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PubMed2005

Prevention of surgical site infection after open prosthetic inguinal hernia repair: efficacy of parenteral versus oral prophylaxis with amoxicillin-clavulanic acid in a randomized clinical trial.

The aim of this prospective study was to compare the efficacy of oral versus parenteral prophylactic amoxicillin-clavulanic acid for preventing surgical site infection after open prosthetic mesh repair of inguinal hernia. A total of 480 inguinal-hernia patients were randomly assigned to two groups. Group I (n = 240) received 1.313 g oral amoxicillin-clavulanic acid 2 hours before operation, and group II (n = 240) received 1.2 g of the same drug combination intravenously approximately 30 minutes before surgery. Patients were examined four times during 1 year of follow-up (at 7-10 days, 4-6 weeks, 6 months, and 12 months postoperation), and data related to surgical site infections were collected. Seventy-two patients were excluded due to confounding factors during and after the operation. There were no statistically significant differences between group I (final n = 208) and group II (final n = 200) with respect to age, sex distribution, body mass index, American Anesthesiology Association grade, frequencies of different hernia types, duration of surgery, and the experience levels of the principal surgeon in the operations. One of the 208 (0.5%) patients in group I and 3 of the 200 (1.5%) patients in group II developed superficial surgical site infections (p > 0.05). None of the infections required mesh removal. There were no deep surgical site infections in either group, and there was one case of hernia recurrence in each group. For patients undergoing open prosthetic repair of inguinal hernia, oral amoxicillin-clavulanic acid is safe, significantly less costly, and equally effective in preventing surgical site infection as the same dose given parenterally.

Administration, Oral↗
PubMed2006

Determination of clavulanic acid in calf plasma by liquid chromatography tandem mass spectrometry.

A method for the quantification of clavulanic acid in calf plasma using high-performance liquid chromatography combined with electrospray ionization (ESI) mass spectrometry, operating in the negative ionization mode (LC-MS/MS), is presented. Sample preparation includes a simple and fast deproteinization with acetonitrile and a back-extraction of the acetonitrile with dichloromethane. Chromatography is performed on a reversed-phase PLRP-S polymeric column using 0.05% formic acid in water and acetonitrile. The limit of quantification is 25 ng/ml, which is lower than other published methods using ultraviolet (UV), fluorimetric or mass spectrometric detection. The limit of detection is calculated to be 3.5 ng/ml. The stability of clavulanic acid was demonstrated according to The Guidelines of Bioanalytical Method Validation of The Food and Drug Administration (FDA): freeze and thaw stability, short-term stability, long-term stability, stock solution stability and postpreparative stability. The method is used in a pharmacokinetic and bioequivalence study of amoxycillin/clavulanic acid formulations in calves.

Administration, Oral↗
PubMed1991

[Randomized study of amoxicillin-clavulanic acid versus amoxicillin-metronidazole combinations in pyogenic infections of dental origin].

Thirty patients, without any valve defect, cardiac malformation or previous antibiotic administration and presenting dental infections, have been treated either with amoxycillin-clavulanic acid or amoxycillin and metronidazole. Aerobic and anaerobic bacteria have been isolated. These infections were due to mixed flora. Nearly one half of anaerobes were Peptostreptococcus, S. milleri and S. sanguis being predominant among aerobes. The species identified were those found in the mouth in the absence of infection becoming as opportunistic flora. The percentage of cures was equivalent in the two groups. the association amoxycillin-clavulanic acid seems to be as active as amoxycillin + metronidazole on the microflora isolated from dentogenous pyogenic infections.

Adolescent↗
PubMed1984

Amoxycillin and clavulanic acid in the treatment of urinary infection.

The pharmacokinetics and clinical efficacy of amoxycillin combined with clavulanic acid in the treatment of 32 children with urinary tract infection were studied. Twenty one (80%) of 26 children with proved urinary tract infection showed a favourable clinical and bacteriological response. Fifteen of these children had amoxycillin resistant organisms and were treated successfully. In 20 children the serum and urine concentrations of amoxycillin and clavulanic acid were measured after the first oral dose.

Amoxicillin↗
PubMed2005

X-ray crystal structure of ornithine acetyltransferase from the clavulanic acid biosynthesis gene cluster.

The orf6 gene from the clavulanic acid biosynthesis gene cluster encodes an OAT (ornithine acetyltransferase). Similar to other OATs the enzyme has been shown to catalyse the reversible transfer of an acetyl group from N-acetylornithine to glutamate. OATs are Ntn (N-terminal nucleophile) enzymes, but are distinct from the better-characterized Ntn hydrolase enzymes as they catalyse acetyl transfer rather than a hydrolysis reaction. In the present study, we describe the X-ray crystal structure of the OAT, corresponding to the orf6 gene product, to 2.8 A (1 A=0.1 nm) resolution. The larger domain of the structure consists of an alphabetabetaalpha sandwich as in the structures of Ntn hydrolase enzymes. However, differences in the connectivity reveal that OATs belong to a structural family different from that of other structurally characterized Ntn enzymes, with one exception: unexpectedly, the alphabetabetaalpha sandwich of ORF6 (where ORF stands for open reading frame) displays the same fold as an DmpA (L-aminopeptidase D-ala-esterase/amidase from Ochrobactrum anthropi), and so the OATs and DmpA form a new structural subfamily of Ntn enzymes. The structure reveals an alpha2beta2-heterotetrameric oligomerization state in which the intermolecular interface partly defines the active site. Models of the enzyme-substrate complexes suggest a probable oxyanion stabilization mechanism as well as providing insight into how the enzyme binds its two differently charged substrates.

Acetyltransferases↗
PubMed1993

Relative efficacy of tazobactam, sulbactam and clavulanic acid in enhancing the potency of ampicillin against clinical isolates of Enterobacteriaceae.

Three beta-lactamase inhibitors were combined with ampicillin in a fixed 2:1 ratio. The activity of ampicillin was enhanced by tazobactam and by clavulanic acid, and to a lesser extent by sulbactam when tested against fresh clinical isolates of Enterobacteriaceae. At a concentration of 8 micrograms/ml, ampicillin alone inhibited 49.6% of 2,434 consecutive isolates of enteric bacilli compared to 81% inhibited by ampicillin combined with tazobactam or clavulanic acid and 69.3% inhibited by the sulbactam/ampicillin combination. A four-fold or greater reduction in ampicillin MICs was observed in comparable numbers of isolates with all three combinations, but the most marked effects were seen with strains that were highly resistant to ampicillin.

Ampicillin↗
PubMed1984

Cephalosporin-resistance in the Bacteroides fragilis group and the effect of clavulanic acid.

Thirty-five beta-lactam-resistant isolates of the Bacteroides fragilis group were examined for the susceptibility to eight cephalosporins, alone, and in combination with a subinhibitory concentration of the beta-lactamase inhibitor, clavulanic acid. The majority of strains tested became fully susceptible to cephaloridine, cefotaxime and ceftriaxone in the presence of clavulinic acid whereas the effect of the inhibitor on the susceptibility to compounds such as cefsulodin and ceftazidime and to a lesser extent cefoperazone varied according to species. Bact. fragilis strains almost invariably showed substantial reductions in MICs whereas those of other species, especially Bact. thetaiotaomicron, were influenced to a lesser extent. Susceptibility to cefoxitin was unaffected by the inhibitor but a few strains with high level resistance to latamoxef (moxalactam) became susceptible in the presence of clavulanic acid. All strains were found to produce beta-lactamase as determined by the nitrocefin test and these were characterized by isoelectric focusing.

Bacteroides fragilis↗
PubMed1987

Concentrations of ticarcillin and clavulanic acid in human bone after prophylactic administration of 5.2 g of timentin.

The penetration of ticarcillin and clavulanate into their distribution space within human bone was determined after prophylactic administration of 5.2 g of timentin (5 g of ticarcillin plus 0.2 g of clavulanic acid) to 20 patients undergoing hip surgery. All samples were taken 45 to 85 min postadministration. The mean concentrations of ticarcillin in spongiosa and corticalis bone were 57.1 and 70.5 mg/kg, respectively; those of clavulanic acid were 17.8 and 32.5 mg/kg, respectively. No infections occurred in these patients.

Aged↗
PubMed1986

Penetration of amoxycillin and clavulanic acid into bone.

The levels of amoxycillin and clavulanic acid have been measured in bone, serum and synovial fluid following the administration of 1.2 g Augmentin prior to hip replacement. Both antibiotics readily enter synovial fluid in levels similar to that found in serum. The levels found in bone are a minimum of ten times lower than those found in serum. Sequential administration of Augmentin with a six-hourly dose schedule does not increase the levels found in any of the tissues studied.

Aged↗
PubMedDate not supplied

[Rapid determination of the synergy of clavulanic acid and beta lactams by measuring the intracellular ATP by bioluminescence].

Twenty clinical isolates of ampicillin- and carbenicillin-resistant or susceptible (two strains) Gram-negative rods, producing at least one beta-lactamase, were examined for susceptibility to a combination of ampicillin or carbenicillin with clavulanic acid (enzymatic inhibitor). Synergy was evaluated by the reduction of the beta-lactam agar dilution MIC and by the measurement of intracellular AYP using firefly bioluminescence. The potentiation effect of clavulanic acid was variable, depending on resistance levels, species and types of beta-lactamase (TEM, SHV-1, CARB, OXA, MAL and Cpase). The synergy was significant, with 10 mg/l of inhibitor for all the strains producing TEM-1, TEM-2 and Carb-2 except for one strain of Serratia marcescens (TEM-2). The synergy was weak for Levinea strains (Citrobacter diversus biotype b), biosynthesizing specific penicillinases as MAL-1. No potentiation effect was observed for strains producing a cephalosporinase, such as Escherichia coli and Pseudomonas aeruginosa. This effect appeared to be variable for strains producing the oxacillin-hydrolysing enzyme (OXA-1), such as E. coli and P. aeruginosa. A positive correlation was clearly demonstrated between the MIC values and the intracellular ATP concentration in bacteria within 2 h. The opportunity of using the firefly assay for the rapid determination of synergy between beta-lactam antibiotics and clavulanic acid is discussed.

Adenosine Triphosphate↗
PubMed1986

Synergistic effects of dicloxacillin or clavulanic acid in combination with penicillin G or cephalothin against Yersinia enterocolitica.

Cultures of Yersinia enterocolitica grown at 22 degrees C produced beta-lactamases, whereas cultures grown at 37 degrees C produced these enzymes much less effectively. Both dicloxacillin and clavulanic acid inhibited the beta-lactamase activity of bacterial crude extracts and potentiated the activity of penicillin G or cephalothin against 14 Y. enterocolitica strains. It appeared that the beta-lactamase activity present in Y. enterocolitica cells grown at 37 degrees C was great enough to play a role in bacterial resistance to beta-lactam antibiotics, since combining penicillin G or cephalothin with clavulanic acid or dicloxacillin resulted in synergistic activity against cultures grown at 37 degrees C that was equal to or greater than the activity against cultures grown at 22 degrees C.

Cephalosporins↗
PubMed1986

[The drug combination amoxicillin-clavulanic acid compared to the triple combination ampicillin-gentamicin-metronidazole in the treatment of severe adnexal infections].

Forty-four patients with severe pelvic inflammatory disease were randomly divided into two groups. Single drug therapy with the amoxicillin-clavulanic acid was used in 22 patients (group A). The other 22 patients (group B) were given a combination of ampicillin, gentamicin and metronidazole. Clinical results were comparable in both groups with 91% successes and 9% improvements in group A, against 86% successes, 9% failures, and 5% non-interpretable results in group B. The difference between the two groups was not statistically significant (p = 11.6%). 30% of patients in each group had positive serologic tests for Chlamydiae. This had no influence on therapeutic results but led to secondary prescription of a cycline. Because amoxicillin-clavulanic acid is active against aerobic and anaerobic pathogens, including beta-lactamase-producing microorganisms, it is a satisfactory alternative to the ampicillin-gentamicin-metronidazole combination, especially as it is simpler to use, less toxic and less expensive.

Amoxicillin↗
PubMed1991

Liquid chromatographic determination of amoxycillin and clavulanic acid in pharmaceutical preparations.

A liquid chromatographic method for the simultaneous determination of amoxycillin and potassium clavulanate in tablet and suspension preparations is presented. The method specifies reversed phase column and a buffered mobile phase (CH3OH + KH2PO4-buffer pH 6 + H2O, 15:1:84) isocratically at a rate of 1.0 ml min-1, with detection at 235 nm. The suitability of the chromatographic system developed is tested using replicate injections of the sample and standard preparations. The observed relative standard deviations (RSDs) were within 2%. Recovery experiments conducted utilizing the proposed method gives results of 101.5% +/- 1.72 (n = 6) and 101.22% +/- 1.93 (n = 6) for amoxycillin in tablets and powder for oral administration, respectively. Similarly, recovery experiments for clavulanic acid gave results of 100.33 +/- 1.90 (n = 6) and 99.61 +/- 1.32 (n = 6) in the tablets and suspension powder, respectively. Comparison of the proposed method with the USP method proved it to be satisfactory. The statistical F- and t-tests observed, indicated that there were no significant differences between the two methods regarding precision and accuracy.

Amoxicillin↗
PubMed2003

Application of MEKC for determination of ticarcillin and clavulanic acid in Timentin intravenous preparation.

A micellar electrokinetic chromatography method for simultaneous assay of ticarcillin and clavulanic acid in Timentin i.v. injection preparation was developed. This method ensures excellent separation of both components of Timentin preparation. The validation of the method was performed, and specificity, reproducibility, precision and accuracy were confirmed. The detection and quantitative limits for Timentin were established in the concentrations 0.04 and 0.08 mg/ml, respectively. The elaborated technique was compared with two methods routinely used-UV and high performance liquid chromatography (HPLC). The obtained results and their statistical analysis proved the same precision of all methods, however, no significant differences were observed between CE and HPLC.

Anti-Bacterial Agents↗
PubMed1984

The effect of clavulanic acid on the susceptibility of Bacteroides fragilis to three acyl-ureidopenicillins, ampicillin and carbenicillin.

The susceptibilities of 50 clinical isolates of the Bacteroides fragilis group to ampicillin, carbenicillin, mezlocillin, azlocillin and piperacillin were similar, modal MICs being 8-32 mg/l. However, in the presence of clavulanic acid, 45 and 43 strains became susceptible (MIC less than or equal to 4 mg/l) to ampicillin and carbenicillin respectively whilst 27, 37 and 35 strains became susceptible (MIC less than or equal to 4 mg/l) to mezlocillin, azlocillin and piperacillin. Clavulanic acid did not influence the susceptibility of six (12%) strains. The isoelectric points of the beta-lactamases from Bact. fragilis and Bact. thetaiotaomicron were similar to those found by others.

Ampicillin↗
PubMedDate not supplied

Amoxycillin-clavulanic acid treatment of melioidosis.

Melioidosis is a serious infection with high acute mortality, and a high rate of relapse despite protracted antimicrobial treatment. The current recommended conventional oral treatment regimen is a 4-drug combination of high-dose chloramphenicol, doxycycline and trimethoprim-sulphamethoxazole given for between 6 weeks and 6 months. We have evaluated prospectively the use of amoxycillin-clavulanic acid, to which Pseudomonas pseudomallei is consistently sensitive in vitro, for the oral maintenance treatment of melioidosis. Amoxycillin-clavulanic acid was used either as sole treatment of localized disease, or as maintenance therapy following either parenteral ceftazidime or the conventional 4-drug regime; 20 patients with localized infections and 26 with septicaemic melioidosis received a median of 7.5 (2-12) weeks treatment. After a mean follow-up period of 6 months (range 1-19), 31 patients (67%) remain free of disease. The drug was well tolerated. Three patients had fatal relapses, one other died suddenly at home, and another died from underlying promyelocytic leukaemia. The remaining 10 relapses were treated successfully. Resistance developed in one case. Amoxycillin-clavulanic acid is a safe alternative to the conventional 4-drug antimicrobial combination for the oral treatment of melioidosis. It may be of particular value in children, pregnant women, and in infections with Ps. pseudomallei resistant to the potentially toxic conventional regimen, but the optimum dose and duration of therapy need to be established.

Adolescent↗
PubMed1979

Effect of clavulanic acid on the in vitro synergism between carbenicillin and gentamicin against Serratia marcescens.

Clavulanic acid, a potent beta-lactamase inhibitor, reduced the minimum inhibitory concentrations of carbenicillin for 13 of 15 clinical isolates of Serratia marcescens by at least eightfold. The combination of clavulanic acid and carbenicillin also exhibited synergistic activity with gentamicin against 11 of 15 isolates tested, including 9 of 10 strains which were highly resistant to carbenicillin (minimum inhibitory concentration >/= 8,000 mug/ml) and had previously been found resistant to the synergistic activity between carbenicillin and gentamicin.

Anti-Bacterial Agents↗
PubMed1984

Effect of clavulanic acid on the activities of ten beta-lactam agents against members of the Bacteroides fragilis group.

Clavulanic acid reduced the MICs of amoxicillin, carbencillin , cefamandole, cefotaxime, ceftazidime, ceftizoxime, cephalothin, and penicillin G, but not of cefoxitin or moxalactam, against 77 isolates of the Bacteroides fragilis group, all rapidly beta-lactamase positive by the nitrocefin slide test. It had no effect on the susceptibilities of eight Bacteroides distasonis strains that were slowly beta-lactamase positive (18 h of incubation).

Anti-Bacterial Agents↗