zithromax and Otitis-Media-with-Effusion

Three clinical trials have examined the efficacy and safety of single dose azithromycin (30 mg/kg) in children with uncomplicated acute otitis media (AOM). In the first trial, a small pilot study, the clinical and microbiologic efficacy of single dose azithromycin was comparable with that of 3-day azithromycin or single dose ceftriaxone. A second, non-comparative trial confirmed the clinical and microbiologic efficacy of the single dose regimen. The third study, a large double blind, double dummy trial, demonstrated comparable clinical success rates between single dose azithromycin and 10-day standard amoxicillin/clavulanate. The incidence of drug-related adverse events in patients treated with single dose azithromycin was low in all three trials and similar to rates that have been reported for other antimicrobial agents used for the treatment of patients with AOM. In the amoxicillin/clavulanate trial, compliance with single dose azithromycin was significantly better than with the amoxicillin/clavulanate regimen (P < 0.001). We conclude that a single dose of azithromycin (30 mg/kg) is safe and effective for the treatment of uncomplicated AOM in children.

Topics: Azithromycin; Ceftriaxone; Child; Child, Preschool; Clinical Trials, Phase III as Topic; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Male; Otitis Media with Effusion; Pilot Projects; Randomized Controlled Trials as Topic; Risk Assessment; Severity of Illness Index; Treatment Outcome

Otitis media with effusion (OME) is a common disease in childhood. There is no consensus on the optimal therapeutic option for OME. Considering the known efficacy of acetylcysteine (AC) and azithromycin (AZ) in the treatment of middle ear mucosa, the aim of the study was to assess their efficacy in the management of chronic OME. The study included 90 children with OME, both ears. They are divided into three groups of 30 children. Group 1 (AC) patients were treated with acetylcysteine per os, 3 × 100 mg, for 3 weeks; group 2 (AZ) with body weight adjusted dose of azithromycin for 3 days; and group 3 (AC + AZ) with a combination of acetylcysteine and azithromycin at doses described above. Three measurements were performed. On second measurement, tympanogram improvement was recorded in 45% of 60 ears in group I, 53.3% of 60 ears in group II, and 61.7% of 60 ears in group III. The percentage of improvement was highest in group III. Although between-group differences did not reach statistical significance, the results obtained appear to be clinically relevant. In conclusion, conservative therapy for chronic OME is reasonable. Although study results don't have a strong statistical differences and may not refer clinical improvement results suggest that this combination of drugs (antibiotics, bronchosecretolytics) can be useful in the treatment of OME.

Topics: Acetylcysteine; Acoustic Impedance Tests; Anti-Bacterial Agents; Azithromycin; Child; Child, Preschool; Drug Therapy, Combination; Expectorants; Female; Humans; Male; Otitis Media with Effusion; Prospective Studies

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.

Topics: Acoustic Impedance Tests; Adolescent; Adrenergic Agents; Anti-Bacterial Agents; Azithromycin; Child; Child, Preschool; Ephedrine; Female; Follow-Up Studies; Haemophilus Infections; Humans; Male; Neisseriaceae Infections; Otitis Media with Effusion; Retrospective Studies

To compare the bacteriologic and clinical efficacy of amoxicillin/clavulanate and azithromycin in patients with acute otitis media (AOM), particularly the ability to eradicate the predominant AOM pathogens from middle ear fluid as assessed by mandatory second tympanocentesis.. In this single blind study 238 infants and children with AOM were randomized to receive amoxicillin/clavulanate (45/6.4 mg/kg/day in two divided doses for 10 days) or azithromycin (10 mg/kg on Day 1, then 5 mg/kg daily on Days 2 through 5). Tympanocentesis was performed before the first dose and repeated on Day 4, 5 or 6. Clinical response was assessed at end of therapy between Days 12 and 14 and at follow-up between Days 22 and 28.. Amoxicillin/clavulanate was significantly more likely to eradicate all bacterial pathogens [83% (54 of 65) vs. 49% (35 of 71), P = 0.001] and Haemophilus influenzae [87% (26 of 30) vs. 39% (13 of 33), P = 0.0001] from middle ear fluid than was azithromycin. Amoxicillin/clavulanate was also more likely to eradicate Streptococcus pneumoniae, but the difference was not statistically significant [90% (18 of 20) vs. 68% (13 of 19) [corrected], P = 0.095]. On Days 12 to 14, signs and symptoms were more likely to resolve completely or improve in all culture-positive patients [86% (60 of 70) vs. 70% (51 of 73), P = 0.023] and in those with H. influenzae infections [91% (30 of 33) vs. 65% (22 of 34), P = 0.010] who received amoxicillin/clavulanate compared with those who received azithromycin. Otherwise there were no significant differences between groups in clinical outcomes on Days 12 to 14 or at follow-up.. Our findings indicate that amoxicillin/clavulanate has superior bacteriologic and clinical efficacy compared with azithromycin in children with AOM.

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Child, Preschool; Female; Haemophilus influenzae; Humans; Infant; Male; Microbial Sensitivity Tests; Moraxella catarrhalis; Otitis Media with Effusion; Penicillins; Single-Blind Method; Streptococcus pneumoniae; Treatment Outcome

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.. 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.. 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)).. 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.

Topics: Acute Disease; Administration, Oral; Adolescent; Anti-Bacterial Agents; Azithromycin; Cefixime; Cefotaxime; Ceftibuten; Cephalosporins; Child; Exudates and Transudates; Female; Humans; Male; Otitis Media with Effusion; Time Factors

To determine the relation between early bacteriologic eradication and clinical outcome of acute otitis media (AOM) in infants and young children treated with various antibiotics.. The study group consisted of patients ages 3 to 24 months seen at the Pediatric Emergency Room with: (1) symptoms and physical findings consistent with AOM of < or = 7 days duration; (2) no spontaneous perforation or tympanostomy tubes; (3) positive initial middle ear fluid culture; and (4) a follow-up to at least Day 10+/-2 of the study with a second culture performed 72 to 96 h after initiation of antibiotic treatment. Any patient with a positive middle ear fluid culture 72 to 96 h after initiation of antibiotic treatment was considered to have bacteriologic failure. Otologic evaluation was done by an otolaryngologist unaware of the culture results and of the study drug allocation. A clinical score based on body temperature, report of irritability and ear tugging observed by the parents and the appearance and redness of the ear drum as observed by the otolaryngologist was also used for clinical evaluation.. The study group consisted of 123 patients, of whom 57 (46%) had positive middle ear fluid 72 to 96 h after initiation of antibiotic treatment. Clinical failure was observed in 21 of 57 (37%) patients in whom bacteriologic eradication did not occur vs. only 2 of 66 (3%) patients with bacteriologic eradication after 3 to 4 days of treatment (P < 0.001). Clinical score for both moderate and severe disease decreased significantly faster in those with bacteriologic eradication than in those in whom middle ear fluid was still culture-positive 72 to 96 h after initiation of treatment.. Clinical failures in our population were associated with inability to eradicate the causative organisms of AOM from the middle ear fluid within 3 to 4 days after initiation of antibiotic therapy. Most patients (including those without bacteriologic eradication) improved after 3 to 4 days of treatment, but patients with sterile middle ear fluid felt better after 3 to 4 days of treatment than patients in whom middle ear fluid was still culture-positive.

Topics: Acute Disease; Amoxicillin; Anti-Bacterial Agents; Azithromycin; Bacteria; Cefaclor; Cephalosporins; Child, Preschool; Female; Humans; Infant; Male; Otitis Media with Effusion; Penicillins; Prospective Studies; Treatment Outcome

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.

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Child; Child, Preschool; Ear, Middle; Female; Humans; Infant; Male; Otitis Media with Effusion; Otitis Media, Suppurative

Continuous chemoprophylaxis is effective in the prevention of new episodes of acute otitis media (AOM) in otitis-prone children, but compliance can be a problem and thus efficacy can be decreased. Intermittent chemoprophylaxis has so far shown conflicting results. Azithromycin, which has a peculiar pharmacokinetics, resulting, even after a single dose, in persistently elevated concentrations in respiratory tissues, could permit a periodic administration with higher compliance. We compared a 6-month course of once-weekly azithromycin (5 or 10 mg/kg of body weight) with that of once-daily amoxicillin (20 mg/kg) in a single-blind, randomized study of prophylaxis for recurrent AOM in 159 children aged 6 months to 5 years with at least three episodes of AOM in the preceding 6 months. In the amoxicillin group, 23 (31.1%) of 74 children developed 29 episodes of AOM, while in the 10-mg/kg azithromycin group, 11 (14.9%) of 74 children experienced 15 episodes. The 5-mg/kg/week azithromycin trial was prematurely interrupted after nine cases, due to the high occurrence rate of AOM (55.5%). During the 6-month prophylaxis period, the proportion of children with middle ear effusion declined similarly in both groups. No substantial modification of the nasopharyngeal flora was noted at the end of prophylaxis in both antimicrobial groups. In the 6-month-postprophylaxis follow-up period, about 40% of children in both groups again developed AOM. Azithromycin at 10 mg/kg once weekly can be regarded as a valid alternative to once-daily low-dose amoxicillin for the prophylaxis of AOM. Although in the present study no microbiological drawback was noted, accurate selection of children eligible for prophylaxis is mandatory to avoid the risk of emergence of resistant strains.

Topics: Amoxicillin; Anti-Bacterial Agents; Azithromycin; Child, Preschool; Drug Administration Schedule; Follow-Up Studies; Humans; Infant; Otitis Media with Effusion; Penicillins; Single-Blind Method

Azithromycin is a newly developed azalide antibiotic which is very active against microbes causing respiratory tract infections; tissue concentrations remain elevated for a long time after discontinuation of treatment. A clinical study was conducted to compare azithromycin (10 mg/kg administered as a single daily dose for 3 days) with amoxycillin/clavulanic acid (50 mg/kg/day given b.i.d. for 10 days) in 30 children with otitis media. Sensitivity testing demonstrated good azithromycin activity against beta-haemolytic streptococci, Moraxella catarrhalis, Haemophilus influenzae and Staphylococcus aureus. By day 12, clinical cure was recorded in 14/15 children treated with azithromycin and this was maintained at day 30. In the day 12 and 13/15 children by day 30. It was concluded that a 3-day azithromycin regimen produces a satisfactory clinical response and the eradication of key pathogens, and was acceptable for children.

Topics: Administration, Oral; Amoxicillin; Azithromycin; Child; Child, Preschool; Clavulanic Acid; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Erythromycin; Female; Follow-Up Studies; Humans; Infant; Male; Otitis Media; Otitis Media with Effusion

Topics: Acetylcysteine; Anti-Bacterial Agents; Azithromycin; Humans; Otitis Media; Otitis Media with Effusion

Otitis media with effusion is a clinical manifestation characterised by inflammation of middle-ear mucosa. This study investigated the therapeutic effect of erythromycin, clarithromycin, azithromycin and roxithromycin on a histamine-induced animal model of otitis media with effusion.. The animals were divided into five groups, receiving erythromycin, clarithromycin, azithromycin, roxithromycin or saline solution. The guinea pigs in the study groups received erythromycin (40 mg/kg/day), clarithromycin (15 mg/kg/day), azithromycin (10 mg/kg/day) or roxithromycin (10 mg/kg/day) for 3 days by gastric tube. Four hours after the end of the administration, histamine solution was injected into the right middle ear.. The lowest neutrophil density value obtained using stereological techniques was in the azithromycin group (0.86 ± 0.25 × 10-5/μm3), while the highest value was observed in the control group (6.68 ± 3.12 × 10-5/μm3). The anti-inflammatory properties of clarithromycin, azithromycin and roxithromycin were similar to one another, but better than that of erythromycin.. The use of macrolide antibiotics is recommended, as they show antibacterial and anti-inflammatory efficacy in otitis media with effusion.

Topics: Animals; Anti-Bacterial Agents; Anti-Inflammatory Agents; Azithromycin; Clarithromycin; Disease Models, Animal; Ear, Middle; Erythromycin; Guinea Pigs; Histamine; Otitis Media with Effusion; Roxithromycin

The aim of this study is to examine the internalization of nontypeable Haemophilus influenzae (NTHi) into human epithelial cells.. Bactericidal assay was applied to examine the effects of antibiotics against cell-adherent NTHi using HEp-2 cells. A trans-well chamber assay was applied to examine the internalization and penetration of NTHi using Detroit562 cells.. The adherence of NTHi to HEp-2 cells was noted after 2h of incubation. Azithromycin had a strong bactericidal effect against both cell-associated and non-adherent NTHi, while ceftriaxone did not show bactericidal effects on NTHi adhered to the HEp-2 cells. Three (60.0%) out of five NTHi isolates from the nasopharynx of children with intractable acute otitis media (AOM) internalized into and subsequently penetrated through the epithelial cells at various degrees. Azithromycin had a strong bactericidal effect against the cell-internalized NTHi, while ceftriaxone was bactericidal only against extracellular NTHi.. The potential of NTHi as the intracellular pathogen may contribute to the persistent existence of this pathogen that result in the prolonged and intractable clinical course of AOM. Azithromycin may be a therapeutically significant antibiotic for patients with prolonged respiratory tract infections due to NTHi.

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Bacterial Adhesion; Bacterial Physiological Phenomena; Ceftriaxone; Cell Line; Child; Dose-Response Relationship, Drug; Epithelial Cells; Gentamicins; Haemophilus Infections; Haemophilus influenzae; Humans; In Vitro Techniques; Microbial Sensitivity Tests; Microbial Viability; Otitis Media with Effusion