Efficacy and Tolerability of Azithromycin versus Amoxicillin/Clavulanic Acid in Acute Purulent Exacerbation of Chronic Bronchitis

Abstract

An open randomized trial was conducted in 142 hospitalized and out-patients with acute purulent exacerbation of chronic bronchitis to compare the clinical efficacy and tolerability of azithromycin (n = 69) and amoxicillin/clavulanic acid (n = 73). Azithromycin (500 mg) was administered as a single dose for three days and amoxicillin/clavulanic acid (amoxicillin 875 mg-clavulanic acid 125 mg) was given b.i.d. for 8 days (8.16 +/- 1.18). Before therapy and 24-48 hours after the end of treatment, sputum culture (by positioning five orthodontal swabs at the opening of salivary gland ducts after a washing of the oral cavity with sterile saline solution to avoid oral contamination), chest X-rays, arterial blood gas analysis, trials of respiratory functions and routine blood tests were performed. In the azithromycin group (69 patients) the efficacy rate was 67.6% (46 patients: 34 cured and 12 improved); in 22 patients (32.4%) the treatment failed; 1 patient was not evaluated because of no follow-up. The overall efficacy rate in the amoxicillin/clavulanic acid group (73 patients) was 97.3% (71 patients: 60 cured and 11 improved); in 1 patient (1.4%) the treatment failed and 1 patient was a drop-out for side effects. All pathogens isolated before treatment were susceptible to the antibiotics administered. At the end of treatment microbiological efficacy was 67.1% in the azithromycin group and 98.6% in the amoxicillin/clavulanic acid group. The tolerability was judged good in both treatment groups. Side effects were observed in 1 patient treated with amoxicillin/clavulanic acid (diarrhea), which imposed interruption of treatment, and in 2 patients from the azithromycin group (gastralgia and biochemical laboratory tests: renal function).(ABSTRACT TRUNCATED AT 250 WORDS)

Effect of Efflux on Telithromycin and Macrolide Susceptibility in Haemophilus influenzae

“…However, if pharmacological/pharmacodynamic breakpoints (24-h area under the curve/MIC Ͼ 25) are used, macrolides and ketolides should be ineffective against Ͼ95% of H. influenzae (10). This latter finding is supported by the high bacteriologic failure rates found in clinical trials of macrolides and ketolides for the treatment of acute exacerbations of chronic bronchitis and otitis media caused by H. influenzae (2,3,5,6). It should also be noted that the exact pharmacokinetic/pharmacodynamic parameters for telithromycin have not yet been precisely defined (W. A. Craig, personal communication).…”

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

“…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.…”

“…In one RCT [24] the quinolone levofloxacin was compared with both a macrolide (azithromycin) and A/C. All patients enrolled in the RCTs of the meta-analysis were o18 yrs old, not hospitalised during enrolment (except for one RCT [41] in which both in-patients and outpatients were enrolled) and could be treated on an in-patient or outpatient basis. There was a medical history of CB or CB/chronic obstructive pulmonary disease (COPD) in 16 [24-28, 31-34, 36-42] and two [29,30] RCTs, respectively; in one RCT [26] patients with COPD other than CB were excluded, while in another RCT [35] only patients with COPD (baseline forced expiratory volume in one second (FEV1) ,70% predicted) were included.…”

“…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.…”

“…In eight RCTs [24][25][26][27][28][29][30][31], macrolides were compared with quinolones; specifically clarithromycin was compared with levofloxacin [25,27], gemifloxacin [28] or moxifloxacin [29,31], while azithromycin was compared with levofloxacin [24,26] and moxifloxacin [30]. A/C was compared with quinolones in four RCTs [24,[32][33][34] and with macrolides in eight RCTs [35][36][37][38][39][40][41][42]. In detail, the quinolone compared with A/C was levofloxacin [24], moxifloxacin [32,33] or gemifloxacin [34], while the macrolide compared with A/C was clarithromycin [35,36], azithromycin [37,[39][40][41], dirithromycin [38] or roxithromycin [42].…”