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PubMed1997

[Efficacy and tolerability of pristinamycin vs amoxicillin-clavulanic acid combination in the treatment of acute community-acquired pneumonia in hospitalized adults].

The aim of this double-blind, 2 parallel group, randomized, multicenter study was to compare the efficacy and the safety of pristinamycin (P), 1 g bid, versus amoxicillin-clavulanic acid (AAC), 500 mg q.i.d., for 10-14 days in the treatment of non severe community-acquired pneumonia in hospitalized adults. From December 1992 to July 1994, 180 patients were included: 92 in the group P and 88 in the group AAC. The both groups were similar on demographic, clinical and bacteriological criteria. 96 pathogens of which more than half were pneumococci, were isolated in 79/180 (44%) patients. The primary assessment was the global success rate defined as long-term (D40 +/- 7), clinical, radiological and bacteriological efficacy in the "per protocol" population (75 patients in the group P and 83 in the group AAC). The global success was obtained in 63/75 (84%) patients in the group P and 70/83 (84.3%) patients in the group AAC. At the end of treatment (D14 +/- 3), theses rates were respectively 85.4% and 84.3%. The both treatments were equivalents. Adverse events (mainly gastro-intestinal disorders) were reported by 55/92 (59.8%) patients in the group P and 49/87 (56.2%) patients in the group AAC.

Adult↗
PubMed1997

A short (3-day) course of azithromycin tablets versus a 10-day course of amoxycillin-clavulanic acid (co-amoxiclav) in the treatment of adults with lower respiratory tract infections and effects on long-term outcome.

The efficacy and safety of a 3-day regimen of azithromycin prescribed in the new tablet form and of a 10-day regimen of amoxycillin clavulanic acid (co-amoxiclav, Augmentin) were compared in patients with acute lower respiratory tract infections. Of the 144 enrolled patients, 123 had a Type 1 acute exacerbation of chronic bronchitis (AECB), three patients had pneumonia, and 18 had purulent bronchitis. Treatment was successful, defined as cure or major improvement on day 14, in 59/62 (95%) patients in the azithromycin treatment group compared with 54/61 (90%) patients in the co-amoxiclav. At 30 days, the incidence of success was 77% (48/62) in the azithromycin treated group, compared with 66% (40/61) of co-amoxiclav-treated patients. At 60 days, incidences were 66% (41/62) and 59% (36/61), respectively. Several pathogens were isolated: Haemophilus influenzae in 21 patients (minimum inhibitory concentration (MIC) range for azithromycin 0.12-4 mg/l; co-amoxiclav 0.25-4 mg/l); Streptococcus pneumoniae in nine (MIC azithromycin < or = 0.06 > or = 256 mg/l; co-amoxiclav < or = 0.06-1 mg/l); and Moraxella catarrhalis in 11 (MIC azithromycin < or =0.06-2 mg/l; co-amoxiclav < or = 0.06-0.5 mg/l). Microbiological response rates were comparable. A significant correlation between clinical and microbiological cure was found (p = 0.02, power 0.6). In 15 (10%) patients, positive serology for viruses or atypical pathogens was found. In the co-amoxiclav-treatment group, 24 patients had mild adverse events (12 diarrhoea), compared with 27 treated with azithromycin (p = 0.47). It is concluded that a 3-day regimen of azithromycin prescribed as tablets is as clinically and microbiologically effective as a 10-day regimen of co-amoxiclav in the treatment of acute lower respiratory tract infections. Moreover, since the percentage of viral infections was low and a significant correlation between microbiological and clinical cure was found, this study shows that clinical symptoms can be used to establish which patients with AECB (Type 1) should be treated with antimicrobial agents.

Adult↗
PubMed1998

Treatment of children with secretory otitis media (SOM) with amoxicillin and clavulanic acid (Spektramox) or penicillin-V (Primcillin). Bacteriological findings in the nasopharynx before and after treatment.

A total of 386 children, aged 1-10, with secretory otitis media for at least 3 months were randomly allocated to 2 or 4 weeks' treatment with penicillin-V (Primcillin) or amoxicillin + clavulanic acid (Spektramox). Spektramox was superior (p < 0.01) to Primcillin in eradicating Haemophilus influenzae and Branhamella catarrhalis from the nasopharynx. No difference was noted for Streptococcus pneumoniae and haemolytic streptococci, gr. A, B, C, G. No increase in the number of beta-lactamase-producing bacteria was noted after treatment. The nasopharynx was recolonized with the same bacteria within 4 weeks from cessation of treatment.

Amoxicillin-Potassium Clavulanate Combination↗
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↗
PubMed2003

[Analysis of amoxicillin-clavulanic acid (Xiclav) efficacy and the possibility of early switch from parenteral to oral therapy in the treatment of infections].

Early transition from parenteral to oral antibiotic therapy switch therapy play a major role in treatment because of adverse reactions of long parenteral therapy. In the prospective, comparative and randomized clinical study the efficacy of two treatment regimens were analyzed: XICLAV (amoxicillin + clavulanic acid): parenteral regiment with early transition to oral therapy and parenteral regimen in patients with bacterial infections without transition to the oral dosage form, on the other hand. In our study we've analyzed 240 hospitalized patients in the Clinic of infectious Diseases in Tuzla and Sarajevo too, so in the Institution for infectious diseases in Zenica. The mean age of our patients was 39.6 years, 70.8% females. The major (50.5%) patients had urinary or respiratory tract infectious (bacterial pneumonia 38.8%) but several patients have had skin infections and sepsis. The first 120 patients were initially treated by Xiclav administered parenterally i.v. (adults at a dose of 3 x 1.2 gr i.v.; the children at a dose of 3 x 30 mg/kg) with early oral switch therapy (adults at a dose of 3 x 625 mg per os; the children at a dose of 3 x 25-50 mg/kg); whereas the others (120 patients) were treated parenterally by the regimen mentioned above. The mean length of i.v. therapy and hospitalization in the i.v. group was 4.12/10.21 days respectively (p > 0.05). The clinical efficacy switch of both therapeutic regimens was comparable. The resolution of all clinical symptoms and laboratory signs of infections was noted at 69% patients of both groups, with significant improvements at noted at 69% patients of both groups, with significant improvements at 21% patients and at 10% patients showed clinical failure. The tolerability of Xiclav was very good. The adverse reactions during treatment were observed at 5.2% patients. This study noticed satisfied clinical and bacterial efficacy so did tolerability of Xiclav in the treatment of bacteriological infections. Xiclav apply early transition from parenteral to oral therapy.

Administration, Oral↗
PubMed2001

Early bactericidal activity of amoxicillin in combination with clavulanic acid in patients with sputum smear-positive pulmonary tuberculosis.

The early bactericidal activity (EBA) of an antituberculosis agent is the rate of decrease in viable colony-forming units (CFU) per milliliter of sputum during the first 2 d of treatment of patients with previously untreated smear-positive pulmonary tuberculosis. The objective of this open randomized study was to evaluate the EBA of the combination of amoxicillin 3 g and clavulanic acid 750 mg. Ten patients with a mean age of 34 y and a mean weight of 56 kg received amoxicillin/clavulanic acid and 5 patients with a mean age of 34 y and a mean weight of 57 kg received no drug. In the patients receiving 1 dose of amoxicillin/clavulanic acid daily for 2 d the mean log10CFU/ml of sputum before treatment was 6.7402 (SD 0.539) and after 2 d of treatment 6.7046 (SD 0.609); the corresponding values in patients receiving no drug were 6.7823 (SD 0.563) and 6.7502 (SD 0.673), respectively. The EBA of 0.018 (SD 0.130) in patients receiving amoxicillin/clavulanic acid did not differ significantly from that of 0.016 (SD 0.069) in patients receiving no drug. It is unlikely that the combination of amoxicillin/clavulanic acid has an important place in the treatment of tuberculosis with the exception of those patients with multidrug-resistant tuberculosis who are otherwise therapeutically destitute.

Adult↗
PubMed1983

[Biological effects of coordination compounds of transitional metals. The beta-lactamase inhibitory effect of cis-platin, 2-aminopyridine palladium chloride, clavulanic acid and penicillanic acid sulfonate CP 45,899 in the nitrocefin test and Titertek/microtiter automatic system].

The beta-lactamase-inhibiting activity of 6m-ethyl-pyrid-2-yl-ammine palladium-dichloride (Pd 25681) and cis-dichloro-diammine-platinum(II) was studied and compared with the enzyme inhibitory action of potassium clavulanate and the penicillanic acid sulfone CP 45899. Using the nitrocefin test method and the Titertek/Microtiter equipment CP 45899 and potassium clavulanate were the strongest inhibitors of the Bacillus cereus beta-lactamase. Cis-dichloro-diammine-platinum(II) was fourfold less active than the palladium complex PD 25681 in äquimolar concentration. The following ID50 values were found: CP 45899: 0.0281 microgram; K-clavulanate: 0.1274 microgram; Pd 25681: 3.8603 microgram; cis-dichlorodiammine-platinum(II): 12.5120 microgram/100 microliter.

Antineoplastic Agents↗
PubMed1990

Effect of low concentrations of clavulanic acid on the in-vitro activity of amoxycillin against beta-lactamase-producing Branhamella catarrhalis and Haemophilus influenzae.

Concentrations of amoxycillin/clavulanic acid achievable in the respiratory tract following oral dosage were assessed for in-vitro activity against beta-lactamase-producing strains of Branhamella catarrhalis and Haemophilus influenzae. In agar-dilution studies, 8 mg amoxycillin/l was required to inhibit 45 strains of beta-lactamase-producing B. catarrhalis, whereas all the strains were inhibited by 0.5 mg amoxycillin/l in the presence of 0.01 mg clavulanic acid/l. Similarly, 0.1 mg amoxycillin plus 0.05 mg clavulanic acid/l were bactericidal against beta-lactamase-producing strain of B. catarrhalis and prevented regrowth within 24 h. In tests against 43 beta-lactamase-producing strains of H. influenzae, concentrations of up to 128 mg amoxycillin/l were required for inhibition, whereas 32 strains (75%) were fully sensitive to amoxycillin (MIC 0.5 mg/l) in the presence of 0.12 mg clavulanic acid/l. These concentrations of amoxycillin/clavulanic acid were also bactericidal for a beta-lactamase-producing strain of H. influenzae. The study therefore showed that amoxycillin/clavulanic acid, at concentrations similar to those likely to be achieved in the respiratory tract following oral dosage, was bactericidal in vitro for beta-lactamase-producing isolates of B.catarrhalis and H. influenzae.

Amoxicillin↗
PubMed1989

[Frequency of germ isolation from urinary infections in community practice; their sensitivity to 7 antibiotics including a combination of amoxicillin and clavulanic acid. Evaluation on 1611 samples].

A multicenter study including 10 outpatient private laboratories (hospital laboratories excluded) was carried out in France. 1,611 urines samples from patients with UTI were collected during the forth trimester of 1987. The most frequently recovered pathogens were: E. coli (71%), Proteus mirabilis (9%), Staphylococcus coagulase (6%), Klebsiella (6%), Enterobacter (2%). Other sorts (Streptococcus D, Proteus sp, Pseudomonas aeruginosa, Enterobacter sp) were infrequent (less than 1%). The sensitivity of the aerobic Gram-negative bacteria to ampicillin, clavulanic acid-amoxicillin, cephalothin, gentamicin, pipemidic acid, norfloxacin and co-trimoxazole was tested.

Adult↗