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PubMed2004

[Follow up of 16 cases with congenital toxoplasmosis treated with azithromycin].

OBJECTIVE: To study the therapeutic effects of azithromycin in treatment of congenital toxoplasmosis in children. METHODS: Definite diagnosis of congenital toxoplasmosis was made on the basis of clinical manifestation combined with one or more positive results of the following laboratory tests and excluded other congenital infectious diseases: toxoplasma DNA (TOX-DNA), circulating toxoplasma antigen (TOX-CAG), and toxoplasma IgM antibody (TOX-IgM). All the patients were given oral azithromycin 10 mg/(kg.d) for 6 days followed by 8 days without medication (one course of treatment), and the regimen was persisted for 2 months and then another 2-month treatment was given at a 1-month interval. The authors continued to provide further treatment according to the state of the illness at one month interval. The patients received 2 to 8 (average 5) courses of treatment. The patients were followed-up for 2.5 to 5 (average 4) years. RESULTS: The treatment was effective in all the patients and the patient's condition was improved. The authors repeated in 12 cases the four tests for toxoplasma (TOX-DNA, TOX-CAG, TOX-IgM, and TOX-IgG) 9 months to one and a half years after treatment. In 10 cases all these tests showed negative results, in 2 cases TOX-IgG was positive and in the other 4 cases symptoms disappeared. CONCLUSION: The results of the study showed that oral azithromycin had significant therapeutic effects with little side effect and was well tolerated. Azithromycin may become an alternative therapy in treatment of congenital Toxoplasma gondii infection in children.

Anti-Bacterial Agents↗
PubMed2004

[Evaluation of clinical effectiveness and direct costs of azithromycin treatment for exacerbation of chronic obstructive pulmonary disease in hospitalized patients and ambulatory care].

This paper presents the efficacy and cost of therapy with azithromycin for the treatment of patients with acute exacerbation of chronic obstructive pulmonary disease (COPD). Two subgroups were investigated: out-patients and hospitalized patients--20 in each group (17 women and 23 men). Azithromycin 500 mg was administered sequentially once daily. A complete physical examination including temperature, respiratory rate, cough, production and characteristics of sputum so as general aspects of quality of life assessed by COPD exacerbation questionnaire was made in hospitalized patients on a daily base and in a day 10-14 after the end of therapy. Out-patients were assessed in day 1, 3-5 days after the start of study drug treatment and 10-14 days after the end of therapy. Pulmonary function tests were assessed three times during the whole study course. The results of the study suggest similar duration of therapy with azithromycin in both study subgroups, whereas in out-patients decrease and regression of symptoms were statistically significantly quicker with tendency approximately the same in both study subgroups. The cost of therapy with azithromycin was similar in both subgroups but the complete cost of COPD exacerbation treatment was significantly lower in out-patients in comparison to hospitalized patients group (473.71 PLN and 2587.87 respectively).

Aged↗
PubMed1995

The newer macrolides. Azithromycin and clarithromycin.

Azithromycin and clarithromycin are structural analogues of erythromycin that have similar mechanisms of action. The newer macrolides have several distinct advantages over erythromycin, including improved oral bioavailability; longer half-life, allowing once or twice daily administration; higher tissue concentrations; and fewer gastrointestinal adverse effects. Clarithromycin and azithromycin also have enhanced antimicrobial activity. The clinical efficacy of the newer macrolides has been similar to erythromycin for the treatment of upper and lower respiratory tract and skin and soft tissue infections. New therapeutic roles include the use of azithromycin for C. trachomatis infections and the inclusion of clarithromycin or azithromycin as part of therapeutic regimens for disseminated MAC infections in HIV-infected patients. Further clinical trials are needed to determine the optimal roles for and uses of these new macrolides.

Anti-Bacterial Agents↗
PubMed1995

[Comparative activity of azithromycin against 100 strains of Neisseria gonorrhoeae].

Azithromycin is a new semisynthetic, acid stable C15 macrolid. In our study, we compared in vitro activity of azithromycin with 6 other antibiotics usually recommended for treatment of N. gonorrhoeae infections: erythromycin, ampicillin, amoxicillin, ceftriaxone, spectinomycin, ciprofloxacin. 100 strains have been selected: 95 clinical strains with different resistance patterns: 60 susceptible to beta-lactams, 25 PPNG, 10 chromosomal decreased susceptibility to beta-lactams. Among these strains, 13 had a decreased susceptibility to erythromycin (MIC: 2 and 4 mg/l) and 5 WHO reference strains: A: spectinomycin resistance, B: wild phenotype, C: chromosomal decreased susceptibility to penicillin and tetracycline, D: chromosomal resistance to penicillin and erythromycin+chromosomal decreased susceptibility to chloramphenicol, E: beta-lactamase producing strain (PPNG) and decreased susceptibility to tetracycline. MICs have been determined by GC agar dilution method. Azithromycin is more active than erythromycin on all N. gonorrhoeae patterns with a two log 10 difference for MIC50 and MIC90 (p < 0.0001). Because of pharmacokinetic properties and activity against Chlamydia trachomatis and urogenital mycoplasms often associated with N. gonorrhoeae, azithromycin is a good alternative for the treatment of genital infections.

Anti-Bacterial Agents↗
PubMed1994

Comparison of the effects of midecamycin acetate and azithromycin on gastrointestinal motility in man.

The gastrointestinal motor effects of the macrolide antibiotic, azithromycin, were compared with those of midecamycin acetate. The method of investigation consisted of intraluminal pressure measurements in the gastric antrum and upper small intestine by means of a low compliance perfused catheter system. Eleven healthy volunteers participated in the single blind, placebo-controlled study of both interdigestive and postprandial gastrointestinal motility. Azithromycin was administered by mouth in a single 500 mg dose or in two daily doses of 250 mg; midecamycin acetate was given in a dose of 600 mg b.i.d. The effect of midecamycin acetate on gastric antral and jejunal motility was not significantly different from that of placebo. This was true for both the interdigestive and the postprandial phases of gastrointestinal motility. Peroral treatment with azithromycin resulted in a statistically significant increase in the postprandial antral motility index as compared to placebo. This increase was observed in the distal antrum as well as in the proximal antrum. In addition, the gastric contractions were found to originate higher up in the stomach after azithromycin as compared to placebo or midecamycin acetate.

Adult↗
PubMed1993

[Comparative clinical effectiveness and tolerance of azithromycin (sumamed) and erythromycin in patients with sinusitis].

Clinical efficacy of azithromycin and erythromycin was compared in an open trial in 32 and 18 patients with acute sinusitis respectively. The following pathogens were isolated: Haemophilus influenzae (29.8 per cent), Streptococcus pneumoniae (19.1 per cent), Staphylococcus aureus (10.6 per cent), Streptococcus faecalis (8.5 per cent) and other microbes (8.5 per cent). Azithromycin was administered in a dose of 500 mg on day 1. During the following 4 days it was administered in a dose of 250 mg. Erythromycin was administered in a dose of 500 mg 4 times a day for 8 to 10 days. 91.2 per cent of the aerobic microflora were sensitive to azitromycin and 85.3 per cent were sensitive to erythromycin. One of 14 strains of H. influenzae proved to be resistant to azithromycin, 3 strains were resistant to erythromycin. Complete recovery was stated in 90.6 per cent of the cases treated with azithromycin and 66.7 per cent of the cases treated with erythromycin.

Acute Disease↗
PubMed1994

The new macrolides. Azithromycin and clarithromycin.

Clarithromycin and azithromycin are among the new generation of macrolides that have recently been approved for use. Compared with currently available antibiotics, these agents may be given less frequently and, in the case of azithromycin, for a shorter duration. In vitro data suggest an antimicrobial advantage of both clarithromycin and azithromycin against atypical mycobacterial and toxoplasmal species and possibly Haemophilus influenzae. The cost of both these agents is substantially higher than that of erythromycin and doxycycline, although the convenience of single-dose azithromycin is appealing compared with a 7-day course of doxycycline for chlamydial urethritis and cervicitis. These agents appear to offer advantages over erythromycin in the treatment of Mycobacterium avium-intracellulare. Additional data are needed to establish their role in other bacterial infections.

Azithromycin↗
PubMed1994

[Azithromycin-omeprazole. Treatment for the eradication of Helicobacter pylori].

AIM: To evaluate the benefit of 4-week regimen including azithromycin+omeprazole (vs omeprazole alone) for eradication of Helicobacter pylori. METHODS: Twenty HP positive patients with an ulcer dyspepsia (NUD) were included in this study. They were given either omeprazole 40 mg for 4 weeks alone or in combination with azithromycin 1 g/die for 1 week. Endoscopy was performed before 4 weeks after and 4 months after treatment. The presence of HP was assessed in antral and corporeal biopsies by urease test and histology. RESULTS: HP eradication was observed in 9/10 (90%) patients in the omeprazole+azithromycin group and 0/10 patients in the omeprazole alone group. CONCLUSION: Omeprazole 40 mg for 4 weeks in combination with azithromycin 1 g die for 1 week eradicates HP in 90% of these patients. The good eradication percentage and absence of collateral effect make us extend patients' number to test.

Adult↗
PubMed1993

Uptake and subcellular distribution of azithromycin in human phagocytic cells. Demonstration of the antibiotic in neutrophil polymorphonuclear leucocytes and monocytes by autoradiography and electron microscopy.

Azithromycin (CAS 83905-01-5), a new azalide antibiotic, reached high concentrations in alveolar macrophages obtained from patients. Uptake of [14C] azithromycin by macrophages resulted in an intracellular/extracellular concentration ratio of approximately 634 after 90 min incubation. Electron microscopic autoradiography provided visual evidence for the marked uptake and localization of [3H] azithromycin in human neutrophils and monocytes isolated from healthy volunteers. Quantitative analysis of the autoradiographs showed the distribution of azithromycin over the various compartments of the phagocytic cells.

Autoradiography↗
PubMed1993

[Efficacy and safety of azithromycin in the treatment of female genital Chlamydia trachomatis infections].

Genital tract infections by Chlamydia trachomatis associated to sterility and infertility problems as well as perinatal complications have become increasingly frequent. Azithromycin is a new macrolide with a lower activity spectrum than erythromycin and a longer half life as well as less secondary effects. The objective of the study was to evaluate the safety and efficiency of Azithromycin on genital tract infection by C. trachomatis. MATERIAL AND METHODOLOGY. A total of 30 nonpregnant women between the ages of 19 and 35 were studied; 70% had only one sexual partner. In order to insure the presence of C. trachomatis as unique pathogen, cervicovaginal sampling, clinical evaluation and gynecologic exploration were undertaken. One dose of 1 g orally of Azithromycin was administered evaluating microbiologic and clinical remission at days 7-10, 12-16 and 33-37 after treatment. RESULTS. Two patients abandoned the study; global criteria of the evaluation were good to excellent in 17 cases; moderate to sufficient in six and poor in five. None of the cases reported secondary reactions. Results showed that Azithromycin treatment of cervicitis by C. trachomatis is useful with the advantage of unique dose administration.

Adolescent↗
PubMed1995

[Azithromycin: critical points].

The determination of the French breakpoints (< or = c, > C) were selected by the use of different criteria including bacteriological, pharmacokinetic and obviously clinical criteria. Concerning the bacteriological results, azithromycin, being an acid stable orally administered antimicrobial drug, is in vitro marginally less active than erythromycin against Gram-positive organisms including beta-haemolytic streptococci and Staphylococcus aureus. But in contrast, this azalide is more active than erytromycin against many Gram-negative pathogens, notably Neisseria gonorrhoeae, H. influenzae, Branhamella (Moraxella) catarrhalis, Ureaplasma urealyticum, and Borrelia burgdorferi. The activity of azithromycin is unaffected by the inoculum, unlike of pH, serum, and presence of CO2 for anaerobes. However, erythromycin-resistant micro-organisms are also resistant to azithromycin. Considering the pharmacokinetic criteria and the clinical results such as infections of the lower and upper respiratory tracts, skin and soft tissues, uncomplicated urethritis/cervicitis associated with N. gonorrhoeae, Chlamydia trachomatis or U. urealyticum, the preliminary breakpoints of azithromycin are defined by the following concentrations (< or = 0.12 and > 4 mg/l). Additional experimental and clinical results are required to confirm the in vitro activity against some other bacterial species (E. faecalis, L. monocytogenes, Brucella, P. multocida, or even Salmonella and Shigella).

Anti-Bacterial Agents↗
PubMed1995

[Azithromycin and genital infections].

The lower genital tract infections due to Chlamydia trachomatis are frequent, essentially occurring in young patients, with possible complications and severe sequela, particularly in women where the sterility risk is one of the major consequences. If an effective treatment could be systematically proposed, a good compliance (easy administration and good toleration) is one of the key factor to success. In this context, the azithromycin displays numerous advantages. The azithromycin in vitro activity on Chl. trachomatis strains is permanent with MIC comprised between 0.06 and 0.125 micrograms/ml, with an activity equivalent to those of other macrolides, to tetracyclines and quinolones. Different animal models allow to demonstrate the curative activity of the azithromycin administered as a single dose, at dosage regimen equivalent to those used in man, and a prophylactic activity on the salpingitis onset in provoked Chl. trachomatis infections. Several comparative clinical studies with azithromycin administered as a 1 g single dose displayed very satisfactory results with 98% of bacterial eradication, identical to those obtained with reference treatment. On the other hand, restrictions to the product use are a less constant activity against Neisseria gonorrhoeae and a lack of efficacy on Mycoplasma hominis. The efficacy on Treponema pallidum remains to be clinically tested.

Adult↗
PubMed1995

Review of azithromycin activity against Legionella spp.

Azithromycin is about as active against Legionella spp. in vitro as is erythromycin, with modal MICs approximately 0.5 to 0.125 microgram/ml, depending on the method used. In contrast, azithromycin is much more active against intracellular L. pneumophila than is erythromycin. In a guinea pig model of Legionnaires' disease, azithromycin is much more active than is erythromycin or clarithromycin. Despite the paucity of reports of treatment of Legionnaires' disease with azithromycin, it is likely to be as or more effective than erythromycin.

Animals↗
PubMed1996

Triple therapy with azithromycin, omeprazole, and amoxicillin is highly effective in the eradication of Helicobacter pylori: a controlled trial versus omeprazole plus amoxicillin.

BACKGROUND: Azithromycin is a new-generation, acid-stable macrolide antibiotic that achieves remarkably high concentrations in gastric tissue, persisting above the MIC90 for Helicobacter pylori over a 5-day period after a single 500-mg oral dose. METHODS: We evaluated a new metronidazole-free triple therapy with omeprazole 20 mg b.i.d. plus amoxicillin 1 g b.i.d. (both for 14 days) and azithromycin 500 mg mane (for the first 3 days only) (group I) versus double therapy with omeprazole 20 mg b.i.d. plus amoxicillin 1 g t.i.d., both for 14 days (group II). H. pylori status was determined by urease test and histology before and 6 wk after completion of therapy. RESULTS: Ninety-two patients with peptic ulcer disease or nonulcer dyspepsia completed the study. H. pylori infection was eradicated in 44 (91.6%) of 48 patients randomized to receive triple therapy versus 26 (59.1%) of 44 who received double therapy (p < 0.001). Smoking, but not omeprazole pretreatment, proved to be a risk factor for treatment failure only in the double-therapy group (p = 0.05). All ulcers healed by the time of the 8-wk endoscopic control. Side effects, usually minor, were recorded in 12.5% and 9.1% of patients, respectively (NS), but therapy had to be discontinued in one patient in group I and in three in group II (NS). CONCLUSIONS: Two-week triple therapy with omeprazole, amoxicillin, and (for the first 3 days) low-dose azithromycin is highly effective in eradicating H. pylori. This regimen is safe and well-tolerated, and we recommend that it be used as first-line treatment, as an alternative to less-effective omeprazole-amoxicillin double therapy. Moreover, azithromycin appears to be a new, promising antibiotic for future innovative anti-H. pylori combinations.

Adult↗
PubMed1996

Interaction between midazolam and clarithromycin: comparison with azithromycin.

A comparative pharmacokinetic and pharmacodynamic investigation was carried out on the interaction between the hypnotic midazolam and 2 different macrolide-type antibiotics, clarithromycin and azithromycin. In an open randomized crossover study of 3 phases 12 healthy volunteers received either clarithromycin (250 mg twice a day for 5 days), azithromycin (500 mg once a day for 3 days) or no pretreatment. On the last day of antibiotic treatment they ingested 15 mg midazolam. Plasma samples were collected for midazolam analysis up to 24 h and pharmacodynamic performance measured by a series of tests up to 12 h. Pretreatment with clarithromycin caused large and statistically significant changes in both the pharmacokinetic and pharmacodynamic parameters of midazolam compared to control. For example, the AUC was increased from 248.84-888.75 hng/ml (factor of 3.57, p < 0.0001) and the mean duration of sleep increased from 135.4 min to 281.3 min (p < 0.05). No statistically significant effect was found with azithromycin in any test. It is concluded that a drug interaction exists between midazolam and clarithromycin which could be of clinical importance. No such effect is present with azithromycin.

Adult↗
PubMedDate not supplied

Reduced serum theophylline concentrations after discontinuation of azithromycin: evidence for an unusual interaction.

A 68-year-old man receiving long-term therapy with oral sustained-release theophylline 450 mg twice/day was admitted to the hospital after failing treatment with azithromycin for an acute exacerbation of obstructive lung disease. Peak serum theophylline concentration was 20 microg/ml (normal 10-20 microg/ml). Azithromycin was discontinued and the theophylline dosage reduced by 33%. The subsequent 80% decrease in serum theophylline to 4.6 microg/ml was unexpectedly large. Two rechallenges produced similar transient depressions of serum theophylline concentrations after withdrawal of azithromycin, suggesting an interaction. Withdrawal of azithromycin may leave an increased number of active enzyme sites available as the drug is cleared from the system. In some circumstances, it may be useful for pharmacokinetic interaction studies to continue measuring concentrations after the suspected interacting agent is stopped.

Aged↗
PubMedDate not supplied

Pharmacokinetics of azithromycin after single- and multiple-doses in children.

STUDY OBJECTIVE: To characterize the disposition and tolerance of azithromycin after single and multiple oral doses of 12 mg/kg in children with and without cancer. DESIGN: Open-label, nonrandomized pharmacokinetic study. SETTING: Two pediatric hospitals. PATIENTS: Twelve children with cancer admitted to the inpatient unit for empiric antibiotic treatment of febrile neutropenia, and 16 hospitalized patients receiving antibiotic therapy INTERVENTIONS: Patients received azithromycin suspension either as a single dose or daily dose every morning for 5 consecutive days. Serial blood samples were collected up to 120 hours after a single dose or during and after multiple doses to characterize the pharmacokinetic parameters estimated for a two-compartment absorption model. MEASUREMENTS AND MAIN RESULTS: All 28 patients were evaluable for safety. Azithromycin was well tolerated except in one patient with cancer who experienced abdominal cramps and withdrew from the study. Pharmacokinetic results were not determined in five patients because of insufficient concentration-time data. The mean +/- SD estimates of oral clearance, terminal half-life, maximum concentration in serum (Cmax), and time to achieve Cmax in the 23 evaluable patients were 4.83 +/- 3.59 L/hour/kg, 54.5 +/- 36.4 hours, 318.2 +/- 174.5 microg/L, and 2.4 +/- 1.1 hours, respectively. These estimates did not differ between single-dose (14 patients) and multiple-dose (9 patients) groups. Pharmacokinetic parameters were not different between the 11 children with cancer and the 12 without cancer. CONCLUSION: Azithromycin 12 mg/kg results in proportionately higher serum concentrations than previously published results for lower doses (5 mg/kg). Variability in concentration profiles among patients is substantial, and age or other yet unidentified clinical factors may explain some of the differences observed.

Adolescent↗
PubMed1988

In vitro activity of azithromycin and erythromycin against organisms associated with bacterial vaginosis and chancroid.

The in vitro activity of the new macrolide azithromycin and erythromycin against Haemophilus ducreyi, Gardnerella vaginalis, Bacteroides spp. and Mobiluncus spp. was compared. Gardnerella vaginalis, Mobiluncus spp. and Haemophilus ducreyi were highly susceptible to both agents but azithromycin was more effective overall against all three groups of organisms. The activity of both antibiotics against Bacteroides spp. varied greatly, but azithromycin was again more active. Collectively, 62% of all Bacteroides strains were susceptible to erythromycin (MIC 1 mg/1) and 74% were susceptible to azithromycin.

Azides↗