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PubMed2002

Effects of large dosages of amoxicillin/clavulanate or azithromycin on nasopharyngeal carriage of Streptococcus pneumoniae, Haemophilus influenzae, nonpneumococcal alpha-hemolytic streptococci, and Staphylococcus aureus in children with acute otitis media.

Prior use of antibiotics is associated with carriage of resistant bacteria. Colonization by Streptococcus pneumoniae, Haemophilus influenzae, nonpneumococcal alpha-hemolytic streptococci (NPAHS), and Staphylococcus aureus was evaluated in children receiving antibiotic therapy for acute otitis media and in untreated, healthy control subjects. Children were randomly assigned to receive either amoxicillin/clavulanate (90 mg/kg per day) or azithromycin. Swabs were obtained before initiating therapy and again 2 weeks and 2 months after initiating therapy. We also obtained swabs from control subjects at the time of enrollment and 2 weeks and 2 months after enrollment. The decrease in the rate of carriage of S. pneumoniae and H. influenzae at 2 weeks was significant only in the amoxicillin/clavulanate group (P<.001 and P=.005, respectively). The rate of nasopharyngeal colonization with NPAHS among treated patients increased from 23% to 39% at 2 months (P=.01). This increase was similar for both treatment groups. These results suggest that the competitive balance between organisms is altered by antibiotic therapy.

Acute Disease↗
PubMed2006

Feasibility of azithromycin prophylaxis during a pertussis outbreak among healthcare workers in a university hospital in Paris.

The objective of the present study was to evaluate the feasibility of azithromycin prophylaxis with respect to tolerability and compliance during a pertussis outbreak among healthcare workers in a university hospital ward. Compliance with the prophylaxis regimen was 89%; compliance was 75% from intent-to-treat perspective. The rate of adverse events was 33%. Female sex was associated with reporting of adverse events. Nonstudents and healthcare workers who reported adverse events were less compliant with the prophylaxis regimen.

Adult↗
PubMed1994

Ocular pharmacokinetics of orally administered azithromycin in rabbits.

Azithromycin was orally administered to Dutch-belted rabbits following extracapsular lens extraction in one eye. At various times the animals were sacrificed, and serum and ocular tissues were obtained for drug level determination by HPLC-EC. Following a single dose, peak levels of drug in ocular tissues were measured within 8 hours (cornea > 0.5 micrograms/g [15mg/kg]; > 1.5 micrograms/g [3Omg/kg]). Highest levels were obtained in iris and ciliary body ( > 15 micrograms). Measurable tissue levels persisted for at least 120 hours. Trough levels increased proportionately during drug multiple dose administration. Five days following five daily 15mg/kg doses, corneal levels exceeded 0.5 micrograms/g, and iris and ciliary levels were higher than 15 micrograms/g. Aqueous humor and serum levels were equivalent. Vitreous humor levels, though higher than aqueous humor, were consistently < 1 microgram/ml. Extracapsular cataract extraction did not significantly affect drug uptake.

Administration, Oral↗
PubMed2002

Isocratic liquid chromatographic method for the analysis of azithromycin and its structurally related substances in bulk samples.

An isocratic liquid chromatographic method with UV detection at 215 nm, which is suitable for the analysis of azithromycin (AZT) in bulk samples, is described. AZT is separated from its synthesis intermediates and a degradation product as well as from six unknown impurities on an XTerra RP18 column at 70 degrees C using a mobile phase consisting of acetonitrile-pH 6.5 0.2M K2HPO4-water (35:10:55, v/v/v) at 1.0 mL/min. The XTerra stationary phase contains methyl groups that are incorporated in the bulk structure of the material. This allows for special selectivities. Robustness is evaluated by a full factorial design experiment. The method shows good selectivity, repeatability, linearity, and sensitivity.

Anti-Bacterial Agents↗
PubMed2003

Quantitative thin-layer chromatographic method of analysis of azithromycin in pure and capsule forms.

A validated stability-indicating thin-layer chromatographic (TLC) method of the analysis of azithromycin (AZT) in bulk and capsule forms is developed. Both AZT potential impurity and degradation products can be selectively and accurately estimated in both raw material and product onto one precoated silica-gel TLC plate 60F254. The development system used is n-hexane-ethyl acetate-diethylamine (75:25:10, v/v/v). The separated bands are detected as brown to brownish red spots after spraying with modified Dragendorff's solution. The Rf values of AZT, azaerythromycin A, and the three degradation products are 0.54, 0.35, 0.40, 0.20, and 0.12, respectively. The optical densities of the separated spots are found to be linear in proportion to the amount used. The stress testing of AZT shows that azaerythromycin A is the major impurity and degradation product, accompanied by three other unknown degradation products. The stability of AZT is studied under accelerated conditions in order to provide a rapid indication of differences that might result from a change in the manufacturing process or source of the sample. The forced degradation conditions include the effect of heat, moisture, light, acid-base hydrolysis, sonication, and oxidation. The compatibility of AZT with the excipients used is also studied in the presence and absence of moisture. The amounts of AZT and azaerythromycin A are calculated from the corresponding linear calibration curve; however, the amounts of any other generated or detected unknown impurities are calculated as if it were AZT. This method shows enough selectivity, sensitivity, accuracy, precision, linearity-range, and robustness to satisfy Federal Drug Administration/International Conference of Harmonization regulatory requirements. The method developed can also be used for the purity testing of AZT raw material and capsules, content uniformity testing, dissolution testing, and stability testing of AZT capsules. The potential impurity profiles of both active AZT material and capsule forms are found comparable. The linear range of AZT is between 5 and 30 mcg/spot with a limit of quantitation of 2 mcg/spot. The intraassay relative standard deviation percentage is not more than 0.54%, and the day-to-day variation is not more than 0.86%, calculated on the amounts of AZT RS recovered using different TLC plates.

Anti-Bacterial Agents↗
PubMed1993

Rapid response of AIDS-related bacillary angiomatosis to azithromycin.

A 28-year-old male with AIDS and a CD4 cell count of 100/mm3 presented with fever, hepatosplenomegaly, weight loss, and multiple, polypoid, angiomatous lesions on his face. It was determined by means of biopsy that the lesions were due to bacillary angiomatosis. The patient was treated with oral azithromycin (1 g daily as a single dose). Rapid resolution of the skin lesions was noted. After 1 week of therapy, diminution in the size of the liver and spleen was noted. The only significant side effect noted was diarrhea, which was controlled with symptomatic therapy.

AIDS-Related Opportunistic Infections↗
PubMed1994

A comparison of anticryptosporidial activity of paromomycin with that of other aminoglycosides and azithromycin in immunosuppressed rats.

Of six evaluated aminoglycosides, paromomycin was the only one that showed activity against Cryptosporidium parvum in immunosuppressed rats. Oral dosages > or = 200 mg/kg/day reduced the severity of ileal infections; however, paromomycin was ineffective against cecal and biliary tract infections at 400 mg/kg/day orally and 50 mg/kg/day intraperitoneally. Oral paromomycin (400 mg/kg/day) was also less effective than azithromycin (400 mg/kg/day) against Cryptosporidium infection involving the ileum, cecum, or biliary tract of immunosuppressed rats. The data suggest that paromomycin may be an effective treatment for acute cryptosporidiosis of the small intestine but is probably ineffective against large intestine or biliary tract infections in the immunosuppressed host.

Animals↗
PubMed1990

In-vitro activity of azithromycin and CP-63,956 against Treponema pallidum.

The ability of the macrolide antibiotic azithromycin and its epimer CP-63,956 to inhibit protein synthesis in two pathogenic strains of Treponema pallidum was investigated. Using an in-vitro radiolabelling procedure employing treponemes freshly extracted from infected rabbit testes, our results indicate that both antibiotics were comparable with erythromycin in their ability to inhibit protein synthesis in T. pallidum Nichols strain. An erythromycin-resistant clinical isolate of T. pallidum, designated Street strain 14, exhibited only partial inhibition of protein synthesis at the highest antibiotic concentration tested.

Azithromycin↗
PubMed1996

Comparative activity of azithromycin against clinical isolates of mycobacteria.

Azithromycin exhibited in-vitro activity against 20 clinical isolates of Mycobacterium avium complex for which the MIC90 was 32 mg/L and 22 clinical isolates of other mycobacteria but showed no activity against 20 isolates of Mycobacterium tuberculosis (MIC90 > 128 mg/L) nor against the single isolate of Mycobacterium marinum tested (MIC 128 mg/L). These results suggest that the drug may prove useful for the prophylaxis and treatment of infections due to non-tuberculous mycobacteria, including M. avium complex in patients with AIDS.

Anti-Bacterial Agents↗
PubMed1997

A new semi-solid agar dilution method for determining amoxycillin, clarithromycin and azithromycin MICs for Helicobacter pylori isolates.

The MICs of amoxycillin, clarithromycin and azithromycin for 26 strains of Helicobacter pylori were determined using Mueller-Hinton semi-solid agar (SSA) without CO2 incubation, as in the conventional agar dilution method. The tested H. pylori strains grew satisfactorily in the SSA method within 48 h of incubation. Reasonable values of MICs of three antibiotics for these strains were obtained by this method, avoiding the inactivation of macrolides due to acidification of the medium. By this method, the MICs of the antibiotics for the reference strains were within the acceptable NCCLS ranges for quality control.

Amoxicillin↗
PubMed1998

Comparative anti-inflammatory effects of roxithromycin, azithromycin and clarithromycin.

There are many published reports on the anti-inflammatory effects of macrolides, some dating back to the introduction of erythromycin. Macrolides have been shown to affect a number of the processes involved in inflammation, including the migration of neutrophils, the oxidative burst in phagocytes and the production of various cytokines, although the precise mechanisms are not clear. These effects have been linked to the ability of macrolides to accumulate in mammalian cells. Roxithromycin, a macrolide with better plasma concentrations and higher tissue concentrations than erythromycin, has been tested in a standard animal model used for evaluating anti-inflammatory drugs. When rats were given a prophylactic dose (20 mg/kg), roxithromycin suppressed the oedema produced by injecting carrageenin into the paw with effects almost equal to that seen with the non-steroidal anti-inflammatory drug nimesulide. Azithromycin and clarithromycin, macrolides with better pharmacokinetics than erythromycin, only showed slight anti-inflammatory effects. These results confirm that roxithromycin has anti-inflammatory properties in vivo and encourage the investigation of its mode of action.

Animals↗
PubMed2004

Modification of phagocytosis and cytokine production in peritoneal and splenic murine cells by erythromycin A, azithromycin and josamycin.

OBJECTIVES: The aim of this study was to determine whether pre-incubation of peritoneal or splenic cells with different doses of the macrolides erythromycin A (14-membered ring), azithromycin (15-membered ring) and josamycin (16-membered ring) affects their phagocytic activity or cytokine production. METHODS: Peritoneal and splenic cells from BALB/c mice were pre-incubated with different concentrations of these antibiotics, those similar to serum levels attained with the treatment schedules used in human therapy. RESULTS: From our observations of phagocytic activity and IL-12 production by peritoneal cells, these macrolide antibiotics seem to act mainly as immunosuppressive agents, although they induce peritoneal cells to increase IL-18 production and splenic cells IL-4 production. CONCLUSIONS: Macrolide antibiotics can interfere with the Th1 cell-amplifying activity of IL-18 in conjunction with IL-12 and, in contrast, may induce a Th2 cell response in an IL-4-dependent manner. These results could improve their therapeutic use especially in immunosuppressed patients.

Animals↗
PubMed2002

Impact of single dose azithromycin on group A streptococci in the upper respiratory tract and skin of Aboriginal children.

BACKGROUND: Aboriginal children living in remote Australia experience high rates of bacterial infection such as trachoma, otitis media and streptococcal skin infection, which often progress to associated chronic diseases in later life. METHODS: In February, 1995, single dose azithromycin was given to 130 Aboriginal children with trachoma and their contacts. The impact of this program on respiratory and skin group A Streptococcus pyogenes carriage and infection was also monitored. RESULTS: Immediately before treatment 90% of children had skin sores, 38% of sores had pus and 74% of sores with pus had group A Streptococcus (GAS). Overall 57% of children had GAS skin infections. At 2 to 3 weeks and 2 and 6 months after treatment, this proportion was 10, 32 and 51%, respectively. For the upper respiratory tract GAS recovery rates were 8% before treatment and 0, 11 and 15% at the 2- to 3-week, 2-month and 6-month posttreatment visits, respectively. Multiple types occurred concurrently in individuals, particularly after treatment. Identical types were sometimes recovered simultaneously from the upper respiratory tract and skin, suggesting that the high rates of acute rheumatic fever in this population in the absence of high rates of detectable throat GAS carriage could be related to high rates of skin GAS infection. CONCLUSIONS: There is an urgent need for education, adequate housing, scabies eradication and improved hygiene to reduce skin trauma and subsequent GAS infection in this population. Clinical trials are needed to determine how these measures can best be integrated with the trachoma eradication program to maximize health outcomes.

Adolescent↗
PubMed2002

Tendon or joint disorders in children after treatment with fluoroquinolones or azithromycin.

BACKGROUND: Fluoroquinolones (FQs) have been infrequently used in children, largely because of concern that these agents can cause lesions of the cartilage in juvenile animals. However, the relevance of this laboratory observation to children treated with FQs is unknown. A retrospective, observational study was conducted to assess the incidence and relative risk of tendon or joint disorders (TJDs) that occur after use of selected FQs compared with azithromycin (AZ), a drug with no known effect on cartilage or tendons in humans or animals. METHODS: An automated database was searched to identify patients younger than 19 years who had been prescribed ofloxacin (OFX), levofloxacin, ciprofloxacin (CPX), or AZ. Potential cases of TJD occurring within 60 days of a prescription of one of the study drugs were identified based on assignment of a claims diagnosis consistent with a TJD within this period. Verified cases were identified by a blinded review of abstracts of medical records from subjects identified as potential cases. RESULTS: The incidence of verified TJD was 0.82% for OFX (13 of 1593) and CPX (37 of 4531) and was 0.78% for AZ (118 of 15,073). The relative risk of TJD for OFX and CPX compared with AZ was 1.04 (95% confidence interval, 0.55 to 1.84) and 1.04 (95% confidence interval, 0.72 to 1.51), respectively. The distributions of claims diagnoses and time to onset of TJD were comparable for all groups. The most frequently reported category of TJD involved the joint followed by tendon, cartilage and gait disorder. CONCLUSIONS: In this observational study involving more than 6000 FQ-treated children, the incidence of TJD associated with selected FQ use in children was <1% and was comparable with that of the reference group, children treated with AZ.

Adolescent↗
PubMed1998

Kinetics of Chlamydia trachomatis clearance in patients with azithromycin, as assessed by first void urine testing by PCR and transcription-mediated amplification.

METHODS: Test-of-cure of 19 patients with Chlamydia trachomatis genital infection was assessed by daily collection of first void urine for 7 days just after treatment by azithromycin single-dose. RESULTS: Detection by PCR and TMA of C. trachomatis showed a good correlation between both methods. The observation that post-therapy chlamydial nucleic acid detection is associated to bacterial clearance suggests that all the patients were cured.

Anti-Bacterial Agents↗
PubMed1998

Simultaneous high-performance liquid chromatography analysis of azithromycin and two of its metabolites in human tears and plasma.

This article describes a high-performance liquid chromatographic (HPLC) method for the measurement of azithromycin (AZI) and two of its metabolites, 9a-N-desmethylazithromycin (ADES) and N-desmethylazithromycin (NDES), in human tears and plasma. The drug, metabolites, and internal standard (n-propylazithromycin [IS]) were detected electrochemically after injection of the extracted sample into the HPLC system. The peak height ratio (AZI, ADES, or NDES to IS) varied linearly, with concentrations in the ranges of 0.1 mg/L to 2.0 mg/L (tears) and 0.01 mg/L to 2.0 mg/L (plasma) of AZI, ADES, and NDES; the correlation coefficient (r) was more than 0.994 mg/L for all of the compounds (n=6). The analysis of tear samples collected at different intervals within 12 hours to 144 hours after a dose of 20 mg/kg of AZI from a trachoma patient yielded concentrations ranging from 1.52 mg/L to 0.34 mg/L for AZI, 0.79 mg/L to 0.27 mg/L for ADES, and 1.99 mg/L to less than 0.20 mg/L for NDES. The concentration of AZI in plasma ranged from 0.15 mg/L to 0.01 mg/L, whereas ADES and NDES were undetectable.

Anti-Bacterial Agents↗
PubMed1998

Efficacy of azithromycin in the treatment of cyclosporine-induced gingival hyperplasia in renal transplant recipients.

BACKGROUND: Gingival hyperplasia (GH) is a common side effect of cyclosporine . Azithromycin (Zithromax; AZI) is a macrolide antibiotic reported in case studies to reduce cyclosporine-induced gingival hyperplasia (CIGH) in renal transplant recipients (RTR). METHODS: The efficacy of AZI to treat CIGH in RTR was examined in a double-blind, randomized crossover trial. Patients (n=17) with CIGH were randomized to receive AZI and a matching placebo in alternate order for 5 days, separated by a 2-week washout period. Follow-up visits were conducted at week 6 and week 12. Changes in GH were evaluated by measuring the clinical gingival sulcus depths, tooth length, and the length of the interdental papillae to the cementum-enamel junction of two teeth in each of the four quadrants. RESULTS: Significant improvements were observed in all three types of periodontal measurements, representing reductions of gingival tissue above the medial aspect of the tooth, of the gingival sulcus depth, and of the length of the interdental papillae. Patients reported an improvement in gum bleeding. AZI was well tolerated, and 67% of the patients reported that the treatment was at least somewhat useful. CONCLUSIONS: AZI should be considered for RTR with CIGH.

Adult↗
PubMed2004

Recurrent acute interstitial nephritis induced by azithromycin.

A 14-year-old girl is reported with recurrent, azithromycin-induced, acute interstitial nephritis. The second episode was more severe than the first; and although both were treated with intensive corticosteroid therapy, renal function remained impaired. Although most cases of antibiotic induced acute interstitial nephritis are benign and self-limited, some patients are at risk for permanent renal injury.

Acute Disease↗