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PubMed2004

Effects of azithromycin on cyclosporine-induced gingival hyperplasia in renal transplant patients.

BACKGROUND: Gingival hyperplasia is a well-known complication of cyclosporine therapy, affecting 21% to 35% of renal transplant patients. Metronidazole, clarithromycin, and azithromycin, all azalid antimicrobial agents derived from the macrolide antibiotic erythromycin, have been used for treatment. Marked improvements in gingival hyperplasia have been recorded in particular with azithromycin. The aim of the present study was to investigate histopathological features of cyclosporine-induced gingival hyperplasia and to evaluate the quantitative efficacy of short-term azithromycin therapy. METHODS: Eighteen renal transplant patients with cyclosporine-induced gingival hyperplasia were included in the study. All patients received azithromycin with a dose of 500 mg/d for 3 consecutive days. Changes in gingival hyperplasia were evaluated by measuring the gingival sulcus depth to the cementum-enamel junction of every tooth in each of the four quadrants on days 0, 7, 30, 90, 180. Gum biopsies were obtained on days 0 and 30; the degree of inflammation was classified as "mild," "intermediate," and "severe". RESULTS: Gingival hyperplasia was reduced in all treated patients throughout the study. The degree of improvement was more significant between 0 to 7 and 7 to 30 days than at other times (respectively, P < .0001 and P < .002). Histopathologically, eight patients had severe and one patient moderate chronic inflammation at the beginning of therapy. Three other biopsies were reported as papilloma, mucosal hyperplasia, and normal gingival tissue biopsy. CONCLUSIONS: Azithromycin appears to be useful to treat cyclosporine-induced gingival hyperplasia in renal transplant patients. Treatment is inexpensive and free from known adverse effects.

Adult↗
PubMed2005

Acceptability of azithromycin for the control of trachoma in Northern Tanzania.

Trachoma causes blindness; the prevention strategy includes mass antibiotic treatment. In a community in Northern Tanzania offered mass treatment with azithromycin for the control of trachoma, we used focus group discussions, individual interviews, questionnaires and direct observation to quantify, explore and contextualize reasons for acceptance or refusal of the drug. In the village studied, 76% of the population eligible to receive azithromycin were treated. Uptake was significantly higher among women (79% treated) than men (72%). Factors affecting acceptability included: local prevention norms (such as the belief that injections, rather than oral medicine, should be used for prevention); perceptions of drugs in general and azithromycin in particular; perceptions of the distribution team's expertise; witnessing adverse effects in others; and the timing, quality and quantity of information about azithromycin and its availability. Familiarity with trachoma as a blinding disease was significantly associated with uptake. Individuals who refused treatment seemed to be less altruistic than other respondents. Neither socio-economic status nor use of traditional healers was related to uptake. Pre-distribution community assessment and community education, advance notice of the distribution, standardized distribution guidelines and improved distributor training are recommended to maximize acceptance of azithromycin in future campaigns.

Adult↗
PubMed2003

Efficacy of azithromycin in a murine toxoplasmosis model, employing a Toxoplasma gondii strain from Turkey.

A murine toxoplasmosis model with Balb/C mice was used to investigate the therapeutic and prophylactic efficacy of azithromycin in a native strain of Toxoplasma gondii. Initially, seven groups--four studies and three controls--were established and 10(3) tachyzoites of this native strain of T. gondii were injected intraperitoneally to the mice in groups 1, 2, 3, 4 and 7. Azithromycin was given to groups 1-4 at different times of infection orally between 100 and 300 mg/kg/day for 10 days. Azithromycin was found to be effective at 200 mg/kg/day and above in the prophylaxis, at 250 mg/kg/day and above in the treatment of toxoplasmosis. These results suggest that azithromycin is effective in the prophylaxis and early infection of a highly virulent strain of T. gondii, and it doubled the survival time in the late infection. Azithromycin could be an alternative treatment regimen for human toxoplasmosis, if supported by further clinical investigations.

Animals↗
PubMed2003

Azithromycin vs doxycycline in the treatment of inclusion conjunctivitis.

PURPOSE: The aim of the study was to compare the efficacy and safety of azithromycin and doxycycline in the treatment of chlamydial conjunctivitis in adults. DESIGN: An open, randomized clinical trial. METHODS: Seventy-eight adult patients with incluson conjunctivitis were enrolled in this multicenter clinical study. Patients with chlamydial conjunctivitis as indicated by a positive direct fluorescent antibody (DFA) test or cell culture were randomized to receive a single 1-g dose of azithromycin or doxycycline, 100 mg twice daily for 10 days. A conjuctival swab for cell culture was obtained from all patients immediately before the treatment for subsequent confirmation of the presence of chlamydial infection in the central laboratory. Control examinations were performed 10 to 12 days and 4 to 6 weeks after the treatment initiation. Clinical and bacteriological responses to the treatment were evaluated at the last visit. The occurrence and frequency of adverse events were analyzed as well. RESULTS: Of 78 patients enrolled, 51 completed the study and were evaluated for efficacy. The main reasons for withdrawal were lack of confirmation of the presence of chlamydial infection by the central laboratory and failure to attend the follow-up visit. Eradication of C. trachomatis was achieved in 23 of 25 (92%) patients treated with azithromycin and in 25 of 26 (96%) patients treated with doxycycline. Clinical cure was observed in 15 (60%) and 18 (69%) patients treated with azithromycin and doxycycline, respectively. Both drugs were equally well tolerated. CONCLUSIONS: A single 1-g azithromycin therapy was as effective as standard 10-day treatment with doxycycline (100 mg twice daily) in the treatment of adult inclusion conjunctivitis.

Adolescent↗
PubMed2002

Azithromycin for acute bronchitis: a randomised, double-blind, controlled trial.

BACKGROUND: The value of azithromycin for treatment of acute bronchitis is unknown, even though this drug is commonly prescribed. We have investigated this question in a randomised, double-blind, controlled trial. METHODS: Adults diagnosed with acute bronchitis, without evidence of underlying lung disease, were randomly assigned azithromycin (n=112) or vitamin C (n=108) for 5 days (total dose for each 1.5 g). All individuals were also given liquid dextromethorphan and albuterol inhaler with a spacer. The primary outcome was improvement in health-related quality of life at 7 days; an important difference was defined as 0.5 or greater. Analysis was by intention to treat. FINDINGS: The study was stopped by the data-monitoring and safety committee when 220 patients had been recruited. On day 7, the adjusted difference in health-related quality of life was small and not significant (difference 0.03 [95% CI -0.20 to 0.26], p=0.8). 86 (89%) of 97 patients in the azithromycin group and 82 (89%) of 92 in the vitamin C group had returned to their usual activities by day 7 (difference 0.5% [-10% to 9%], p>0.9). There were no differences in the frequency of adverse effects; three patients in the vitamin C group discontinued the study medicine because of perceived adverse effects, compared with none in the azithromycin group. Most patients (81%) reported benefit from the albuterol inhaler. INTERPRETATION: Azithromycin is no better than low-dose vitamin C for acute bronchitis. Further studies are needed to identify the best treatment for this disorder.

Acute Disease↗
PubMed2002

Comparison of single-dose azithromycin and 12-dose, 3-day erythromycin for childhood cholera: a randomised, double-blind trial.

BACKGROUND: Cholera is a major public-health problem, with children most affected. However, effective single-dose antimicrobial regimens have been identified only for adults. Our aim was to compare the efficacy of azithromycin and erythromycin regimens in the treatment of children. METHODS: We did a double-blind, randomised study of 128 severely dehydrated children (age 1-15 years) with cholera, treated at one of two treatment centres in Bangladesh in 1999. Children were assigned single-dose azithromycin (20 mg/kg bodyweight, maximum individual dose 1 g; n=65) or 12.5 mg/kg erythromycin (maximum dose 500 mg; n=63) every 6 h for 3 days. Patients stayed in hospital for 5 days. We measured fluid balance every 6 h, and obtained a rectal swab or stool sample for culture daily. Our primary outcome measures were clinical success of treatment-ie, cessation of watery diarrhoea within 48 h-and bacteriological success-ie, absence of Vibrio cholerae O1 or O139 from cultures of stool or rectal swab samples after study day 2. Analysis was per protocol. FINDINGS: Two children in both groups withdrew from the study, and we excluded one child in the erythromycin group. Treatment was clinically successful in 48 (76%) patients who received azithromycin and 39 (65%) who received erythromycin (difference 11%, 95% CI -5 to 27, p=0.244); and bacteriologically successful in 45 (71%) and 49 (82%) patients, respectively (10%, -5 to 25, p=0.261). Patients treated with azithromycin had a shorter duration of diarrhoea (median 24 h vs 42 h; difference 12 h, 0-18 h, p=0.019) and fewer episodes of vomiting (1 vs 4; difference 1 episode, 0-3 episodes, p=0.023). INTERPRETATION: Single-dose azithromycin is as effective for treatment of cholera in children as standard erythromycin therapy, but is associated with less vomiting.

Adolescent↗
PubMed1996

Response to oral and intravenous azithromycin in a patient with toxoplasma encephalitis and AIDS.

We present a patient with AIDS and toxoplasma encephalitis who was unable to tolerate established therapy with sulphadiazine or clindamycin but responded to oral azithromycin and pyrimethamine. The patient was maintained on oral azithromycin but subsequently relapsed after 8 months. The recurrence was successfully treated with intravenous azithromycin. The case illustrates that azithromycin can be used to treat patients with toxoplasma encephalitis who are unable to tolerate or fail to respond to other therapeutic agents. Failure of oral azithromycin may be due to inadequate tissue concentrations and patients may further benefit from intravenous administration.

AIDS-Related Opportunistic Infections↗
PubMed2001

Comparison of amoxicillin and azithromycin in the prevention of recurrent acute otitis media.

OBJECTIVE: To compare the outcome of patients with recurrent acute otitis media (AOM) treated either with amoxicillin or with azithromycin. METHODS: This prospective, controlled, and randomized study, compares the outcome of 71 patients with recurrent AOM treated with azithromycin (31 patients) or amoxicillin (40 patients) for the prevention of AOM. azithromycin was given at a dose of 10 mg/kg once a week, whereas amoxicillin was administered daily as a single intake of one third of the therapeutic dosage (20 mg/kg per day). All treatments were prescribed for 3 months. Both groups were homogeneous with regard to the currently accepted predisposing factors of recurrent AOM. Mean age of children was 35.3 months, and average follow-up was 11.5 months. The treatment was considered effective when the number of episodes of AOM dropped to less than 50% after the prophylaxis. RESULTS: Patients in the azithromycin group had a clinical response to prophylaxis (80.6%) comparable to those treated with amoxicillin (89.5%) (P=0.300). The incidence of adverse effects was similar in both groups. CONCLUSION: According to these results, a prophylaxis with azithromycin is as useful as amoxicillin to prevent recurrent AOM.

Acute Disease↗
PubMed2001

Tolerability of 3-day, once-daily azithromycin suspension versus standard treatments for community-acquired paediatric infectious diseases.

Tolerability of azithromycin oral suspension, 10 mg/kg once daily for 3 days, was assessed in paediatric patients (< or = 18 years) with respiratory or skin and soft-tissue infections. Of 2425 patients evaluated, 1213 received azithromycin and 1212 received standard regimens of amoxycillin/clavulanic acid, cefaclor, cefixime, ceftriaxone, clarithromycin, erythromycin, or penicillin V. The incidence of treatment-related adverse events was significantly lower in patients receiving azithromycin than comparators (7.9 vs. 11.5%, P=0.003), while discontinuation rates were similar (1.0 and 1.1%, respectively). Significantly fewer gastrointestinal events were recorded for azithromycin than comparators (6.5 vs. 9.9%, P=0.002), and their duration was significantly shorter (mean 2.3 vs. 5.0 days, P=0.0001). Azithromycin paediatric oral suspension is well tolerated and associated with significantly fewer adverse events than comparators.

Adolescent↗
PubMed2002

The safety of azithromycin in the treatment of adults with community-acquired respiratory tract infections.

The comparative safety of azithromycin was assessed in adult patients (> or =12 years) with community-acquired respiratory tract infections. Of 3229 patients evaluated, 1616 received azithromycin 500 mg once daily for 3 days and 1613 received standard regimens of amoxycillin, amoxycillin/clavulanic acid, cefaclor, clarithromycin, or roxithromycin. A similar incidence of treatment-related adverse events occurred with azithromycin (10.3%) and comparators (11.5%). Significantly fewer patients were withdrawn from azithromycin than comparator treatment (0.4 versus 2.1%; P=0.0001). Most adverse events were mild/moderate in intensity and affected the gastrointestinal system. Azithromycin was as well tolerated as other antibiotics commonly used for bacterial infections in adults.

Adult↗
PubMed2003

Influence of a 3-day regimen of azithromycin on the disposition kinetics of cyclosporine A in stable renal transplant patients.

Some macrolide antibiotics have been shown to produce significant drug-drug interactions through the inhibition of cytochrome P450 (CYP) enzymes. In renal transplant patients these interactions pose potentially serious problems for the safe administration of cyclosporine A (CSA), a substrate of CYP3A4. The effects of azithromycin on CSA disposition kinetics were evaluated in eight stable renal transplant patients. Patients had been stabilized on individualized doses of CSA which remained unchanged throughout the study. Azithromycin was administered for 3 days. Baseline measurements of CSA disposition kinetics were taken prior to azithromycin treatment (study day 2) and after 3 days (study day 5) of azithromycin treatment (500mg/day, orally). The key parameters of interest were the area under the CSA blood concentration versus time curve (AUC) measured for 24h after the morning dose of CSA on both days 2 and 5, and the C(max) values of CSA. The geometric mean ratios (GMRs) of those parameters (day 5/day 2) and their 90% confidence intervals (90% CI) were 107 (98,116) and 119 (104,136), respectively. The 7% increase in exposure level and 19% increase in peak plasma concentration are not likely to be clinically significant. It is concluded that azithromycin (500mg/dayx3 days) does not alter the disposition kinetics of CSA in a clinically significant way, and that CSA dosage adjustments are not warranted in renal transplant patients taking these two drugs together.

Anti-Bacterial Agents↗
PubMed2002

Pharmacokinetics of azithromycin in lung tissue, bronchial washing, and plasma in patients given multiple oral doses of 500 and 1000 mg daily.

The present study compares the pharmacokinetics of azithromycin in plasma, lung tissue, and bronchial washing after oral administration of 500 mg (standard dose) versus 1000 mg daily for 3 days. Samples were taken during surgery for lung resection at various time points up to 204 h after the last drug dose, and azithromycin levels were analyzed by HPLC method. Azithromycin was widely distributed within the lower respiratory tract; sustained concentrations of the drug were detectable at the last sampling time (204 h) in lung tissue and bronchial washing, with long terminal half-lives of 132.86 and 74.32 h at 500 mg daily and 133.32 and 70.5 h at 1000 mg daily, respectively. Doubling the drug dose resulted in a remarkable increase in lung area under the curve (AUC, 1318 hx microg g(-1) vs 2502 hx microg g(-1)) and peak tissue concentration (9.13+/-0.53 microg g(-1) vs 17.85+/-2.4 microg g(-1)). In addition to this, enhanced azithromycin penetration from plasma into bronchial secretion and lung tissue was evidenced by the increase in the ratio of AUC(bronchial washing) versus AUC(plasma) (2.96 vs 5.27 at 500 and 1000 mg, respectively) and AUC(lung) versus AUC(plasma) (64.35 vs 97.73 at 500 and 1000 mg, respectively). In conclusion, the exposure of lung and bronchial washing to azithromycin is increased by doubling the dose, which results in favorable pharmacokinetic profile of the drug in the lower respiratory tract.

Administration, Oral↗
PubMed2003

Efficacy of azithromycin for the treatment of feline chlamydophilosis.

The current recommended treatment for feline chlamydophilosis involves daily oral administration of antimicrobials to all cats within an affected group for a prolonged period of time (4-6 weeks). Not surprisingly, owner compliance can be poor resulting in apparent treatment failure. Recent anecdotal evidence, supported by its efficacy in the treatment of Chlamydia trachomatis infection in humans, has suggested that azithromycin may offer an alternative by allowing less frequent dosing for a shorter duration. A clinical trial was designed to evaluate the efficacy of azithromycin for the treatment of chlamydia (Chlamydophila felis) infection in cats. Whilst azithromycin, given at 10-15 mg/kg daily for 3 days and then twice weekly, provided a similar, rapid resolution of clinical signs and negative isolation scores as doxycycline, C felis was re-isolated in four out of the five cats treated. Furthermore, even daily administration of azithromycin to chronically infected cats was ineffective in clearing infection. The azithromycin protocols used here were therefore found to be unsuccessful in eliminating the carriage of this strain of C felis.

Administration, Oral↗
PubMed2000

Evaluation of the efficacy of atovaquone alone or in combination with azithromycin against acute murine toxoplasmosis.

Mice were infected intraperitoneally with 10,000 tachyzoites of Toxoplasma gondii (RH) strain and, 24 h later, were treated orally for 10 days with atovaquone and azithromycin, either alone or in combination. Evaluation of the efficacy of the drugs was performed by microscopic examination of smears prepared from the organs of the mice, and by subinoculation of visceral and brain suspensions from surviving mice into healthy mice at the end of the experiments. It was found that 58%, 83% and 100% of the mice survived after administration of 75, 150 or 200 mg/kg per day of azithromycin, respectively. Moreover, 8%, 17% and 25% of the mice survived after treatment with atovaquone at 20, 50 or 100 mg/kg per day, respectively. No synergistic or additive effects of combinations of atovaquone and azithromycin were observed. However, azithromycin did not eradicate the parasite from the brain and viscera of the infected mice, whereas atovaquone at 20, 50 and 100 mg/kg per day removed the parasite from viscera and at 100 mg/kg per day eradicated the parasite from the brain of infected mice. The combinations of atovaquone and azithromycin failed to completely eradicate the parasite from the brain and viscera of infected mice.

Animals↗
PubMed1998

Low- versus high-dose azithromycin triple therapy for Helicobacter pylori infection.

BACKGROUND: We report a clinical trial which evaluated the effectiveness of triple therapy containing low- and high-dose azithromycin to treat Helicobacter pylori infection. METHODS: From March 1997 to March 1998, patients infected with H. pylori were assigned to receive either: Treatment 1: ranitidine bismuth citrate (RBC) (400 mg b.d.) and amoxycillin (1 g b.d.) for 10 days with azithromycin 500 mg o.m. for 3 days: or Treatment 2: RBC and amoxycillin for 10 days with azithromycin 1 g o.m. for 3 days. H. pylori eradication was established by a urea breath test at least 4 weeks after therapy. Side-effects and compliance were assessed using a diary. RESULTS: Sixty-eight patients were enrolled. Fifty-seven per cent of patients were treated for active peptic ulcer disease or a history of peptic ulcer disease. Treatment 1 cured H. pylori in 44% and 44% by per protocol and intention-to-treat analysis, respectively. The corresponding eradication rates for Treatment 2 were 79% and 75%. Two patients taking Treatment 2 dropped out of the study because of side-effects. CONCLUSIONS: With RBC and amoxycillin for 10 days, azithromycin at a dose of 1 g/day for 3 days was significantly better at curing H. pylori infection than azithromycin 500 mg/day for 3 days.

Adult↗
PubMed1999

Interpretation of middle ear fluid concentrations of antibiotics: comparison between ceftibuten, cefixime and azithromycin.

AIMS: The aim of this study was to determine the potential influence of variables such as the cell content in the fluid, and serum levels, on the concentrations of ceftibuten, cefixime and azithromycin in the middle ear fluid of patients suffering from acute otitis media. METHODS: This randomized, open study compared the penetration of ceftibuten (9 mg kg(-1) 18 patients), cefixime (8 mg kg(-1), 16 patients) and azithromycin (10 mg kg(-1) 16 patients) into the intracellular and extracellular compartments of middle ear fluid of 50 paediatric patients (aged 8-14 years) with acute otitis media. Middle ear fluid was extracted by tympanocentesis 4, 12 and 24 h after dosing and divided into two fractions: with cells (as collected) (C+) and cell-free (C-). Antibiotics were assayed in C+ and C- samples by h.p.l.c. RESULTS: Ceftibuten achieved greater penetration into middle ear fluid than cefixime and azithromycin. Higher concentrations of ceftibuten (CTB) and cefixime (CFX) were found in the C- fraction (CTB: 4h 13.3+/-1.86; 12h 4.7+/-1.18; 24h 0.5+/-0.2. CFX: 4h 3.2+/-1.4; 12h 1.5+/-0.5; 24h>(0.1 mgl(-1)) than in the C+ fraction (CTB:4 h 8.4+/-4.3; 12 h 2.88+/-1.19; 24 h 0.3+/-0.27. CFX: 4 h 1.2+/-0.6; 12 h 0.8+/-0.2; 24 h>0.1 mg l(-1)) at the each time point, while the opposite was true for azithromycin (C-: 4 h 0.11+/-0.04; 12 h 0.12+/-0.08; 24 h 0.23+/-0.12. C+: 4 h 0.38+/-0.24; 12 h 0.9+/-0.03; 24 h 1.05+/-0.3 mg l(-1)). CONCLUSIONS: This study demonstrates that the penetration of antibiotics into the middle ear fluid is influenced by its serum concentrations as well as by the cell content in the fluid. Ceftibuten achieved higher middle ear fluid concentrations than cefixime in C+ and C- fractions at all time points. Both ceftibuten and cefixime concentrations are negatively influenced by the cell content in the fluid. In contrast the concentration of azithromycin to the middle ear fluid is positively influenced by the cell content in the fluid.

Acute Disease↗
PubMed2003

The natural history of recurrent acute tonsillitis and a clinical trial of azithromycin for antibiotic prophylaxis.

The pharmacokinetics of azithromycin (Zitromax), Pfizer Inc., USA) in tonsil tissue warranted the present trial. In 110 patients eligible for tonsillectomy because of recurrent acute tonsillitis, surgery was replaced by randomized medication with azithromycin 500 mg or placebo once per week for 6 months. Subsequently, their clinical condition and microbiology was monitored for 12 months. Acute tonsillitis developed in 40% of the patients who received azithromycin and in 49% of the patients in the placebo group (P > 0.05). Accordingly, 45% of all patients developed acute tonsillitis. Resistance to azithromycin was not detected. In this trial long-term medication with azithromycin was not efficacious in recurrent acute tonsillitis. As all patients were eligible for tonsillectomy according to current criteria, it is surprising that only 45% developed acute tonsillitis during the trial period. Therefore, the criteria for tonsillectomy in recurrent acute tonsillitis must be revised.

Acute Disease↗
PubMed2003

Is oral azithromycin effective for the treatment of cyclosporine-induced gingival hyperplasia in cardiac transplant recipients?

Anecdotal evidence suggests that azithromycin is effective for the treatment of cyclosporine-induced gingival hyperplasia in solid-organ transplant recipients. We present the cases of two heart transplant patients who insidiously developed gingival hyperplasia, likely because of immunosuppression with cyclosporine, which was treated with azithromycin. Evidence supporting the efficacy of azithromycin in the treatment of cyclosporine-induced gingival hyperplasia in solid organ transplant recipients was searched for, identified, and then critically assessed. While no data were found specifically evaluating azithromycin in cardiac transplant patients, there were nine pertinent papers identified that evaluated the clinical question of interest in the renal transplant population [Wahlstrom et al. (1995) The New England Journal of Medicine 332, 753; Boran et al. (1996) Transplantation Proceedings 28, 2316; Gomez et al. (1997) Nephrology Dialysis Transplantation 12, 2694; Ljutic (1997) Dialysis & Transplantation 26, 787; Puig et al. (1997) Transplantation Proceedings 29, 2379; Nash et al. (1998) Transplantation 65, 1611; Nowicki et al. (1998) Annals of Transplantation 3, 25; Wirnsberger et al. (1998) Transplantation Proceedings 30, 2117; Citterio et al. (2001) Transplantation Proceedings 33, 2134]. These studies and case reports are summarized. While more evidence is required to support routine use of azithromycin for the treatment of cyclosporine-induced gingival hyperplasia in cardiac transplant recipients, preliminary published evidence from renal transplant patients is certainly favourable.

Administration, Oral↗