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PubMed1996

[Omeprazole, clarithromycin and amoxicillin therapy for Helicobacter pylori infection].

The aim of this study is to determine the eradication rate in Helicobacter pylori (Hp) infection using omeprazole 20 mg twice daily, clarithromycin 500 mg twice daily and amoxicillin 1,000 mg twice daily for one or two weeks, in comparison with colloidal bismuth subcitrate 240 mg twice daily, amoxicillin 1,000 mg twice daily and metronidazole 400 mg twice daily for two weeks. 141 patients with Hp associated chronic gastritis or duodenal ulcer were randomly divided into 3 groups. Group I (n = 48) treated with triple therapy of omeprazole, clarithromycin and amoxicillin for 1 week. Group II (n = 47) treated with the same drug and dosage for 2 weeks. Group III (n = 46) treated with triple therapy of colloidal bismuth subcitrate, amoxicillin and metronidazole for 2 weeks. The Hp status was determined by rapid urease test and histology of Warthin-Starry silver stain. The eradication rates of Group I, Group II and Group III were 89.6%, 95.7% and 71.7% respectively. The difference between Group I and Group III, or Group II and Group III was significant. The difference of eradication rate between Group I and Group II was statistically insignificant. The frequency of side effects in Group III was higher than that in Group I or Group II. Although 21.1% of the patients in Group I and II experienced a metallic taste, none discontinued the medication. Our results show that triple therapy with omeprazole, clarithromycin and amoxicillin is an effective and well tolerated treatment for eradication of Hp infection and may be an alternative regimen to the old standard triple therapy.

Adult↗
PubMed1998

Clarithromycin with minocycline and clofazimine for Mycobacterium avium intracellulare complex lung disease in patients without the acquired immune deficiency syndrome. GETIM. Groupe d'Etude et de Traitement des Infections à Mycobactéries.

SETTING: An open clinical trial for the treatment of Mycobacterium avium intracellulare complex (MAIC) lung disease in human immunodeficiency virus (HIV)-seronegative patients. OBJECTIVE: To assess the efficacy and tolerance of clarithromycin (0.75-2 g/day) combined with minocycline (200 mg/day) and clofazimine (100 mg/day) for 15 months. DESIGN: The study was carried out from August 1992 to June 1994 by pulmonologists of various French medical centres. The patients to be enrolled were of either sex, over 18 years of age, HIV-seronegative and suffering from MAIC lung disease, with a confirmed bacteriological and radiological diagnosis. Examinations were to be performed after 1, 2, 3, 6, 9, 12 and 15 months of treatment. RESULTS: Thirty patients were included, 16 males and 14 females. Eight did not complete the study due to deviations from protocol or adverse effects. The remainder completed the study with a post-treatment follow-up of 27 +/- 7 months. Among the 22 evaluable patients, 18 had a history of lung disease. Tolerance to the drugs was generally good, apart from three cases of hepatic disturbances and three cases of ototoxicity, which required a decrease in clarithromycin dosage after a short interruption of treatment. There were 14 treatment successes, seven treatment failures, defined by absence of bacteriologic conversion, and in one patient the disease evolution remains uncertain. CONCLUSION: The combination of clarithromycin with minocycline and clofazimine proved effective with persistently negative cultures in 64% of the patients, and an overall good drug tolerance.

Adult↗
PubMed1998

[Severe bronchorrhea accompanying alveolar cell carcinoma: treatment with clarithromycin and inhaled beclomethasone].

We report the efficacy of oral clarithromycin and inhaled beclomethasone against severe bronchorrhea in a patient with alveolar cell carcinoma. A 54-year-old man produced about 500 to 900 ml of clear and egg-white-like sputum each day. Anti-cancer chemotherapy and erythromycin therapy did not reduce the volume of sputum. After administration of clarithromycin and inhaled beclomethasone, sputum volume decreased to about 300 nl each day and the patient's ability to perform daily activities improved. Two months later, clarithromycin was stopped and the patient was treated with inhaled beclomethasone alone. Sputum volume did not increase for 6 months, although the chestroentgenographic findings gradually worsened. Then the sputum volume gradually increased. Five months after the sputum volume began to increase, he was producing about 2 liters of sputum each day and died of respiratory failure. Although the levels of CA 19-9, SLX, and CEA in serum were all within the normal range, the sputum contained high levels of CA 19-9 (1,133,620 U/ml), SLX (3,000 U/ml), and CEA (283 ng/ml). In patients with bronchorrhea, measurement of tumor markers in sputum may be useful for the diagnosis of alveolar cell carcinoma.

Adenocarcinoma, Bronchiolo-Alveolar↗
PubMed1998

[Treatment with omeprazole, clarithromycin and amoxicillin for one week. Their efficacy and tolerance in eradicating Helicobacter pylori in primary care].

OBJECTIVE: To study the effectiveness and tolerance of the combination of omeprazole, clarithromycin and amoxycillin taken for a week on the eradication of Helicobacter pylori (HP) in patients with peptic ulcer and symptomatic chronic gastritis. DESIGN: Intervention study. SETTING: Urban health centre. PATIENTS: 121 patients, diagnosed by fiber gastroscopy and with an HP infection demonstrated by the urease test, breath test, serology or biopsy, were studied prospectively. 13 suffered from a gastric ulcer, 54 from duodenal ulcer and 54 from chronic gastritis. Two patients stopped treatment because of side-effects, but were included in the study (analysis by treatment intention). INTERVENTIONS: The combination of omeprazole (20 mg/12 hours), amoxycillin (1 gr/12 hours) and clarithromycin (500 mg/12 hours) was administered for a week. No medication was prescribed afterwards. Therapeutic compliance (count of tablets and interview) and side-effects were systematically evaluated. Four to eight weeks later patients took a breath test with Urea C14 to confirm eradication. RESULTS: Average age was 47 (SD 14.5); 54% were women. Eradication was confirmed in 80.2% of cases (CI 95%; 73.1-87.3). Side-effects were light or moderate in all cases: the most common were dysgeusia (67%), nausea (18%) and diarrhoea (17%). CONCLUSIONS: The triple therapy of omeprazole, amoxycillin and clarithromycin for a week is efficacious in eradicating HP. It is extremely easy to apply, and there are few relevant side-effects.

Amoxicillin↗
PubMed1998

Quantitative determination of the macrolide antibiotics erythromycin, roxithromycin, azithromycin and clarithromycin in human serum by high-performance liquid chromatography using pre-column derivatization with 9-fluorenylmethyloxycarbonyl chloride and fluorescence detection.

A validated, highly sensitive and precise high-performance liquid chromatographic (HPLC) method for the determination of the macrolides erythromycin, azithromycin, clarithromycin and roxithromycin in human serum is described. A diethyl ether extract, obtained from serum using a saturated sodium carbonate solution, was treated with 9-fluorenylmethyl-oxycarbonyl chloride (FMOC-Cl) for 40 min at 40 degrees C and chromatographed on a base-deactivated octadecyl column, maintained at 50 degrees C during elution, using an eluent composed of acetonitrile-hydrogenphosphate buffer, pH 7.5, with 0.125% triethylamine (3:2, v/v). Fluorescence detection was used at an excitation wavelength of 255 nm and an emission wavelength of 315 nm. Erythromycin, clarithromycin, roxithromycin and azithromycin were found to have retention times of 8.8, 15.7, 17.1 and 20.7 min, respectively. Recoveries ranging from 93 to 104% were found with reproducibility coefficients of variation of 1.1-5%. Mean correlation coefficients of 0.9997, 0.9998, 0.9996 and 0.9994 were found for the linear calibration curves (n = 2) of erythromycin (0.320-16.1 mg/l), roxithromycin (3.24-19.4 mg/l), clarithromycin (0.190-19.4 mg/l) and azithromycin (0.0988-4.94 mg/l), respectively.

Anti-Bacterial Agents↗
PubMed2004

Comparative in vitro activities of linezolid, telithromycin, clarithromycin, levofloxacin, moxifloxacin, and four conventional antimycobacterial drugs against Mycobacterium kansasii.

Mycobacterium kansasii is one of the most pathogenic and frequent nontuberculous mycobacteria isolated from humans. Patients with adverse drug reactions, resistant isolates, or suboptimal response require alternative treatment regimens. One hundred forty-eight consecutive clinical isolates of M. kansasii were tested for antimicrobial susceptibilities by the BACTEC 460 system (NCCLS) with two different inoculation protocols, one conventional and one alternative. In the alternative protocol, the inoculum 12B vial was incubated until the growth index was between 250 and 500. Four conventional antimycobacterial drugs (isoniazid, rifampin, streptomycin, and ethambutol) were studied with standard critical concentrations. The in vitro activities of linezolid, telithromycin, clarithromycin, levofloxacin, and moxifloxacin were determined by measuring radiometric MICs. All isolates tested were identified as M. kansasii genotype I and were resistant to isoniazid at a concentration of 0.4 mug/ml. One hundred twenty isolates (81.1%) were inhibited by 1 microg of isoniazid per ml. A high level of resistance to isoniazid (>10 microg/ml) was observed in six isolates (4.1%). Only five strains (3.4%) were resistant to rifampin (>1 microg/ml). All isolates studied were susceptible to streptomycin and ethambutol. The MICs at which 90% of the isolates were inhibited (in micrograms per milliliter) were as follows: linezolid, 1 (range, < or =0.25 to 2); telithromycin, >16 (range, 4 to >16); clarithromycin, 0.5 (range, < or =0.03 to 1); levofloxacin, 0.12 (range, 0.12 to 0.25); and moxifloxacin, 0.06 (range, < or =0.06 to 0.12). The susceptibility testing results with both inoculation protocols showed perfect correlation. In conclusion, all M. kansasii isolates showed decreased susceptibility to isoniazid, but resistance to rifampin was infrequent. Quinolones, especially moxifloxacin, were the most active antimicrobial agents tested, followed by clarithromycin. Linezolid also showed good activity against these microorganisms, but telithromycin's in vitro activity was poor.

Anti-Bacterial Agents↗
PubMed2003

Average bioequivalence of generic clarithromycin tablets in healthy Thai male volunteers.

The objective of this study was to assess bioequivalence of 500-mg clarithromycin tablets in 24 healthy volunteers. In a randomized, single dose, fasting state, two-period, crossover study design with a 1-week washout period, each subject received a 500-mg clarithromycin tablet. Plasma samples were collected over a 24-h period after administration and were analyzed by using a validated method using high performance liquid chromatography (HPLC) with electrochemical detection. The time to reach the maximal concentration (t(max),h), the peak concentration (C(max),ng/ml) and the area under the curve (AUC(0- infinity),ng h/ml) of the Reference and Test formulations were 2.1+/-0.7 vs 2.1+/-0.7, 2474+/-702 vs 2559+/-744 and 15803+/-6120 vs 17683+/-6650, respectively. Relative bioavailability was 1.12. The 90% confidence interval (90% CI) of C(max) and AUC(0- infinity) were 95.6-110.8% and 3.5-122.0%, respectively. Bioequivalence between the test and reference preparation can be concluded.

Clarithromycin↗
PubMed2006

Application of liquid chromatography/ion trap mass spectrometry to the characterization of the related substances of clarithromycin.

A selective reversed-phase liquid chromatography/mass spectrometry (LC/MS(n)) method was developed for the characterization of components of the semi-synthetic macrolide clarithromycin. Mass spectral data were acquired online on a LCQ ion trap mass spectrometer equipped with an electrospray ionization source operated in the positive ion mode. One unknown compound was structurally elucidated and two other unknowns were characterized using the MS/MS and MS(n) collision-induced dissociation spectra of reference substances as interpretative templates, combined with knowledge of the nature of functional group fragmentation behaviour. Given the importance attached to the identification of impurities of unknown identity in pharmaceutical substances, this study is useful for companies producing clarithromycin.

Chromatography, Liquid↗
PubMed1996

Western blot monitoring of disseminated Nocardia nova infection treated with clarithromycin, imipenem, and surgical drainage.

A case of disseminated infection due to Nocardia nova with subcutaneous popliteal and retrosternal abscesses and lung involvement in an immunocompromised patient is reported. The patient did not respond to sulfonamide therapy. Clinical recovery was obtained upon treatment with imipenem then clarithromycin. Western blot studies revealed an antibody response to a known Nocardia-specific 55-kDa antigen in four successive sera samples collected in the period from the time of admission to seven months later. The resolution of the disseminated nocardiosis and efficacy of the clarithromycin treatment were assessed on the basis of disappearance of the antibodies to the 55-kDa antigen, without invasive sampling.

Anti-Bacterial Agents↗
PubMed1998

Susceptibility of European respiratory tract isolates to trovafloxacin, ciprofloxacin, clarithromycin, azithromycin and ampicillin.

As part of the Artemis project, 11500 isolates (3000 from patients with respiratory tract infections) were collected throughout six European countries between 1994 and 1996. Twenty-seven hospitals or laboratories participated in this first phase of the study. The activities of three classes of antimicrobial agents (fluoroquinolones, beta-lactam agents, macrolides) are presented for the six most frequently isolated pathogens (Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Klebsiella pneumoniae). Overall, trovafloxacin and ciprofloxacin activities were similar for Haemophilus influenzae, Moraxella catarrhalis and Klebsiella pneumoniae isolates. Of the Streptococcus pneumoniae isolates, 6% were resistant to penicillin. Trovafloxacin had the highest activity against the Streptococcus pneumoniae isolates, with a minimum inhibitory concentration of 0.25 mg/l for 90% of isolates (MIC90); all strains tested were susceptible to trovafloxacin. The MIC90 of ciprofloxacin for Streptococcus pneumoniae was 3 mg/l, and overall 52% of the strains were susceptible; 9% were resistant. Azithromycin and clarithromycin exhibited similar activity against all collected pathogens, except Haemophilus influenzae. All strains of Haemophilus influenzae were susceptible to azithromycin compared with 79% for clarithromycin, with respective MIC90s of 2 and 16 mg/l. The data presented demonstrate differences in the susceptibility patterns of six major respiratory tract pathogens in Europe.

Ampicillin↗
PubMedDate not supplied

Clarithromycin 250 mg b.i.d. for 5 or 10 days in the treatment of adult patients with purulent bronchitis.

This Phase III, double-blind, randomized, multicenter study compared the safety and efficacy of clarithromycin, 250 mg b.i.d. administered for either 5 or 10 days, in the treatment of 221 adult patients with purulent bronchitis. Clinical evaluations were performed pre-treatment, during treatment, post-treatment, and at a follow-up visit. Both regimens were well tolerated and effective. No significant differences were observed between patients treated for 5 days and those treated for 10 days in post-treatment, clinical success (98%, 83/85; 99%, 73/74, respectively), or bacterial eradication (100%, 37/37; 94%, 33/35) rates, or in the number of patients reporting drug-related adverse events (16%, 18/112; 24%, 26/109, respectively). Clarithromycin administered for 5 days was at least as safe and as effective as a 10-day regimen in the treatment of purulent bronchitis.

Adolescent↗
PubMed1990

Comparative in vitro activity of azithromycin, clarithromycin, erythromycin and lomefloxacin against Mycoplasma pneumoniae, Mycoplasma hominis and Ureaplasma urealyticum.

The in vitro activity of three macrolides, azithromycin, clarithromycin and erythromycin and a new fluoroquinolone, lomefloxacin, against pathogenic mycoplasma (16 to 18 strains of Mycoplasma pneumoniae, 41 to 77 strains of Mycoplasma hominis, 65 to 104 strains of Ureaplasma urealyticum) was compared. The three macrolides were highly active against Mycoplasma pneumoniae. Clarithromycin was the most active macrolide against Ureaplasma urealyticum whereas azithromycin was somewhat more active than erythromycin against Mycoplasma hominis. Lomefloxacin was moderately active against all three mycoplasma species.

4-Quinolones↗
PubMed1998

Azithromycin and clarithromycin inhibition of 50S ribosomal subunit formation in Staphylococcus aureus cells.

The ID50 values for azithromycin and clarithromycin inhibition of translation and of 50S assembly in Staphylococcus aureus cells have been measured. For clarithromycin, 50% inhibition of growth occurred at 0.075 microg/ml, and the effects on translation and 50S formation were equivalent at 0.15 microg/ml. The inhibition of these processes by azithromycin was less effective, with an ID50 of 2.5 microg/ml for growth and 5 microg/ml for inhibition of translation and 50S formation. The additive effects of each of these drugs on translation and 50S formation account quantitatively for their observed influence on cellular growth rates. In macrolide-treated cells, there was also a direct relationship between the loss of ribosomal RNA from the 50S subunit and its accumulation as oligoribonucleotides. These results are compared with the previously described effects of erythromycin on these same processes.

Anti-Bacterial Agents↗
PubMed2000

Clarithromycin and amoxicillin susceptibility of Helicobacter pylori strains isolated from adult patients with gastric or duodenal ulcer in Italy.

Helicobacter pylori strains, isolated from 100 gastric biopsies from 49 previously untreated adult patients with endoscopy and histology-confirmed gastric or duodenal ulcer, were tested for in vitro antimicrobial susceptibility. Strains were isolated from biopsies of 75.5% (37 of 49) patients before therapy and of 13.5% after therapy. Clarithromycin and amoxicillin susceptibility testing was performed on pretreatment and posttreatment strains by using the agar disk diffusion method and E-test, a quantitative technique for the minimal inhibitory concentration (MIC) determination. All strains (n = 53) were susceptible to amoxicillin by the two methods. Three strains of 34 (8.8%) patients were resistant to clarithromycin: two by both methods and one by E-test (MIC > 2 microg/ml). E-test, although more expensive than the disk diffusion method, is easy to perform and is a reliable method for testing H. pylori susceptibility to antimicrobial agents in the clinical microbiology laboratory.

Adolescent↗
PubMed2004

Efficacy of metronidazole for the treatment of clarithromycin-resistant Helicobacter pylori infection in a Japanese population.

BACKGROUND: Eradication of Helicobacter pylori has become a common treatment for several diseases. There is an increase in antibiotic-resistant strains, which causes the failure of eradication. The aim of this study was to investigate the usefulness of metronidazole for the treatment of H. pylori infection in patients who failed eradication therapy. METHODS: Seventy H. pylori-positive patients who had failed eradication treatment with first-line triple therapy, which consisted of a proton pump inhibitor, amoxicillin, and clarithromycin, were enrolled into the study. Before the second-line therapy, patients underwent endoscopy to obtain H. pylori strains to test susceptibility to antibiotics. Lansoprazole (30 mg b.d.), amoxicillin (750 mg b.d.), and metronidazole (250 mg b.d.) were administered for 1 week, and the result was tested by 13C-UBT. RESULTS: H. pylori was isolated from 62 patients, and 52 of them (83.9%) were clarithromycin resistant. There was no amoxicillin- or metronidazole-resistant strain. No major adverse effects were seen, and all the patients completed the 1-week regimen. The eradication rates of lansoprazole-amoxicillin-metronidazole were 96.2% (51/53; 95% CI, 87.0%-99.5%) using both intention-to-treat analysis and per protocol analysis. CONCLUSIONS: Lansoprazole-amoxicillin-metronidazole triple therapy is an effective and promising second-line H. pylori eradication therapy in a north Japanese population, which has a low frequency of metronidazole resistance.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed1998

Relevance of antibiotic sensitivities in predicting failure of omeprazole, clarithromycin, and tinidazole to eradicate Helicobacter pylori.

Omeprazole 20 mg once (o.d.) or twice daily (b.d.), clarithromycin 250 mg b.d., and tinidazole 500 mg b.d. for 7 days (OCT) is an effective regimen against Helicobacter pylori, but the effect of 5-nitroimidazole resistance is unclear. We aimed to evaluate this using the disc diffusion technique (Mast Diagnostics, Bootle, UK) and E-test (Cambridge Diagnostics Services, Cambridge, UK) to assess 5-nitroimidazole resistance. H. pylori was cultured from antral biopsies of infected patients, as determined by 13C-urea breath test (13C-UBT), histology, and/or rapid urease test. Patients were prescribed OCT and H. pylori eradication was assessed by 13C-UBT at least 4 weeks after completion of therapy. Antibiotic sensitivities to metronidazole and clarithromycin were evaluated by the disc diffusion method and by the measurement of minimum inhibitory concentration (MIC) using the E-test. One hundred and forty-one H. pylori-infected patients were enrolled in the study and the organism was successfully cultured from 119 patients (84%). The overall eradication rate was 125/141 (89%). OCT was successful in 62/69 (90%) patients harboring fully sensitive strains of H. pylori, compared with 42/45 (93%) of patients with strains that were resistant to metronidazole alone (P = 0.74, Fisher's exact test). MIC was assessed in 22 samples. Using a cut-off point of >32 microg/ml to define metronidazole resistance eradication rates were higher against sensitive (9/12; 75%) than resistant (3/10; 30%) strains (P = 0.08, Fisher's exact test). 5-Nitroimidazole resistance assessed by the disc diffusion technique is not helpful in predicting OCT failure, but the E-test may be of value.

Adult↗
PubMed2000

Impact of moxifloxacin versus clarithromycin on normal oropharyngeal microflora.

A multiple-dose, randomized, double-blind, controlled, cross-over trial was performed in 12 healthy male subjects in order to investigate the effect of a 7-day treatment with moxifloxacin (400 mg orally, once daily) versus clarithromycin (500 mg orally, twice daily) on the normal oropharyngeal microflora. Moxifloxacin caused significant reductions in levels of alpha-streptococci and Neisseria cocci during the treatment period, while the numbers of gram-negative anaerobic bacteria increased markedly during moxifloxacin administration. Clarithromycin administration caused a suppression of micrococci and corynebacteria, while no significant changes were recorded in the anaerobic microflora. No new colonizing moxifloxacin-resistant strains were isolated during the investigation period.

Adult↗
PubMed2002

Successful treatment with faropenem and clarithromycin of pulmonary Mycobacterium abscessus infection.

Mycobacterium abscessus accounts for 80% of rapidly growing mycobacterial pulmonary infections and can be lethal. Treatment is difficult because of the paucity of effective drugs. We describe a patient with pulmonary M. abscessus infection who was treated with a regimen that included faropenem, a novel oral penem, and clarithromycin. He showed favorable responses to the treatment for more than 12 months. In vitro, faropenem had considerable inhibitory activities against 56 strains of rapidly growing mycobacteria, including M. peregrinum, M. chelonae, M. fortuitum, and M. abscessus (stated in order of increasing minimal inhibitory concentrations). Thus, faropenem has the potential to be used as an adjunctive drug with clarithromycin for the treatment of infection with rapidly growing mycobacteria, including M. abscessus.

Anti-Bacterial Agents↗