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At least 217 records · Page 12Linked to original sources
PubMed1985

Clinical trial of the efficacy and safety of ticarcillin and clavulanic acid.

Forty-three hospitalized patients were treated with a new antibiotic combination containing ticarcillin plus the beta-lactamase inhibitor, clavulanic acid, in a fixed combination for intravenous use. A variety of infections were treated, including pneumonia, bacteremia, urinary tract infection, and osteomyelitis. Of 50 episodes of infection in 43 patients, 44 clinical cures were obtained, with 5 patients improving and 1 patient failing to respond to treatment. In vitro susceptibility testing of 101 clinical isolates was notable for the rarity of resistance to the combination antibiotic. Of specific interest, all 14 isolates of Staphylococcus aureus were susceptible to ticarcillin plus clavulanic acid, whereas only 2 of the 14 isolates were susceptible to ticarcillin alone. Adverse reactions to the study drug were minimal; eosinophilia, unaccompanied by other allergic phenomena, and oral candidiasis were most frequent. Overall, the combination of ticarcillin with the beta-lactamase inhibitor, clavulanic acid, appears to be a safe and effective drug for the treatment of infections caused by susceptible organisms.

Aged↗
PubMed1987

Amoxycillin, amoxycillin-clavulanic acid and metronidazole in the treatment of clue cell-positive discharge. A comparative clinical and laboratory study.

In an open study, 30 women with clue cell-positive discharge (CCPD) were treated for seven days with either amoxycillin, amoxycillin-clavulanic acid or metronidazole (ten in each group). Patients were monitored on days 2, 4, 9 and 15. Clinical and microscopical parameters were used to assess treatment efficacy. Gas-liquid chromatography of vaginal secretions was also performed. The succinate-lactate ratio had good correlation with the clinical findings. All patients treated with metronidazole were cured by day 4, suggesting that a three-day course is as effective as the standard seven-day regimen. Treatment with amoxycillin-clavulanic acid was less effective resulting in the cure of seven patients by day 15. Amoxycillin established normal secretions in only four patients. Gastro-intestinal complaints, although common in patients treated with amoxycillin-clavulanic acid, were generally mild. We consider amoxycillin-clavulanic acid a possible alternative in the treatment of CCPD.

Adult↗
PubMed1985

Clavulanate-potentiated ticarcillin: high-performance liquid chromatographic assays for clavulanic acid and ticarcillin isomers in serum and urine.

High-performance liquid chromatographic assays for the determination of clavulanic acid and ticarcillin in biological fluids are described. The clavulanic acid assay uses serum ultrafiltrate and direct injection of diluted urine with reversed-phase ion-pair/counter-ion chromatography. The ticarcillin assay allows, for the first time, the separation and quantitation of two isomers of ticarcillin. The performance of these assays has been evaluated and found to be satisfactory for routine clinical use and thus the assays have been applied to the study of the pharmacokinetics of these analytes in a subject with renal failure.

Anti-Bacterial Agents↗
PubMed1985

Randomized comparative study of amoxicillin-clavulanic acid and co-trimoxazole in the treatment of acute urinary tract infections in adults.

The efficacy and safety of amoxicillin-clavulanic acid were compared with those of co-trimoxazole in the treatment of acute urinary tract infections. A total of 104 patients (mean age, 52 years) with clinical and laboratory evidence of acute urinary tract infection were enrolled in the study. Characteristics and infecting organisms were equivalent in both groups of patients. Escherichia coli was the predominant bacteria pathogen in both groups. Both drugs resulted in clinical improvement in 100% of the patients; bacteriological cure after the termination of therapy was 95% with amoxicillin-clavulanic acid and 83% with co-trimoxazole (P less than 0.001). Side effects were not severe enough to necessitate discontinuation of the antimicrobial agents. Amoxicillin-clavulanic acid is effective and safe therapy for acute urinary tract infections caused by susceptible bacteria.

Acute Disease↗
PubMed1992

Single-dose amoxycillin-clavulanic acid vs. cefotetan for prophylaxis in elective colorectal surgery: a multicentre, prospective, randomized study. The PRODIGE Group.

A prospective, multicentre, randomized trial was carried out in 19 hospitals in order to compare the efficacy of amoxycillin-clavulanic acid with cefotetan as antibiotic prophylaxis in patients undergoing elective colorectal surgery. Since the main purpose of the study was to demonstrate equivalence between the two regimens, the protocol planned the inclusion of 200 patients. Eligible patients were randomly assigned to receive either amoxycillin-clavulanic acid (2.2 g) or cefotetan (2 g) in a single infusion on the induction of anaesthesia. Failure of prophylaxis was defined as occurrence of infection of intestinal origin, either minor (wound cellulitis) or major (abscess, peritonitis, septicaemia) within the 30-day postoperative period. Among 221 randomized patients, 208 (105 amoxycillin-clavulanic acid, 103 cefotetan) aged 66 +/- 12 years (mean +/- SD) were evaluated while 13 were withdrawn. Colorectal cancer was the indication for surgery in 73% of cases. Eleven (10 +/- 6%, 95% confidence interval) and 13 (13 +/- 7%) failures were observed in the amoxycillin-clavulanic acid and cefotetan groups (P = 0.63 chi-square test) respectively. Most infections occurred before the 10th postoperative day (8% failures at this time, estimated by the Kaplan-Meier method). The results of the trial demonstrate that amoxycillin-clavulanic acid and cefotetan have similar efficacy when used for prophylaxis of infection after elective colorectal surgery.

Adult↗
PubMed2006

[Treatment of acute maxillary sinusitis in adults. Comparison of cefpodoxime-proxetil and amoxicillin-clavulanic acid].

OBJECTIVE: The aim was to demonstrate the equivalence of the clinical efficacy and safety of cefpodoxime-proxetil (200 mg bid for 5 days) to that of amoxicillin-clavulanic acid (1 g/125 mg bid for 8 days) in adults with acute maxillary sinusitis. METHOD: In this prospective, multicenter, centrally-randomized, open-label study, 73 general practitioners and 11 ear, nose, and throat specialists included 512 patients with unilateral acute maxillary sinusitis. RESULTS: The clinical success rates at day 12-19 in the per-protocol population (primary analysis) were 92.3% (215/233) in the cefpodoxime-proxetil group and 93.6% (204/218) in the amoxicillin-clavulanic acid group. The 95% confidence interval of [6.5%; 3.9%] demonstrated that cefpodoxime-proxetil was not inferior to amoxicillin-clavulanic acid. Cure rates at follow-up (day 25-30) were 90.6% and 92.7%, respectively. Results were similar in the intent-to-treat population. Compliance was significantly better in the cefpodoxime-proxetil group (99.2% versus 95.5%; p=0.011). Tolerance was also significantly better: 1.2% (3/247) of cefpodoxime-proxetil patients reported a treatment-related adverse event, compared with 10.7% (26/244) in the amoxicillin-clavulanic acid group (p<0.001). Most events were gastrointestinal and of mild to moderate intensity. CONCLUSION: In this study, a 5-day course of cefpodoxime-proxetil at 200 mg bid was as clinically effective as amoxicillin-clavulanic acid 1 g/125 mg bid for 8 days with a significantly better safety profile and compliance.

Acute Disease↗
PubMed2003

Variable absorption of clavulanic acid after an oral dose of 25 mg/kg of Clavubactin and Synulox in healthy dogs.

The aims of this investigation were to calculate the pharmacokinetic parameters and to identify parameters, based on individual plasma concentration-time curves of amoxicillin and clavulanic acid in dogs, that may govern the observed differences in absorption of both drugs. The evaluation was based on the data from plasma concentration-time curves obtained following a single dose in an open, randomized, two-way crossover study involving 24 male Beagle dogs treated with two Amoxi-Clav formulations (A Clavubactin and B Synulox, each with 200/50 mg). Plasma amoxicillin and clavulanic acid concentrations were determined using validated bioassay methods. The half-life of elimination of amoxicillin was 1.5 h (t1/2 = 1.52 +/- 0.19 h, Cmax = 11.4 +/- 2.74 microg/mL), and that of clavulanic acid 0.76 h (t1/2 = 0.71 +/- 0.23 h, Cmax = 2.06 +/- 1.05 microg/mL). There was a fivefold variation in the AUCt of clavulanic acid for both formulations, while the AUCt of amoxicillin varied by a factor of 2. The mean ratio of the AUCt amoxicillin : clavulanic acid was 12.7 +/- 3.65 for formulation A and 11.8 +/- 5.22 for formulation B (P = 0.51).

Administration, Oral↗
PubMed1978

Combined activitiy of clavulanic acid and ticarcillin against ticarcillin-resistant, gram-negative bacilli.

Fifty-one clinical isolates of ticarcillin-resistant, gram-negative bacilli were tested for susceptibility to combinations of ticarcillin and clavulanic acid (BRL 14151), a potent beta-lactamase inhibitor. Minimal inhibitory concentrations (MICs) were measured by a microdilution method, and minimal bactericidal concentrations for selected strains were measured by the broth dilution method. Ticarcillin MICs were >/=128 mug/ml for all and >/=512 mug/ml for 38 (75%) of the strains. Thirty-nine strains of Enterobacteriaceae tested included Escherichia coli (14), Klebsiella pneumoniae (16), Citrobacter sp. (3), Enterobacter sp. (3), Salmonella enteritidis (1), Serratia marcescens (1), and Proteus mirabilis (1). Ticarcillin MICs for 34 strains (88%) were lowered at least threefold by the addition of 1.0 mug of clavulanic acid per ml. Against 33 strains (85%), the MICs were 64 mug or less per ml in the presence of 5 mug of clavulanic acid per ml. In contrast, the MICs for seven of eight strains of Pseudomonas aeruginosa were unaffected by the addition of up to 10 mug of clavulanic acid per ml. Ticarcillin with 5 mug of clavulanic acid per ml was bactericidal against ticarcillin-resistant (MIC >/= 2,048 mug/ml) E. coli, K. pneumoniae, Enterobacter, and P. mirabilis.

Anti-Bacterial Agents↗
PubMedDate not supplied

Tissue and serum concentrations of amoxycillin and clavulanic acid in patients having reconstructive vascular surgery.

Fifteen patients received amoxycillin/clavulanic acid combination intravenously at anaesthetic induction as part of a three-dose schedule of antibiotic prophylaxis for vascular surgery. After 30 min, the mean serum concentration of amoxycillin was 39.9 mg/l and clavulanic acid was 9.3 mg/l. Mean amoxycillin tissue concentrations in fat, 5.1 mg/l; vein, 7.5 mg/l; and artery, 4.8 mg/l, were lower than serum values. Mean clavulanic acid concentrations were: fat, 0.7 mg/l; vein, 1.2 mg/l; and artery, 1.6 mg/l. At the end of surgery, the serum amoxycillin level was always greater than 6 mg/l and clavulanic acid greater than 2 mg/l, which were both still within the therapeutic range. Concentrations in fat had declined by the end of the surgery ranging from 0.76 to 5.2 mg/l for amoxycillin and from 0.03 to 0.6 mg/l for clavulanic acid, there being almost none detected in four cases. Serum and tissue concentrations of both compounds 30 min after injection were sufficient to inhibit the growth of 97% of pathogenic organisms recovered from the skin of 135 vascular surgical patients. In a few cases tissue levels of the compounds were below inhibitory concentrations for coliforms and anaerobes at the time of skin closure, although they were still effective against most Gram-positive organisms. Amoxycillin/clavulanic acid combination is suitable antibiotic prophylaxis for vascular surgery.

Adipose Tissue↗
PubMed1994

Increased beta-lactamase activity in Branhamella catarrhalis after exposure to amoxicillin and clavulanic acid.

Branhamella catarrhalis, previously regarded as a harmless member of the normal nasopharyngeal flora, has periodically been implicated as the major pathogen in representative cases of a variety of infections such as sinusitis, pneumonia, septicemia and meningitis. In addition, beta-lactamase production of these microorganisms, first described in 1977, has been reported with increasing frequency, up to 80%. The first-choice drug for the therapy of the infections caused by beta-lactamase producing strains of B. catarrhalis is amoxicillin combined with clavulanic acid. The aim of our work was to determine the influence of amoxicillin and clavulanic acid on the biosynthesis of beta-lactamase of B. catarrhalis. Our results point out that the combination of amoxicillin and clavulanic acid produces only a slight increase in enzyme activity in 5003 and 462 strains. Clavulanic acid alone caused no increase in enzyme production. Ravasio strain showed no increase in enzyme formation after exposure to antibiotics.

Amoxicillin↗
PubMed1988

Effect of clavulanic acid on the susceptibility of clinical anaerobic bacteria to ticarcillin: a multicenter study.

Over 2,000 recent clinical isolates of anaerobic bacteria were tested at five medical centers for susceptibility to ticarcillin, ticarcillin plus clavulanic acid, clindamycin, and metronidazole. At 64 micrograms/ml, ticarcillin inhibited 92% of all isolates, but 98% were inhibited at this concentration when 2 micrograms/ml of clavulanic acid was added. With different Bacteroides species, clavulanic acid reduced ticarcillin MICs 2- to 32-fold; other anaerobic species were not significantly affected.

Bacteria, Anaerobic↗
PubMed1991

Amoxicillin-clavulanic acid for treating drug-resistant Mycobacterium tuberculosis.

This report describes two patients with multidrug resistant tuberculosis who were successfully treated with the addition of amoxicillin-clavulanic acid to second-line drugs. Mycobacterium tuberculosis possesses a beta-lactamase contributing to its resistance to beta-lactam antibiotics. The combination of clavulanic acid, a beta-lactamase inhibitor, and amoxicillin has been shown bactericidal for M tuberculosis in vitro. These data suggest that resistant tuberculosis may warrant a trial of treatment including amoxicillin-clavulanic acid.

Adult↗
PubMed1988

Immunogenicity and allergenicity studies on two beta-lactam structures, a clavam, clavulanic acid, and a carbapenem: structure-activity relationships.

Two newer beta-lactam-containing structures, a clavam, clavulanic acid, and a carbapenem, MM22383, have been studied for their intrinsic immunogenicity and allergenicity. Clavulanic acid has a very low immunogenic and allergenic potential, in contrast to MM22383 which is a contact sensitiser in guinea pigs and an immunogen in rabbits. Evidence for the allergenic potential of MM22383 in man through occupational exposure is also presented. Consideration of the chemistry of these two compounds with respect to their reactivity with protein provides a rationale for the marked difference in their behaviour. The importance of stable hapten-protein conjugates and epitope density is discussed in relation to immunogenicity.

Adult↗
PubMed1982

Activities of amoxicillin and clavulanic acid combinations against urinary tract infections.

Urinary tract infection caused by beta-lactamase-producing bacteria were treated with 500 mg of amoxicillin three times daily plus either 250 or 125 mg of clavulanic acid three times daily. The overall cure rate was 63.6%, 77.7% with the high dose of clavulanic acid and 53.8% with the low dose. Gastrointestinal intolerance was common in the high-dose clavulanic acid regimen.

Administration, Oral↗
PubMedDate not supplied

[Amoxicillin-clavulanic acid and oral anticoagulants: a possible dangerous association].

We describe a 68-year-old male patient, treated with amoxicillin-clavulanic acid for 18 days and oral anticoagulants. He developed a cholestatic hepatitis with conjugated bilirubin of 11 mg/dL and a concomitant overdose of oral anticoagulants (INR 7). Nausea, vomiting, jaundice and large ecchymoses occurred 41 days after treatment with amoxicillin-clavulanic acid; the clinical manifestations resolved within 1 week and the liver tests returned to normal 48 days after therapy withdrawal. The mechanism of the amoxicillin-clavulanate-induced hepatitis is probably immunoallergic; this complication occurs mainly in subjects with a metabolic and/or immunologic idiosyncrasy. The pharmacokinetics of this antibiotic, which is not directly metabolized by cytochrome P450, may be affected by the concomitant use of drugs under cytochrome P450 control. When using amoxicillin-clavulanic acid, one should take into account its potential hepatic toxicity and possible interaction with oral anticoagulants. However, it appears to be crucial to follow the correct indications for both drugs. In fact, in the patient described above amoxicillin-clavulanic acid was wrongly administered as prophylaxis after a cutaneous biopsy of the nose. The same occurred with the oral anticoagulants prescribed to the patient for a single episode of paroxysmal atrial fibrillation which had occurred one year previously.

Administration, Oral↗
PubMedDate not supplied

Amoxycillin and clavulanic acid in the treatment of urinary tract infections in children.

The efficacy of amoxycillin-clavulanic acid combination in the treatment of urinary tract infections resistant, in vitro, to amoxycillin was studied in 42 children. Of the 24 children with urinary tract infection for the first time, combination therapy, dosing twice daily for 5 days (40 mg/kg.day), cleared the infection in 23 (96%) cases. Relapse occurred in four (17%) cases within 30 days. Of the 18 children who presented with recurrent urinary tract infections therapy, as above, cleared the infection in 16 (89%) cases. In these cases, long-term therapy was performed at a dosage of 20 mg/kg once daily. Tolerance was good; gastro-intestinal disorders in five (12%) cases which regressed by dosing at 8 h rather than 12 h intervals. In conclusion, amoxycillin-clavulanic acid can be considered a first choice treatment of urinary tract infections in children.

Amoxicillin↗
PubMed1983

Double-blind comparative study of two dosage regimens of cefaclor and amoxicillin-clavulanic acid in the outpatient treatment of soft tissue infections.

A total of 88 patients were enrolled in a double-blind comparison of cefaclor and amoxicillin-clavulanic acid for the outpatient treatment of soft tissue infections (abscesses, cellulitis, and impetigo). In 84 clinically evaluable patients, high cure rates were obtained for all treatment groups (64 to 85%). Patients who received amoxicillin-clavulanic acid had a much higher incidence of gastrointestinal side effects than did patients who received cefaclor (34 versus 3%, P less than 0.005). However, only five patients with gastrointestinal reactions to amoxicillin-clavulanic acid had symptoms severe enough to warrant halting the completion of antibiotic therapy.

Adult↗
PubMed1985

Ticarcillin plus clavulanic acid versus moxalactam in the treatment of skin and soft tissue infections.

A formulation of 3.0 g of ticarcillin and 0.1 g of clavulanic acid was evaluated in the treatment of skin and soft tissue infections, and its efficacy was compared with that of moxalactam in a randomized open study. Thirty-three patients received 3.1 g of ticarcillin plus clavulanic acid every six hours via intravenous infusion, and 36 patients received 2.0 g of moxalactam every eight hours via intravenous infusion. Diagnostic categories included intramuscular abscesses, cellulitis, skin ulcers, gangrene, and perirectal abscesses. The average age of the patients and the duration of therapy were similar in both groups. Overall, 45 aerobic and 25 anaerobic bacteria were isolated from the ticarcillin plus clavulanic acid-treated patients; 58 aerobic and 24 anaerobic bacteria were isolated from the moxalactam-treated patients. Thirty of 33 patients in the ticarcillin plus clavulanic acid-treated group had a satisfactory response; a skin rash developed in one patient; therapy failed in one patient with Staphylococcus aureus infection; and one patient died as a result of a bleeding peptic ulcer. In the moxalactam-treated group, 32 of 36 patients had a satisfactory response; a skin rash developed in one patient; therapy failed in a patient with Pseudomonas aeruginosa infection; and two patients were unevaluable. Ticarcillin plus clavulanic acid as a single agent was found to be as effective as moxalactam in the treatment of skin and soft tissue infections.

Adolescent↗