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PubMedDate not supplied

An international clinical trial on the efficacy and safety of roxithromycin in 40,000 patients with acute community-acquired respiratory tract infections.

An ongoing eight-country study is being conducted in an unprecedented number of general practice patients with acute upper and lower respiratory tract infections to compare the efficacy and tolerance of roxithromycin 150 mg b.i.d. for 7-14 days with the data acquired in the prelaunch studies of these same parameters. The target population is 40,000 (to be achieved by the end of 1991) and we report the interim results from 32,405 patients, 18,020 with upper and 14,385 with lower respiratory tract infections. In acute pharyngitis/tonsillitis sinusitis, and otitis, clinical resolution or improvement has been achieved in 97%, 96%, and 96% of cases, respectively. The figures for bronchitis, exacerbation of chronic bronchitis, and pneumonia are 97%, 94%, and 95%. Side effects have been reported in only 4% of patients to date, 75% consisting of moderate gastrointestinal upsets. Of the patients, 1% withdrew from treatment because of side effects. These interim figures confirm the data from the prelaunch, controlled comparative trials and show roxithromycin to be an appropriate choice of first-line antibiotic therapy in the management of respiratory tract infections in general practice.

Acute Disease↗

PubMedDate not supplied

Comparison of two oral antibiotics, roxithromycin and amoxicillin plus clavulanic acid, in lower respiratory tract infections.

In a randomized, multicenter, open-label study, 490 ambulatory adult patients with lower respiratory tract infection (LRTI) were randomized to roxithromycin (ROX) 150 mg b.i.d. orally (n = 244) or amoxicillin plus clavulanic acid (AMX + CA) as 500 mg AMX + 125 mg CA t.i.d orally (n = 24). Clinical results were analyzed in 477 patients with acute bronchitis (79%), chronic bronchitis (CB) (14%), and pneumonia (7%). There were significantly more patients with underlying disease (cardiovascular diseases, p = 0.045; and alcoholism, (p less than 0.001), and more patients over the age of 65 years (p = 0.045) in the ROX group. Overall clinical efficacy was similar in both groups: 88% (206:235) in the ROX group and 85% (205:242) in the AMX + CA group. Side effects were reported in 67 cases (28%) in the AMX + CA group and in 21 cases (9%) in the ROX group (p less than 0.0001), causing withdrawal in 21 and three cases, respectively (p less than 0.001). Thus, despite being administered to a significantly older and more ill group of patients with LRTI, roxithromycin was as effective as amoxicillin plus clavulanic acid and better tolerated.

Acute Disease↗

PubMedDate not supplied

Clinical evaluation of roxithromycin 300 mg once daily as an alternative to 150 mg twice daily.

A multicenter, double-blind, randomized, two-arm study was conducted to compare two dosage regimens of roxithromycin--150 mg b.i.d. and 300 mg once daily--in 1588 patients with infectious disease, 1573 of whom were evaluable for safety and 1391 for efficacy. There were no significant differences in demographic or disease characteristics at presentation. Treatment duration averaged 10 days in both groups. Clinical response rates (% satisfactory response) were similar in both arms (b.i.d. versus once daily, respectively): upper respiratory tract, 95.3 and 95.0; lower respiratory tract, 93.1 and 93.6; and skin and soft tissue, 93.1 and 93.0. Bacteriologic response was also similar. The overall incidences of adverse events were 8.5% for daily dosing and 7.2% for b.i.d. dosing, but there was a slightly greater frequency of gastrointestinal events (p less than 0.03) was observed with the once-daily regimen. Thus roxithromycin 300 mg once daily can be recommended as an effective and well-tolerated alternative to the conventional b.i.d. regimen.

Adult↗

PubMedDate not supplied

Comparative efficacy and safety of roxithromycin and clarithromycin in upper respiratory tract infections.

Roxithromycin 300 mg once daily was compared with clarithromycin 250 mg b.i.d. in an open randomized trial in 200 patients with upper respiratory tract infection: sinusitis, pharyngotonsillitis, and otitis media. Average treatment duration was 9 days. Roxithromycin was more effective (p less than 0.01) particularly in otitis media and pharyngotonsillitis, and better tolerated (only 4% side effects, p less than 0.05).

Aged↗

PubMed2004

Simultaneous determination of roxithromycin and ambroxol hydrochloride in a new tablet formulation by liquid chromatography.

A rapid and accurate liquid chromatographic method is described for the simultaneous determination of roxithromycin and ambroxol hydrochloride in a new tablet formulation. Chromatographic separation of the two drugs was achieved on a Diamonsil C(18) column (200 mm x 4.6 mm, 5 microm). The mobile phase consisting of a mixture of acetonitrile, methanol and 0.5% ammonium acetate (39:11:50 (v/v), pH 5.5) was delivered at a flow rate of 1.0 ml/min. Detection was performed at 220 nm. Linearity, accuracy and precision were found to be acceptable over the concentration range of 201.2-2012.0 microg/ml for roxithromycin and 42.7-427.0 microg/ml for ambroxol hydrochloride, respectively. Separation was complete in less than 10 min. The proposed method can be used for the quality control of formulation products.

Ambroxol↗

PubMed1998

A comparative investigation of the restorative effects of roxithromycin on neutrophil activities.

The effects of roxithromycin, a macrolide antibiotic, on neutrophil activities were investigated in six seriously handicapped patients with severe mental retardation. Neutrophil activities were evaluated by flow cytometry using a heparinized blood analysis method. All six patients showed decreased levels of neutrophil phagocytosis, intracellular killing, and CD11b expression. Treatment with roxithromycin in vitro selectively restored the decreased phagocytic and bactericidal activities of neutrophils in these patients. There was no significant restorative effect with cefaclor, ofloxacin, or aztreonam. These results suggest the need to consider therapeutic effects of antibiotics on neutrophil functions in patients at increased risk for bacterial infections due to decreased neutrophil activities.

Adolescent↗

PubMed2001

Study on the electrochemical detection of the macrolide antibiotics clarithromycin and roxithromycin in reversed-phase high-performance liquid chromatography.

The optimal conditions of the amperometric detection of the macrolide antibiotics clarithromycin and roxithromycin were found by cyclic voltammetric studies and HPLC-electrochemical detection responses obtained in different temperatures (25.5-60 degrees C) and different but almost isoelutropic binary, ternary and quaternary mixtures of aqueous buffer (pH 7), methanol, acetonitrile and isopropanol. These conditions were also proved to be applicable for the quantitative detection of clarithromycin in human plasma using roxithromycin as an internal standard and vice versa. It was demonstrated that increased attention has to be paid to eluent composition and column temperature to ensure sensitive and reproducible electrochemical responses as well as regularly shaped peaks for both macrolides tested.

Anti-Bacterial Agents↗

PubMed2001

Postantibiotic effects and postantibiotic sub-MIC effects of erythromycin, roxithromycin, tilmicosin, and tylosin on Pasteurella multocida.

When intermittent dosing is used during treatment, the concentrations of antibiotics fluctuate and subinhibitory concentrations may occur between doses. Postantibiotic effects (PAEs) and postantibiotic subinhibitory effects (PA SMEs) on bacteria may provide additional, valuable information for the rational use of a drug in clinical practice. In this study tilmicosin was the most active antibiotic tested against P. multocida type D with MICs ranging from 4-16 mg/l. Roxithromycin and tilmicosin induced a statistically significantly longer PAE than did tylosin against P. multocida types A and D (P < 0.05). The duration of PAEs and PA SMEs were proportional to the concentrations of drugs used for exposure. The PA SMEs were substantially longer than PAEs on P. multocida. Tilmicosin had a longer PA SME compared with erythromycin, roxithromycin and tylosin for P. multocida. The computerized incubator used in the present study provided an efficient and convenient determination of PAE and PA SME, allowing frequent measurements of the bacterial growth.

Anti-Bacterial Agents↗

PubMed1993

In vitro activity of azithromycin against Chlamydia trachomatis, Ureaplasma urealyticum and Mycoplasma hominis in comparison with erythromycin, roxithromycin and minocycline.

The in vitro activity of azithromycin against 40 strains of Chlamydia trachomatis, Ureaplasma urealyticum and Mycoplasma hominis was investigated in comparison with erythromycin, roxithromycin and minocycline. All C. trachomatis strains were inhibited by azithromycin at a concentration < or = 0.5 microgram/ml. The initial minimum inhibitory concentration (MIC) of the drug for U. urealyticum was 4 microgram/ml, whereas some resistance against the drug was shown by M. hominis. Erythromycin and roxithromycin presented almost comparable activities, whereas minocycline was slightly more active than macrolides against C. trachomatis (MIC < or = 0.25) and more active against M. hominis (initial MIC < or = 1 micrograms/ml). Only 97% of U. urealyticum strains were susceptible to 8 micrograms/ml of minocycline.

Azithromycin↗

PubMed2002

Effects of erythromycin, clarithromycin, roxithromycin and azithromycin on murine gut colonization by Candida albicans.

Male Crl:CD1(ICR) BR mice were fed either chow containing Candida albicans or regular chow. The gastrointestinal tract of the C. albicans-fed mice was permanently colonized by the yeast. Groups of C. albicans-colonized mice were subsequently treated either with a macrolide (erythromycin, clarithromycin, roxithromycin or azithromycin) for 10 days or a normal saline solution (controls). Other controls included non-colonized mice receiving the same antibiotics or a saline solution. Our data are as follows: (i) C. albicans-colonized mice treated with each macrolide had highly significant increase in colony counts of C. albicans in their stools compared to C. albicans-colonized mice treated with saline only; (ii) discontinuation of macrolide treatment showed a trend towards lower colony counts, which was not statistically significant (colony counts were sustained even after discontinuation of antibiotic treatment); (iii) dissemination of C. albicans did not occur; (iv) mice fed regular chow treated with the study drugs or saline did not have any yeasts in their stools. In conclusion, oral erythromycin, clarithromycin, roxithromycin and azithromycin cause a modest increase of the C. albicans concentration of the gastrointestinal tract. This increase is not associated with a higher risk of disseminated candidiasis.

Animals↗

PubMed1990

The penetration of roxithromycin into human skin.

The skin penetration of roxithromycin was studied in 27 surgical patients treated with 300 mg orally followed by three oral doses of 150 mg 12-hourly. Peak plasma and skin concentrations of 7.9 +/- 1.2 mg/l and 31.3 +/- 3.7 mg/kg occurred 2.5 and 4 h after last dosing respectively. The plasma and skin half-lives were 7.7 and 6.0 h, and the mean plasma and skin area under the curve values were 64.3 mg/l.h and 155.3 mg/kg.h. Skin/plasma concentration ratios were 4.9 +/- 0.5, 9.7 +/- 1.2, 7.6 +/- 0.8 and 5.9 +/- 1.1, at 3, 4, 5 and 6 h after last dosing respectively. These results demonstrate that roxithromycin achieves high levels in human skin.

Female↗

PubMed1993

Comparison of azithromycin, roxithromycin, and cephalexin penetration kinetics in early and mature abscesses.

During the process of abscess formation, a myriad of changes are observed histologically that impede the penetration of antimicrobial agents into infection loci. A Staphylococcus aureus foreign body abscess, developed in rats, was employed to evaluate the penetration kinetics of azithromycin, roxithromycin and cephalexin at various stages of abscess development; the progressive patho-histological changes of abscess formation were also characterized in this model. In an early abscess (18 h post-challenge), azithromycin penetration into inflammatory fluid was enhanced (AUC of 351 vs 130 mg.h/kg) and residence prolonged relative to an inflammation control (half-life of 88 vs 27 h). In contrast, roxithromycin and cephalexin penetration into, and residence in, inflammatory fluid were unaltered in the early abscess. However, penetration into, and egress from, a mature abscess (ten days post-challenge) were impeded for all three antimicrobials (P < or = 0.03). The penetration kinetics of azithromycin into inflammatory fluid in an early abscess were independent of the dose regimen, but dependent on the total dose. The persistently high concentrations of azithromycin in inflammatory fluid within abscess were associated with the infiltration of phagocytic cells and encapsulation by fibrous tissue. These data are consistent with a phagocytic delivery mechanism for azithromycin, whereby the presence of high concentrations of azithromycin in inflammatory fluid are a consequence of augmented drug distribution via the release of accumulated intracellular drug from the infiltrating phagocytic cells and fibroblasts associated with abscess formation.

Abscess↗

PubMed1998

Activity of azithromycin, clarithromycin, roxithromycin, dirithromycin, quinupristin/dalfopristin and erythromycin against Legionella species by intracellular susceptibility testing in HL-60 cells.

We evaluated a human monocyte cell line (HL-60) as a model for testing the intracellular activity of anti-Legionella antibiotics; 1.5 x 10(6) HL-60 cells/well were differentiated into adherent cells and infected with 1.5 x 10(7) cfu of Legionella pneumophila. The most active agents against L. pneumophila as judged by broth dilution MICs were (in order of activity) azithromycin, clarithromycin, roxithromycin, quinupristin/dalfopristin, erythromycin and dirithromycin. The most active inhibitors of L. pneumophila intracellular multiplication were (in order of activity) azithromycin, erythromycin, quinupristin/dalfopristin, roxithromycin, dirithromycin and clarithromycin. All the agents were highly active against Legionella micdadei and Legionella bozemanii when compared with L. pneumophila.

Anti-Bacterial Agents↗

PubMed1998

AIDS-related cryptosporidial diarrhoea: an open study with roxithromycin.

In immunocompromised patients, cryptosporidial diarrhoea is a debilitating and potentially life-threatening infection for which no effective specific therapy exists. In an uncontrolled study of 24 AIDS patients with diarrhoea exclusively due to Cryptosporidium spp., treatment with roxithromycin, 300 mg bd for 4 weeks, produced symptomatic improvement of diarrhoea in 79% of cases, with 50% of patients achieving complete response. The response rate was 100% in a subgroup of five patients with no previous or concomitant opportunistic infections. In complete responders, improvement was rapid, occurring within 3-5 days, and the duration of response was at least 6 months. Response did not appear to be correlated with the degree of immunodeficiency. The most limiting adverse effects were abdominal pain (two patients), elevated hepatic enzymes (two patients) and abdominal pain with elevated hepatic enzymes (one patient). Minor symptoms, such as gastrointestinal upset, occurred in nine patients. We conclude that roxithromycin is relatively well tolerated and effective against cryptosporidial diarrhoea in AIDS patients. Further studies to optimize dosing regimens are required.

AIDS-Related Opportunistic Infections↗

PubMed1993

Treatment of concomitant eye and genital chlamydial infection with erythromycin and roxithromycin.

A single blind study of 10 days' randomly allocated treatment with erythromycin (1000 mg/day) and roxithromycin (300 mg/day) in 14 (group A) and 13 (group B) adults, respectively, all with culture-proven chlamydial conjunctivitis was performed. For comparison, 14 days' treatment with 1 g erythromycin daily given to 35 adults (Group C) with chlamydial conjunctivitis was also evaluated. Follow-up was made approximately one month after start of therapy. Only 2 of the 37 men and 1 of the 25 women studied, all of whom had signs of conjunctivitis, had noticed concomitant symptoms of infection from the genital tract. Nasopharyngeal cultures were chlamydia-positive in 7 (50%), 7 (54%) and 20 (57%) of the patients in Group A, B and C, respectively, while for genital cultures the corresponding figures were 9 (64%), 8 (62%) and 23 (66%), respectively. The course with erythromycin in group C cured the conjunctivitis in 34 (97%) of the patients both clinically and microbiologically. Ten days' treatment with the same dose (Group A) did not eradicate chlamydiae from the eye in one, from the nasopharynx in 5 and from the genital tract in still another patient. The roxithromycin treatment (Group B) resulted in negative chlamydial cultures from the eyes in all 13 cases, while the nasopharyngeal and genital cultures were still positive in one patient each. The study showed that in spite of the eye being cured by macrolide therapy, other sites like the nasopharynx and the genital tract may still be colonized, why sampling for C. trachomatis from these sites should be made in tests for cure in chlamydial conjunctivitis cases.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

PubMed1994

Effect of CO2 on susceptibilities of anaerobes to erythromycin, azithromycin, clarithromycin, and roxithromycin.

The Oxyrase agar dilution method (Oxyrase, Inc., Mansfield, Ohio), which provides an anaerobic environment without added CO2, was compared with the reference agar dilution method recommended by the National Committee for Clinical Laboratory Standards (anaerobic chamber with 10% CO2) to test the susceptibilities of 302 gram-negative and gram-positive anaerobes to erythromycin, azithromycin, clarithromycin, and roxithromycin. For erythromycin, the overall MIC for 50% of isolates tested (MIC50) was 0.5 micrograms/ml and the MIC90 was 8.0 micrograms/ml by the Oxyrase method, whereas they were 4.0 and 64.0 micrograms/ml, respectively, under standard anaerobic conditions with CO2. At a breakpoint of 4.0 micrograms/ml, 88% of strains were susceptible to erythromycin by the Oxyrase method, whereas 63% were susceptible in the chamber. The corresponding MIC50s and MIC90s of azithromycin, clarithromycin, and roxithromycin by the Oxyrase method were 0.5 and 8.0, 0.25 and 4.0, and 0.5 and 16.0 micrograms/ml, respectively, whereas in the chamber they were 4.0 and > 64.0, 2.0 and 64.0, and 2.0 and 64.0 micrograms/ml, respectively. At a breakpoint of 8.0 micrograms/ml for these three drugs, 89, 92, and 85% of the isolates, respectively, were susceptible by the Oxyrase method, whereas 67%, 72, and 68% of the isolates, respectively, were susceptible in the chamber. Most strains resistant to all four compounds by both methods were Bacteroides distasonis, Fusobacterium mortiferum, Fusobacterium varium and non-Clostridium perfringens Clostridium species. Results of the study may lead to a reappraisal of the role played by macrolides and azalides in the treatment of anaerobic infections.

Azithromycin↗

PubMed1995

Postantibiotic effects and postantibiotic sub-MIC effects of roxithromycin, clarithromycin, and azithromycin on respiratory tract pathogens.

Pharmacodynamic parameters have become increasingly important for the determination of the optimal dosing schedules of antibiotics. In this study, the postantibiotic effects (PAEs), the postantibiotic sub-MIC effects (PA SMEs), and the sub-MIC effects (SMEs) of roxithromycin, clarithromycin, and azithromycin on reference strains of Streptococcus pyogenes group A, Streptococcus pneumoniae, and Haemophilus influenzae were investigated. The PAE was induced by 2x MICs (S. pneumoniae) or 10x MICs of the different drugs for 2 h, and the antibiotics were eliminated by washing and dilution. The PA SMEs were studied by addition of 0.1, 0.2, and 0.3x MICs during the postantibiotic phase of the bacteria, and the SMEs were studied by exposition of the bacteria to the drugs at the sub-MICs only. Growth curves were followed by viable counts for 24 h. The SMEs were generally very short. A PAE of 2.9 to 8 h was noted for all antibiotics against all strains. Clarithromycin induced a statistically significantly shorter PAE on S. pneumoniae than did roxithromycin and azithromycin and did so also against H. influenzae in comparison with azithromycin. The PA SMEs were long and varied at 0.3x MIC between 6.4 19.6 h. This pronounced suppression of regrowth of bacteria which are first treated with a suprainhibitory concentration of antibiotics and then reexposed to sub-MIC levels indicates that long dosing intervals for macrolides and azalides can be allowed.

Azithromycin↗

PubMed2002

Effect of telithromycin (HMR 3647) on polymorphonuclear neutrophil killing of Staphylococcus aureus in comparison with roxithromycin.

HMR 3647 (telithromycin), a new ketolide, is active on intracellular pathogens. It was previously demonstrated that it inhibits superoxide anion production in a time- and concentration-dependent manner, at concentrations which inhibit 50% of the control response of about 55 microg/ml (5 min) to 30 microg/ml (30 min); these values are similar to those obtained with roxithromycin, a classical erythromycin A derivative. Here we investigated whether these drugs modified the bactericidal activity of human polymorphonuclear neutrophils (PMN) on four strains of Staphylococcus aureus with different profiles of susceptibility to macrolides and ketolides. We found that the main factor involved in killing was the antibacterial potency of the drugs, although combinations of antibiotics with PMN were slightly more active than each component used alone against two of the four strains. In addition, high concentrations of the drugs, which impaired the PMN oxidative burst, did not impair PMN bactericidal activity. Likewise, some cytokines which enhance PMN oxidative metabolism did not modify PMN bactericidal activity in the presence or absence of macrolides or ketolides. These data suggest that oxygen-independent mechanisms contribute to the bactericidal activity of PMN on these strains of S. aureus. Both live and/or heat-killed bacteria impaired the uptake of telithromycin and roxithromycin (but not that of levofloxacin, a quinolone) in a concentration-dependent manner, owing to a modulation of PMN transductional systems involved in the activation of the macrolide carrier.

Anti-Bacterial Agents↗