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 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.

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 Two vs. three weeks of treatment with amoxicillin-clavulanate for stabilized community-acquired complicated parapneumonic effusions. A preliminary non-inferiority, double-blind, randomized, controlled trial

2020 ◽  
Vol 5 (1) ◽  
Author(s):  
José M. Porcel ◽  
Lucia Ferreiro ◽  
Laura Rumi ◽  
Esther Espino-Paisán ◽  
Carmen Civit ◽  
...  
Keyword(s):  
Adverse Events ◽  
Clinical Success ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Primary Objective ◽  
Double Blind ◽  
Pleural Thickening ◽  
Small Series ◽  
Amoxicillin Clavulanate ◽  
Clinical Stability

AbstractBackgroundThe optimal duration of antibiotic treatment for complicated parapneumonic effusions (CPPEs) has not been properly defined. Our aim was to compare the efficacy of amoxicillin-clavulanate for 2 vs. 3 weeks in patients with CPPE (i.e. those which required chest tube drainage).MethodsIn this non-inferiority, randomized, double-blind, controlled trial, patients with community-acquired CPPE were recruited from two centers in Spain and, after having obtained clinical stability following 2 weeks of amoxicillin-clavulanate, they were randomly assigned to placebo or antibiotic for an additional week. The primary objective was clinical success, tested for a non-inferiority margin of<10%. Secondary outcomes were the proportion of residual pleural thickening of>10 mm at 3 months, and adverse events. The study was registered with EudraCT, number 2014-003137-25. We originally planned to randomly assign 284 patients.ResultsAfter recruiting 55 patients, the study was terminated early owing to slow enrolment. A total of 25 patients were assigned to 2 weeks and 30 patients to 3 weeks of amoxicillin-clavulanate. Clinical success occurred in the 25 (100%) patients treated for 2 weeks and 29 (97%) treated for 3 weeks (difference 3%, 95% CI −3 to 9.7%). Respective between-group differences in the rate of residual pleural thickening (−12%, 95%CI −39 to 14%) and adverse events (−7%, 95%CI −16 to 2%) did not reach statistical significance.ConclusionsIn this small series of selected adult patients with community-acquired CPPE, amoxicillin-clavulanate treatment could be safely discontinued by day 14 if clinical stability was obtained.

scholarly journals Phase 2, Randomized, Double-Blind Study of the Efficacy and Safety of Two Dose Regimens of Eravacycline versus Ertapenem for Adult Community-Acquired Complicated Intra-Abdominal Infections

2013 ◽  
Vol 58 (4) ◽  
pp. 1847-1854 ◽  
Author(s):  
Joseph S. Solomkin ◽  
Mayakonda Krishnamurthy Ramesh ◽  
Gintaras Cesnauskas ◽  
Nikolajs Novikovs ◽  
Penka Stefanova ◽  
...  
Keyword(s):  
Clinical Success ◽  
Clinical Success Rate ◽  
Blind Study ◽  
Double Blind Study ◽  
Phase 2 ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Gram Negative ◽  
Abdominal Infections

ABSTRACTEravacycline is a novel fluorocycline, highly active against Gram-positive and Gram-negative pathogensin vitro, including those with tetracycline and multidrug resistance. This phase 2, randomized, double-blind study was conducted to evaluate the efficacy and safety of two dose regimens of eravacycline compared with ertapenem in adult hospitalized patients with complicated intra-abdominal infections (cIAIs). Patients with confirmed cIAI requiring surgical or percutaneous intervention and antibacterial therapy were randomized (2:2:1) to receive eravacycline at 1.5 mg/kg of body weight every 24 h (q24h), eravacycline at 1.0 mg/kg every 12 h (q12h), or ertapenem at 1 g (q24h) for a minimum of 4 days and a maximum of 14 days. The primary efficacy endpoint was the clinical response in microbiologically evaluable (ME) patients at the test-of-cure (TOC) visit 10 to 14 days after the last dose of study drug therapy. Overall, 53 patients received eravacycline at 1.5 mg/kg q24h, 56 received eravacycline at 1.0 mg/kg q12h, and 30 received ertapenem. For the ME population, the clinical success rate at the TOC visit was 92.9% (39/42) in the group receiving eravacycline at 1.5 mg/kg q24h, 100% (41/41) in the group receiving eravacycline at 1.0 mg/kg q12h, and 92.3% (24/26) in the ertapenem group. The incidences of treatment-emergent adverse events were 35.8%, 28.6%, and 26.7%, respectively. Incidence rates of nausea and vomiting were low in both eravacycline groups. Both dose regimens of eravacycline were as efficacious as the comparator, ertapenem, in patients with cIAI and were well tolerated. These results support the continued development of eravacycline for the treatment of serious infections, including those caused by drug-resistant Gram-negative pathogens. (This study has been registered at ClinicalTrials.gov under registration no. NCT01265784.)

scholarly journals The EDGI new take on EDGE: EUS-directed transgastric intervention (EDGI), other than ERCP, for Roux-en-Y gastric bypass anatomy: a multicenter study

2019 ◽  
Vol 07 (10) ◽  
pp. E1231-E1240 ◽  
Author(s):  
Matthew R. Krafft ◽  
William Hsueh ◽  
Theodore W. James ◽  
Thomas M. Runge ◽  
Todd H. Baron ◽  
...  
Keyword(s):  
Gastric Bypass ◽  
Retrospective Study ◽  
Adverse Events ◽  
Multicenter Study ◽  
Clinical Success ◽  
Endoscopic Biopsy ◽  
Success Rates ◽  
Moderate Severity ◽  
Excluded Stomach ◽  
Heterogenous Group

Abstract Background and study aims Indications for accessing the duodenum, and/or excluded stomach in Roux-en-Y gastric bypass (RYGB) patients extend beyond diagnosis and treatment of pancreaticobiliary maladies. Given the high technical and clinical success of EUS-directed transgastric ERCP (EDGE) in RYGB anatomy, we adopted this transgastric (anterograde) approach to evaluate and treat luminal and extraluminal pathology in and around the excluded gut in RYGB patients. EUS-directed transgastric intervention (“EDGI”), other than ERCP, is the terminology we have chosen to describe this heterogenous group of transgastric diagnostic and/or interventional endoscopic procedures (transgastric interventions) performed via a lumen-apposing mental stent (LAMS) in select patients with RYGB. Patients and methods A multicenter (n = 4), retrospective study of RYGB patients with suspected luminal or extraluminal pathology, in or around the duodenum and/or excluded stomach, underwent EDGI using LAMS between December 2015 and January 2019. Results A total of 14 patients (78.6 % women; mean age, 55.7 + 12.4 years) underwent EDGI via LAMS. Technical and clinical success rates of EDGI were 100 %. The most common transgastric interventions were diagnostic EUS of extraluminal pathology (n = 6, 42.7 %) and endoscopic biopsy of gastroduodenal luminal abnormalities (n = 5, 35.7 %). Two moderate-severity adverse events due to LAMS maldeployment occurred during EUS-JG creation (14.3 %), and each instance was successfully rescued with a bridging stent. Conclusions A variety of gastroduodenal luminal and extraluminal disorders in RYGB patients can be effectively diagnosed and managed using EDGI via LAMS.

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 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.

scholarly journals High-Dose Azithromycin versus High-Dose Amoxicillin-Clavulanate for Treatment of Children with Recurrent or Persistent Acute Otitis Media

2003 ◽  
Vol 47 (10) ◽  
pp. 3179-3186 ◽  
Author(s):  
Antonio Arrieta ◽  
Adriano Arguedas ◽  
Pilar Fernandez ◽  
Stan L. Block ◽  
Paz Emperanza ◽  
...  
Keyword(s):  
Otitis Media ◽  
Clinical Success ◽  
Acute Otitis Media ◽  
High Dose ◽  
Success Rates ◽  
Double Blind ◽  
Amoxicillin Clavulanate ◽  
Risk Patients ◽  
History Of ◽  
Intent To Treat

ABSTRACT Infants and young children, especially those in day care, are at risk for recurrent or persistent acute otitis media (AOM). There are no data on oral alternatives to high-dose amoxicillin-clavulanate for treating AOM in these high-risk patients. In this double-blind, double-dummy multicenter clinical trial, we compared a novel, high-dose azithromycin regimen with high-dose amoxicillin-clavulanate for treatment of children with recurrent or persistent AOM. Three hundred four children were randomized; 300 received either high-dose azithromycin (20 mg/kg of body weight once a day for 3 days) or high-dose amoxicillin-clavulanate (90 mg/kg divided twice a day for 10 days). Tympanocentesis was performed at baseline; clinical response was assessed at day 12 to 16 and day 28 to 32. Two-thirds of patients were aged ≤2 years. A history of recurrent, persistent, or recurrent plus persistent AOM was noted in 67, 18, and 14% of patients, respectively. Pathogens were isolated from 163 of 296 intent-to-treat patients (55%). At day 12 to 16, clinical success rates for azithromycin and amoxicillin-clavulanate were comparable for all patients (86 versus 84%, respectively) and for children aged ≤2 years (85 versus 79%, respectively). At day 28 to 32, clinical success rates for azithromycin were superior to those for amoxicillin-clavulanate for all patients (72 versus 61%, respectively; P = 0.047) and for those aged ≤2 years (68 versus 51%, respectively; P = 0.017). Per-pathogen clinical efficacy against Streptococcus pneumoniae and Haemophilus influenzae was comparable between the two regimens. The rates of treatment-related adverse events for azithromycin and amoxicillin-clavulanate were 32 and 42%, respectively (P = 0.095). Corresponding compliance rates were 99 and 93%, respectively (P = 0.018). These data demonstrate the efficacy and safety of high-dose azithromycin for treating recurrent or persistent AOM.

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