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PubMed2006

Biomarkers to monitor drug-induced phospholipidosis.

Di-docosahexaenoyl (C22:6)-bis(monoacylglycerol) phosphate (BMP) was identified as a promising phospholipidosis (PL) biomarker in rats treated with either amiodarone, gentamicin, or azithromycin. Sprague-Dawley rats received either amiodarone (150 mg/kg), gentamicin (100 mg/kg) or azithromycin (30 mg/kg) once daily for ten consecutive days. Histopathological examination of tissues by transmission electron microscopy (TEM) indicated different degrees of accumulation of phospholipidosis in liver, lung, mesenteric lymph node, and kidney of drug-treated rats but not controls. Liquid chromatography coupled to mass spectrometry (LC/MS) was used to identify levels of endogenous biochemical profiles in rat urine. Urinary levels of di-docosahexaenoyl (C22:6)-bis(monoacylglycerol) phosphate (BMP) correlated with induction of phospholipidosis for amiodarone, gentamicin and azithromycin. Rats treated with gentamicin also had increased urinary levels of several phosphatidylinositol (PI), phosphatidylcholine (PC), and phosphatidylethanolamine (PE) species.

Amiodarone↗

PubMed1993

Compliance with antibiotic therapy: a comparison of deuterium oxide tracer, urine bioassay, bottle weights, and parental reports.

OBJECTIVE: To compare three traditional measures of compliance with antibiotic therapy (parent report diary, preregimen and postregimen bottle-weight difference, and urine bioassay for antibiotic activity), with a deuterium oxide tracer measure of compliance. METHODS: Clinical trial in which all four compliance measures were used for subjects participating in a comparison of the efficacy of azithromycin and penicillin in treating group A beta-hemolytic streptococcal infection. Subjects were 41 children, aged 3 to 15 years (average age, 7.9 years), in a suburban pediatric private practice, who had positive rapid streptococcal antigen test results. RESULTS: Of the 41 subjects, 20 children were randomly assigned to receive azithromycin and 21 to receive penicillin. Compliance was uniformly high by all four measures. Parent diaries indicated that all doses were administered. Urine bioassays were obtained for 40 subjects, and all showed antibiotic activity. Differences in bottle weights were obtained for 27 subjects and showed that 142% of the prescribed medication was missing from the bottles at the end of the regimen. The deuterium oxide measure was obtained for 40 subjects and showed that 107% of the prescribed azithromycin and 92% of the prescribed penicillin were ingested. The correlation coefficient between measured and expected deuterium enrichment was 0.89. There was no significant correlation between the bottle-weight measure and the deuterium oxide tracer. CONCLUSIONS: The bottle-weight measure overestimates compliance; the deuterium oxide tracer is feasible for use in an office setting and produces a high correlation between the expected urinary enrichment and the measured enrichment. Increased use of this quantitative and direct measure would improve the accuracy of compliance measurement in trials of pediatric liquid medications.

Adolescent↗

PubMed2001

In vitro susceptibility of recent clinical isolates of Chlamydia trachomatis to macrolides and tetracyclines.

We tested the in vitro activity of clarithromycin, azithromycin, roxithromycin, erythromycin, doxycycline, and tetracycline against 50 clinical isolates of Chlamydia trachomatis. The minimal inhibitory concentrations (MICs) and the minimal bactericidal concentrations (MBCs) were determined in a tissue culture system using cycloheximide treated McCoy cells. MIC values for all the isolates were < or =0.015 microg/ml for clarithromycin, < or =0.125 microg/ml for roxithromycin and azithromycin, and < or =0.25 microg/ml for erythromycin and doxycycline. Almost half of the isolates (44%) were inhibited only by a concentration of 0.5 microg/ml of tetracycline. MBC as high as 4 microg/ml was displayed by doxycycline and tetracycline against 8% and 4% of the isolates respectively of the agents recommended by the Center for Disease Control as drugs of choice for the treatment of chlamydial infections, azithromycin exhibited a markedly better in-vitro activity than did erythromycin and doxycycline.

Anti-Bacterial Agents↗

PubMed1996

In vitro activity of macrolides against intracellular Legionella pneumophila.

The antibacterial effects of clarithromycin, azithromycin, and erythromycin were determined against five strains of Legionella pneumophila including L. pneumophila ATCC 33823 and four clinical isolates. Extracellular minimum inhibitory concentrations (MICs) and MBCs were determined by a microdilution method. Clarithromycin was the most active drug (MIC < or = 0.015-0.06), followed by azithromycin (MIC 0.03-0.12) and erythromycin (MIC 0.06-0.25). The antibacterial effect of these macrolides was then determined against L. pneumophila grown intracellularly in MRC-5 human fetal lung fibroblast cells. At two and eight times the extracellular MBC, erythromycin, azithromycin, and clarithromycin were equally effective in inhibiting growth of these five strains of intracellular L. pneumophila.

Anti-Bacterial Agents↗

PubMed2005

Acute exacerbation of chronic bronchitis: expanding short-course therapy.

Recent management guidelines for acute exacerbation of chronic bronchitis (AECB) have provided antimicrobial options for different classes of patients according to varying disease severity or risk of treatment failure. In a pivotal, double-blind, double-dummy study comparing azithromycin microspheres (2 g single dose) with the respiratory quinolone levofloxacin (500 mg once daily x 7 days) for the treatment of AECB, the two regimens were equally effective and well tolerated in patients with mild-to-moderate disease (clinical cure rate 93.6% vs. 92.7%, respectively [95% confidence interval (CI) for difference, -3.4, 5.5] and overall bacteriological eradication rate 91.9% vs. 94.4%, respectively (95% CI for difference, -8.8, 3.8). Interestingly, additional post hoc analyses suggest that a single dose of azithromycin also provides comparable clinical efficacy to levofloxacin in patients with a forced expiratory volume in 1 s (FEV1) of less than 70% of the predicted value, a risk factor that would place them in a more severe stratum. These data support azithromycin microspheres as an appropriate option in patients with mild-to-moderate AECB. The potential role of this preparation and other macrolides in patients at higher risk of therapeutic failure requires additional prospective data.

Acute Disease↗

PubMed1999

Pharmacological considerations in the emergence of resistance.

Resistance to macrolides in vitro is increasingly being reported. However, there has been no corresponding increase in clinical failures noted. Lack of clinical failures due to resistance is most likely the result of the high intracellular concentrations that these drugs achieve in phagocytes. In the case of clarithromycin, concentrations in both monocytes and granulocytes fluctuate between peaks of approximately 22-25 mg/l and troughs of approximately 5 mg/l during a standard dosing interval. In contrast, azithromycin attains concentrations of over 60 mg/l in granulocytes and at least 100 mg/l in monocytes. After 7 days, azithromycin concentrations of >32 mg/l are still observed. These data also imply that against pathogens with increasing minimum inhibitory concentrations (MICs), macrolides with relatively lower or less sustained intracellular concentrations will become ineffective clinically much sooner than compounds, such as azithromycin, that concentrate to a high degree and are retained in white blood cells for prolonged periods.

Anti-Bacterial Agents↗

PubMed2003

Structural basis for the antibiotic activity of ketolides and azalides.

The azalide azithromycin and the ketolide ABT-773, which were derived by chemical modifications of erythromycin, exhibit elevated activity against a number of penicillin- and macrolide-resistant pathogenic bacteria. Analysis of the crystal structures of the large ribosomal subunit from Deinococcus radiodurans complexed with azithromycin or ABT-773 indicates that, despite differences in the number and nature of their contacts with the ribosome, both compounds exert their antimicrobial activity by blocking the protein exit tunnel. In contrast to all macrolides studied so far, two molecules of azithromycin bind simultaneously to the tunnel. The additional molecule also interacts with two proteins, L4 and L22, implicated in macrolide resistance. These studies illuminated and rationalized the enhanced activity of the drugs against specific macrolide-resistant bacteria.

Anti-Bacterial Agents↗

PubMed2003

The possibility of eliminating blinding trachoma.

Global elimination of blinding trachoma, the world's leading preventable cause of blindness, now seems possible. The disease, which persists most severely in the poorest parts of Africa and Asia, is already eliminated in North America and Europe. On a scientific basis, the case for elimination was outlined at a WHO global scientific meeting in 1996. To facilitate action, WHO founded the Alliance for Global Elimination of Trachoma by 2020 (GET 2020) in 1997. In 1998 a World Health Assembly resolution called for member states to take steps to eliminate blinding trachoma by 2020 using the WHO recommended SAFE strategy (surgery of late stage disease, antibiotics for acute infection, and improved facial hygiene and environmental change-ie, improved access to water and sanitation). These developments contributed to the decision by Pfizer Inc to donate azithromycin in support of national programmes implementing SAFE and, with the Edna McConnell Clark Foundation, to found the International Trachoma Initiative as a charity dedicated to the elimination of blinding trachoma by 2020. Reports of the early programme scope and impact are encouraging. In ten national programmes currently underway (constituting about 50% of the global burden) more than 55,000 lid surgeries have halted further corneal damage and prevented blindness, and more than 6 million treatments with azithromycin have been given with reductions in acute infections of around 50% in children. Morocco, one of the first countries to implement SAFE with azithromycin, has achieved remarkable results and expects to eliminate blinding trachoma by 2005. If political will and public-health support can be mobilised, the goal of eliminating this cause of blindness can become a reality by 2020.

Africa↗

PubMed1996

Cure of Helicobacter pylori infection in the elderly: effects of eradication on gastritis and serological markers.

BACKGROUND: Specific data on anti-H. pylori treatments in elderly people are very scarce. The aim of the study was to evaluate in the elderly the efficacy of different anti-H. pylori therapies and the behaviour of serum anti-H. pylori antibodies, pepsinogen A and C, and PGA/PGC ratio induced by the anti-H. pylori treatment. METHODS: One hundred and twenty-one dyspeptic patients aged > 60 years (mean age, 73 years; range, 61-89 years) with H. pylori-positive gastric ulcers (17 patients), duodenal ulcers (33 patients) or chronic gastritis (71 patients) were treated with one of the following anti-H. pylori treatments: (A) omeprazole 20 mg/day plus azithromycin 500 mg/day for 3 days; (B) omeprazole 20 mg/day plus azithromycin 500 mg/day for 3 days plus metronidazole 250 mg q.d.s. for 7 days; (C) omeprazole 40 mg/day plus azithromycin 500 mg/day for 3 days plus metronidazole 250 q.d.s. for 7 days; (D) omeprazole 20 mg/day plus clarithromycin 250 b.d. for 7 days; (E) omeprazole 20 mg/day plus clarithromycin 250 b.d. for 7 days plus metronidazole 250 q.d.s. for 7 days; and (F) omeprazole 40 mg/day plus clarithromycin 250 mg b.d. for 7 days plus metronidazole 250 mg q.d.s. for 7 days. At the baseline and 2 months after therapy, endoscopy and serum anti-H. pylori antibodies, pepsinogen A and C, and PGA/PGC ratio were measured. RESULTS: Ten patients (8.2%) dropped out of the study. Six patients (4.9%) reported side-effects. The eradication rates of the six regimens, expressed using intention-to-treat and per protocol analysis, were, respectively: (A) 39% and 44%; (B) 50% and 56%; (C) 65% and 77%; (D) 47% and 50%; (E) 85% and 90%; and (F) 83% and 87%. The triple therapy for regimens E and F was significantly more effective than dual therapies (regimens A and D; intention-to-treat = P < 0.007, per protocol = P < 0.001) or the triple therapy for regimens B and C (intention-to-treat = P < 0.009, per protocol = P < 0.03). Patients cured of H. pylori infection showed a significant decrease in the activity of gastritis (P < 0.0001), a significant drop in IgG anti-H. pylori (P = 0.0004) and pepsinogen C (P < 0.0001), and an increase in PGA/PGC ratio (P < 0.001), while patients remaining H. pylori-positive showed no changes in the serum parameters. CONCLUSIONS: In the elderly, triple therapy with omeprazole+metronidazole+clarithromycin for 1 week is well tolerated and highly effective; anti-H. pylori antibody and PGC serum levels decrease soon after anti-H. pylori therapy only in patients cured of H. pylori infection.

Aged↗

PubMed1998

[Short-term (6 days) eradication of Helicobacter pylori infection in the practice of a health insurance physician].

OBJECTIVE: To obtain epidemiological data concerning Helicobacter pylori (H.p.) infections and peptic ulcer in patients with upper abdominal pain in a routine non-hospital based health-insurance practice, as well as to test the efficacy of H.p. eradication, especially with a new shortterm treatment scheme in this setting. PATIENTS AND METHODS: H.p. status and possible peptic ulceration (urease test, biopsies of gastric antrum and body) were determined in 1242 consecutive patients with upper abdominal pain examined gastroscopically. Patients who were H.p. positive and had a peptic ulcer or recurrent gastritis with erosions were given dual or triple medication (lansoprazole or pantoprazole with one or two antibiotics: amoxycillin, clarithromycin, azithromycin, tinidazole), under conditions of controlled compliance. RESULTS: The H.p. infection rate was 45.9% for the whole group (mean age: 49.9 years). An acute ulceration was found in 10.4% of the whole group, i.e. 20.1% of the 129 H.p. positive patients. 194 patients were given an eradication treatment. In 62 of them, put on a new 6-day eradication regimen (azithromycin, 1 x 500 mg daily; tinidazole, 1 x 2000 mg/d; and pantoprazole, 2 x 40 mg/d), an eradication rate of 93% (under protocol) or 92% (intention to treat) was achieved. INTERPRETATION: In routine non-hospital practice a 6-day modified triple-medication treatment with azithromycin, tinidazole and pantoprazole proved efficacious in eradicating H.p. infection. It not only caused few side effects and was cheap, but also achieved high patient compliance.

2-Pyridinylmethylsulfinylbenzimidazoles↗

PubMed1998

[Macrolide antibiotic-induced vasculitis (Churg-Strauss syndrome)].

BACKGROUND: Macrolides are known to have relatively few side effects and are prescribed in cases of allergic reaction to penicillin. The new macrolides, for example Azithromycin and Roxithromycin, are increasingly preferred over erythromycin at the ear, nose, and throat out-patient department due to improved oral reabsorption (acid resistance), better penetration into tissue, prolonged half-life, extended antibacterial activity, modest side effects, and better pharmacokinetics. There are only few case reports concerning side effects of macrolides. We report on the appearance of a Churg Strauss-Syndrome (CSS) in a patient following intake of the macrolide antibiotic azithromycin and roxithromycin. PATIENT: A 50-year-old patient with asthma for three years presented with arthritis and mononeuritis multiplex. Laboratory and radiological investigations revealed eosinophilia (64%), eosinophilic infiltrations of bone marrow, raised IgE-level, and transient pulmonary infiltrates. THERAPY AND DEVELOPMENT: Intravenous steroid therapy was started and resulted in normalization of eosinophilia, IgE-level, and asthmatic symptoms. The neurologic deficits showed only a weak tendency for improvement. CONCLUSION: The diagnosis of CSS was established on the basis of clinical criterias and laboratory investigations. The diagnosis was supported by the fact that a similar course of the disease was observed one year ago following administration of azithromycin, another macrolide.

Anti-Bacterial Agents↗

PubMed2001

Persistently positive culture results in a patient with community-acquired pneumonia due to Legionella pneumophila.

We describe a patient with community-acquired pneumonia due to Legionella pneumophila serogroup 6. This patient was found to have bronchoalveolar carcinoma of the lung by means of cytologic testing in 1 of 2 bronchoalveolar lavage samples, but no lesions were visible on bronchoscopy. Despite intravenous administration of azithromycin to the patient, repeat culture and polymerase chain reaction showed persistence of Legionella; the isolates remained susceptible to azithromycin. The patient did not respond to 14 doses of daily intravenously administered azithromycin. The poor outcome may have been partially due to the suspected underlying lung malignancy, as shown by cytologic examination, and by a delay in seeking medical attention.

Aged↗

PubMed2002

Effect of antipyretic agents on uptake, transport, and release of antimicrobial agents by human polymorphonuclear leukocytes.

Polymorphonuclear leukocytes (PMNL) concentrate, transport, and release certain antimicrobial agents as they move in a chemotactic gradient. Antipyretic agents are frequently used in febrile patients receiving antimicrobial agents. Thus, the influence of ibuprofen, acetaminophen, and acetylsalicylic acid on uptake, transport, and release of azithromycin and moxifloxacin was studied. Uptake of the antimicrobial agents by human PMNL and the effect of the antipyretics were quantitated by bioassay of released antimicrobial agent. Transport and release were determined in chemotactic plates overlaid with sentinel bacteria that could detect transported and released antimicrobial agent. None of the antipyretics altered PMNL directed or non-directed movement. Uptake of azithromycin was significantly inhibited by acetylsalicylic acid but not by the other antipyretics. All of the antipyretic agents studied at therapeutic levels inhibited transport and release of both azithromycin and moxifloxacin. Administration of any of these antipyretic agents with antimicrobial agents that are transported and released by PMNL could compromise the efficacy of therapy.

Acetaminophen↗

PubMed2003

Incomplete immune reconstitution after initiation of highly active antiretroviral therapy in human immunodeficiency virus-infected patients with severe CD4+ cell depletion.

Immune function was observed for 144 weeks in 643 human immunodeficiency virus (HIV)-infected subjects who (1) had nadir CD4+ cell counts of <50 cells/mm3, followed by a sustained increase to > or =100 cells/mm3 after the initiation of HAART, and (2) were enrolled in a randomized trial of continued azithromycin prophylaxis versus withdrawal for prevention of Mycobacterium avium complex disease. The median CD4+ cell count was 226 cells/mm3 at entry and 358 cells/mm3 at week 144. Anergy (80.2% of patients) and lack of lymphoproliferative response to tetanus toxoid (TT; 73%) after immunization and impaired antibody responses after receipt of hepatitis A (54%) and TT (86%) vaccines were considered to be evidence of impaired immune reconstitution. Receipt of azithromycin did not have an effect on CD4+ cell count but was associated with higher rates of delayed-type hypersensitivity responses to TT (25% of subjects who received azithromycin vs. 15% of those who did not; P=.009) and mumps skin test antigen (29% vs. 17%; P=.001). Although the subjects had only partial responses to immune function testing, the rate of opportunistic infections was very low, and none of the tests was predictive of risk.

Acquired Immunodeficiency Syndrome↗

PubMed1998

Immunomodulatory treatment of Mycobacterium avium complex bacteremia in patients with AIDS by use of recombinant granulocyte-macrophage colony-stimulating factor.

Eight AIDS patients with Mycobacterium avium complex (MAC) bacteremia were randomized to receive azithromycin with or without granulocyte-macrophage colony-stimulating factor (GM-CSF) for 6 weeks to examine the effect of GM-CSF administration on clearance of mycobacteremia and on monocyte function. Superoxide anion production was significantly increased ex vivo in monocytes from patients receiving GM-CSF but not in those from patients receiving azithromycin alone. Relative to monocytes obtained from untreated healthy controls, median differences in viable intracellular MAC at 2, 4, and 6 weeks were -0.76, -0.94, and -0.47 log10 cfu/mL of lysate for cells from patients receiving GM-CSF versus -0.15, -0.11, and -0.19 log10 cfu/mL for cells from patients receiving azithromycin alone. Although no effect on mycobacteremia was detected, the administration of GM-CSF to AIDS patients with MAC bacteremia resulted in activation of their blood monocytes, as evidenced by increased superoxide anion production and enhanced mycobactericidal activity. GM-CSF deserves further investigation in the treatment of mycobacterial infections.

AIDS-Related Opportunistic Infections↗

PubMed1998

Combination drug therapy for cryptosporidiosis in AIDS.

Aside from effective antiretroviral therapy, there is no consistently effective antiparasitic therapy for cryptosporidiosis in AIDS. The purpose of this study was to assess safety, efficacy, and durability of combination therapy with paromomycin and azithromycin for chronic cryptosporidiosis. Patients with AIDS, chronic cryptosporidiosis, and < 100 CD4 cells/microL were treated with open-label paromomycin (1.0 g twice a day) plus azithromycin (600 mg once a day) for 4 weeks, followed by paromomycin alone for 8 weeks. In 11 patients, median stool frequency decreased from 6.5/day (baseline) to 4.9/day (week 4) and 3.0/day (week 12). Median reductions in 24-h oocyst excretion were 84%, 95%, and >99% at 2, 4, and 12 weeks, respectively. None of the responses were attributable to antiretrovirals. Of 5 survivors at 12-30 months of follow-up, 3 remain asymptomatic off medications, and 2 have chronic, mild diarrhea. Treatment of cryptosporidiosis with azithromycin and paromomycin was associated with significant reduction in oocyst excretion and some clinical improvement.

AIDS-Related Opportunistic Infections↗

PubMed1994

Treatment of disseminated disease due to the Mycobacterium avium complex in patients with AIDS.

Perhaps the most important recent advance in the field of infections due to the Mycobacterium avium complex (MAC) is the identification and development of more effective agents for the treatment and prevention of disseminated disease. These agents include clarithromycin, azithromycin, rifabutin and other rifamycins, ethambutol, clofazimine, fluoroquinolones, amikacin, and liposome-encapsulated gentamicin. Most clinicians currently use multidrug therapy to maximize efficacy and to minimize the emergence of resistance. Prospective clinical trials of multidrug regimens suggest that MAC colony counts in blood decline during therapy, usually with alleviation of clinical symptoms. The small size and short duration of these trials have not permitted an evaluation of survival or quality of life. Because the contribution of any single agent to multidrug trials is difficult to assess, short-term trials of monotherapy have been conducted recently; clarithromycin, azithromycin, ethambutol, and liposome-encapsulated gentamicin have been most active. Rifabutin and rifampin, clofazimine, amikacin, and ciprofloxacin may contribute to the efficacy of multidrug regimens. Current recommendations include the following: (1) disseminated MAC disease should be treated in patients with AIDS; (2) initial treatment should consist of at least two agents; (3) oral clarithromycin or azithromycin is the preferred first agent; (4) ethambutol is the most rational choice for the second agent; and (5) in appropriate cases, additional agents (rifampin or rifabutin, clofazimine, ciprofloxacin, or parenteral amikacin) may be added. Therapy should continue for life.

AIDS-Related Opportunistic Infections↗

PubMed1995

New treatments for Chlamydia trachomatis genital infection.

To provide information for the formulation of treatment guidelines, we review recently published articles and abstracts on advances in the treatment of Chlamydia trachomatis genital infection. We ask specific questions about new treatments that are answered on the basis of the results of clinical trials and efficacy studies. New, potentially effective treatments for C. trachomatis genital infection include azithromycin and ofloxacin. Clinical studies indicate that the efficacy of these agents is equivalent to that of the current recommended agent doxycycline. Both azithromycin and ofloxacin are substantially more expensive than doxycycline. Azithromycin has the advantage of being given as a single dose, while doxycycline and ofloxacin are administered for 1 week. Issues of compliance, cost, and toxicity for specific patients should be considered when deciding whether to treat C. trachomatis genital infections with these agents.

Azithromycin↗