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PubMed2003

No clinically significant effect of erythromycin or azithromycin on the pharmacokinetics of voriconazole in healthy male volunteers.

AIMS: The antibiotic erythromycin is a potent inhibitor of cytochrome P450 CYP3A4 metabolism. As CYP isozymes, including CYP3A4, are involved in the metabolism of the new triazole voriconazole, this study investigated the effects of multiple-dose erythromycin or azithromycin on the steady-state pharmacokinetics of voriconazole in healthy male subjects. METHODS: In an open, randomized, parallel-group, single-centre study, 30 healthy male subjects aged 20-41 years received oral voriconazole 200 mg twice daily for 14 days plus either erythromycin (1 g twice daily on days 8-14), azithromycin (500 mg once daily on days 12-14) or placebo (twice daily on days 8-14). Only morning doses were administered on day 14. Plasma concentrations of voriconazole were measured up to 12 h postdose on days 7 and 14, and plasma pharmacokinetic parameters were calculated. Adverse events and standard laboratory test results were recorded before and throughout the study. RESULTS: Comparison of the voriconazole Cmax day 14/day 7 ratio for the voriconazole + erythromycin group with that of the voriconazole + placebo group yielded a ratio of 107.7%[90% confidence interval (CI) 90.6, 128.0]; for the voriconazole + azithromycin group, the ratio was 117.5% (90% CI 98.8, 139.7). Comparison of the voriconazole AUCtau day 14/day 7 ratios of the voriconazole + erythromycin and voriconazole + azithromycin groups with that of the voriconazole + placebo group showed ratios of 101.2% (90% CI 89.1, 114.8) and 107.9% (90% CI 95.1, 122.4), respectively. For voriconazole tmax, the differences between the day 14-day 7 calculations for the voriconazole + erythromycin or the voriconazole + azithromycin groups and that of the voriconazole + placebo group were - 0.2 h (90% CI - 0.8, 0.3) and - 0.1 h (90% CI - 0.7, 0.5), respectively. None of these changes was considered clinically relevant. The study drugs were well tolerated by subjects in all groups; the most common study drug-related adverse events were visual disturbances, reported in all groups, and abdominal pain, present in the voriconazole + erythromycin group. CONCLUSIONS: Coadministration of erythromycin or azithromycin does not affect the steady-state pharmacokinetics of voriconazole in a clinically relevant manner in healthy male subjects.

Adult↗
PubMed2003

The efficacy of azithromycin in the treatment of acute infraorbital space infection.

PURPOSE: In this study, we aimed to evaluate the role of azithromycin in the treatment of acute infraorbital space infection. MATERIALS AND METHODS: Sixty patients (39 men and 21 women; age range, 18 to 47 years) who had acute infraorbital space infection with pain, swelling, and general malaise were included in the study. After initial surgical therapy, patients were randomly allocated to receive either 500 mg azithromycin once daily for 3 days, 250 mg erythromycin stearate every 6 hours for 3 days, or no antibiotic. Patients were assessed at the time of admission and after 1, 2, 3, and 7 days. Pain, swelling, cervical lymphadenopathy, and sublingual temperature were assessed at each visit. Data were collected, and all groups were compared for differences in pain and swelling using the Mann-Whitney U test and for differences in lymphadenopathy and sublingual temperature using Fisher's exact test. RESULTS: At the time of admission, no 2 groups were statistically different at the.05 level in relation to age, gender, and presenting clinical signs or symptoms. At days 2 and 3, patients who received azithromycin had a significant reduction in pain (P =.002 and P =.02, respectively) and swelling (P =.001 and P =.013, respectively) compared with those who received no antibiotic. At day 3, patients who received erythromycin had a significant reduction in pain (P =.03) and swelling (P =.046) compared with those who received no antibiotic. In a comparison of the patients who received azithromycin with those who received erythromycin, there was no significant difference (P >.05) in the reduction of pain at any time of the study. However, at day 2, patients who received azithromycin had a significantly greater reduction in swelling (P =.002) than those who received erythromycin. In relation to the percentage of the patients with cervical lymphadenopathy and raised sublingual temperature (>37.2 degrees C), no 2 groups were statistically different at any time of the study. After 3 days of treatment, patients who received the antibiotics were clinically improved, and all patients (n = 60 patients) reviewed after 7 days had resolution of their clinical signs and symptoms. CONCLUSION: This study emphasizes the importance of surgical drainage and proves that both azithromycin and erythromycin are effective adjunctive treatments in the therapy of relatively mild odontogenic orofacial infections.

Adolescent↗
PubMed2000

Atovaquone and azithromycin for the treatment of babesiosis.

BACKGROUND: Babesiosis is a tick-borne, malaria-like illness known to be enzootic in southern New England. A course of clindamycin and quinine is the standard treatment, but this regimen frequently causes adverse reactions and occasionally fails. A promising alternative treatment is atovaquone plus azithromycin. METHODS: We conducted a prospective, nonblinded, randomized trial of the two regimens in 58 subjects with non-life-threatening babesiosis on Nantucket, on Block Island, and in southern Connecticut. The subjects were assigned to receive either atovaquone (750 mg every 12 hours) and azithromycin (500 mg on day 1 and 250 mg per day thereafter) for seven days (40 subjects) or clindamycin (600 mg every 8 hours) and quinine (650 mg every 8 hours) for seven days (18 subjects). RESULTS: Adverse effects were reported by 15 percent of the subjects who received atovaquone and azithromycin, as compared with 72 percent of those who received clindamycin and quinine (P<0.001). The most common adverse effects with atovaquone and azithromycin were diarrhea and rash (each in 8 percent of the subjects); with clindamycin and quinine the most common adverse effects were tinnitus (39 percent), diarrhea (33 percent), and decreased hearing (28 percent). Symptoms had resolved three months after the start of therapy in 65 percent of those who received atovaquone and azithromycin and 73 percent of those who received clindamycin and quinine (P=0.66), and after six months no patient in either group had symptoms. Three months after the completion of the assigned regimen, no parasites could be seen on microscopy, and no Babesia microti DNA was detected in the blood of any subject. CONCLUSIONS: For the treatment of babesiosis, a regimen of atovaquone and azithromycin is as effective as a regimen of clindamycin and quinine and is associated with fewer adverse reactions.

Adult↗
PubMed2006

Single-dose azithromycin for the treatment of cholera in adults.

BACKGROUND: Single-dose azithromycin is effective in the treatment of severe cholera in children, but its effectiveness in adults has not been evaluated. METHODS: We conducted a double-blind, randomized trial comparing the equivalence of azithromycin and ciprofloxacin (each given in a single 1-g dose of two 500-mg tablets) among 195 men with severe cholera caused by Vibrio cholerae O1 or O139. Patients were hospitalized for five days. A stool culture was performed daily. Primary outcome measures were clinical success (the cessation of watery stools within 48 hours after drug administration) and bacteriologic success (the inability to isolate V. cholerae after 48 hours). RESULTS: Therapy was clinically successful in 71 of 97 patients receiving azithromycin (73 percent) and in 26 of 98 patients receiving ciprofloxacin (27 percent) (P<0.001) and bacteriologically successful in 76 of 97 patients receiving azithromycin (78 percent) and in 10 of 98 patients receiving ciprofloxacin (10 percent) (P<0.001). Patients who were treated with azithromycin had a shorter duration of diarrhea than did patients treated with ciprofloxacin (median, 30 vs. 78 hours); a lower frequency of vomiting (43 percent vs. 67 percent); fewer stools (median, 36 vs. 52); and a lower stool volume (median, 114 vs. 322 ml per kilogram of body weight). The median minimal inhibitory concentration of ciprofloxacin for the 177 isolates of V. cholerae O1 was 0.25 mug per milliliter, which was 11 to 83 times as high as that in previous studies at this site. CONCLUSIONS: Single-dose azithromycin was effective in the treatment of severe cholera in adults. The lack of efficacy of ciprofloxacin may result from its diminished activity against V. cholerae O1 strains currently circulating in Bangladesh. (ClinicalTrials.gov number, NCT00229944.).

Adult↗
PubMed2001

A comparative study of azithromycin and pseudoephedrine hydrochloride for otitis media with effusion in children.

We compared the outcomes of two different regimens--azithromycin and pseudoephedrine hydrochloride (PHCl)--for the treatment of otitis media with effusion (OME) in children. In a double-blind randomized clinical study, a total of 90 children aged between 2 and 13 years with persistent OME were randomly assigned to one of 3 treatment groups. The first group received azithromycin at a dose of 10 mg/kg once daily for 3 days and this regimen was repeated weekly for up to 12 weeks according to the results of tympanometry and pneumatic otoscopy. The second group received azithromycin at a dose of 10 mg/kg once daily for 3 days for the first week, and this regimen was repeated for 1 day a week for the following 11 weeks. The third group received PHCl, 4 mg/kg, 3 times daily for up to 12 weeks. Each patient underwent pneumatic otoscopic and tympanometric investigations at baseline and at Weeks 4, 8 and 12. The outcomes in the azithromycin-treated groups were superior to that in the decongestant group. However, the difference between the outcomes in the azithromycin groups according to the treatment protocol was not statistically significant. Azithromycin therapy, particularly a once-weekly regimen, helps patients to comply with treatment and also helps us to achieve good results with minimal therapy.

Acoustic Impedance Tests↗
PubMed2004

Intermittent azithromycin treatment for respiratory symptoms in patients with chronic Chlamydia pneumoniae infection.

Chlamydia pneumoniae (Cpn) is a common respiratory pathogen with a biphasic replicative cycle and has a tendency to cause chronic infections. Azithromycin is commonly used for the treatment of Cpn infections, but little is known about the optimal dose and duration of therapy. In this prospective double-blind, randomized study the effects of azithromycin and placebo were compared regarding longstanding airway and/or pharyngeal symptoms in patients with chronic Cpn infection. Further, effects on antibody titres and lung function were assessed. 103 patients were treated with either azithromycin 500 mg daily for 5 d, repeated 3 times with a 23-d interval, or placebo. Patients were examined 4 months and 1 y after completed treatment. Evaluation of symptoms showed general improvement and less hawking in patients treated with azithromycin compared to placebo after 4 months, but there was no sustained difference 1 y after completed treatment. The antibody titres remained stable, and there was no influence on lung function. Adverse events, primarily gastrointestinal, were more frequently reported with azithromycin than placebo. In conclusion, azithromycin was effective for reduction of respiratory symptoms in patients with chronic Cpn infection, but prolonged intermittent treatment with high doses did not eradicate the chronic infection.

Anti-Bacterial Agents↗
PubMed2003

Azithromycin found to be comparable to levofloxacin for the treatment of US travelers with acute diarrhea acquired in Mexico.

Increased drug resistance among enteropathogens is an emergent problem in travelers' diarrhea. This randomized, double-blind trial was conducted in Guadalajara, Mexico, during the summers of 1999-2001 to compare azithromycin with levofloxacin for the treatment of travelers' diarrhea. A total of 217 US adults were randomized to receive a single oral dose of azithromycin (1000 mg; 108 persons) or levofloxacin (500 mg; 109 persons), with a follow-up period of 4 days. Three patients in each group dropped out of the study. The median time between initiation of therapy and passage of the last unformed stool (azithromycin group, 22.3 h; levofloxacin group, 21.5 h) and the number of unformed stools passed during the 4-day follow-up period (azithromycin group, 6.5; levofloxacin group, 5.5) were similar. Treatment failure occurred in 10 patients (9.5%) receiving azithromycin and 8 patients (7.5%) receiving levofloxacin. Possible minor, self-limiting adverse events occurred in 57 patients in each treatment group. Azithromycin was found to be a safe and effective alternative to levofloxacin for the treatment of acute travelers' diarrhea in US adult travelers to Mexico.

Adult↗
PubMed2004

Short-course azithromycin for the treatment of uncomplicated typhoid fever in children and adolescents.

We studied 149 children and adolescents 3-17 years of age with clinical typhoid fever who were treated with either oral azithromycin (20 mg/kg per day; maximum dose, 1000 mg/day) or intravenous ceftriaxone (75 mg/day; maximum dose, 2.5 g/day) daily for 5 days. Blood and stool specimens were obtained for culture before the initiation of therapy and were repeated on days 4 and 8 of treatment. Isolation of Salmonella enterica serovar Typhi or S. enterica serovar Paratyphi from the initial culture was required for inclusion in the final analysis. S. Typhi was isolated from 68 patients, 32 of whom were receiving azithromycin. Cure was achieved in 30 (94%) of 32 patients in the azithromycin group and in 35 (97%) of 36 patients in the ceftriaxone group (P=NS). Mean time to clearance of bacteremia was longer in the azithromycin group than in the ceftriaxone group. No patient who received azithromycin had a relapse, compared with 6 patients who received ceftriaxone. A 5-day course of azithromycin was found to be an effective treatment for uncomplicated typhoid fever in children and adolescents.

Adolescent↗
PubMed2005

A multicenter study of azithromycin, alone and in combination with chloroquine, for the treatment of acute uncomplicated Plasmodium falciparum malaria in India.

BACKGROUND: Azithromycin has demonstrated in vitro and in vivo activity against Plasmodium falciparum, but small treatment studies have given mixed results. METHODS: Participants with fever and with both a blood smear and a rapid diagnostic test positive for falciparum malaria were randomly assigned to groups that were treated with either azithromycin or chloroquine or to matched groups receiving a placebo. After an interim analysis, open-label combination therapy with both drugs was initiated. RESULTS: At day 28, 5 (33%) of 15 participants in the azithromycin-treated group had remained free of fever, compared with 4 (27%) of 15 in the chloroquine-treated group. All subsequently enrolled participants then received combination therapy with azithromycin and chloroquine. In 61 (97%) of 67 participants, resolution of fever and parasitemia had occurred by day 7, and, through day 28, no clinical or parasitologic relapse had occurred in them. CONCLUSIONS: Resolution of parasitemia was inadequate with monotherapy with either azithromycin or chloroquine, but combination therapy provided substantially improved clinical and parasitologic outcomes. The combination of azithromycin and chloroquine may be an effective alternative treatment for falciparum malaria and deserves further study.

Adolescent↗
PubMed1999

Azithromycin versus erythromycin for community-acquired pneumonia: a cost-minimization analysis.

The costs of i.v. erythromycin versus azithromycin (in terms of medication use and treatment of adverse effects) when these drugs were used with other antimicrobials to treat community-acquired pneumonia (CAP) were compared. The medical records of patients receiving i.v. azithromycin or erythromycin as part of combination antimicrobial therapy for the treatment of CAP at a 473-bed level 1 trauma center in Kentucky were retrospectively reviewed. Data were collected for patients treated from December 1, 1997, through March 31, 1998. Patient data collected included occurrence of phlebitis or pain at the injection site, number of line changes due to phlebitis, and culture results. Cost data collected included drug acquisition cost, pharmacy cost of drug preparation, nursing time to administer the agent, cost of drug supplies, and cost of managing complications. Three time-and-motion studies were conducted to determine technician preparation time and pharmacist verification time. The medical records of 62 patients were identified and reviewed; 50 patients were enrolled in the study (25 in the azithromycin group and 25 in the erythromycin group). The average total days of therapy was 5.1 for the azithromycin group and 5.6 for the erythromycin group. The average total cost, including the cost of complications ($4.36 per patient in the erythromycin group), was $66.46 in the azithromycin group and $96.56 in the erythromycin group. The difference in costs between the two groups was not significant. There was no significant cost difference between azithromycin- and erythromycin-containing combination antimicrobial therapy in the treatment of CAP.

Anti-Bacterial Agents↗
PubMed1991

Activity of azithromycin against cryptosporidia in immunosuppressed rats.

Dexamethasone-immunosuppressed rats infected with Cryptosporidium parvum were used to assess the macrolides azithromycin and spiramycin for anticryptosporidial activity. Azithromycin consistently prevented ileal infection, while spiramycin was ineffective. The anticryptosporidial activity of azithromycin was dose-related, 200 mg/kg/day being the minimum dose that prevented infection. Therapeutically, azithromycin eliminated an established overt infection of the small intestine in immunosuppressed rats, but the infection recurred after azithromycin treatment was stopped. These findings suggest that azithromycin is a potentially useful anticryptosporidial agent and that long-term continuous administration may be necessary to treat cryptosporidiosis in the immunocompromised host.

Animals↗
PubMed1990

Efficacy of azithromycin in the treatment of guinea pigs infected with Legionella pneumophila by aerosol.

Azithromycin and erythromycin were compared for efficacy in guinea pigs infected with an aerosol containing Legionella pneumophila. When administered intraperitoneally, azithromycin was very effective in the treatment of experimental Legionnaires' disease. Even at the low dose of 3.6 mg/kg/day it gave 100% survival and eliminated lung infectivity two days following infection. In contrast, erythromycin at a much higher dose (96 mg/kg/day) gave only 83.3% survival and failed to eliminate organisms from the lung six days after infection. The histological findings confirmed the superiority of azithromycin. A single dose of azithromycin given intraperitoneally at 3.6 or 14.4 mg/kg gave survival rates of 83.3 and 100%, respectively. Azithromycin was also found to be superior to erythromycin in eliminating lung infectivity and reducing mortality, when administered orally. However, oral administration of azithromycin was not as effective as intraperitoneal when assessed by lung histopathology, although it was still superior to oral erythromycin treatment.

Administration, Oral↗
PubMed1990

Azithromycin in the treatment of sexually transmitted disease.

One hundred and eighty-two patients were enrolled in a randomized third-party blinded study to assess the efficacy and safety of azithromycin in the treatment of sexually transmitted diseases. Three regimens of azithromycin, including a single oral dose, were compared with a standard treatment with doxycycline. The patients were followed for four weeks. Efficacy was evaluated in 168 patients (113 azithromycin, 55 doxycycline). Fourteen patients had negative cultures or did not come for all follow-up visits. Of the 168, 138 were infected with Chlamydia trachomatis, 43 with Neisseria gonorrhoeae, and 45 with Ureaplasma urealyticum. Ninety-six per cent of patients with chlamydial infections and 92% of those with gonorrhoea were cured with azithromycin. Two patients infected with N. gonorrhoeae, four with C. trachomatis and six with U. urealyticum had positive cultures on follow-up visits after receiving azithromycin. Of these 11 patients with positive cultures on follow-up visits, seven (five with U. urealyticum and two with C. trachomatis) violated the protocol by having intercourse with infected individuals during the study. Azithromycin was very well tolerated; one patient complained of mild abdominal pain shortly after receiving the drug, seven patients complained of mild nausea and two patients had mild diarrhoea.

Adolescent↗
PubMed1990

Comparison of the acid stability of azithromycin and erythromycin A.

In acidic aqueous media, erythromycin A is rapidly degraded via intramolecular dehydration to form erythromycin-6.9-hemiketal and then anhydroerythromycin, both of which possess little antimicrobial activity. Azithromycin, a new azalide antibiotic, has a methyl-substituted nitrogen in place of the carbonyl at the 9a position of the aglycone ring, thus blocking the internal dehydration pathway. As a result, azithromycin decomposition occurs primarily via acid-catalysed hydrolysis of the ether bond to the neutral cladinose sugar. Rate constants and the time for 10% decay (T1/10) were determined for both azithromycin and erythromycin A at pH2 using various levels of acetonitrile cosolvent and constant ionic strength. Semi-log plots of the decay rate constants versus the reciprocal of the solution dielectric constants were used to extrapolate to totally aqueous conditions. In solution at 37 degrees C and pH2 with ionic strength mu = 0.02, azithromycin was degraded with a T1/10 of 20.1 min while erythromycin underwent 10% decay in only 3.7 sec. The activation energy for hydrolysis of the ether bond connecting cladinose to azithromycin was 25.3 kcal/mol while the internal dehydration reaction of erythromycin had an activation energy of 15.6 kcal/mol. A solution stability profile was generated for azithromycin over the pH range of 1.0 to 4.1 at 30 degrees C. Stability was found to improve ten-fold for each unit increase in pH.

Acetonitriles↗
PubMed1990

Efficacy of azithromycin for therapy of active syphilis in the rabbit model.

Azithromycin was shown to be as effective as standard benzathine penicillin and erythromycin in the therapy of active syphilis in the rabbit model. Following production of primary chancres by intradermal inoculation of 10(6) Treponema pallidum, groups of six rabbits were treated with benzathine penicillin (200,000 units im weekly for two weeks), erythromycin base (30 mg/kg/day orally four times daily for 15 days) or azithromycin (30 mg/kg/day given orally once or twice daily for 15 days); one group was untreated. Daily darkfield (DF) microscopic examinations of chancre aspirates were conducted to identify motile organisms. Although all treated animals became DF negative prior to completion of therapy, the median time to DF negativity was longer in animals given azithromycin once daily, compared with animals receiving benzathine penicillin (P less than 0.01); no difference was seen in comparison with animals receiving erythromycin. Untreated animals remained DF positive for greater than 15 days. The mean maximum lesion diameters for all treated animals were similar and were significantly smaller than in untreated rabbits; fewer lesions ulcerated in treated than in untreated animals. Subsequent dose-ranging studies indicated that administration of lower doses of azithromycin (15 mg/kg/day given orally either once or twice daily, or 7.5 mg/kg/day given once daily) was as effective as benzathine penicillin for therapy of active syphilis in this model, though the median time to darkfield negativity was significantly longer in the azithromycin-treated animals (P less than 0.01). Persistent infection was demonstrable in lymph nodes of untreated animals, but no evidence of virulent T. pallidum was found three months following transfer of tissue from any animal treated with penicillin, erythromycin, or azithromycin.

Animals↗
PubMed1992

Erythema migrans: comparison of treatment with azithromycin, doxycycline and phenoxymethylpenicillin.

Azithromycin, doxycycline and phenoxymethylpenicillin were compared in a prospective, randomized study of 64 patients with typical erythema migrans. Twenty patients were treated with oral azithromycin, 250 mg bd for two days followed by 250 mg od for eight days, 21 patients were given phenoxymethylpenicillin 1 million IU tds for 14 days and 23 patients received doxycycline, 100 mg bd for 14 days. All patients were followed up for 24 months. There were no significant differences between the groups with respect to the persistence of cutaneous lesions after starting treatment; the mean durations were 10.5 days in the penicillin group, 8.8 days in the doxycycline group and 8.6 days in the azithromycin group. There were statistically significant differences in terms of the resolution of associated local and/or systemic symptoms. The response time was shortest in patients treated with azithromycin. Two patients who received phenoxymethylpenicillin and two given doxycycline subsequently developed major manifestations of Lyme borreliosis; these did not occur in patients receiving azithromycin. Although azithromycin has been shown to be effective in the treatment of erythema migrans, further studies will be needed to determine the optimal dosage and duration of therapy.

Adolescent↗
PubMed1993

Efficacy of azithromycin compared with spiramycin in the treatment of odontogenic infections.

Sixty patients with acute odontogenic infections were randomly allocated to oral treatment with azithromycin 500 mg/day once-daily for three days (n = 30) or spiramycin 3,000,000 units three-times daily for seven days (n = 30). Baseline and post-treatment oral specimens were collected from patients to test for pathogenic bacteria. Aerobic bacteria were tested using the Kirby-Bauer disc diffusion method, and anaerobic bacteria with a broth microdilution method, for their susceptibility to azithromycin and spiramycin. A greater incidence of resistance was found in the spiramycin group than in the azithromycin group. The bacteriological assessment showed that the normal balance of microflora was re-established in 67% of patients treated with azithromycin vs 53% in the group treated with spiramycin. Clinical cure was higher in the azithromycin treatment group (97%) compared with the spiramycin group (73%). These results indicate that three-day azithromycin, possibly because of its unusual pharmacokinetics, is more effective than seven-day spiramycin in the treatment of odontogenic infections.

Azithromycin↗
PubMed1993

Once-daily azithromycin in the treatment of adult skin and skin-structure infections.

The aim of this prospective, blinded, randomized study was to demonstrate the efficacy and safety of oral azithromycin and dicloxacillin in the treatment of adults with acute skin and skin-structure infections. Sixty-two patients were included in the intent-to-treat group and 60 were evaluable for analysis. Azithromycin was given as a 500 mg once-daily dose for three days and dicloxacillin as 250 mg qid for seven days. Isolated pathogens included primarily Staphylococcus aureus, Streptococcus spp., and coagulase-negative staphylococci. Clinical resolution was 83.3% in the azithromycin group and 83.9% in the dicloxacillin group, with bacteriological eradication of 90.0% in the azithromycin group and 87.1% in the dicloxacillin group. Persistence of infection was recorded in one patient in the dicloxacillin group and superinfection in one patient in the azithromycin group. Azithromycin appears to be a safe and effective antibiotic for the treatment of adult patients with acute skin and skin-structure infections.

Abscess↗