Double-Blind Comparative Trial of Ciprofloxacin versus Clarithromycin in the Treatment of Acute Bacterial Sinusitis

Abstract

This multicenter, randomized, double-blind trial compared the efficacy and safety of ciprofloxacin (CIP; 500 mg twice daily for 10 days, placebo for 4 days) to those of clarithromycin (CLARI; 500 mg twice daily for 14 days) in 560 adults with clinically documented and radiologically confirmed acute sinusitis. Of 457 efficacy-valid adults (236 CIP, 221 CLARI), clinical resolution plus improvement at the end of therapy was 84% for CIP-treated patients compared to 91% of CLARI recipients (CI95 = -0.131, -0.013). At the 1-month follow-up, more than twice as many CLARI-treated patients, 18 (10%), experienced a relapse, compared to 7 (4%) CIP-treated patients. The combined clinical response analyses (end of therapy and 1 -month follow-up) demonstrated that CIP and CLARI were statistically equivalent (CI95 = -0.106, 0.044). Diarrhea, nausea, headache, and dizziness were the most frequently reported drug-related adverse events in both treatment groups; diarrhea and taste perversion were reported more frequently among CLARI recipients. In summary, the combined end of therapy and follow-up clinical evaluation analyses revealed that CIP and CLARI were equally effective in the management of acute sinusitis, although twice as many relapses were reported among CLARI recipients.

Clinical efficacy and time to symptom resolution of 5-day telithromycin versus 10-day amoxicillin–clavulanate in the treatment of acute bacterial sinusitis

“…The 88.6% clinical success rate visit achieved with telithromycin at the TOC in this study is similar to that seen in previous studies with telithromycin [31][32][33][34] and comparable with rates of clinical success observed for other antibacterials in similarly designed ABS clinical trials [9][10][11][12][13][14][15] .…”

“…Antibacterial therapy should therefore provide coverage of these organisms. The most commonly prescribed antibacterials are -lactams, second-and third-generation cephalosporins, and macrolides 5,6 ; numerous clinical trials involving adult patients with ABS have demonstrated clinical efficacy rates for these agents ranging from 82 to 98% [9][10][11][12][13][14][15][16][17][18][19][20][21][22] . Recently, however, the choice of antibacterial therapy for ABS has become complicated by increased bacterial resistance -in particular, among S. pneumoniae [23][24][25][26][27][28] .…”

Efficacy and side effects of antibiotics in the treatment of acute rhinosinusitis: a systematic review

“…No major side effects were otherwise observed. of antibiotics had an efficacy ranging from 50-88% (19,24,32,(34)(35)(36)(37)(38)(39) , as compared to an efficacy of 14-91% (19,24,32,(34)(35)(36)(37)(38)(39) for placebos compared in the studies. A similar comparison of the side effects showed that 2.7-59% (1,9,24,(35)(36)(37)(38)(39) of patients on antibiotics reported side effects, while 0-40.7% (19,24,(35)(36)(37)(38)(39) of patients on placebos showed adverse effects.…”

Antibiothérapie par voie générale en pratique courante dans les infections respiratoires hautes de l'adulte et l'enfant. Argumentaire

“…Les examens bactériologiques sont rarement effectués en routine. En revanche, ils font partie des protocoles d'études réalisées pour l'évaluation des antibiotiques [188][189][190]. Dans presque toutes les études françaises, le recueil des sécrétions est fait par voie endonasale au méat moyen [191,192].…”