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PubMed2001

Azithromycin-containing regimens for treatment of Mycobacterium avium complex lung disease.

Ninety-two patients were assessable in 3 consecutive, open, noncomparative, prospective, controlled, single-center trials of the use of multidrug regimens that contain azithromycin for treating pulmonary Mycobacterium avium complex (MAC) disease. Azithromycin was provided at a dose of 300-600 mg per day with oral companion drugs administered daily (regimen A, 29 patients); 600 mg 3 times weekly (t.i.w.), with oral companion drugs administered daily (regimen B, 20 patients); and 600 mg (t.i.w.), with oral companion drugs administered t.i.w. (regimen C, 43 patients). All regimens included rifabutin (or rifampin) and ethambutol as companion drugs as well as initial streptomycin. Treatment success was defined as 12 months of negative cultures while on therapy. Treatment failure was defined as sputum culture positivity after at least 6 months of therapy. Of the patients in each regimen who reached study end points, 17 of 29 (59%) were in regimen A, 11 of 20 (55%) were in regimen B, and 28 of 43 (65%) were in regimen C met the treatment success criterion. There were no statistically significant differences in outcome between the 3 regimens. These studies demonstrate the effectiveness of daily and t.i.w. regimens containing azithromycin for treatment of MAC lung disease.

Adult↗
PubMed1998

Randomized, open-label trial of azithromycin plus ethambutol vs. clarithromycin plus ethambutol as therapy for Mycobacterium avium complex bacteremia in patients with human immunodeficiency virus infection. Veterans Affairs HIV Research Consortium.

Disseminated Mycobacterium avium complex (MAC) infection continues to be a common opportunistic infection in patients infected with human immunodeficiency virus (HIV). The optimal therapy for disseminated MAC infection is unclear. We compared azithromycin plus ethambutol with clarithromycin plus ethambutol in the treatment of disseminated MAC infection in HIV type 1-infected patients, examining the frequency of bacteremia clearance, time to clearance, and study drug tolerance after 16 weeks of therapy. Fifty-nine patients for whom blood cultures were positive for MAC were enrolled in the study from 10 university-affiliated Veterans Affairs Medical Centers. Thirty-seven patients were evaluable for determination of quantitative bacteremia and clinical outcomes. Clearance of bacteremia was seen at the final visit in 37.5% of azithromycin-treated patients and in 85.7% of clarithromycin-treated patients (P = .007). The estimated median time to clearance of bacteremia was also significantly different between the two treatment arms: 4.38 weeks for clarithromycin recipients vs. > 16 weeks for azithromycin recipients (P = .0018). Only one isolate developed macrolide resistance during therapy. Abatement of symptoms, other laboratory-evident abnormalities, and adverse effects were similar in the two groups. At the doses used in this study, clarithromycin/ethambutol produced a more rapid resolution of bacteremia than did azithromycin/ethambutol, and clarithromycin/ethambutol was more effective at sterilization of blood cultures after 16 weeks of therapy.

AIDS-Related Opportunistic Infections↗
PubMed1998

Weekly oral azithromycin as prophylaxis for agents causing acute respiratory disease.

Since the 1950s the U.S. military has used intramuscular injections of benzathine penicillin G (BPG) to control outbreaks of respiratory disease. In an effort to find an alternative prophylaxis, a randomized field trial was conducted among 1,016 male U.S. Marine trainee volunteers at high risk for respiratory disease. Participants were evaluated for evidence of acute respiratory infection by serological tests on pretraining and posttraining sera (63 days apart). Oral azithromycin prophylaxis (500 mg/w) outperformed BPG, preventing infection from Streptococcus pyogenes (Efficacy [E] = 84%; 95% confidence interval [CI], 63%-93%), Streptococcus pneumoniae (E = 80%; 95% CI, 50%-92%), Mycoplasma pneumoniae (E = 64%; 95% CI, 25%-83%), and Chlamydia pneumoniae (E = 58%; 95% CI, 15%-79%) in comparison with results in a no-treatment group. Azithromycin group subjects reported few side effects and less respiratory symptoms than the BPG and no-treatment groups. According to serological tests, oral azithromycin is an effective alternative prophylaxis to BPG for military populations.

Administration, Oral↗
PubMed1994

Pilot study of azithromycin for treatment of primary and secondary syphilis.

Azithromycin has in vitro activity against Treponema pallidum and is effective against experimental syphilis in rabbits. We undertook an open, noncomparative pilot study of oral azithromycin (500 mg once daily for 10 days) to treat 16 patients with primary or secondary syphilis who were seronegative for human immunodeficiency virus. Cure was documented for 11 of 13 patients observed > or = 3 months; three patients were lost to follow-up. The serological response of one patient with secondary syphilis was indeterminate, and one patient with primary syphilis had either relapse or reinfection. Four patients had mild gastrointestinal side effects, and another patient had an episode of nausea and vomiting; all side effects occurred in the first 3 days and resolved spontaneously as treatment continued. Azithromycin shows promise as an alternative agent for treatment of early syphilis; controlled trials and assessment of other dosage regimens are indicated.

Administration, Oral↗
PubMed1996

Azithromycin activity against Mycobacterium avium complex lung disease in patients who were not infected with human immunodeficiency virus.

We initiated a prospective trial of an azithromycin-containing regimen for the treatment of human immunodeficiency virus-negative patients with Mycobacterium avium complex (MAC) lung disease; the initial 4 months of therapy were with azithromycin (600 mg/d) alone. The primary study endpoint was microbiological response measured at 4 and 6 months of therapy. Of 29 patients enrolled in the study, 23 completed therapy. Fifty-two percent of these 23 patients were male, and 65% were smokers. All 23 patients were older than 45 years of age; 83% had bilateral disease, and 48% had fibrocavitary disease. Macrolide (clarithromycin)-susceptible MAC isolates were recovered from these 23 patients before treatment. Cultures of sputum from 38% of these patients became negative, and the positivity of cultures of sputum from 76% of these patients was significantly reduced. Sixty-eight percent of sputum cultures were strongly positive (> 200 colonies) before therapy, while only 27% were strongly positive after therapy. Although most patients continued to receive 600 mg of azithromycin/d, the high incidence of gastrointestinal side effects (76%) and altered hearing (41%) suggests the need for lower or less frequent dosing. Macrolide (clarithromycin) resistance did not develop in any MAC isolates during monotherapy. These results, which demonstrate that azithromycin is active against MAC pulmonary disease, provide a rationale to include this drug in the initial multidrug regimens recommended for the treatment of this disease.

Aged↗
PubMed1997

A comparison of oral azithromycin with topical oxytetracycline/polymyxin for the treatment of trachoma in children.

Trachoma, an infectious keratoconjunctivitis caused by Chlamydia trachomatis, is a leading cause of preventable blindness in developing countries. In this study we compared oral azithromycin with oxytetracycline/polymyxin eye ointment (once daily for 5 days every 4 weeks; total of six treatment cycles) for the treatment of active endemic trachoma in 168 rural Egyptian children. A suspension of azithromycin was administered to children as a dose of 20 mg/kg by one of three schedules: a single dose, one dose a week for 3 weeks, and one dose every 4 weeks for a total of six doses. The children's clinical status and chlamydial infection rates were evaluated for 1 year. The clinical cure rates were 35% 2 months after initial treatment, 16% at 8 months (during the annual autumn epidemic of purulent conjunctivitis), and 47% at 1 year. The pretreatment chlamydial infection rate of 33% (determined by direct immunofluorescence) decreased to 5% at 2 months and was 9% at 12 months. There were no significant clinical or laboratory differences among the four treatment groups. Thus, 1-6 doses of azithromycin were equivalent to 30 days of topical oxytetracycline/polymyxin ointment and may offer an effective alternative means of controlling endemic trachoma.

Administration, Oral↗
PubMed1997

Relationship of adverse events to serum drug levels in patients receiving high-dose azithromycin for mycobacterial lung disease.

We treated 39 elderly human immunodeficiency virus-noninfected patients with Mycobacterium avium complex and/or Mycobacterium abscessus lung disease with azithromycin (600 mg daily), given initially as monotherapy. Adverse events occurred in 33 of 39 patients (85%) receiving azithromycin alone, most commonly gastrointestinal (GI) symptoms (32 of 39, or 82%) and hearing impairment (10 of 39, or 26%). Twenty-four of 39 patients (62%) required a lower dose or withdrawal of the drug. The mean serum level in patients who required a dose reduction because of hearing impairment was 0.8 +/- 0.4 microg/mL, and that in patients whose reduction was necessitated by GI symptoms was 0.7 +/- 0.4 microg/mL; in comparison, the mean serum level was 0.3 +/- 0.16 microg/mL in patients with no adverse events (P = .004 and .003, respectively). Decreasing the daily dose to 300 mg resulted in resolution of most adverse events. Serum levels with monotherapy were comparable to levels after the addition of other antituberculous drugs that included rifampin or rifabutin. Thus, a 300-mg rather than 600-mg daily dose of azithromycin is better tolerated by elderly patients, and serum levels appear unaffected by other antituberculous agents, including rifampin.

Adult↗
PubMed1995

Activities of clarithromycin, azithromycin, and ofloxacin in combination with liposomal or unencapsulated granulocyte-macrophage colony-stimulating factor against intramacrophage Mycobacterium avium-Mycobacterium intracellulare.

The effects of ofloxacin, clarithromycin, and azithromycin in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) against Mycobacterium avium-Mycobacterium intracellulare (MAI) were evaluated in an in vitro human macrophage infection model. Treatment of MAI-infected macrophages with GM-CSF alone induced a maximal killing effect at 1000 U/mL, and the potency was increased 100-fold by encapsulating the cytokine within liposomes. Antibiotics were applied at concentrations close to their clinically achievable serum trough and peak levels. Addition of GM-CSF to azithromycin and therapeutic trough concentrations of ofloxacin and clarithromycin was associated with significant (P < .01) augmentation of antimycobacterial activity compared with the effects of the agents alone. However, the enhancement effect by GM-CSF was not seen with therapeutic peak concentrations of ofloxacin and clarithromycin. Thus, GM-CSF may be a useful adjunct in the treatment of MAI infections with azithromycin, clarithromycin, and ofloxacin.

Azithromycin↗
PubMed1990

In-vitro activity of azithromycin against various Gram-negative bacilli and anaerobic bacteria.

The MICs of azithromycin, erythromycin and roxithromycin were determined (by an agar dilution method) for 65 strains of Gram-negative bacteria responsible for endocarditis and gastrointestinal infections, for 20 strains of non-fermenting Gram-negative bacteria and for 16 strains of anaerobic bacteria. The MICs of azithromycin were up to eight times lower than those of erythromycin and (except in the case of Flavobacterium spp.) up to 16 times lower than those of roxithromycin. Azithromycin was ineffective against strains showing a high degree of erythromycin resistance.

Azithromycin↗
PubMed1993

A comparison of the efficacy of azithromycin and clarithromycin in oral therapy of experimental airborne Legionnaires' disease.

The activities of two new macrolides, azithromycin and clarithromycin, were compared in an aerosol-infected guinea-pig model of legionnaires' disease. The results of this study indicate that a low oral dose of azithromycin (3.6 mg/kg) administered once daily gives 100% survival in Legionella pneumophila-infected animals. An eight-fold higher dose of clarithromycin (28.8 mg/kg) given twice-daily was required to achieve the same effect. Similarly, azithromycin was more effective than clarithromycin in preventing pyrexia and in reducing numbers of bacteria and lesions in the lung.

Administration, Inhalation↗
PubMed1993

Open study of the safety and efficacy of a single oral dose of azithromycin for the treatment of uncomplicated gonorrhoea in men and women.

An open, non-comparative study was undertaken to assess the safety and efficacy of a single 1 g oral dose of azithromycin in patients with uncomplicated gonorrhoea. One hundred and eighteen patients (105 male, 13 female) took part in the study. Only patients culture-positive for Neisseria gonorrhoeae were evaluated. The majority of male patients (84) had urethral gonorrhoea, but four had rectal and two pharyngeal infections. Four patients had positive cultures at more than one site (two urethral and rectal; two urethral and pharyngeal). All nine female patients had infection of the cervix only. Bacteriological eradication of N. gonorrhoeae was achieved in 76/82 (93%) patients with positive urethral cultures, 9/9 with positive cervical, 4/4 with positive rectal, and 2/2 with positive pharyngeal cultures. Twenty-two patients (18 males, four females) had concomitant chlamydial infection. Chlamydia trachomatis was eradicated in all patients who returned for follow-up assessment and in whom culture was done. Azithromycin was very well tolerated, with only two patients reporting mild-to-moderate side-effects. This study shows that single-dose azithromycin is effective in uncomplicated gonorrhoea and in mixed gonococcal and chlamydial infections.

Administration, Oral↗
PubMed1996

Drug interactions with azithromycin and the macrolides: an overview.

Evidence interactions between individual macrolides and a number of pharmacologically active compounds that are frequently co-administered to patients with bacterial infections is reviewed. Theophylline is strongly associated with erythromycin interaction; clarithromycin may also interact with this drug. Azithromycin, spiramycin and rokitamycin, however, do not appear to have any effect on theophylline pharmacokinetics. The other therapeutic agents considered are cyclosporin, the antiepileptics, carbamazepine and phenytoin, terfenadine, warfarin, oral contraceptives, agents used in the management of gastritis and peptic ulcer and zidovudine. With the exception of interaction with antacids, there is no evidence that azithromycin, unlike most other macrolides, interacts with any of these agents to produce clinically significant adverse effects. The explanation for this variation appears to be azithromycin's inability to induce and bind to the cytochrome P450 IIIA enzyme system.

Anti-Bacterial Agents↗
PubMed1996

Penetration of azithromycin into middle ear effusions in acute and secretory otitis media in children.

In an open-label study, the concentrations of azithromycin in middle ear effusions and plasma were determined in 29 children between 1 and 8 years of age with a diagnosis of either secretory otitis media of at least 1 month's duration or acute otitis media. Azithromycin (10 mg/kg) was administered as a single dose 12, 24 or 48 h before the insertion of tympanostomy tubes to 17 children with secretory otitis media and once daily for 5 days (10 mg/kg on day 1, 5 mg/kg on days 2-5) to 12 children with acute otitis media. In the 16 evaluable patients with secretory otitis media, azithromycin penetrated middle ear effusions, with group mean concentrations approximately two orders of magnitude greater than the concurrent plasma concentrations 12, 24 and 48 h after administration. Similar plasma:effusion ratios were found 24 and 48 h after starting once-daily therapy in 10 evaluable patients with acute otitis media.

Acute Disease↗
PubMed1997

Effect of combination therapy of rifampicin and azithromycin on TNF levels during a rat model of chronic osteomyelitis.

The purpose of the present study was to evaluate the combination of azithromycin and rifampicin on experimental chronic osteomyelitis due to Staphylococcus aureus. Alterations in bone bacterial titre, activity of tumour necrosis factor (TNF), a cytokine implicated in inflammation-induced bone pathology, and histopathological changes during infection and following antibiotic treatment were evaluated. Rats were infected with S. aureus by direct tibial inoculation and then randomized 56 days after infection to receive saline treatment or a combination of azithromycin and rifampicin (50 mg/kg po and 25 mg/kg sc respectively) once daily for 21 days. The combination of azithromycin and rifampicin was successful as determined by dramatic reduction in bone bacterial counts (approximately log 4 cfu), but regrowth of the organisms occurred suggesting that the duration of treatment was insufficient. TNF alpha mRNA and TNF activity were constantly elevated by approximately 20- and >200-fold, respectively, and remained elevated irrespective of antimicrobial treatment. Bone histology revealed extensive increase in bone turnover in both the infected and antibiotic treated bones with no difference being observed between the groups. This suggests that, in infected bone, the elevated TNF levels observed may be directly related to the bone pathology and both remain largely unchanged despite potent antibiotic therapy.

Animals↗
PubMed1997

Antimicrobial interference of a subinhibitory concentration of azithromycin on fimbrial production of Porphyromonas gingivalis.

The first pathogenic mechanism of Porphyromonas gingivalis, which is mainly responsible for adult periodontal diseases, is the attachment of fimbriae appendages to oral epithelial cells. The ability of a subinhibitory concentration of azithromycin to inhibit the expression of fimbriae in various strains of P. gingivalis isolated was investigated. A one-eighth subinhibitory concentration of azithromycin was evaluated in vitro. The antibiotic was active in 75% of P. gingivalis strains isolated, judged by both electrophoresis and transmission electron microscopy. The results indicate that the subinhibitory concentration of azithromycin is capable of blocking the pathogenic mechanism of P. gingivalis in vitro, and, therefore, can be used in vivo as a treatment for recurrent periodontitis.

Anti-Bacterial Agents↗
PubMed1998

Anti-anaerobic activity of erythromycin, azithromycin and clarithromycin: effect of pH adjustment of media to compensate for pH shift caused by incubation in CO2.

The activity of erythromycin, azithromycin and clarithromycin against 112 anaerobes was tested by the Oxyrase agar dilution MIC method at pH 7.2 without supplemental CO2 and by an agar dilution MIC method in CO2 with media adjusted to pH 8.0. MICs (mg/L) of erythromycin, azithromycin and clarithomycin against Bacteroides fragilis ATCC 25285 and Bacteroides thetaiotaomicron ATCC 29741 were similar by the two methods. MICs for 94 clinical isolates tested by the two methods were within two dilutions of each other. Eighteen additional isolates required CO2, and did not grow in Oxyrase. With the exception of fusobacteria, with which azithromycin yielded the lowest MICs, clarithromycin had the lowest MICs with both methods. These results show that the pH effect of incubation in CO2 can be avoided by using the Oxyrase method, or by incubating in CO2 with pH adjusted to 8.0. The latter method has the advantage of allowing testing of strains requiring CO2.

Anti-Bacterial Agents↗
PubMed1999

Comparative in-vitro activity of moxifloxacin, minocycline and azithromycin against Chlamydia spp.

The in-vitro activity of moxifloxacin, a new 8-methoxyquinolone, was compared with minocycline and azithromycin against 40 strains of Chlamydia trachomatis, Chlamydia pneumoniae and Chlamydia psittaci. Both the MIC and the MBC of moxifloxacin ranged from 0.03 to 0.125 mg/L. MICs of minocycline ranged from 0.015 to 0.06 mg/L and MBCs between 0.03 and 0.25 mg/L. MICs of azithromycin ranged from 0.03 to 0.125 mg/L and the MBCs between 0.06 and 0.5 mg/L. MBC values of moxifloxacin were the same as MICs in 32 (80%) of 40 strains tested, whereas those of minocycline and azithromycin were two to four times higher than their MICs. These data confirm those previously obtained indicating that quinolones kill chlamydial strains at concentrations equivalent to their MICs.

Anti-Bacterial Agents↗
PubMed2000

Activity of nitazoxanide alone and in combination with azithromycin and rifabutin against Cryptosporidium parvum in cell culture.

The in vitro activity of nitazoxanide alone and in combination with azithromycin and rifabutin was investigated against four clinical isolates of Cryptosporidium parvum. The susceptibility tests were performed by inoculation of the isolates on toe cell monolayers and determination of the parasite count after 48 h incubation at 37 degrees C. The culture medium was supplemented with Dulbecco's modified Eagle's medium containing serial dilutions of each agent. Antibiotic-free plates were used as controls. Experiments were performed in triplicate. Nitazoxanide showed moderate anticryptosporidial activity: it suppressed the growth of parasites by >50% at 8 mg/L. A parasite reduction of 79.8-83.9% was observed when nitazoxanide 8 mg/L was combined with azithromycin 8 mg/L and rifabutin 8 mg/L. The study suggests that nitazoxanide may be active in inhibiting C. parvum growth in vitro upon combination with azithromycin or rifabutin.

AIDS-Related Opportunistic Infections↗