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PubMed2005

Effect of amoxicillin sulbactam in threatened preterm labour with intact membranes: a randomised controlled trial.

OBJECTIVE: To determine whether treatment with amoxicillin-sulbactam in women with threatened idiopathic preterm labour will prolong the gestation and reduce preterm birth rates in a Latin-American population. METHODS: A double-blind, placebo-controlled, randomized trial was conducted in 96 women who were hospitalized for preterm labour between 24 and 34 weeks of gestation at the Pereira Rossell Hospital, in Montevideo, Uruguay. The primary outcome measure was prematurity. The sample size was calculated a priori based on the hospital database. Statistical analyses were performed using the t-test, chi square, weighted mean difference (WMD) and relative risk (RR) with their confidence intervals (95% CI). Analysis by intention-to-treat. RESULTS: Out of 47 patients assigned for antibiotics, 43 completed the treatment. There were no significant statistical differences between antibiotics and placebo group in prematurity (RR:1.04, 95% CI: 0.59, 1.84), prolongation of pregnancy (WMD:0.23, 95% CI: -0.96, 1.42) and other perinatal outcomes. CONCLUSION: Antibiotics did not prove to have benefits in improving perinatal outcomes in this Latin American population.

Adolescent↗
PubMed2005

Piperacillin-sulbactam versus piperacillin-tazobactam: a multicentre, randomised, single-blind, controlled clinical trial.

The objective of this study was to compare the efficacy and safety of piperacillin-sulbactam (PIP-SBT) and piperacillin-tazobactam (PIP-TAZ) in the treatment of bacterial respiratory and urinary tract infections. A randomised, single-blind, controlled clinical trial was performed. Differences in clinical efficacy, bacteriology and safety between the two groups were subjected to statistical analysis, including intent-to-treat (ITT) analysis. A total of 215 cases were enrolled, with 203 complete cases (99 PIP-SBT, 104 PIP-TAZ). A total of 209 cases (103 PIP-SBT, 106 PIP-TAZ) were included in the ITT analysis and a total of 212 cases (104 PIP-SBT, 108 PIP-TAZ) were included in the safety analysis. Overall efficacy rates of PIP-SBT and PIP-TAZ were 93.2% and 93.4%, respectively. Overall bacterial eradication rates of the two groups were 95% and 97.59%, respectively. Among the PIP-SBT group, eight patients (7.69%) had adverse events, including four probable drug-related events. Among the PIP-TAZ group, nine patients (8.33%) had adverse events, including one definitely drug-related and four probable drug-related events. All differences between the two groups were insignificant. PIP-SBT could be a suitable replacement for PIP-TAZ in the therapy of community-acquired respiratory and urinary tract infections caused by beta-lactamase-producing bacterial isolates.

Adult↗
PubMed2005

Amoxicillin-sulbactam versus amoxicillin-clavulanic acid for the treatment of non-recurrent-acute otitis media in Argentinean children.

Streptococcus pneumoniae (Sp) and Haemophilus influenzae (Hi) are the leading bacterial cause of acute otitis media (AOM), having the nasopharynx (NP) as their reservoir. In October 2001 we began a prospective, multicenter, randomized, evaluator blind study, comparing the efficacy of amoxicillin-sulbactam (Ax/S) and amoxicillin-clavulanic acid (Ax/C) for the treatment of non-recurrent AOM (nr-AOM). Both antimicrobial susceptibility (AS) to Ax/S and Ax/C from Sp and Hi carried by study children (aged 6-48 months with nr-AOM) and, clinical outcome after treatment with high dose of either Ax/C (7:1) or Ax/S (4:1) (amoxicillin dose: 80 mg/(kg day), b.i.d. for 10 days) were assessed. Nasal cultures (NCs) were taken at Day 0. Follow-up NCs, were done only for Sp carriers. On final analysis 247/289 pts (85.5%) were fully evaluable (120 Ax/S and 127 Ax/C). NP carriage rate of Hi and Sp at Day 0 was 32.2% (93/289 pts) and 28.7% (83/289 pts), respectively. Persistent Sp carriage was detected only in 2 pts. Hi betalactamase positive rate was 13% (12/93). MICs for Ax/S and Ax/C were identical when tested against Sp and Hi isolates (range < or = 0.016-1.0 and < or = 0.016-0.25 mg/L, respectively). Clinical efficacy at Days 12-14 and 28-42 were 98.3% (115/117) and 94.2% (97/103) for Ax/S; and 98.3% (115/117) and 95.1% (98/103) for Ax/C, respectively (pNS). We conclude, that Sp and Hi isolated from NCs of nr-AOM pts were highly sensitive to both drugs and correlated with high clinical efficacy rate.

Acute Disease↗
PubMed2004

ESR investigation of gamma irradiated sulbactam sodium.

In the present work, radiolysis of gamma irradiated sulbactam sodium (SS) was investigated through detailed ESR studies performed at low and at high temperatures on the radiolytic products induced in this drug after gamma irradiation in the dose range of 3-15 kGy. While unirradiated SS presented no ESR signal, irradiated SS exhibited an ESR spectrum with many resonance peaks. Variations of the spectrum pattern and of the intensities of resonance peaks with microwave power, applied radiation dose, storage time and temperature were followed. A radical with unpaired electron localised on the carbon atom of five membered ring directly attached to two CH(3) groups and SO(2)(-) ionic radical called as species A and B, respectively, were found to be produced after gamma radiolysis of SS. The characteristic spectral and kinetic features of these species were determined by spectrum simulation calculation and by curve fitting techniques using experimental signal intensity data as input. Although, species A was fairly unstable at room and especially at high temperatures, species B were observed to be relatively stable even at high temperatures having activation energies of E(A) (+/-4)kJ/mol and E(B) (+/-3)kJ/mol, respectively, at room temperature. Four different mathematical functions were tried to explore the dosimetric features of SS and a linear function of applied dose described best the dose-response data obtained for stable species, that is, radical B, in the dose range of 0-10 kGy. An accuracy of 4% in the dose measurements was concluded to be achievable through back-projection dose calculations if SS were used as a dosimetric material.

Anti-Bacterial Agents↗
PubMed2005

A new fractional wavelet approach for the simultaneous determination of ampicillin sodium and sulbactam sodium in a binary mixture.

A new application of the fractional wavelet transform (FWT) was proposed for the simultaneous determination of ampicillin (AP) and sulbactam (SB) in a pharmaceutical combination for injection. FWT approach is a new powerful tool for removing noise and irrelevant information from the absorption spectra. Cardinal information having higher peak amplitude, eliminated noise, sharp peaks with shrinking width of spectral range was obtained by the application of FWT procedure to the original absorption spectra. In this paper, FWT approach was subjected to the data vector of the UV-signals obtained from AP and SB in the wavelength range of 211.5-313.8 nm. Derivative transform was applied to the original absorption signal together with its FWT generalization. The calibration graphs for AP and SB were obtained by measuring the FWT and usual derivative amplitudes at zero-crossing points. The method validation was carried out by using the synthetic mixture analysis. Our proposed FWT approach was compared with the usual derivative spectrophotometry and chemometric methods (CLS, PCR and PLS) and a good agreement was reported.

Absorption↗
PubMed1994

Clinical and molecular epidemiology of acinetobacter infections sensitive only to polymyxin B and sulbactam.

A nosocomial outbreak of infections due to imipenem-resistant Acinetobacter baumannii occurred in a New York hospital after increased use of imipenem for cephalosporin-resistant klebsiella infections. We identified all A baumannii isolates over 12 months, reviewed corresponding patient records, and compared strains with different antibiotic susceptibility patterns by restriction endonuclease analysis. Environmental surveillance cultures were done before and after institution of control measures. 59 patients harboured imipenem-resistant A baumannii, and 18 were infected. Isolates from patients were resistant to all routinely tested antibiotics, including imipenem. Further studies showed susceptibility to polymyxin B and sulbactam. These isolates were identical by restriction endonuclease analysis to A baumannii isolates susceptible to imipenem alone, or to imipenem and amikacin, but differed from broadly susceptible isolates. Surveillance cultures showed hand and environmental colonisation by imipenem-resistant strains. Infection and colonisation were eliminated by intensive infection control measures, and irrigation of wounds with polymyxin B. Increased use of imipenem against cephalosporin-resistant klebsiella may lead to imipenem resistance among other species, particularly acinetobacter. Such resistance appears to derive from a prior multi-resistant clone, in contrast to one which retains susceptibility to several antibiotics.

Acinetobacter↗
PubMed2003

Nosocomial multi-drug resistant Acinetobacter baumannii bloodstream infection: risk factors and outcome with ampicillin-sulbactam treatment.

The emergence of multidrug-resistant (MDR) Acinetobacter baumannii poses a therapeutic problem. The aim of this study was to assess the risk factors for nosocomial MDR-A. baumannii bloodstream infection (BSI) and the efficacy of ampicillin-sulbactam (A/S) in its treatment. Of 94 nosocomial A. baumannii BSI during the year 2000, 54% involved MDR strains, 81% of which were genetically related. Various risk factors for MDR-A. baumannii were found, of which intensive-care unit admission and prior aminoglycoside therapy were independently associated with MDR-A. baumannii acquisition on multivariate analysis. Of MDR-A. baumannii BSI cases, 65% received A/S and 35% inadequate antibiotic therapy, whereas of 43 non-MDR cases, 86% were treated according to susceptibility and 14% inappropriately with antibiotics to which these organisms were resistant. Crude mortality was comparable in the adequately treated groups. Respective mortalities among patients treated adequately and inadequately were 41.4 and 91.7% (p<0.001). Among severely ill patients, A/S therapy significantly decreased the risk of death (P=0.02 OR=7.64). MDR-A. baumannii has become highly endemic in our institution. A/S appears to be one of the last effective and safe empirical resorts for treatment of MDR A. baumannii BSI.

Acinetobacter Infections↗
PubMed1990

Simultaneous determination of ampicillin and sulbactam by liquid chromatography: post-column reaction with sodium hydroxide and sodium hypochlorite using an active hollow-fibre membrane reactor.

A high-performance liquid chromatographic method has been developed for the simultaneous determination of ampicillin (ABPC) and sulbactam (SBT) in serum and urine. The method involves separation of ABPC and SBT from the background components of serum and urine on a C18 column, post-column reaction with sodium hydroxide and sodium hypochlorite using an active hollow-fibre membrane reactor, and detection at 270 nm. At ABPC and SBT concentrations of 10 and 5 micrograms/ml in urine and serum samples, the precisions (relative standard deviations) were 0.9-2.5% (n = 8). The detection limits were 20 and 5 ng for ABPC and SBT, respectively, at a signal-to-noise ratio of 3.

Ampicillin↗
PubMed2003

Treating foot infections in diabetic patients: a randomized, multicenter, open-label trial of linezolid versus ampicillin-sulbactam/amoxicillin-clavulanate.

Foot infections in diabetic patients are predominantly caused by gram-positive cocci, many of which are now antibiotic resistant. Because linezolid is active against these pathogens, we compared the efficacy and safety of intravenous and oral formulations with that of intravenous ampicillin-sulbactam and intravenous and oral amoxicillin-clavulanate given for 7-28 days in a randomized, open-label, multicenter study of all types of foot infection in diabetic patients (ratio of linezolid to comparator drug recipients, 2:1). Among 371 patients, the clinical cure rates associated with linezolid and the comparators were statistically equivalent overall (81% vs. 71%, respectively) but were significantly higher for linezolid-treated patients with infected foot ulcers (81% vs. 68%; P=.018) and for patients without osteomyelitis (87% vs. 72%; P=.003). Cure rates were comparable for inpatients and outpatients and for both oral and intravenous formulations. Drug-related adverse events were significantly more common in the linezolid group, but they were generally mild and reversible. Linezolid was at least as effective as aminopenicillin/beta-lactamase inhibitors for treating foot infections in diabetic patients.

Acetamides↗
PubMedDate not supplied

Single-dose pharmacokinetics of intravenous sulbactam in pediatric patients.

The pharmacokinetics of intravenously administered sulbactam were studied in 17 pediatric patients two to 14 years of age. Single doses of 12.5 or 25 mg/kg were infused over 3 min, and in previously healthy children, mean peak plasma concentrations 5 min after dosing were 71 and 163 micrograms/ml, respectively. Noncompartmental and compartmental calculations resulted in similar pharmacokinetic parameters. Linear pharmacokinetics were found in the concentration range studied. The mean terminal-phase half-life was 1.75 hr, the mean total plasma clearance was 180 ml/min per 1.73 m2, and the mean apparent volume of distribution was 340 ml/kg. Approximately 70%-80% of an intravenous dose was excreted unchanged in the urine. In children with cystic fibrosis, both total plasma clearance and apparent volume of distribution were significantly increased. The data support the intravenous administration of 12.5-25 mg of sulbactam/kg every 6 to 8 hr for assessing the adequacy of this drug as an adjunct to beta-lactam therapy for various bacterial infections in children.

Adolescent↗
PubMedDate not supplied

In vitro bactericidal activity of sulbactam plus ampicillin against methicillin-resistant Staphylococcus aureus.

By a microtiter checkerboard method, the in vitro bactericidal activity of sulbactam/ampicillin was tested against three groups of Staphylococcus aureus strains: group PR (penicillin-resistant through the production of penicillinase; methicillin-susceptible both at 30 degrees C in medium containing 5% NaCl and at 35 degrees C in medium without NaCl; n = 10); group MR1 (methicillin-resistant under the former conditions but not under the latter; n = 15); and group MR2 (methicillin-resistant under both sets of conditions; n = 20). Sulbactam/ampicillin was synergistic against all strains (fractional bactericidal index, less than or equal to 0.10). Moreover, there was a linear relation in each group between the different concentrations of the two antibiotics required for bactericidal activity. Thus, an equation of bactericidal synergy could be formulated for the combination. The bactericidal activity of sulbactam/ampicillin was assessed against one strain of each group and against a reference strain (S. aureus ATCC 6538 P) in an in vitro model simulating the kinetics of both antibiotics in human blood after intravenous administration of 2 g of ampicillin and 1 g of sulbactam. The observed rate of killing was approximately 99% except with the MR2 strains, against which the combination was bacteriostatic.

Ampicillin↗
PubMed1984

Ampicillin combined with sulbactam or metronidazole for single-dose chemoprophylaxis in major gynaecological surgery.

A double-blind, placebo-controlled and randomized trial involving a total of 295 patients was carried out to define the role of chemoprophylaxis in major gynaecological surgery in our hospital. Perioperative administration of a single dose of ampicillin (500 mg) plus sulbactam (500 mg) (regimen A), or ampicillin (500 mg) plus metronidazole (1 g suppository) (regimen B), gave similar results. After abdominal hysterectomy, the rates of post-operative wound infection and febrile morbidity were significantly reduced from 24% (12/49) and 20% (10/49) in the placebo group to 3-4% (A = 2/51, B = 3/58) and 2% (A = 1/51, B = 1/58) respectively. After vaginal hysterectomy, pelvic/vaginal infection or febrile morbidity was found in 30% (3/10) of patients in the placebo group but none in either treatment group (A = 10, B = 8). After other types of operation, the rates of infectious complications were reduced, but not statistically significantly, from 11% (4/38) to 4% (A + B 2/71). However, the rates of post-operative urinary tract infection remained similar in the placebo and treatment groups (12-16%).

Adult↗
PubMed1986

Variation in the potentiation of beta-lactam antibiotic activity by clavulanic acid and sulbactam against multiply antibiotic-resistant bacteria.

Using a broth microdilution method, we studied 120 strains of beta-lactamase-producing clinical isolates to determine the potentiating effect of clavulanic acid and sulbactam (both beta-lactamase inhibitors) on the antibacterial activity of a variety of beta-lactam antibiotics. All antibiotics were tested alone and in combination with each inhibitor simultaneously using low (10(5) cfu/ml) and high (10(7) cfu/ml) inocula. Against the strains of Escherichia coli and Haemophilus influenzae the addition of both inhibitors significantly potentiated the activity of most antibiotics at the low inoculum. At the high inoculum, however, this effect was abrogated against E. coli and most strains of H. influenzae. Antibiotic activity was significantly enhanced by the inhibitors at both inoculum sizes with Bacteroides fragilis. Antibiotic resistance of Pseudomonas aeruginosa was little affected by the inhibitors. Among methicillin-resistant staphylococci, antibiotic potentiation by the inhibitors was more significant for Staphylococcus aureus than the coagulase-negative staphylococci.

Anti-Bacterial Agents↗
PubMed1990

A randomized clinical study of cefoperazone and sulbactam versus gentamicin and clindamycin in the treatment of intra-abdominal infections.

This report summarizes the experience of investigators in four medical centres who compared the combination of cefoperazone/sulbactam against gentamicin/clindamycin in the treatment of intra-abdominal infections. One hundred and fifty-two patients were enrolled in the study and all were evaluable for safety and tolerance, 110 were evaluable for efficacy. Of the 76 patients (49 male, 27 female) treated with cefoperazone/sulbactam 66 (86.8%) were cured, five (6.6%) improved and five (6.6%) failed to respond to treatment. Of 34 patients treated with gentamicin/clindamycin, 21 (61.8%) were cured, four (11.8%) improved and nine (26.4%) failed. Cure rates for patients receiving cefoperazone/sulbactam were significantly higher than those of patients receiving gentamicin/clindamycin (P less than 0.006). Failures in both groups were attributable in part to pseudomonal and enterococcal infection and abscess formation. The addition of sulbactam to cefoperazone rendered cefoperazone-resistant organisms susceptible to cefoperazone in 11 of the 76 cases (14.4%) and thus permitted treatment with this agent. The present study confirms the safety and clinical efficacy of cefoperazone/sulbactam and suggests that this combination is a viable alternative to an aminoglycoside plus clindamycin for intra-abdominal infections.

Abdomen↗
PubMed1993

Activity of 13 beta-lactam agents combined with BRL 42715 against beta-lactamase producing gram-negative bacteria compared to combinations with clavulanic acid, tazobactam and sulbactam.

The activity of six cephalosporins, six penicillins and one monobactam combined with BRL 42715, clavulanic acid, sulbactam or tazobactam at 0.1, 0.5, 1, 2, 5 and 10 mg/L was determined for 45 beta-lactamase producing Gram-negative bacteria. The combination of BRL 42715 with any of the agents was more active than any of the other inhibitor and beta-lactam combinations. Unlike the other beta-lactamase inhibitors, BRL 42715 enhanced the activity of the beta-lactams for strains that constitutively expressed Richmond & Sykes Class I beta-lactamase and against strains expressing extended-spectrum plasmid-mediated beta-lactamases.

Anti-Bacterial Agents↗
PubMed1993

In-vitro evaluation of the four beta-lactamase inhibitors: BRL42715, clavulanic acid, sulbactam, and tazobactam.

The in-vitro synergic activities of BRL42715, a new beta-lactamase inhibitor, clavulanic acid, sulbactam, and tazobactam combined with ampicillin, piperacillin, cephalothin, or cefoperazone were tested against various bacteria producing known types of beta-lactamase. BRL42715 showed the best synergistic activity among the inhibitors tested against strains producing penicillinases of type I, II, III, V, and that from Klebsiella pneumoniae, cephalosporinases, and oxyiminocephalosporinases (except that from Klebsiella oxytoca). Clavulanic acid combined with the beta-lactams tested showed the best synergic activity of the inhibitors against strains producing type IV penicillinase and oxyiminocephalosporinase from K. oxytoca. The 50% inhibitory doses of BRL42715 were superior to those of clavulanic acid against various types of beta-lactamases except for type IV penicillinase and the oxyiminocephalosporinase from K. oxytoca. The inhibitory activity of BRL42715 against cephalosporinases from various bacteria was 10(4) to 10(6)-fold greater than that of clavulanic acid. The synergic effects of BRL42715 and clavulanic acid on the activity of piperacillin were compared against six clinical isolates of bacteria resistant to piperacillin. The synergic activity of BRL42715 was greater than that of clavulanic acid in all six isolates.

Anti-Bacterial Agents↗
PubMed1996

In-vitro activity of cephalosporins alone and combined with sulbactam against various strains of Acinetobacter baumannii with different antibiotic resistance profiles.

The beta-lactamases of six strains of Acinetobacter baumannii were investigated using analytical isoelectric focusing, and the MIC values for 16 beta-lactam antibiotics determined against the strains. Three strains produced a chromosomal cephalosporinase (pI > 8.5), one strain a CARB-5 beta-lactamase (pI = 6.35), one strain a TEM-1 penicillinase (pI = 5.4) as well as a cephalosporinase (pI > 8.5), and one carbapenem-resistant strain a beta-lactamase with a pI > 8.5. Ceftazidime, cefepime, cefpirome, imipenem and meropenem were found to be the most effective beta-lactams against five strains. Sulbactam was active against four of the strains at 1-4 mg/L and showed enhanced killing effects with cefpirome.

Acinetobacter↗