Randomized Double-Blind Study Comparing 3- and 6-Day Regimens of Azithromycin with a 10-Day Amoxicillin-Clavulanate Regimen for Treatment of Acute Bacterial Sinusitis

Henry, Dan; Riffer, Ernie; Sokol, William N.; Chaudry, Naumann I.; Swanson, R. N.

doi:10.1128/aac.47.9.2770-2774.2003

Cited by 34 publications

(48 citation statements)

References 12 publications

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“…In a study the efficacy and side effects of 500 mg azithromycin taken daily for 3 and 6 days were compared with those of co-amoxiclav 500/125 mg taken 3 times a day for 10 days with regard to treatment of acute sinusitis in adults . The efficacy of azithromycin was obtained 88.8% and 89.3% for 3 and 6 days, respectively, and that of co-amoxiclav was reported 84.9% (Henry, Riffer, Sokol, Chaudry, & Swanson, 2003). In our study, the cure rate in azithromycin group was 88% and in co amoxiclav group was 83/3% at tenth day, this shows our findings are in line with this study.…”

Section: Discussionsupporting

confidence: 83%

Comparison of Efficacy and Side Effects of Azithromycin and Co-Amoxiclav in the Treatment of Acute Sinusitis in Adults: A Randomized Clinical Trial

Amani¹,

Mohammadi-Najafabadi²,

Ahmadi³

2016

GJHS

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Background: Regarding high prevalence of common cold and sinusitis in Chaharmahal and Bakhtiari Province and the lack of studies on patients referring hospitals in this province, this study was conducted to determine and compare the efficacy and side effects of azithromycin and co-amoxiclav. Methods:This study was a double-blinded randomized clinical trial. The study population of this clinical trial was consisted of 90 patients with acute sinusitis aged 12-65 years. At least two major criteria or one major criterion and two minor criteria with duration of at least 7 days and at most 28 days, were some of the sinusitis diagnostic criteria for inclusion of the patients into the study. The patients were examined for symptoms prior to and twice after the treatment. The treatment was administration with 500 mg azithromycin tablet per day for three days in group 1 (G1) and 625 mg co-amoxiclav tablet every 8 h for 10 days in group 2 (G2). The data were analyzed by repeated measures analysis of variance, independent t-test, and chi-square in Stata software and P < 0.05 was considered significant. Results:Mean±Standard deviation age of all patients was 32.14±9.91 years. Out of 90 participants in the study, 50 (55.56%) were male and the rest were female. The patients' symptoms were quantitatively similar in the two groups (22.3±2 and 22.2±1.9 in G1 and G2, respectively) prior to the intervention. The score at second examination decreased to 3.7±2.1 in G1 and to 9.4±2.7 in G2, significantly different from that prior to intervention and between the two groups (P<0.001). Although the score decreased in the two groups at third examination, it was not significant in the two groups (P=0.652). The cure rate in azithromycin group was derived 87.5% and 88%, and in co-amoxiclav group 32.4% and 83.3% at the days 5 and 10 of treatment, respectively. The most prevalent side effects in the two groups were diarrhea and nausea. The prevalence of diarrhea was obtained 21% and 33% in G1 and G2, respectively. Conclusion:No significant difference in side effects was seen between the two groups. Although the cure was faster in the patients treated with azithromycin than those treated with co-amoxiclav, co-amoxiclav is still considered as adequately working against acute sinusitis bacterial pathogens. In view of this efficacy, co-amoxiclav seems to lead to no drug resistance and could be used to treat the patients.

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Section: Discussionsupporting

confidence: 83%

Comparison of Efficacy and Side Effects of Azithromycin and Co-Amoxiclav in the Treatment of Acute Sinusitis in Adults: A Randomized Clinical Trial

Amani¹,

Mohammadi-Najafabadi²,

Ahmadi³

2016

GJHS

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“…While the incidence of treatment-related diarrhea (12.3%) was higher in the azithromycin treatment arm than in the amoxicillin/clavulanate arm, it is lower than the rate of treatment-related diarrhea reported in a study of the recently approved 3-day azithromycin regimen for bacterial sinusitis (17.0%) (12). The overall difference in treatment-related adverse events between treatments was primarily due to diarrhea, since the number of patients with adverse events other than diarrhea was only slightly higher for azithromycin-treated patients.…”

Section: Discussionmentioning

confidence: 46%

Novel, Single-Dose Microsphere Formulation of Azithromycin versus 7-Day Levofloxacin Therapy for Treatment of Mild to Moderate Community-Acquired Pneumonia in Adults

D'Ignazio

Camere

Lewis

et al. 2005

Antimicrob Agents Chemother

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This randomized, double-blind, noninferiority study was designed to demonstrate that a single 2.0-g oral dose of a novel microsphere formulation of azithromycin was at least as effective as 7 days of levofloxacin, 500 mg/day, in the treatment of adult patients with mild to moderate community-acquired pneumonia (Fine classes I, II, and III). In total, 427 subjects were randomly assigned to receive either a single 2.0-g dose of azithromycin microspheres (n ‫؍‬ 213) or a 7-day regimen of levofloxacin (n ‫؍‬ 214). At baseline, 219 of 423 (51.8%) treated subjects had at least one pathogen identified by culture, PCR, or serology. The primary end point was the clinical response (cure or failure) in the "clinical per protocol" population at test of cure (days 13 to 24). Clinical cure rates were 89.7% (156 of 174) for azithromycin microspheres and 93.7% (177 of 189) for levofloxacin (treatment difference, ؊4.0%; 95% confidence interval, ؊9.7%, 1.7%). Bacteriologic success at test of cure in the "bacteriologic per protocol" population was 90.7% (97 of 107) for azithromycin microspheres and 92.3% (120 of 130) for levofloxacin (treatment difference, ؊1.7%; 95% confidence interval, ؊8.8%, 5.5%). Both treatment regimens were well tolerated; the incidence of treatment-related adverse events was 19.9% and 12.3% for azithromycin and levofloxacin, respectively. A single 2.0-g dose of azithromycin microspheres was at least as effective as a 7-day course of levofloxacin in the treatment of mild to moderate community-acquired pneumonia in adult outpatients.

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“…This base model was then expanded in a third step to link changes in the free plasma concentrations over time to the corresponding free tissue concentrations (cf. equation 2), with the concentrations calculated as the ratio of the amount and the respective tissue volume: (2) where k in and k out are the first-order rate constants describing the distribution of AZM in and out of the tissue, respectively. Given the affinity of protonated AZM to negatively charged phospholipids ( …”

Section: Methodsmentioning

confidence: 99%

“…A zithromycin (AZM) is a semisynthetic macrolide antibiotic with a broad range of activity against Gram-positive bacteria and some community-acquired Gram-negative pathogens, including Haemophilus influenzae and Moraxella catarrhalis, and it is extensively used in the clinic setting for the treatment of respiratory tract infections (1,2). Compared to the older macrolides, AZM is thought to have advantageous pharmacokinetic (PK) and pharmacodynamic (PD) properties, particularly due to its large distribution volume (ϳ23 liter/kg of body weight) and long halflife of 68 to 79 h (3), which allows for a convenient once-daily dosing regimen and a short overall duration of treatment of 3 to 5 days (4).…”

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confidence: 99%

Development of a Population Pharmacokinetic Model Characterizing the Tissue Distribution of Azithromycin in Healthy Subjects

Zheng

Matzneller

Zeitlinger

et al. 2014

Antimicrob Agents Chemother

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Recent clinical trials indicate that the use of azithromycin is associated with the emergence of macrolide resistance. The objective of our study was to simultaneously characterize free target site concentrations and correlate them with the MIC 90 s of clinically relevant pathogens. Azithromycin (500 mg once daily [QD]) was administered orally to 6 healthy male volunteers for 3 days. The free concentrations in the interstitial space fluid (ISF) of muscle and subcutaneous fat tissue as well as the total concentrations in plasma and polymorphonuclear leukocytes (PMLs) were determined on days 1, 3, 5, and 10. All concentrations were modeled simultaneously in NONMEM 7.2 using a tissue distribution model that accounts for nonlinear protein binding and ionization state at physiological pH. The model performance and parameter estimates were evaluated via goodness-of-fit plots and nonparametric bootstrap analysis. The model we developed described the concentrations at all sampling sites reasonably well and showed that the overall pharmacokinetics of azithromycin is driven by the release of the drug from acidic cell/tissue compartments. The model-predicted unionized azithromycin (AZM) concentrations in the cytosol of PMLs (6.0 ؎ 1.2 ng/ml) were comparable to the measured ISF concentrations in the muscle (8.7 ؎ 2.9 ng/ml) and subcutis (4.1 ؎ 2.4 ng/ml) on day 10, whereas the total PML concentrations were >1,000-fold higher (14,217 ؎ 2,810 ng/ml). The total plasma and free ISF concentrations were insufficient to exceed the MIC 90 s of the skin pathogens at all times. Our results indicate that the slow release of azithromycin from low pH tissue/cell compartments is responsible for the long terminal half-life of the drug and thus the extended period of time during which free concentrations reside at subinhibitory concentrations.

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Randomized Double-Blind Study Comparing 3- and 6-Day Regimens of Azithromycin with a 10-Day Amoxicillin-Clavulanate Regimen for Treatment of Acute Bacterial Sinusitis

Cited by 34 publications

References 12 publications

Comparison of Efficacy and Side Effects of Azithromycin and Co-Amoxiclav in the Treatment of Acute Sinusitis in Adults: A Randomized Clinical Trial

Comparison of Efficacy and Side Effects of Azithromycin and Co-Amoxiclav in the Treatment of Acute Sinusitis in Adults: A Randomized Clinical Trial

Novel, Single-Dose Microsphere Formulation of Azithromycin versus 7-Day Levofloxacin Therapy for Treatment of Mild to Moderate Community-Acquired Pneumonia in Adults

Development of a Population Pharmacokinetic Model Characterizing the Tissue Distribution of Azithromycin in Healthy Subjects

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