A short (3-day) course of azithromycin tablets versus a 10-day course of amoxycillin–clavulanic acid (co-amoxiclav) in the treatment of adults with lower respiratory tract infections and effects on long-term outcome

Hoepelman, I. M.; Möllers, Marius J.; Schie, Mathijs H. van; Greefhorst, A.P.M.; Schlösser, N. J. J.; Damsté, E.J Sinninghe; Moosdijk, C.N.F van de; Dalinghaus, W.H; Eland, M.E; Mol, Stijn J.M.; Rozenberg-Arska, M.

doi:10.1016/s0924-8579(97)00043-5

Cited by 68 publications

(30 citation statements)

References 17 publications

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“…These results are in line with a second study that investigated the use of azithromycin ). In addition, the clinical and bacteriologic outcomes in the present study are consistent with results from other studies in which conventional 3-and 5-day dosing regimens of azithromycin have been used to treat patients with mild to moderate CAP (3,13).…”

Section: Discussionsupporting

confidence: 89%

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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Section: Discussionsupporting

confidence: 89%

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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“…Similarly, in one RCT [23] in which azithromycin was compared with A/C for the treatment of patients with various acute lower tract respiratory infections (including ABECB), specific data on clinical outcomes of patients with ABECB could not be extracted. Thus,19 RCTs that compared macrolides with quinolones (n58) [24][25][26][27][28][29][30][31] and A/C with quinolones (n54) [24,[32][33][34] or macrolides (n58) [35][36][37][38][39][40][41][42] were included in the meta-analysis. In one RCT [24] the quinolone levofloxacin was compared with both a macrolide (azithromycin) and A/C.…”

Section: Selected Rctsmentioning

confidence: 99%

“…Patients presented with ABECB characterised as Anthonisen type I, II or III in two RCTs [29,30] (in these two RCTs a macrolide was compared with a quinolone), or Anthonisen type I or II in 10 RCTs [24-27, 31, 33, 36, 38, 40, 41]. In contrast, in the remaining RCTs [28,32,34,35,37,39,42] only patients with an Anthonisen type I [28,34,35,37,39] or type II [32,42] ABECB were enrolled.…”

Section: Selected Rctsmentioning

confidence: 99%

“…In nine RCTs, data regarding the use of systemic corticosteroids before the occurrence of ABECB [26,27,30,33,[37][38][39][40]42] were not provided, while in four RCTs the use of systemic corticosteroids at a dose of o10 mg of prednisone [25,41] or at any dose [34,36] was an exclusion criterion. In the six RCTs [24,28,29,31,32,35] in which relevant data were provided, there was no statistically significant difference regarding the use of systemic corticosteroids at baseline between the compared groups.…”

Section: Selected Rctsmentioning

confidence: 99%

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Macrolides, quinolones and amoxicillin/clavulanate for chronic bronchitis: a meta-analysis

Siempos

Dimοpoulos²,

Korbila³

et al. 2007

Eur Respir J

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The comparative effectiveness and safety of macrolides, quinolones and amoxicillin/ clavulanate (A/C) for the treatment of patients with acute bacterial exacerbation of chronic bronchitis (ABECB) was evaluated in the present study.PubMed, Current Contents and the Cochrane Central Register of Controlled Trials were searched to identify relevant randomised controlled trials (RCTs).In total, 19 RCTs (20 comparisons) were included in the present analysis. There was no difference regarding treatment success in intention-to-treat and clinically evaluable patients between macrolides and quinolones, A/C and quinolones or A/C and macrolides. The treatment success in microbiologically evaluable patients was lower for macrolides compared with quinolones (odds ratio (OR) 0.47, 95% confidence interval (CI) 0.31-0.69). Fewer quinolonerecipients experienced a recurrence of ABECB after resolution of the initial episode compared with macrolide-recipients during the 26-week period following therapy. Adverse effects in general were similar between macrolides and quinolones. Administration of A/C was associated with more adverse effects (mainly diarrhoea) than quinolones (OR 1.36, 95% CI 1.01-1.85).Macrolides, quinolones and amoxicillin/clavulanate may be considered equivalent for the treatment of patients with an acute bacterial exacerbation of chronic bronchitis in terms of shortterm effectiveness. Quinolones are associated with better microbiological success and fewer recurrences of acute bacterial exacerbation of chronic bronchitis than macrolides, while amoxicillin/clavulanate is associated with more adverse effects than both comparators.

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“…4,5 It is used to treat many adult and paediatric patients, 6,7 in respiratory tract infection, [8][9][10] skin, soft tissue infections, otitis media, 8,11,12 sinusitis, pharyngitis, acute bronchitis, gastrointestinal infections, community-acquired pneumonia, cystic fibrosis, 13,14 tonsilitis, 15 anti-inflammatory in COPD patient, 16 in 18,19 Azithromycin is derived from erythromycin; however it differs chemically from erythromycin in that a methyl substituted nitrogen atom is incorporated into the lactone ring and semisynthetic erythromycin derivative. 20 It exhibits a more extensive spectrum of activity, greater acid stability, better oral bioavailability and more favorable pharmacokinetic behavior than erythromycin.…”

Section: Introductionmentioning

confidence: 99%

Spectrophotometric analysis of Azithromycin and its pharmaceutical dosage forms: Comparison between Spectrophotometry and HPLC

Sharmin

Shanta

Bachar

2015

Dhaka Univ. J. Pharm. Sci

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A simple, reliable, precise and sensitive UV-spectrophotometric method was developed and validated for the estimation of azithromycin in pharmaceutical dosage form and compared with official USP 2010 method. The proposed method utilizes the oxidation of azithromycin with potassium permanganate to liberate formaldehyde. This formaldehyde reacts with acetone-ammonium reagent and produces yellow colored chromogen 3,5-diacetyl-2,6-dihydrolutidine. The colored solution exhibited a maximum absorption at 412 nm which can be detected with UVspectrophotometer. The method was found linear over the concentration range 80% to 120% of the working concentration (R 2 =0.999). The intra-and inter-day RSD (n = 6) was ≤ 2.0%. The developed method was validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. The proposed method was successfully applied for determination of azithromycin and the results have been compared with HPLC and thus enabling the utility of this new method for routine analysis azithromycin in pharmaceutical dosage forms.

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A short (3-day) course of azithromycin tablets versus a 10-day course of amoxycillin–clavulanic acid (co-amoxiclav) in the treatment of adults with lower respiratory tract infections and effects on long-term outcome

Cited by 68 publications

References 17 publications

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

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

Macrolides, quinolones and amoxicillin/clavulanate for chronic bronchitis: a meta-analysis

Spectrophotometric analysis of Azithromycin and its pharmaceutical dosage forms: Comparison between Spectrophotometry and HPLC

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