampicillin-sulbactam against clinical multiresistant Acinetobacter baumannii isolates.

We evaluated the in vitro activity of ampicillin-sulbactam in comparison with that of broad-spectrum antimicrobial agents against Acinetobacter baumannii isolates. Two hundred and twelve clinical isolates collected between January 1993 and March 1995 from two tertiary hospitals located in São Paulo, Brazil were tested for susceptibility by the disk diffusion method against several broad-spectrum antimicrobial agents, including imipenem, ciprofloxacin, ceftazidime, aztreonam, amikacin, and polymyxin B. All strains were susceptible to polymyxin B. The second most active compound was the combination ampicillin-sulbactam (88% susceptibility). Only 79% of the isolates were susceptible to imipenem. Ciprofloxacin was active against 60 (28%) and amikacin against 34 (16%) isolates. Ceftazidime was the most active cephalosporin; however, only 9% of the isolates were susceptible to this compound. Both aztreonam and ampicillin alone showed very poor activity against this species (1% susceptibility). The prevalence of severe infections due to A. baumannii is increasing very rapidly in the tertiary hospitals of São Paulo and there are very few options for the treatment of these infections. Polymyxin B is invariably in vitro active against this species; however, this compound can cause severe side effects and is not commercially available for intravenous use in Brazil and in several other countries. Our results indicated that the combination ampicillin-sulbactam may be an alternative drug for the treatment of infections due to multiresistant A. baumannii; however, further studies are necessary to evaluate the clinical role of this compound for the treatment of severe infections.

Acinetobacter↗
PubMed1986

Concentration of sulbactam and ampicillin in serum and the myometrium.

Sulbactam 1g and ampicillin 2g were administered intravenously to 12 patients, and concentrations of the drugs were determined in the serum and myometrium for up to 120 minutes after infusion. The ratio of sulbactam to ampicillin was about 1:2 in the serum and myometrium. Both drugs penetrated well into the myometrium, and median concentrations of sulbactam and ampicillin were 65% and 68%, respectively, of those in the serum. Sulbactam/ampicillin was effective for perioperative prophylaxis and should be effective as therapy for pelvic infections.

Ampicillin↗
PubMed1999

Imipenem-cilastatin versus sulbactam-cefoperazone plus amikacin in the initial treatment of febrile neutropenic cancer patients.

The treatment of infectious complications in cancer patients has evolved as a consequence of the developments in the chemotherapy of cancer patients. In this prospective, randomized study, we compared imipenem-cilastatin and sulbactam-cefoperazone with amikacin in the empiric therapy of febrile neutropenic (< 1000/mm3) patients with liquids and solid tumours. Of 30 evaluable episodes, 15 were treated with imipenem-cilastatin and 15 were treated with sulbactam-cefoperazone plus amikacin. 73% of episodes were culture-positive: gram-positive pathogens accounted for 62% of the isolates. Bacteremia was the most frequent site of infection. The initial clinical response rate for both regimens was 60% (p > 0.05). No major adverse effects occurred. This study demonstrated that imipenem-cilastatin monotherapy and combination therapy of sulbactam-cefoperazone plus amikacin were equally effective empiric therapy for febrile granulocytopenic cancer patients.

Adolescent↗
PubMedDate not supplied

[Pharmacological studies of sulbactam and its association with semisynthetic beta-lactam antibiotics].

The acute toxicity, local tolerance and pharmacokinetic properties of sulbactame manufactured by the Iaşi Antibiotic Investigation Centre, alone or in association with ampicillin or amoxicillin were tested. Some tests were made comparatively with the product Unasyn--Pfizer. The obtained data show that this beta-lactamase inhibitor has a low toxicity--DL50 i.p. in mice over 4,000 mg/kg, both alone or associated with the two semisynthetic beta-lactamic antibiotics. The local tolerance is good and the serum levels of the above mentioned associations are above towards the tested bacteria and are similar or very close to those of Unasyn. It is believed that the therapeutical use of the association sulbactame + ampicillin or sulbactame + amoxicillin is very useful in the beta-lactamase producing germs infection.

Amoxicillin↗
PubMed1992

Evaluation of sulbactam plus ampicillin for treatment of experimentally induced Klebsiella pneumoniae lung infection in foals.

Efficacy of sulbactam, a beta-lactamase inhibitor, in combination with ampicillin, was evaluated for treatment of experimentally induced pneumonia caused by beta-lactam-resistant Klebsiella pneumoniae. Infection was experimentally induced in 18 healthy weanling foals that were randomly allocated to 3 treatment groups: sulbactam plus ampicillin (S/A, 3.3 and 6.6 mg/kg of body weight, respectively), ampicillin (6.6 mg/kg), or vehicle only. Foals were treated daily for 7 days; the observer was unaware of treatment status. Compared with ampicillin and vehicle, treatment with S/A resulted in a statistically significant (P less than 0.05) decrease in severity of pneumonia, with regard to bronchoalveolar lavage cytologic findings (decreased total cell and neutrophil numbers, and increased lymphocyte numbers) and extent of macroscopic lesions in lung tissue of the noninoculated regions. Marked trends toward improvement of S/A-treated foals were observed for quantitative results of bacteriologic culture of bronchoalveolar lavage fluid samples (P less than 0.07), macroscopic pathologic features of the whole lung (P less than 0.1), and histopathologic variables (P less than 0.07), compared with ampicillin- and vehicle-treated foals. Treatment effects were not observed for radiographic, hematologic, and blood gas abnormalities that resulted from infection. In conclusion, the combination of sulbactam plus ampicillin was found to have synergistic effects in vivo, to reduce the extent and severity of experimentally induced gram-negative lung infection in foals.

Ampicillin↗
PubMed1989

[Kinetics of the antibacterial effect of ampicillin and sulbactam combinations in dynamic and static conditions].

Kinetics of antimicrobial effect (AME) of ampicillin/sulbactam combinations (ratios of 4:1 to 1:2) on ampicillin resistant bacterial strains producing beta-lactamases of types II, III, IV and V according to Richmond classification was studied with using the computerized system MS-2 (turbidimetric recording) and an in vitro dynamic model (microcalorimetric recording). The concentrations of the drugs in system MS-2 (static conditions) corresponded to the maximum ones observed in serum of humans after bolus intravenous administration of ampicillin in a dose of 0.5 g and sulbactam in doses of 0.125 to 0.5 g. The pharmacokinetic profiles of the drugs observed in the human serum after their oral and intravenous administration and in the tissue-chamber fluid after intravenous administration of ampicillin (0.5 g) and sulbactam (0.125 g) were simulated in the dynamic model. The combination efficacy was estimated with using the parameter of AME duration (TE) reflecting shifts in the curves of the microbial regrowth in the presence of the drugs against the curve of the control growth (in the absence of the drugs) and the parameter of the AME intensity (IE) evaluated by the area between the curves. It was noted that increasing of the ampicillin/sulbactam ratio from 1:4 to 1:1 was accompanied by an increase in the AME. Further increasing of the sulbactam content in the combination did not result in higher AME. For combined ampicillin/sulbactam dosage forms the ratios of 1:1 to 2:1 should be recommended.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Oral↗
PubMed1989

Clinical evaluation of sulbactam plus ampicillin in the treatment of general pediatric infections.

Sixty pediatric patients (27 males and 33 females) between the ages of 7 months and 11.7 years (mean age = 4.3 yr) were treated with parenteral sulbactam plus ampicillin (1:2 ratio) for lower respiratory tract infections (29 cases), upper respiratory tract infections (4 cases), urinary tract infections (25 cases) or skin/soft tissue infections (2 cases). The infection was mild in 6 cases, moderate in 44 and severe in 10. The infection was acute in 57 patients, recurrent in 1 (cystitis) and was a flare-up of a chronic infection in 2 (pyelonephritis and cystitis). The children received an average dose of 48 mg/kg/d of sulbactam plus 96 mg/kg/d of ampicillin by the i.m. route (43 cases) or by i.v. drip (17 cases) in 3-4 divided doses. The length of treatment ranged between 3 and 10 d (mean duration = 6 d). At the end of therapy, clinical cure was achieved in 53 patients (88.3%), while 6 (10%) had a marked improvement. Only 1 patient, with a lower respiratory tract infection, did not respond to therapy. All 25 patients with urinary tract infection experienced bacteriological cure at the end of treatment. No side effects were reported. Mild and transient changes in laboratory parameters from baseline values were observed in 10 patients (eosinophilia, elevation of SGOT or SGPT) without clinical consequence. Sulbactam plus ampicillin was effective and safe in the treatment of bacterial infections in children and appears to be useful in the treatment of those infections in which beta-lactamase-producing organisms are involved.

Ampicillin↗
PubMed1987

Microbiological properties of sulbactam combined with ampicillin.

Several in vitro parameters of sulbactam combined with ampicillin (Sbt/Amp) were studied in order to evaluate and compare its microbiological properties with those of beta-lactamase stable beta-lactams (ceftriaxone, cefamandole, cefoxitin). The intrinsic activity of Sbt/Amp was satisfactory and comparable to that of other beta-lactams and no significant difference was observed against beta-lactamase producing or non-producing bacteria. Besides, it was determined that sulbactam, when combined with ampicillin at different ratios (1:2, 5:1), with and without preincubation (60 min) reduces the hydrolysis of ampicillin determined by ten different standard beta-lactamases. The hydrolysis rates of ampicillin become as low as those of cefoxitin, cefamandole and ceftriaxone, which are beta-lactamase stable cephalosporins. In fact, all the antibiotics under examination were slightly hydrolyzed by several beta-lactamases, but such slight hydrolysis did not affect the antibacterial activity against beta-lactamase producing bacteria. About 50% of non-beta-lactamase producing bacteria (18 strains of different bacterial species) produced an inducible beta-lactamase after ten daily subcultures with sub-inhibitory concentrations of each antibiotic, but minimum inhibitory concentrations (MICs) of Sbt/Amp never increased after stimulation in contrast with other drugs whose MICs were much higher in consequence of this procedure. Finally, no spontaneous resistant mutant to Sbt/Amp was detected, but several mutants appeared in response to the other drugs. Sulbactam makes ampicillin as effective as beta-lactamase stable cephalosporins and its use does not determine an increase of resistance or selection of resistant mutants.

Ampicillin↗
PubMed1987

[Sulbactam and clavulanic acid: studies of enzyme kinetics and synergism with ampicillin and mezlocillin].

Both inhibitors clavulanic acid and sulbactam exhibit high affinity (Ki-values less than 10(-6) mol/l) to the beta-lactamases of gram-negative bacteria with predominant penicillinase activity and lowered affinity to enzymes with cephalosporinase activity (above all clavulanic acid). As compared to sulbactam there was a stronger synergism of clavulanic acid with ampicillin or mezlocillin in those isolates producing either a plasmid-mediated or a chromosomally-mediated penicillinase. In beta-lactamase-overproducing Klebsiella ssp. variants both inhibitors could protect neither ampicillin nor mezlocillin from breakdown-independent of the synergy observed in the corresponding wild-type strains. Moreover, there was a marked synergism between mezlocillin (but not ampicillin) and sulbactam in beta-lactamase-overproducing Enterobacter cloacae variants. There was no strong relation between the amount of enzyme produced and the resulting synergy between inhibitor and antibiotic among clinical isolates. These observations agree with the results obtained for routinely performed susceptibility testing of amoxycillin/clavulanic acid and ampicillin/sulbactam.

Ampicillin↗
PubMed1987

Efficacy of sulbactam-ampicillin in an induced Pasteurella haemolytica pneumonia model in calves.

Therapeutic efficacy of sulbactam, a beta-lactamase inhibitor, in combination with ampicillin was evaluated in an ampicillin-resistant Pasteurella haemolytica pneumonia model in cattle, using an IV agar emboli method of infection. Groups of cattle given vehicle (group 1, n = 19) or ampicillin (group 2, n = 8) had 74% and 50% mortality, respectively, whereas group 3 (n = 11) given sulbactam-ampicillin had no mortality. Morbidities were 100% in groups 1 and 2 and 27% in group 3. Retrospectively, mortalities and morbidities were significantly (P less than 0.001) lower for group 3 given sulbactam-ampicillin when compared with those in groups 1 and 2 given vehicle or ampicillin, respectively. Evidence of embolic pneumonic pasteurellosis was observed histologically.

Ampicillin↗
PubMedDate not supplied

[Activity of sulbactam and clavulanic acid, alone and combined, on Acinetobacter calcoaceticus].

Sulbactam and clavulanic acid, both beta-lactamase inhibitors, were studied alone or associated on 85 isolates of Acinetobacter calcoaceticus. When sulbactam was tested alone the minimal inhibitory concentration (MIC) was less than 2 micrograms/ml with the carbenicillin-sensitive strains of A. Calcoaceticus and between 8 to 16 micrograms/ml with the carbenicillin-resistant strains. In the presence of clavulanic acid (5 or 10 micrograms/ml) the MIC of sulbactam on all the carbenicillin-resistant strains decreased to less than 4 micrograms/ml.

Acinetobacter↗
PubMed1995

[Comparative in vitro activity of ampicillin, cefoperazone, their combinations with sulbactam and other antibiotics with respect to staphylococci and pneumococci].

Antibiotic susceptibility of 225 Staphylococcus strains and 42 Pneumococcus strains was assayed with the method of serial microdilutions. Methicillin resistant Staphylococcus strains (S. aureus and coagulase negative strains) were characterized by high susceptibility to cephalosporins and ampicillin + sulbactam combination, as well as to ciprofloxacin, rifampicin and vancomycin (70 to 100 per cent of the susceptible strains). Less than 50 per cent of the strains was susceptible to erythromycin. The methicillin resistant Staphylococcus strains preserved their high susceptibility to vancomycin and rifampicin (the coagulase negative strains also preserved their susceptibility to ciprofloxacin). Four Pneumococcus strains with the intermediate resistance to benzylpenicillin were isolated (for 9.6 per cent of the strains the MIC was 0.12 to 1.0 micrograms/ml). The growth of 2 out of these 4 strains was inhibited by the ampicillin + sulbactam combination in a concentration of less than 0.5 micrograms/ml and by cefotaxime and the cefoperazone + sulbactam combination in a concentration of less than 1.0 micrograms/ml. The growth of the other 2 strains was inhibited by betalactams in concentrations higher than the above mentioned.

Ampicillin↗
PubMed1994

[Value of mono-antibiotic therapy using piperacillin associated with sulbactam and possibly followed by vancomycin in febrile neutropenia in solid tumors].

We evaluated the efficacy and safety of a monotherapy by piperacillin and sulbactam potentially associated to vancomycin as an empiric antimicrobial therapy in febrile neutropenic patients treated with nephrotoxic chemotherapy for solid tumors. Twenty-three patients were treated during 32 episodes with piperacillin 4 g i.v. every 8 hours and sulbactam 1 g IV every 8 hours. If the patient remained febrile after 48 hours, 1 g of vancomycin i.v. was added every 12 hours as indicated by our study design. The mean duration of neutropenia was 5.5 days (2-13 days). In ten episodes, the granulocyte nadir was < 100/mm3. Infection was microbiologically documented in seven episodes (22%) with six Gram negative bacilli and 3 Gram positive cocci. There were 19 apyrexia with piperacillin and sulbactam (59%) and further seven were resolved by the addition of vancomycin (total success: 81%). Failure was observed in six episodes consecutive to germ resistance (one episode), clinical deterioration (one episode), relapsing fever related to Pseudomonas infection (one episode), persistent fever despite withdrawal of neutropenia and no microbiological documentation (two episodes) and protocol violation (one episode). Neither septic death nor toxicity were observed. We conclude that this empirical treatment is active and safe in short period febrile neutropenic episodes in patients heavily treated with nephrotoxic chemotherapy for solid tumors.

Adolescent↗
PubMed1995

In-vitro activity of cefoperazone-sulbactam combination against cefoperazone resistant clinical isolates in a Malaysian general hospital.

Beta-lactamase production is one of the major mechanisms of resistance amongst bacteria especially the enteric bacilli. The purpose of this study is to assess the in-vitro activity of Sulperazon, a combination of cefoperazone and an irreversible beta-lactamase inhibitor, sulbactam, against the cefoperazone resistant isolates of aerobic gram-negative bacilli. A total of 92 such strains were tested. It was found that at a concentration of < or = 8 mg/l of sulbactam added to cefoperazone 82% of Klebsiella spp, 100% of E. coli, 100% of Enterobacter spp, 33% of Pseudomonas aeruginosa, 67% of Pseudomonas spp and 62% of Acinetobacter spp that were resistant to cefoperazone alone were susceptible to the combination. Hence it is concluded that the addition of sulbactam to cefoperazone does expand the spectrum of the in-vitro activity of cefoperazone.

Cefoperazone↗