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PubMed2005

Evolution of a new drug formulation: the rationale for high-dose, short-course therapy with azithromycin.

The rationale for the use of high-dose, short-course azithromycin treatment regimens is based on the pharmacokinetic properties of azithromycin. Its long elimination half-life (approximately 60 h) and antibacterial potency make short-course (1-day) regimens feasible. Azithromycin is concentrated within phagocytic cells, which deliver it in a targeted manner to sites of infection. In vitro and in vivo models demonstrate that azithromycin is taken up, transported and released at the sites of infection by polymorphonuclear neutrophils and macrophages. Uptake is not saturable, so delivery of the total azithromycin therapeutic regimen as a single dose of azithromycin microspheres should lead to increased uptake and delivery of the drug to sites of infection. By achieving higher drug concentrations at the site of infection, a single, high dose of azithromycin microspheres should maximize efficacy. The new microsphere formulation allows for 'front loading' of the dose to achieve the highest drug levels early in the course of infection while maintaining favorable tolerability.

Animals↗
PubMed2002

Improved tonsillar disposition of azithromycin following a 3-day oral treatment with 20 mg kg(-1) in paediatric patients.

The present study was performed in order to compare azithromycin concentrations in tonsils of paediatric patients treated with different dose regimens of this antibiotic. Sixty-four children, scheduled to undergo surgical removal of tonsils, were treated with azithromycin 10 or 20 mgkg(-1) daily as oral suspension for 3 days. Samples of blood and tonsil were collected during surgery at days 0.5, 2.5, 4.5, 6.5 or 8.5 after the last dose. Azithromycin concentrations were measured by reversed phase high-performance liquid chromatography. In patients treated with 10 mgkg(-1), the highest concentrations of azithromycin were detected in plasma and tonsils at day 0.5 and 2.5, respectively. Consistent drug levels could be measured in tonsils up to 8.5 days. After administration of 20 mgkg(-1), azithromycin tonsillar concentrations were higher than those obtained with 10 mgkg(-1) up to day 6.5, whereas plasma levels did not differ significantly. The present results indicate that an improved tonsillar distribution of azithromycin can be achieved when this antibiotic is administered for 3 days at doses higher than 10 mgkg(-1) daily. These findings give pharmacokinetic support to the suggestion that increments of azithromycin dosing might ensure enhanced therapeutic levels at infective sites of the upper respiratory tract.

Administration, Oral↗
PubMed2000

The safety and efficacy of short course (5-day) moxifloxacin vs. azithromycin in the treatment of patients with acute exacerbation of chronic bronchitis.

Chronic bronchitis is common among adults and infectious exacerbations contribute considerably to morbidity and mortality. We aimed to compare the safety and efficacy of moxifloxacin to azithromycin for the treatment of patients with acute exacerbations of chronic bronchitis (AECB) of suspected bacterial origin. Between October 1998 and April 1999, 567 patients with AECB were enrolled at 37 centers across the United States and Canada of which 280 (49%) had acute bacterial exacerbation of chronic bronchitis (i.e. pretherapy pathogen). Patients were randomized to either oral moxifloxacin 400 mg administered once daily for 5 days or azithromycin for 5 days (500 mg qd x 1, then 250 mg qd x 4). For the purpose of study blinding, all patients received encapsulated tablets. The main outcome measure was clinical response at the test-of-cure visit (14-21 days post-therapy). Secondary measures included bacteriologic response and a time-course of bacteriological eradication (one center only). Three patient populations were analysed for efficacy: clinically-valid, microbiologically-valid (i.e. those with a pretherapy pathogen), and intent-to-treat (i.e. received at least one dose of study drug). For the efficacy-valid group, clinical response at the test-of-cure visit was 88% for patients in each treatment group. In 237 microbiologically-valid patients, corresponding clinical resolution rates were 88% for 5-day moxifloxacin vs. 86% for 5-day azithromycin. Bacteriological eradication rates at the end of therapy were 95% for 5-day moxifloxacin and 94% for the azithromycin group. Corresponding eradication rates at the test-of-cure visit were 89% and 86%, respectively. Of note, eradication rates at test-of-cure for Haem. philos influenzae and H. parainfluenzae for moxifloxacin were 97% and 88% compared to 83% and 62% respectively for azithromycin. Among 567 intent-to-treat patients (283 moxifloxacin and 284 azithromycin), drug-related events were reported for 22% and 17%, respectively. Diarrhea and nausea were the most common drug-related events reported in each treatment group. Moxifloxacin 400 mg once daily for 5 days was found to be clinically and bacteriologically equivalent to 5-day azithromycin for the treatment of AECB of proven bacterial etiology. Given its excellent in-vitro activity, especially against antibiotic-resistant respiratory pathogens, and its acceptable safety profile, moxifloxacin should be considered an effective alternative therapy for patients with AECB of suspected bacterial origin.

Acute Disease↗
PubMed2005

Single-dose azithromycin versus penicillin G benzathine for the treatment of early syphilis.

BACKGROUND: Pilot studies suggest that a single, 2-g oral dose of azithromycin may be an alternative to a 2.4-MU intramuscular dose of penicillin G benzathine in the prevention and treatment of syphilis. We evaluated the efficacy of treatment with azithromycin in a developing country. METHODS: A total of 328 subjects, 25 with primary and 303 with high-titer (a titer of at least 1:8 on a rapid plasmin reagin [RPR] test) latent syphilis, were recruited through screening of high-risk populations in Mbeya, Tanzania, and randomly assigned to receive 2 g of azithromycin orally (163 subjects) or 2.4 million units of penicillin G benzathine intramuscularly (165 subjects). The primary outcome was treatment efficacy, with cure defined serologically (a decline in the RPR titer of at least two dilutions by nine months after treatment) and, in primary syphilis, by epithelialization of ulcers within one or two weeks. RESULTS: The average age of participants was 27.0 years, 235 (71.6 percent) were female, and 171 (52.1 percent) were seropositive for human immunodeficiency virus. Cure rates were 97.7 percent (95 percent confidence interval, 94.0 to 99.4) in the azithromycin group and 95.0 percent (95 percent confidence interval, 90.6 to 97.8) in the penicillin G benzathine group (95 percent confidence interval for the difference, -1.7 to 7.1 percent), achieving prespecified criteria for equivalence. Cure rates were also similar three and six months after treatment in the two groups and in all subgroups. Cure rates at three months were 59.4 percent (95 percent confidence interval, 51.8 to 67.1) in the azithromycin group and 59.5 percent (95 percent confidence interval, 51.8 to 67.3) in the penicillin G benzathine group and at six months were 85.5 percent (95 percent confidence interval, 79.4 to 90.6) and 81.5 percent (95 percent confidence interval, 74.8 to 87.4), respectively. CONCLUSIONS: Single-dose oral azithromycin is effective in treating syphilis and may be particularly useful in developing countries in which the use of penicillin G benzathine injections is problematic. However, recent reports of azithromycin-resistant Treponema pallidum in the United States indicate the importance of continued monitoring for resistance.

Administration, Oral↗
PubMed2005

Effects of dehydration on corneal tissue absorption of topical azithromycin in rabbits.

PURPOSE: To assess the corneal tissue absorption of azithromycin in desiccated and normal eyes of rabbits. METHODS: A total of 25 New Zealand Albino rabbits weighing 2-3 kg each were included. One eye of each rabbit was desiccated. The other eye was left as control. Azithromycin 1.5% topical eyedrops were instilled in both eyes. Five rabbits were sacrificed at each of the following time points: 30 min, 3 hr, 6 hr, and 12 hr. Corneal tissues specimens were subjected to high-performance liquid chromatography mass spectrometry. A paired t test was used to evaluate the statistical difference in corneal tissue absorptions of azithromycin at each time point. RESULTS: The mean corneal tissue levels of azithromycin in dry eyes were 66.3 microg/ml, 92.6 microg/ml, 117.5 microg/ml, and 179.9 microg/ml, and the mean corneal tissue levels of azithromycin in normal eyes were 42.0 microg/ml, 43.4 microg/ml, 43.3 microg/ml, and 80.0 microg/ml at 30 min, 3 hr, 6 hr, and 12 hr respectively. Both groups showed increase in corneal tissue absorption overtime (p < 0.0001). Significantly higher levels of azithromycin were noted in dry eyes at each time point except at the 30-min time point. CONCLUSIONS: This study demonstrated that corneas exposed to desiccation showed statistically significant increase in azithromycin level compared to normal eyes.

Absorption↗
PubMed2000

A randomized, double-blind trial comparing azithromycin and clarithromycin in the treatment of disseminated Mycobacterium avium infection in patients with human immunodeficiency virus.

Two hundred and forty-six patients infected with human immunodeficiency virus (HIV) who also had disseminated Mycobacterium avium complex received either azithromycin 250 mg every day, azithromycin 600 mg every day, or clarithromycin 500 mg twice a day, each combined with ethambutol, for 24 weeks. Samples drawn from patients were cultured and clinically assessed every 3 weeks up to week 12, then monthly thereafter through week 24 of double-blind therapy and every 3 months while on open-label therapy through the conclusion of the trial. The azithromycin 250 mg arm of the study was dropped after an interim analysis showed a lower rate of clearance of bacteremia. At 24 weeks of therapy, the likelihood of patients' developing 2 consecutive negative cultures (46% vs. 56%, P=.24) or 1 negative culture (59% vs. 61%, P=.80) was similar for azithromycin 600 mg (n=68) and clarithromycin (n=57), respectively. The likelihood of relapse was 39% versus 27% (P=.21) on azithromycin compared with clarithromycin, respectively. Of the 6 patients who experienced relapse, none of those randomized to receive azithromycin developed isolates resistant to macrolides, compared with 2 of 3 patients randomized to receive clarithromycin [corrected]. Mortality was similar in patients comprising each arm of the study (69% vs. 63%; hazard, 95.1% confidence interval, 1.1 [0.7, 1.7]). Azithromycin 600 mg, when given in combination with ethambutol, is an effective agent for the treatment of disseminated M. avium disease in patients infected with HIV.

AIDS-Related Opportunistic Infections↗
PubMed2002

Adverse and beneficial secondary effects of mass treatment with azithromycin to eliminate blindness due to trachoma in Nepal.

Mass administration of azithromycin to eliminate blindness due to trachoma has raised concerns regarding the emergence of antimicrobial resistance. During 2000, we compared the antimicrobial resistance of nasopharyngeal pneumococcal isolates recovered from and the prevalence of impetigo, respiratory symptoms, and diarrhea among 458 children in Nepal before and after mass administration of azithromycin. No azithromycin-resistant pneumococci were isolated except from 4.3% of children who had received azithromycin during 2 previous mass treatments (P<.001). There were decreases in the prevalence of impetigo (from 14% to 6% of subjects; adjusted odds ratio [OR], 0.41; 95% confidence interval [CI], 0.21-0.80) and diarrhea (from 32% to 11%; adjusted OR, 0.26; 95% CI, 0.14-0.43) 10 days after azithromycin treatment. The absence of macrolide-resistant isolates after 1 mass treatment with azithromycin is encouraging, although the recovery of azithromycin-resistant isolates after 2 mass treatments suggests the need for resistance monitoring when multiple rounds of antimicrobial treatment are given.

Anti-Bacterial Agents↗
PubMed2004

Comparison of atovaquone and azithromycin with trimethoprim-sulfamethoxazole for the prevention of serious bacterial infections in children with HIV infection.

BACKGROUND: Trimethoprim-sulfamethoxazole (TMP-SMZ) has been used extensively for the prevention of Pneumocystis carinii (also referred to as "Pneumocystis jiroveci") pneumonia (PCP) and other opportunistic infections in human immunodeficiency virus (HIV)-infected children. Because the efficacy of TMP-SMZ for treatment of bacterial infections is limited, it is sometimes poorly tolerated, and there is risk of emergence of drug-resistant strains associated with widespread use, we evaluated a regimen that included atovaquone and azithromycin. METHODS: A randomized, double-blind, placebo-controlled trial was designed to determine whether atovaquone-azithromycin had equivalent efficacy to TMP-SMZ for the prevention of serious bacterial infections and to compare the long-term tolerance, PCP breakthrough rates, and nonserious bacterial infection rates among HIV-infected children aged 3 months to 19 years. Children qualified for PCP prophylaxis (on the basis of Centers for Disease Control and Prevention recommendations) were randomized to receive atovaquone-azithromycin or TMP-SMZ daily for >or=2 years. RESULTS: Data from 366 of the 369 eligible patients (median duration of follow-up, 3 years) showed that the estimated rates of serious bacterial infection-related events were lower among atovaquone-azithromycin recipients than among TMP-SMZ recipients (17.3 vs. 24.2 events per 100 patient-years; difference, 6.9 events per 100 patient-years; 95% confidence interval [CI], -0.22 to 14.12). Rates for all end points (serious bacterial infection, PCP, Mycobacterium avium complex infection, and serious and nonserious bacterial infection-related deaths) were 19.7 and 27.7 events per 100 patient-years, respectively (difference, 7.9 events per 100 patient-years; 95% CI, -0.28 to 15.54 events per 100 patient-years). The results marginally favored atovaquone-azithromycin therapy statistically. Atovaquone-azithromycin and TMP-SMZ therapies had similar adverse event profiles. CONCLUSIONS: We conclude that, in HIV-infected children, atovaquone-azithromycin is as effective as TMP-SMZ for the prevention of serious bacterial infections and is similarly tolerated.

AIDS-Related Opportunistic Infections↗
PubMed2005

Significant reduction in inflammatory response in the macaque model of chlamydial pelvic inflammatory disease with azithromycin treatment.

We inoculated 45 female macaques in the cervix with Chlamydia trachomatis once weekly for 5 weeks and randomly assigned them to treatment with doxycycline (n=12), azithromycin (n=12), or placebo (n=21). At hysterectomy, cervical cultures remained positive in 12 of 21 placebo-treated monkeys, versus 0 of 12 doxycycline- or azithromycin-treated monkeys (P<.01); cervical ligase chain reaction remained positive in 15 placebo-, 1 doxycycline-, and 0 azithromycin-treated monkeys. Tubal swabs remained positive in 3 placebo-, 1 doxycycline-, and 0 azithromycin-treated monkeys. Immunopathologic damage was moderate to widespread in upper and lower reproductive-tract tissues from placebo- and doxycycline-treated monkeys but were significantly reduced in azithromycin-treated monkeys. Transforming growth factor- beta was also significantly less prevalent in azithromycin-treated monkeys. Azithromycin treatment dramatically reduced the inflammatory response and was highly effective in eradicating C. trachomatis from the lower and upper reproductive tract (12/12), compared with doxycycline (7/12) and placebo (3/21).

Animals↗
PubMed1998

Successful double-blinded, randomized, placebo-controlled field trial of azithromycin and doxycycline as prophylaxis for malaria in western Kenya.

Azithromycin prevents malaria in animal models and early clinical trials. We determined the prophylactic efficacy of three antibiotic regimens given for 10 weeks (azithromycin, 250 mg daily; azithromycin, 1,000 mg weekly; and doxycycline, 100 mg daily) relative to that of placebo for 232 adult volunteers residing in an area of intense malaria transmission. Any confirmed parasitemia during the study was considered a prophylactic failure. Two hundred thirteen volunteers (92%) completed the study. The prophylactic efficacies were as follows: daily azithromycin, 82.7% (95% confidence interval [CI], 68.5%-91.1%); weekly azithromycin, 64.2% (95% CI, 47.1%-77.1%); and daily doxycycline, 92.6% (95% CI, 79.9%-97.5%). All regimens were well tolerated. We concluded that both 100 mg of doxycycline and 250 mg of azithromycin, given daily, were effective as prophylaxis for malaria in this setting. If studies with nonimmune volunteers confirm these results for semi-immune volunteers, a daily azithromycin regimen may have special utility for individuals with contraindications to treatment with doxycycline or other antimalarial agents.

Adolescent↗
PubMed1995

Use of azithromycin for the treatment of Campylobacter enteritis in travelers to Thailand, an area where ciprofloxacin resistance is prevalent.

We evaluated the use of azithromycin (500 mg) or ciprofloxacin (500 mg) daily for 3 days for the treatment of acute diarrhea among United States military personnel in Thailand. Stool cultures were obtained and symptoms were recorded on study days 0, 1, 2, 3, and 10. Campylobacter species were the most common pathogen isolated (44 isolates from 42 patients). All Campylobacter isolates were susceptible to azithromycin; 22 were resistant to ciprofloxacin. Among the 42 patients with campylobacter infection, there were 2 clinical and 6 bacteriologic treatment failures in the ciprofloxacin group and no treatment failures in the azithromycin group (P = .021 for bacteriologic failures). Overall, azithromycin was as effective as ciprofloxacin in decreasing the duration of illness (36.9 hours vs. 38.2 hours, respectively) and the number of stools (6.4 vs. 7.8, respectively). Among those not infected with Campylobacter species (n = 30), the duration of illness was 32.9 hours vs. 20.7 hours (P = .03) for the azithromycin and ciprofloxacin groups, respectively. Azithromycin is superior to ciprofloxacin in decreasing the excretion of Campylobacter species and as effective as ciprofloxacin in shortening the duration of illness. Azithromycin therapy may be an effective alternative to ciprofloxacin therapy in areas where ciprofloxacin-resistant Campylobacter species are prevalent.

Adult↗
PubMed1990

Comparative studies of azithromycin in skin and soft-tissue infections and sexually transmitted infections by Neisseria and Chlamydia species.

Two open, randomized, single centre studies have investigated the efficacy and safety of azithromycin (CP-62,993) in the treatment of infections by azithromycin-sensitive pathogens: (A) acute bacterial infections of skin or soft tissue (compared with erythromycin; n = 82); and (B) urethritis and/or cervicitis caused by Neisseria gonorrhoeae and/or Chlamydia trachomatis (compared with doxycycline; n = 108). In study A, azithromycin was administered to 42 patients for five days at a dosage of 250 mg bd on day 1 and 250 mg once daily on days 2-5; erythromycin was given to 40 patients for seven days at a dosage of 500 mg every 6 h. In study B, azithromycin was administered either as a single 1 g dose or as a single 500 mg dose on day 1 and 250 mg once daily on days 2 and 3; doxycycline was given at a dose of 100 mg every 12 h for seven days. In study A, 68 patients were clinically assessed: clinical cure or improvement in patients receiving azithromycin or erythromycin was achieved in 86% and 82%, respectively. The principal causative pathogen was Staphylococcus aureus; there was eradication of 15/25 pathogens (60%) with azithromycin and 13/23 (57%) with erythromycin. In study B, 94 and 93 patients were clinically assessed at weeks 1 and 2, respectively: clinical cure was achieved with all treatment regimens at week 1; at week 2 there was reappearance of symptoms in one patient with a mixed infection who had received 3-day azithromycin.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1990

Relationship of high tissue concentrations of azithromycin to bactericidal activity and efficacy in vivo.

Measurement of killing kinetics of azithromycin against strains of Streptococcus pneumoniae and Klebsiella pneumoniae in vitro showed that it had a limited bactericidal activity (greater than 90% kill) for the first eight hours of incubation, but developed complete bactericidal activity (greater than 99.9% kill) by 24 h incubation. Since high and sustained tissue levels of azithromycin occur in animals and humans, it was proposed that it might produce a bactericidal effect in vivo. This was demonstrated in a lung infection model in mice, designed to mimic the in-vitro killing studies. A 25 mg/kg dose of azithromycin given 24 h before intranasal challenge reduced the recoverable Str. pneumoniae population by greater than 99.9%, in comparison with untreated controls. Erythromycin did not produce a bactericidal effect at 100 mg/kg, and roxithromycin only reduced the viable count by 96%, at a dose of 50 mg/kg. Against a K. pneumoniae lung infection, a 50 mg/kg dose of azithromycin reduced the bacterial count by 99%. The bactericidal effect was correlated with lung tissue concentrations of azithromycin. In a proliferating Escherichia coli paper disc infection model, extravascular fluid concentrations of azithromycin were correlated with a 99.9% reduction in bacterial count, while corresponding serum concentrations were always less than the MIC. Dosing with azithromycin eradicated Haemophilus influenzae from the bulla (middle ear) of gerbils, as was not the case with erythromycin and roxithromycin. This effect was correlated with the antibiotic concentration in bulla lavage.

Animals↗
PubMed1993

Comparative efficacies of azithromycin and ciprofloxacin against experimental Salmonella typhimurium infection in mice.

Azithromycin was compared with ciprofloxacin for the treatment of established intracellular infection with Salmonella typhimurium LT-2 in CF-1 mice. For studies of mortality, mice received five times the LD50 of organisms intraperitoneally and were given drugs intragastrically once daily for seven days. For studies of in-vivo antibacterial activity, splenic viable counts were measured in mice that had received 0.5 times the intraperitoneal LD50 and had been given drugs for three days. The MICs of azithromycin and ciprofloxacin, respectively, against LT-2 were 4.0 and 0.03 mg/L. The 50% protective doses of the drugs required to prevent mortality were azithromycin 24.7 mg/kg/day, and ciprofloxacin 30.2 mg/kg/day. Treatment with azithromycin and ciprofloxacin in doses of 25 and 100 mg/kg/day resulted in reduction of mean log10 cfu per spleen. Splenic concentrations of azithromycin up to 8 h after treatment exceeded its MIC against the LT-2 strain, whereas serum levels were less than the MIC. These results indicated that azithromycin given orally once daily was as effective as ciprofloxacin against established murine Salmonella infection and that the efficacy of azithromycin correlated with adequate tissue concentrations of antibiotic.

Animals↗
PubMed1993

Clinical safety and tolerance of azithromycin in children.

An analysis of the safety data emanating from several clinical trials of the use of azithromycin in children has been undertaken. The studies compared azithromycin with standard regimens of various comparator agents: co-amoxiclav, amoxycillin, penicillin V, erythromycin, dicloxacillin and flucloxacillin, in the treatment of otitis media, pharyngitis and skin infections. Side-effects, based on the investigators' assessments of the severity and possible relationship to the study drugs, were measured within 35 days of the start of therapy. The total number of side-effects reported was significantly lower in the azithromycin-treated patients (46/606; 7.6%) than in the comparator-treated patients (72/523; 13.8%; P = 0.001). Two (0.3%) and five (1.0%) patients, respectively, withdrew from treatment in each group. The most frequently reported side-effects were gastrointestinal with an incidence of 5.6% (34 patients) in the azithromycin group and 11.7% (61 patients) in the comparator group (P < 0.001). The only other organ system with more than 0.5% of subjects reporting side-effects was the skin, with nine (1.5%) patients in the azithromycin and 11 (2.1%) patients in the comparator group complaining of dermatological reactions. Azithromycin was equally well tolerated in children of all ages. Inspection of individual studies showed no significant differences in laboratory test abnormalities between treatment groups. Overall, the most frequently (> or = 1% incidence) reported treatment-related laboratory test abnormalities were changes in neutrophil count (3.2%), lactate dehydrogenase (1.5%), blood urea (1.3%) and potassium (1.2%) in the azithromycin group; and in neutrophil (3.2%) and eosinophil count (2.1%) in the comparator group.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1993

Preferential concentration of azithromycin in an infected mouse thigh model.

The possibility of augmentation of azithromycin delivery to infection loci was evaluated by the use of Staphylococcus aureus thigh infection models with CD-1 mice. The intramuscular infections that developed were characterized by rapid growth of bacteria and induction of a localized oedema that was assessed gravimetrically. Microscopic examination of infected thighs showed massive infiltration of polymorphonuclear leucocytes (viable and degranulated), when compared to saline-injected thighs, from 24 to > or = 72 h after infection. Azithromycin concentrations were enhanced significantly (P < or = 0.02) in infected thigh tissues compared with contralateral non-infected tissues, and correlated with oedema from 24-72 h after challenge and dosing. The azithromycin levels in infected tissue after a 5 mg/kg dose were sufficient to cause a significant reduction in the number of cfu. If azithromycin administration was delayed until inflammation was more severe, the result was an even greater preferential concentration of azithromycin into the infected thigh. Preferential concentration of azithromycin was not observed when extensive oedema was produced by injection of histamine. However, this oedema was not associated with a significant influx of polymorphonuclear leucocytes. In comparative studies, macrolide antibiotics known to be concentrated in phagocytes, such as erythromycin, roxithromycin, and clarithromycin, were not concentrated preferentially in infected tissues under the experimental conditions used; tissue levels were above or at the in-vitro MIC level for < or = 24 h. The data indicate that delivery of biologically available azithromycin to infected tissues is enhanced by cellular inflammatory processes.

Animals↗
PubMed1993

Multicentre evaluation of azithromycin and penicillin V in the treatment of acute streptococcal pharyngitis and tonsillitis in children.

Of 96 children (aged 2-12 years) with either acute pharyngitis or acute tonsillitis, 49 received a single daily dose of azithromycin 10 mg/kg (maximum 500 mg) for three days, and 47 received penicillin V at a dose of 125 mg or 250 mg qid (depending on body weight) for ten days. Clinical assessments and laboratory safety tests were performed during and after therapy. Before enrollment, all patients were screened for group A beta-haemolytic streptococci (GABHS) with a rapid test, and a throat swab was taken for confirmatory culture. The presence of GABHS at baseline was confirmed in 41 azithromycin- and 44 penicillin V-treated patients. Cure or improvement was seen in 98% and 100% of azithromycin- and penicillin V-treated patients, respectively. At day 11, bacterial eradication was achieved in 39/41 (95%) azithromycin-treated patients, 38 (93%) of whom were considered clinically cured, while one patient (2%) relapsed. In the penicillin V group, 42/44 (95%) had GABHS eradicated, with 41 (93%) clinically cured and three patients (7%) improved. The remaining two patients in each group were clinically cured despite persistence of Streptococcus pyogenes. At follow-up evaluation (day 30), re-occurrence was observed in 5/37 (14%) and 3/40 (8%) of azithromycin- and penicillin V-treated patients, respectively; all patients were asymptomatic. Both drugs were well-tolerated with only two patients in the azithromycin group complaining of side effects. Treatment related laboratory test abnormalities were observed in 6/47 (13%) and 4/45 (9%) azithromycin- and penicillin V-treated patients, respectively, but none was judged to be clinically significant.(ABSTRACT TRUNCATED AT 250 WORDS)

Acute Disease↗
PubMed1993

Multicentre comparison of azithromycin versus erythromycin in the treatment of paediatric pharyngitis or tonsillitis caused by group A streptococci.

In this open study, 93 children (aged 2-12 years) with a clinical diagnosis of pharyngitis or tonsillitis caused by Streptococcus pyogenes (culture and/or ELISA test positive) were given azithromycin, as a single daily dose of 10 mg/kg (maximum 500 mg) for three days (n = 46); or erythromycin ethylsuccinate, 30-50 mg/kg daily given in three divided doses, for ten days (n = 47). Forty-four of 46 azithromycin patients, and 46 of 47 erythromycin patients, had S. pyogenes isolated at baseline and were included in the clinical and bacteriological analyses. At the end of treatment (day 10-12), 38 (86%) of the 44 azithromycin patients were considered cured, four (9%) improved, one (2%) failed and one relapsed. In the erythromycin group, 30 of 46 (65%) were considered cured, 15 (33%) improved and one (2%) failed. Eradication of S. pyogenes was achieved in 40 of 44 (91%) and 45 of 46 (98%) azithromycin and erythromycin patients, respectively. Re-occurrence of S. pyogenes, assessed 28-32 days after start of treatment, occurred in five of 37 (14%) azithromycin patients (three with clinical symptoms) and five of 39 (13%) erythromycin patients (four with clinical signs). There were no statistically significant differences in clinical or bacteriological efficacy between the two groups. Both drugs were well-tolerated, with side-effects (mainly gastrointestinal) reported in five of 46 (11%) azithromycin patients and in six of 47 (13%) erythromycin patients, one of whom withdrew from treatment. No laboratory abnormalities were observed in the azithromycin patients, but were recorded in two of 43 (5%) erythromycin patients.(ABSTRACT TRUNCATED AT 250 WORDS)

Acute Disease↗