scholarly journals Efficacy and Safety of a 10-Day Course of 400 or 600 Milligrams of Grepafloxacin Once Daily for Treatment of Acute Bacterial Exacerbations of Chronic Bronchitis: Comparison with a 10-Day Course of 500 Milligrams of Ciprofloxacin Twice Daily

1998 ◽  
Vol 42 (1) ◽  
pp. 114-120 ◽  
Author(s):  
S. Chodosh ◽  
S. Lakshminarayan ◽  
H. Swarz ◽  
S. Breisch
Keyword(s):  
Adverse Events ◽  
Chronic Bronchitis ◽  
Clinical Success ◽  
Efficacy And Safety ◽  
Success Rates ◽  
Double Blind ◽  
Once Daily ◽  
End Of Treatment ◽  
Evaluable Population

ABSTRACT A randomized, prospective, double-blind, double-dummy, multicenter study investigated the efficacy and safety of 10 days of oral therapy with grepafloxacin at 400 mg once daily, grepafloxacin at 600 mg once daily, or ciprofloxacin at 500 mg twice daily in 624 patients with acute bacterial exacerbations of chronic bronchitis. At the end of treatment, clinical success (cure or improvement) was achieved for 93% (140 of 151), 88% (137 of 156), and 91% (145 of 160) of patients in the groups receiving grepafloxacin at 400 mg, grepafloxacin at 600 mg, and ciprofloxacin, respectively (clinically evaluable population). At follow-up (14 to 28 days posttreatment), the clinical success rates were 87% (124 of 143), 81% (122 of 151), and 80% (123 of 154) in the groups receiving grepafloxacin at 400 mg and 600 mg and ciprofloxacin, respectively. A total of 379 pathogens were isolated from 290 patients, with the most common isolates being Moraxella catarrhalis(21%), Staphylococcus aureus (20%), Haemophilus influenzae (18%), and Streptococcus pneumoniae(7%). For the evaluable population, successful bacteriologic response was obtained at the end of treatment for 96% (92 of 96), 98% (87 of 89), and 92% (82 of 90) of patients receiving grepafloxacin at 400 mg, grepafloxacin at 600 mg, and ciprofloxacin, respectively, and was maintained in 86% (82 of 95), 88% (78 of 89), and 82% (69 of 84) of patients, respectively, at follow-up. All pretreatment S. pneumoniae isolates were susceptible to grepafloxacin, but two strains were resistant to ciprofloxacin. All treatments were well tolerated, with the most frequently reported drug-related adverse events being nausea, taste perversion, and headache. All drug-related adverse events in the grepafloxacin groups were mild or moderate in severity. This study demonstrates that 10-day courses of grepafloxacin given at 400 or 600 mg once daily were as effective, clinically and bacteriologically, as ciprofloxacin given at 500 mg twice daily for the treatment of acute bacterial exacerbations of chronic bronchitis.

scholarly journals 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

2003 ◽  
Vol 47 (9) ◽  
pp. 2770-2774 ◽  
Author(s):  
Dan C. Henry ◽  
Ernie Riffer ◽  
William N. Sokol ◽  
Naumann I. Chaudry ◽  
Robert N. Swanson
Keyword(s):  
Adverse Events ◽  
Multicenter Study ◽  
Clinical Success ◽  
Double Blind Study ◽  
Efficacy And Safety ◽  
Success Rates ◽  
Double Blind ◽  
Once Daily ◽  
Acute Bacterial Sinusitis ◽  
Amoxicillin Clavulanate

ABSTRACT A randomized, double-blind, multicenter study of adults with acute bacterial sinusitis (ABS) compared the efficacy and safety of two azithromycin (AZM) regimens, 500 mg/day once daily for 3 days (AZM-3) or 6 days (AZM-6) to the efficacy and safety of an amoxicillin-clavulanate (AMC) regimen of 500-125 mg three times daily for 10 days. A total of 936 subjects with clinically and radiologically documented ABS were treated (AZM-3, 312; AZM-6, 311; AMC, 313). Clinical success rates were equivalent among per-protocol subjects at the end of therapy (AZM-3, 88.8%; AZM-6, 89.3%; AMC, 84.9%) and at the end of the study (AZM-3, 71.7%; AZM-6, 73.4%; AMC, 71.3%). Subjects treated with AMC reported a higher incidence of treatment-related adverse events (AE) (51.1%) than AZM-3 (31.1%, P < 0.001) or AZM-6 (37.6%, P < 0.001). More AMC subjects discontinued the study (n = 28) than AZM-3 (n = 7) and AZM-6 (n = 11) subjects. Diarrhea was the most frequent treatment-related AE. AZM-3 and AZM-6 were each equivalent in efficacy and better tolerated than AMC for ABS.

scholarly journals Comparative efficacy and safety of 3-day azithromycin and 10-day penicillin V treatment of group A beta-hemolytic streptococcal pharyngitis in children.

1996 ◽  
Vol 40 (4) ◽  
pp. 1005-1008 ◽  
Author(s):  
L Pacifico ◽  
F Scopetti ◽  
A Ranucci ◽  
M Pataracchia ◽  
F Savignoni ◽  
...  
Keyword(s):  
Clinical Success ◽  
Streptococcal Pharyngitis ◽  
Efficacy And Safety ◽  
Comparative Efficacy ◽  
Once Daily ◽  
Penicillin V ◽  
Oral Regimen ◽  
Beta Hemolytic Streptococcus ◽  
Group A

The efficacy and safety of a 3-day course of azithromycin oral suspension (10 mg/kg of body weight once daily) were compared with those of penicillin V (50,000 U/kg/day in two divided doses) in children aged 3 to 12 years for the treatment of symptomatic pharyngitis caused by the group A beta-hemolytic streptococcus (GABHS). For the 154 evaluable patients, the original infecting strain of GABHS was eliminated at the end of follow-up (34 to 36 days after treatment started) from 67 (85.8%) of 78 penicillin-treated patients and 41 (53.9%) of 76 azithromycin-treated patients (P < 0.0001). Overall clinical success was achieved in 71 (91.0%) of 78 penicillin V-treated patients and 57 (75.0%) of 76 azithromycin-treated patients (P < 0.05). Potential drug-related adverse events were reported for 5.5 and 8.6% of the penicillin V- and azithromycin-treated patients, respectively (P = 0.6). In the present study, a once-daily (10 mg/kg), 3-day oral regimen of azithromycin was as safe as a 10-day course of penicillin but did not represent an effective alternative to penicillin for the treatment of GABHS pharyngitis, even for those children with azithromycin-susceptible strains.

Azithromycin versus Pivampicillin in the Treatment of Acute Exacerbations of Chronic Bronchitis: A Single-Blind, Double-Dummy, Multicentre Study

2000 ◽  
Vol 28 (3) ◽  
pp. 101-110 ◽  
Author(s):  
P Schouenborg ◽  
N Gerdes ◽  
HH Rasmussen ◽  
N Wickers-Nielsen ◽  
E Mathiassen
Keyword(s):  
Multicentre Study ◽  
Chronic Bronchitis ◽  
Clinical Symptoms ◽  
Clinical Success ◽  
Well Being ◽  
End Of Treatment ◽  
Acute Exacerbations ◽  
Single Blind ◽  
Oral Azithromycin

This single-blind, double-dummy, multicentre study compared oral azithromycin, administered as tablets, 500 mg once daily for 3 days, versus oral pivampicillin, 700 mg twice daily for 10 days, in adults with acute exacerbations of chronic bronchitis (not needing parenteral antibiotic therapy, hospitalization or oxygen support). Clinical success (cure + improvement) rates were similar for both groups at the end of treatment (day 10; azithromycin, 124 of 133 [93%]; pivampicillin, 79 of 92 [86%]) and at follow-up (day 52; 98 of 126 [78%] versus 66 of 81 [81%]). The treatments produced similar levels of pathogen eradication at the end of treatment (49 of 54 [91%] versus 32 of 37 [86%]). Azithromycin-treated patients had significantly reduced chest discomfort at the end of treatment, and a trend towards improved lung function. The two groups were similar with respect to improvements in other clinical symptoms and patient well-being, and to the incidences of adverse events and treatment discontinuations. This oral azithromycin regime is an effective treatment for acute exacerbations of chronic bronchitis, similar in efficacy to the longer pivampicillin regime and may offer superior patient compliance.

Efficacy and Safety of a Novel, Single-dose Azithromycin Microsphere Formulation Versus 10 Days of Levofloxacin for the Treatment of Acute Bacterial Sinusitis in Adults

2005 ◽  
Vol 133 (2) ◽  
pp. 194-200 ◽  
Author(s):  
John J. Murray ◽  
Paz Emparanza ◽  
Eugenijus Lesinskas ◽  
Margaret Tawadrous ◽  
Jeanne D. Breen
Keyword(s):  
Single Dose ◽  
Clinical Success ◽  
Maxillary Sinusitis ◽  
Efficacy And Safety ◽  
Success Rates ◽  
Radiographic Evidence ◽  
Double Blind ◽  
Acute Bacterial Sinusitis ◽  
Cure Rates ◽  
International Multicenter

Objective To compare the efficacy and safety of a single 2.0-g dose of a novel azithromycin microsphere formulation with that of 10 days of levofloxacin, 500 mg/d, when used to treat adults with uncomplicated acute bacterial maxillary sinusitis (ABS). Study Design and Setting An international, multicenter, randomized, double-blind, double-dummy trial. Eligible outpatients ≥18 years of age with clinical and radiographic evidence of ABS underwent maxillary sinus aspiration before randomization. Primary endpoint was clinical efficacy at the test-of-cure visit (day 17-24). Results Clinical success rates were 94.5% (242/256) in azithromycin-microspheres-treated patients and 92.8% (233/251) in the levofloxacin group. In patients with documented Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis, clinical cure rates were 97.3% (36/37), 96.3% (26/27), and 100% (8/8), respectively, for the azithromycin group and 92.3% (36/39), 100% (30/30), and 90.9% (10/11), respectively, for the levofloxacin group. Conclusions Single-dose azithromycin microspheres provided clinical and bacteriologic efficacy and safety comparable to 10 days of levofloxacin. Significance A novel microsphere formulation of azithromycin given as a single dose was safe and effective for the treatment of ABS.

scholarly journals Phase 2, Randomized, Dose-Ranging Study Evaluating the Safety and Efficacy of Anidulafungin in Invasive Candidiasis and Candidemia

2004 ◽  
Vol 48 (6) ◽  
pp. 2021-2024 ◽  
Author(s):  
David S. Krause ◽  
John Reinhardt ◽  
Jose A. Vazquez ◽  
Annette Reboli ◽  
Beth P. Goldstein ◽  
...  
Keyword(s):  
Invasive Candidiasis ◽  
Laboratory Data ◽  
Signs And Symptoms ◽  
Success Rates ◽  
Once Daily ◽  
Safety And Efficacy ◽  
Evaluable Population ◽  
Safety Parameters ◽  
Dose Ranging

ABSTRACT This study evaluated the safety and efficacy of anidulafungin, a novel echinocandin, in patients with invasive candidiasis, including candidemia. A total of 123 eligible patients were randomized to one of three intravenous regimens, 50, 75, or 100 mg once daily. Treatment continued for 2 weeks beyond resolution or improvement of signs and symptoms. The primary efficacy criterion was a successful global response rate (i.e., clinical and microbiological success) in the evaluable population at the follow-up (FU) visit, 2 weeks after end of therapy (EOT). One hundred twenty (120) patients received at least one dose of anidulafungin; 68 were evaluable. Review of adverse events and laboratory data indicated no dose response for safety parameters. Non-albicans Candida species accounted for approximately one-half of all isolates. Success rates at EOT were 84, 90, and 89% in the 50-, 75-, and 100-mg groups, respectively. At FU, the success rates were 72, 85, and 83%. Phase 3 studies of anidulafungin for the treatment of invasive candidiasis and candidemia are warranted.

scholarly journals Daily Oral Grepafloxacin vs. Twice Daily Oral Doxycycline in the Treatment ofChlamydia trachomatisEndocervical Infection

1998 ◽  
Vol 6 (3) ◽  
pp. 109-115 ◽  
Author(s):  
W. M. McCormack ◽  
D. H. Martin ◽  
E. W. Hook III ◽  
R. B. Jones
Keyword(s):  
Clinical Success ◽  
Clinical Signs ◽  
Positive Culture ◽  
Signs And Symptoms ◽  
The United States ◽  
Response To Therapy ◽  
Success Rates ◽  
Once Daily ◽  
Oral Doxycycline

Objective:To compare the efficacy and safety of a 7-day course of treatment with oral grepafloxacin, 400 mg once daily, and oral doxycycline, 100 mg twice daily, in patients with chlamydial cervicitis.Methods:Women aged 18 years or older attending 17 sexually transmitted disease clinics in the United States who had clinical signs of mucopurulent cervicitis or who had a recent positive culture or nonculture test forChlamydia trachomatisor who had contact with a male partner with a positive culture forC. trachomatiswere enrolled into this randomized, double-blind, active-controlled clinical study. The diagnosis of chlamydial cervicitis was based on culture forC. trachomatis. Patients were randomized to receive a 7-day course of treatment with either oral grepafloxacin, 400 mg once daily, or oral doxycycline, 100 mg twice daily. Response to therapy was assessed 3–8 days and 21–28 days after completion of treatment. The primary measure of efficacy was eradication ofC. trachomatisat the 21–28 day follow-up visit. Clinical success, defined as improvement or complete resolution of the signs and symptoms of cervicitis, was a secondary measure of efficacy.Results:Of the 451 female patients enrolled, 228 received grepafloxacin and 223 received doxycycline. In all, 154/451 (35%) patients were evaluable at the 21–28 day follow-up (81 who received grepafloxacin and 73 who received doxycycline). Microbiologic and clinical success rates demonstrated the equivalence of the two treatments. TheC. trachomatiseradication rates were 96.3% (78/81) and 98.6% (72/73) for patients receiving grepafloxacin or doxycycline, respectively. The two study drugs were also equivalent in resolving clinical signs and symptoms, with clinical success rates of 88.9% (64/72) and 89.5% (51/57) for patients treated with grepafloxacin and doxycycline, respectively. Both drugs were well tolerated, with 47% of patients receiving grepafloxacin and 46% of patients receiving doxycycline experiencing drug-related adverse events, none of which was serious.Conclusions:Seven days of treatment with oral grepafloxacin, 400 mg once daily, was as effective as 7 days of treatment with oral doxycycline, 100 mg twice daily, in patients with cervicitis caused byC. trachomatis. Both agents were well tolerated and had comparable safety profiles. Grepafloxacin’s once-daily dosing regimen may offer advantages in terms of patient compliance.

scholarly journals A Phase 2, Randomized, Double-Blind, Multicenter Trial To Evaluate the Safety and Efficacy of Three Dosing Regimens of Isavuconazole Compared with Fluconazole in Patients with Uncomplicated Esophageal Candidiasis

2015 ◽  
Vol 59 (3) ◽  
pp. 1671-1679 ◽  
Author(s):  
J. Viljoen ◽  
N. Azie ◽  
A.-H. Schmitt-Hoffmann ◽  
M. Ghannoum
Keyword(s):  
Fungal Infections ◽  
Clinical Success ◽  
Multicenter Trial ◽  
Primary Treatment ◽  
Phase 2 ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Once Daily ◽  
Esophageal Candidiasis ◽  
Dosing Regimens

ABSTRACTEsophageal candidiasis is a frequent cause of morbidity in immunocompromised patients. Isavuconazole is a novel, broad-spectrum antifungal developed for the treatment of opportunistic fungal infections. This phase 2 trial compared the efficacy and safety of three oral dosing regimens of isavuconazole with an oral fluconazole regimen in the primary treatment of uncomplicated esophageal candidiasis. The isavuconazole regimens were as follows: 200 mg on day 1 and then 50 mg once daily (arm A), 400 mg on day 1 and then 400 mg once-weekly (arm B), and 400 mg on day 1 and then 100 mg once daily (arm C). Patients in arm D received fluconazole at 200 mg on day 1 and then 100 mg once daily. The minimum treatment duration was 14 days. The primary endpoint was the rate of endoscopically confirmed clinical response at end of therapy. Safety and tolerability were also assessed. Efficacy was evaluated in 153 of 160 enrolled patients. Overall, 146 (95.4%) achieved endoscopically confirmed clinical success. Each of the isavuconazole regimens was shown to be not inferior to fluconazole, i.e., arm A versus D, −0.5% (95% confidence interval [CI] −10.0 to 9.4), arm B versus D, 3.5% (95% CI, −5.6 to 12.7), and arm C versus D, −0.2% (95% CI, −9.8 to 9.4). The frequency of adverse events was similar in arm A (n= 22; 55%), arm B (n= 18; 45%), and arm D (n= 22; 58%), but higher in arm C (n= 29; 71%). In summary, efficacy and safety of once-daily and once-weekly isavuconazole were comparable with once-daily fluconazole in the primary treatment of uncomplicated esophageal candidiasis.

scholarly journals Comparative study of efficacy and safety of garenoxacin and moxifloxacin in acute exacerbation of chronic bronchitis in COPD patients

2018 ◽  
Vol 7 (3) ◽  
pp. 410
Author(s):  
Ajay Kumar Sinha ◽  
Bhavana Srivastava ◽  
Dinesh Chand Punera ◽  
Renu Khanchandani
Keyword(s):  
Adverse Effects ◽  
Comparative Study ◽  
Chronic Bronchitis ◽  
Acute Exacerbation ◽  
Bacterial Infections ◽  
Clinical Success ◽  
Clinical Success Rate ◽  
Secondary Outcome ◽  
Efficacy And Safety ◽  
Once Daily

Background: Acute exacerbation of chronic bronchitis in COPD (AECB) is the major cause of morbidity, mortality and marked reduction in quality of life and imposes significant burden on both patients and healthcare systems. Bacterial infections causing AECB frequently require antibacterial treatment, so more evidences are needed to guide better antibiotic choice. Objective of the study was planned to compare efficacy and safety of Garenoxacin, a new fluoroquinolone versus moxifloxacin for treatment of Acute exacerbation of Chronic bronchitis in COPD patient.Methods: This was a prospective open label comparative study done in department of pharmacology and T.B & Chest of Government Medical College attached Dr Shusila Tiwari Hospital, Haldwani. 60 subjects with clinical symptoms suggestive of Anthonisen type II AECOPD (any two of following criteria: Increased dyspnea, cough, sputum purulence) were enrolled and randomized to receive either Moxifloxacin 400 mg once daily for 7 days or Garenoxacin 400mg once daily for 7 days. The primary outcome measure was clinical success rate at day 7 visit. Secondary outcome measures were changes in clinical global impression (CGI) scales and incidence of adverse events.Results: The mean age of patient was 60.98±9.9 years and 57.9±9.3 years in the Moxifloxacin and Garenoxacin groups. The clinical success rates were comparable with 86.2% in moxifloxacin group 84.6% and in garenoxacin group. Adverse effects were mild and self limiting. We observed two adverse effects in garenoxacin and three in moxifloxacin group.Conclusions: The result of study showed that garenoxacin is comparable to moxifloxacin in terms of efficacy and safety.

scholarly journals Review of Efficacy and Safety of Duloxetine 40 to 60 mg Once Daily in Patients with Diabetic Peripheral Neuropathic Pain

2012 ◽  
Vol 2012 ◽  
pp. 1-12 ◽  
Author(s):  
Vladimir Skljarevski ◽  
Elijah P. Frakes ◽  
Doron Sagman ◽  
Sarah Lipsius ◽  
Alexandra N. Heinloth ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Adverse Events ◽  
Brief Pain Inventory ◽  
Primary Outcome Measure ◽  
Pain Severity ◽  
Efficacy And Safety ◽  
Open Label ◽  
Double Blind ◽  
Peripheral Neuropathic Pain ◽  
Once Daily

We summarize efficacy and safety findings from 4 double-blind, placebo-controlled, 12-week studies and 1 open-label, uncontrolled, 34-week maintenance-of-effect (MOE) study that examine duloxetine 40 and 60 mg once daily (QD) in patients with diabetic peripheral neuropathic pain (DPNP). In all placebo-controlled studies, duloxetine showed significantly (P≤.01) greater reduction in pain severity (weekly mean of 24-hour average pain severity ratings, primary outcome measure) compared with placebo. In all placebo-controlled studies, duloxetine showed significantly (P≤.05) greater improvement on brief pain inventory-Interference ratings. Patient global impression of improvement ratings were superior to placebo (P≤.01) for duloxetine patients in all placebo-controlled studies. Response rates (based on 30% pain reduction) ranged from 57% to 68% for duloxetine and from 35% to 47% for placebo and were statistically significantly different (P≤.01) between treatment groups in 3 out of 4 studies. The open-label study showed maintenance of analgesic effect of duloxetine in DPNP. In the duloxetine groups, 4.3% to 14.9% of patients discontinued because of adverse events (placebo groups: 2.6% to 7.4%). Most commonly reported treatment-emergent adverse events were nausea, somnolence, and headache. Duloxetine 40 and 60 mg QD was efficacious and well tolerated in the management of DPNP.

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