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Treatment of early syphilis with azithromycin.

An open, noncomparative study was performed to establish the efficacy of azithromycin in the treatment of early syphilis. Sixteen patients were treated with oral azithromycin: 1g the first day and then 500 mg for the following 8 days. Two patients were excluded from the study, leaving 14 patients for the evaluation of the efficacy. Venereal Disease Research Laboratory (VDRL) negativity was observed in 3 out of 6 patients treated for primary syphilis after 3 months and in all patients after 6 months. Two of 8 patients treated for manifest or early latent secondary syphilis had VDRL negativity after 3 months and 4 patients after 6 months. This study demonstrates that azithromycin is effective in the treatment of early syphilis. Two patients experienced gastrointestinal side effects which did not require treatment interruption.

Administration, Oral↗

Efficacy of a three day course of azithromycin in moderately severe community-acquired pneumonia.

This study was designed to evaluate the efficacy of a 3 day course of azithromycin in low to moderately severe community-acquired pneumonia. Forty patients with low to moderately severe community-acquired pneumonia (29 males, 11 females, mean age 46 +/- 17 yrs; 20 pretreated with betalactams for 2-10 days with no results before admission to hospital; 18 with evidence of co-morbidity) were enrolled in an open, randomized study with azithromycin, 500 mg q.d. oral therapy for 3 days, versus clarithromycin, 250 mg b.i.d. oral therapy for 10 +/- 2 days. The aetiology of pneumonia was identified in 18 patients by serology (nine Mycoplasma pneumoniae, four Chlamydia pneumoniae, five Legionella pneumophila; one patient with chlamydial infection also had Klebsiella pneumoniae bacteraemia). A presumptive aetiological diagnosis was obtained with sputum culture in three other patients (one Haemophilus influenzae, two Haemophilus parainfluenzae), all strains were sole isolates with 10(8) Colony forming units (CFU), and with Gram stain in one patient with Streptococcus pneumoniae. All patients in the azithromycin group (one after a second 3 day course), and all but two (of those available for evaluation) of the clarithromycin group were cured. Defervescence occurred after 2.6 +/- 1.6 days, and chest roentgenogram cleared after 8.9 +/- 3.3 days, with no difference between the two groups. Tolerance was good, and there were no withdrawals from therapy.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Azithromycin in the prophylaxis of opportunistic infections in AIDS.

Prevention of opportunistic infections contributes to improved quality of life and survival in individuals with acquired immunodeficiency syndrome (AIDS). Agents which are more effective and convenient, less costly, and better tolerated are needed for multiple organism primary prophylaxis. Azithromycin, azalide with high and prolonged intracellular levels, promise to provide to protection against Mycobacterium avium complex (MAC) disease in those with advanced AIDS when given weekly. A large trail comparing rifabutin (300 mg daily), a currently approved primary prophylactic agent for MAC, with azithromycin (1200 mg weekly) has been completed and is under analysis. If weekly azithromycin provides equivalent or better protection from disseminated MAC, the cost effectiveness and convenience of MAC prophylaxis may be improved.

AIDS-Related Opportunistic Infections↗

Treatment of chancroid with azithromycin.

A randomized, comparative study undertaken in Nairobi, Kenya and a non-comparative evaluation undertaken in Carletonville, South Africa have both shown that a single oral dose of azithromycin 1 g is effective in the treatment of the genital ulcer disease (GUD), chancroid, with cure rates of 89% and 92% recorded respectively. While treatment failure was associated with human immunodeficiency virus seropositivity and lack of circumcision in Kenya, no such association could be found in the South African study. In both series, azithromycin treatment resulted in cure of both Haemophilus ducreyi culture-positive and culture-negative cases of GUD, including two cases subsequently diagnosed as lymphogranuloma venereum. A combination of single-dose azithromycin with single-dose benzathine penicillin may provide effective 'single-visit' syndromic treatment for GUD in many developing countries.

Anti-Bacterial Agents↗

Treatment of syphilis with azithromycin.

The efficacy of oral azithromycin (500 mg daily for 10 days or 500 mg on alternate days for 11 days) in 100 patients with seropositive syphilis was studied. Clinical manifestations regressed more rapidly in azithromycin-treated patients compared with patients who received erythromycin or penicillin, and there was also a more rapid reduction in serum antibody levels. In 90.3% of patients, the complete resolution of classic serological tests was observed within 4 months of completion of the azithromycin treatment. The immobilization (TPI) test and absorbed fluorescent treponema antibody tests became negative 12 months after treatment in 40% of patients. After 4 years of follow-up, no symptoms of neurosyphilis or syphilitic changes of visceral organs were observed.

Administration, Oral↗

Azithromycin as the first-line treatment of non-gonococcal urethritis (NGU): a study of follow-up rates, contact attendance and patients' treatment preference.

AIMS: To identify any differences in follow-up rates or sexual contact attendance rates in men presenting with non-gonococcal urethritis (NGU) after treatment by single dose azithromycin rather than longer standard duration therapies and to identify patients' treatment preferences. METHODS: A prospective study was performed on 200 consecutive men attending a genito-urinary medicine (GUM) clinic with new episode, microscopically confirmed NGU. The first 100 patients were treated with standard duration therapy (Group S) whilst the second 100 patients received a single 1 g oral dose of azithromycin (Group A). Patient-led contact tracing was arranged and patients were asked to return for review when a test of cure was performed, contact attendance noted and the patient's treatment preference ascertained. RESULTS: Both groups were predominantly heterosexual and over 60% gave a history of previous sexually transmitted disease (STD). There were no significant differences in efficacy between Groups S and A. However, the index follow-up rate and percentage of traceable sexual contacts attending was higher in Group A. In both groups contacts of homosexual men were more likely to attend the GUM clinic. More additional visits were made by Group S due to mislaid medication or compliance problems. Over 70% of patients questioned expressed a preference for single dose therapy. CONCLUSION: Single dose therapy with 1 g of azithromycin is as efficacious as longer duration therapies with advantages in patient follow-up rates and contact attendance and for the majority of patients would be their treatment of choice. A cost analysis supports the practical application of this regimen.

Adult↗

Pilot studies of azithromycin, letrazuril and paromomycin in the treatment of cryptosporidiosis.

Pilot studies of the safety and efficacy of 3 drugs thought to have anticryptosporidial activity were carried out to determine whether any of them are suitable for large-scale clinical trials. Open studies of the use of azithromycin, letrazuril and paromomycin in patients with acquired immunodeficiency syndrome (AIDS) and confirmed cryptosporidial diarrhoea for at least a month. Azithromycin 500 mg daily was ineffective. Letrazuril 150-200 mg daily was associated with an improvement in symptoms in 40% of patients treated and cessation of excretion of cryptosporidial oocysts in the stool in 70%; however biopsies remained positive. Paromomycin therapy was associated with a complete resolution of diarrhoea in 60% of patients treated and some improvement in symptoms in a further 5% but it did not eliminate the infection. None of the drugs had any major toxicities. Dose escalation studies of azithromycin should be performed. Letrazuril should be further investigated for efficacy in double-blind placebo-controlled trials. Paromomycin appears to result in prolonged symptomatic remission of cryptosporidial diarrhoea, but has no effect on cryptosporidial cholangitis.

AIDS-Related Opportunistic Infections↗

Presence of macrolide resistance in respiratory flora of HIV-Infected patients receiving either clarithromycin or azithromycin for Mycobacterium avium complex prophylaxis.

Clarithromycin 500 mg po bid or azithromycin 1200 mg po weekly is recommended as first line prophylaxis for Mycobacterium avium complex (MAC) in patients with HIV infection whose CD4 counts are <50 cells/microL. HIV-infected patients with CD4+ T-cell counts <200 cells/microL were randomized to receive either clarithromycin 500 mg po bid or azithromycin 1200 mg po weekly for 12 weeks. Nasopharyngeal swabs for Streptococcus pneumoniae and Haemophilus influenzae plus an anterior nare culture for Staphylococcus aureus were obtained at pretreatment, at 6 weeks, and at 12 weeks. A throat culture for oral flora was obtained for susceptibility testing against erythromycin. Minimum inhibitory concentrations (MICs) for clarithromycin and azithromycin were performed on all S. pneumoniae, H. influenzae, and S. aureus isolates. The study was terminated after respiratory flora, from all participants, revealed macrolide resistance. Because results of recent randomized trials indicate minimal efficacy of continuing MAC prophylaxis in patients who respond to potent combination antiretroviral therapy, the observed high incidence of macrolide-resistant bacterial colonization of the respiratory tract in this trial supports the discontinuation of macrolide prophylaxis in all AIDS patients whose CD4 counts have risen above 100 cells/microL.

AIDS-Related Opportunistic Infections↗

Azithromycin and lower respiratory tract infections.

Azithromycin is a macrolide antibiotic that has been structurally modified from erythromycin with an expanded spectrum of activity and improved tissue pharmacokinetic characteristics relative to erythromycin. This allows once-daily administration for 3-5 days of treatment compared with traditional multi dosing 7-10-day treatment regimens. It has been successfully employed in lower respiratory tract infections. Recent data indicate that azithromycin may exert anti-inflammatory/immunomodulatory effects that may be of use in the treatment of both acute and chronic airway diseases. This review examines the role of azithromycin in lower respiratory tract infections analysing published data on exacerbations of chronic bronchitis, community-acquired pneumonia and cystic fibrosis both in adults and children. In addition, pharmacokinetic and pharmacodynamic properties of the drug are also considered.

Adult↗

Azithromycin in the treatment of mucosal leishmaniasis.

This report describes three elderly patients with mucosal form of American tegumentary leishmaniasis associated with chronic cardiopathy. Due to the known toxicity of classical drugs with activity against Leishmania sp., the patients received three oral courses of azithromycin therapy in single 500 mg daily dose during ten days, every other month. All lesions healed after the third series. One of the patients relapsed and a new series of azithromycin was prescribed. Azithromycin may be an alternative drug for the treatment of leishmaniasis in special situations due to its optimal mucosal and intraphagocyte concentration, single daily posology, high tolerance and oral administration. The mechanism of this drug on Leishmania sp. is unknown at present.

Aged↗

[Evaluation of the efficacy of azithromycin and pyrimethamine, for treatment of experimental infection of mice with Toxoplasma gondii cystogenic strain].

The efficacy of prolonged administration of azithromycin and pyrimethamine was evaluated in mice experimentally infected with cystogenic strain of Toxoplasma gondii. The animals were intraperitoneally inoculated with one cyst of T. gondii and after 20 days were allocated into four groups: GI, infected without treatment; GII, infected and treated with the association of pyrimethamine (12.5 mg/kg/day) and azithromycin (100 mg/kg/day); GIII, infected and treated with the same dose of pyrimethamine; and GIV, infected and treated in the same way with azithromycin. The oral treatment lasted 120 days, after this period all the animals were sacrificed and the count of cysts in the brain was done. The association of both drugs provided the best results, by diminishing the cyst count in the brain of the animals treated in this way.

Animals↗

Potential interaction between azithromycin and warfarin.

Azithromycin is considered unlikely to interact with warfarin. Unlike other macrolide antibiotics, it is not hepatically metabolized and did not produce an interaction with warfarin in a single-dose study. A 71-year-old woman with a prosthetic heart valve, stabilized with warfarin, had international normalized ratios (INRs) maintained between 2.5 and 3.5. Six days after she received a prescription for a 5-day course of azithromycin, her INR was 15.16. Phytonadione 10 mg was administered subcutaneously, and warfarin was held for 3 days until her INR fell to 2.10. She then was restabilized with warfarin. Until more information is known about the safety of warfarin and azithromycin, caution is advised when the agents are given together. Close monitoring of INR is recommended, and warfarin dosage adjustment may be necessary.

Aged↗

Intravenous azithromycin-induced ototoxicity.

Intravenous azithromycin is increasingly administered for treatment of hospitalized patients with community-acquired pneumonia. Macrolide antibiotics cause ototoxicity, which occurs most frequently when high serum concentrations are achieved. Current dosing guidelines for intravenous azithromycin can result in much higher serum concentrations than is seen with oral administration. We describe a 47-year-old woman who developed complete deafness after receiving 8 days of intravenous azithromycin.

Anti-Bacterial Agents↗

Efficacy of azithromycin dihydrate in treatment of cryptosporidiosis in naturally infected dairy calves.

The objective of this study was to evaluate the therapeutic efficacy of azithromycin treatment of cryptosporidiosis in naturally infected calves under field conditions. Fifty Holstein calves with cryptosporidiosis infection were divided into 5 groups: 1 group (10 calves) was unmedicated and served as the control group and was given distilled water only, whereas the other groups (10 animals per group) were medicated orally with azithromycin at the doses of 500 (group 1), 1,000 (group 2), 1,500 (group 3), and 2,000 mg (group 4) PO once daily for 7 days. The animals were examined clinically and fecal samples were collected on the 1st (inclusion day), 7th, 14th, and 21st days of the study. Drug efficacy was assessed by evaluating diarrhea, oocyst shedding, and weight gains from days 1 to 21 (4 assessments). Significant differences were observed in reductions of oocyst shedding (P < .05) and the fecal diarrhea incidence (P < .05) in groups 3 and 4 when compared with groups 1 and 2 and the control group. Weight gain of medicated calves was significantly higher than that of the unmedicated calves throughout the study (P < .05). The drug significantly suppressed oocyst shedding and resulted in significant improvements in clinical signs. Therefore, this suppression may have significant effect on the reduction of environmental contamination by cryptosporidial oocysts. From the economic point view, authors suggest that the most effective dose of azithromycin for the treatment of cryptosporidiosis in calves should be at 1,500 mg/d for 7 days.

Animals↗

Azithromycin for treatment of community acquired pneumonia caused by Legionella pneumophila: a retrospective study.

A clinical, retrospective and non-comparative study was undertaken to assess the clinical efficacy and tolerability of azithromycin in the treatment of community-acquired pneumonia caused by Legionella pneumophila. A total of 16 patients with a serologically confirmed diagnosis of Legionnaires' diseases were included. Azithromycin was administered orally at a total dose of 1.5 g for either 3 or 5 days. All patients were no side-effects requiring discontinuation of the treatment. Further increase of abnormal baseline liver function was recorded in 2 patients and in 1 patient mild, transient eosinophilia. Equal clinical efficacy and tolerability were observed with the 3- and 5-day dosage regimen. These results indicate that azithromycin given at a standard dose of 1.5 g is effective and well tolerated in the treatment of Legionnaires' disease.

Adult↗

Accumulation and clearance of orally administered erythromycin and its derivative, azithromycin, in juvenile fall chinook salmon Oncorhynchus tshawytscha.

Fall Chinook salmon Oncorhynchus tshawytscha were fed practical diets medicated with azithromycin (30 mg kg(-1) fish for 14 d) or erythromycin (100 mg kg(-1) fish for 28 d) either 1, 2, or 3 times beginning 14 d after initiation of exogenous feeding (February) and ending at smoltification (June). Average tissue concentrations of azithromycin increased from 19.0 microg g(-1) in fry to 44.9 microg g(-1) in smolts, and persisted in the tissues > 76 d after treatment ceased. Tissue concentrations of erythromycin were comparatively low, ranging from 0.2 microg g(-1) in fry to 10.4 microg g(-1) in smolts. Erythromycin was not detectable 21 d post-treatment. Neither antibiotic caused histopathologically significant lesions in the trunk kidney or other organ tissues. The high tissue concentrations and prolonged retention of azithromycin in Chinook may be factors that increase the efficacy of the antibiotic against Renibacterium salmoninarum, compared with erythromycin, particularly in early life history stages before covertly infected fish show clinical signs of disease.

Administration, Oral↗

Azithromycin in one week quadruple therapy for H pylori eradication in Iran.

AIM: To investigate eradication rates, patient compliance and tolerability of a 1-wk Azithromycin-based quadruple therapy versus the 2-wk conventional therapy. METHODS: A total of 129 H pylori-positive patients were randomized to either omeprazole 20 mg, bismuth subcitrate 240 mg, azithromycin 250 mg, and metronidazole 500 mg, all twice daily for 1-wk (B-OAzM) or omeprazole 20 mg, bismuth subcitrate 240 mg, amoxicillin 1 g, and metronidazole 500 mg all twice daily for 2-wk (B-OAM). H pylori infection was defined at entry by histology and rapid urease test and cure of infection was determined by negative urea breath test. RESULTS: H pylori eradication rates produced by B-OAzM and B-OAM were 74.1% and 70.4% respectively based on an intention to treat analysis, and 78.1% versus 75.7% respectively based on a per-protocol analysis. The incidence of poor compliance was lower, although not significantly so, in patients randomized to B-OAzM than for B-OAM (3.5% versus 4.3%) but intolerability was similar in the two groups ( 35% versus 33.3%). CONCLUSION: 1-wk azithromycin based quadruple regimen achieves an H pylori eradication rate comparable to that of standard 2-wk quadruple therapy, and is associated with comparable patient compliance and complications.

Adolescent↗

Azithromycin in a triple therapy for H.pylori eradication in active duodenal ulcer.

AIM: To assess and compare the efficacy and safety of two triple regimes: A) metronidazole, amoxicillin and omeprazole, which is still widely used in Russia, and B) azithromycin, amoxicillin and omeprazole in healing active duodenal ulcer and H.pylori eradication. METHODS: 100 patients with active duodenal ulcer were included in the open, multicentre, randomized study with comparative groups. Patients were randomly assigned to one of the following one-week triple regimes: A) metronidazole 500 mg bid, amoxicillin 1 g bid and omeprazole 20 mg bid (OAM, n=50) and B) azithromycin 1 g od for the first 3 days (total dose 3 g), amoxicillin 1 g bid and omeprazole 20 mg bid (OAA, n=50). Omeprazole 20 mg od was given after the eradication course as a monotherapy for three weeks. The control endoscopy was performed 8 weeks after the entry. H.pylori infection was determined in the entry of the study and four weeks after the cessation of treatment by means of histology and CLO-test. RESULTS: 97 patients completed the study according to the protocol (1 patient of the OAM group did not come to the control endoscopy, 2 patients of the OAA group stopped the treatment because of mild allergic urticaria). Duodenal ulcers were healed in 48 patients of the OAM group (96 %; CI 90.5-100 %) and in 46 patients of the OAA group (92 %; CI 89.5-94.5 %) (p=ns). H.pylori infection was eradicated in 15 out of 50 patients with OAM (30 %; CI 17-43 %) and in 36 out of 50 patients treated with OAA (72 %; CI 59-85 %) (P<0.001)- ITT analysis. CONCLUSION: The triple therapy with omeprazole, amoxicillin and metronidazole failed to eradicate H.pylori in the majority of patients, which is an essential argument to withdraw this regimen out of the national recommendations. Macrolide with amoxicillin are preferable to achieve higher eradication rates. Azithromycin (1 g od for the first 3 days) can be considered as a successful component of the triple PPI-based regimen.

Adolescent↗