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

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.

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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

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.47.9.2770-2774.2003 ◽

2003 ◽

Vol 47 (9) ◽

pp. 2770-2774 ◽

Cited By ~ 23

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.

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SINGLE-DOSE PRULIFLOXACIN VERSUS SINGLE-DOSE PEFLOXACIN IN THE TREATMENT OF ACUTE UNCOMPLICATED URINARY TRACT INFECTION IN WOMEN

Urogynaecologia ◽

10.4081/uij.2004.5 ◽

2010 ◽

Vol 18 (3) ◽

pp. 5

Author(s):

M. CERVIGNI ◽

G. ORTICELLI ◽

M. BOLOGNA ◽

F. NATALE ◽

E. SALVATORI ◽

...

Keyword(s):

Single Dose ◽

Urinary Tract ◽

Eradication Rate ◽

Clinical Success ◽

Therapeutic Option ◽

Uncomplicated Urinary Tract Infection ◽

Efficacy And Safety ◽

Success Rates ◽

The One ◽

Tract Infections

The aim of the study was to compare the efficacy and safety of singledose prulifloxacin vs. single-dose pefloxacin in the treatment of patients with acute uncomplicated urinary tract infections. Two hundred and thirty-one female out-patients were considered microbiologically evaluable and randomly treated with 600 mg prulifloxacin (116 patients) or 800 mg pefloxacin (115 patients). The most commonly isolated uropathogen at baseline was Escherichia coli (71.4%), followed by Proteus mirabilis (10.8%) and Klebsiella pneumoniae (7.8%). Five-seven days posttreatment, the eradication rate was 97.4% and 92.2% in the prulifloxacin and pefloxacin group, respectively. The one-tailed 95% confidence interval analysis showed the equivalence of treatments. Four weeks from treatment no relapses, reinfections or superinfections were observed. The clinical success rates were 92.2% in the prulifloxacin and 84.3% pefloxacin groups. The safety profile was very good with both drugs. The results of the study make it possible to consider prulifloxacin a possible therapeutic option in patients with acute uncomplicated UTIs.

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Telavancin versus Standard Therapy for Treatment of Complicated Skin and Skin Structure Infections Caused by Gram-Positive Bacteria: FAST 2 Study

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.50.3.862-867.2006 ◽

2006 ◽

Vol 50 (3) ◽

pp. 862-867 ◽

Cited By ~ 121

Author(s):

Martin E. Stryjewski ◽

Vivian H. Chu ◽

William D. O'Riordan ◽

Brian L. Warren ◽

Lala M. Dunbar ◽

...

Keyword(s):

Standard Therapy ◽

Clinical Success ◽

Therapy Group ◽

Success Rates ◽

Standard Therapy Group ◽

Gram Positive ◽

Double Blind ◽

Skin Structure ◽

Complicated Skin ◽

Cure Rates

ABSTRACT Telavancin is a bactericidal lipoglycopeptide with a multifunctional mechanism of action. We conducted a randomized, double blind, active-control phase II trial. Patients ≥18 years of age with complicated skin and skin structure infections caused by suspected or confirmed gram-positive organisms were randomized to receive either telavancin at 10 mg/kg intravenously every 24 h (q24h) or standard therapy (antistaphylococcal penicillin at 2 g q6h or vancomycin at 1 g q12h). A total of 195 patients were randomized and received at least one dose of study medication. Clinical success rates were similar in all analysis populations at test of cure. In microbiologically evaluable patients with Staphylococcus aureus at baseline (n = 91), 96% of the telavancin group and 90% of the standard-therapy group were cured. Among patients with methicillin-resistant S. aureus (MRSA) at baseline (n = 45), clinical cure rates were also 96% for telavancin and 90% for standard therapy. Microbiologic eradication in patients with S. aureus infection was better with telavancin compared to standard therapy (92% versus 78%, P = 0.07) and significantly better in patients with MRSA (92% versus 68%; P = 0.04). Therapy was discontinued for an adverse event (AE) in 6% and 3% of the patients receiving telavancin and standard therapy, respectively. Except for two cases of rash in the telavancin group, these AEs were similar in type and severity in the two groups. The overall incidences and severities of AEs and laboratory abnormalities were similar between the two groups. These data support the ongoing studies assessing the efficacy and safety of telavancin in the treatment of serious gram-positive infections, particularly involving MRSA.

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SINGLE-DOSE PRULIFLOXACIN VERSUS SINGLE-DOSE PEFLOXACIN IN THE TREATMENT OF ACUTE UNCOMPLICATED URINARY TRACT INFECTION IN WOMEN

Urogynaecologia ◽

10.4081/uij.2003.69 ◽

2010 ◽

Vol 17 (2) ◽

pp. 69 ◽

Cited By ~ 6

Author(s):

M. CERVIGNI ◽

G. ORTICELLI ◽

M. BOLOGNA ◽

F. NATALE ◽

E. SALVATORI ◽

...

Keyword(s):

Single Dose ◽

Urinary Tract ◽

Eradication Rate ◽

Clinical Success ◽

Therapeutic Option ◽

Uncomplicated Urinary Tract Infection ◽

Efficacy And Safety ◽

Success Rates ◽

The One ◽

Tract Infections

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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

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.42.1.114 ◽

1998 ◽

Vol 42 (1) ◽

pp. 114-120 ◽

Cited By ~ 37

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.

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Clarithromycin versus Amoxicillin alone or with Clavulanate in Acute Maxillary Sinusitis: A Meta-analysis of Clinical Trials

The Open Infectious Diseases Journal ◽

10.2174/1874279302113010001 ◽

2021 ◽

Vol 13 (1) ◽

pp. 1-9

Author(s):

Daryl J. Hoban ◽

Jos Nauta

Keyword(s):

Drug Treatment ◽

Clinical Success ◽

Maxillary Sinusitis ◽

Meta Analysis ◽

Study Drug ◽

Total Daily Dose ◽

Success Rates ◽

Rate Difference ◽

Daily Dose ◽

Cure Rates

Objective: A meta-analysis was performed to explore the relative effects of clarithromycin and amoxicillin (with or without clavulanate potassium) in the treatment of acute maxillary sinusitis. Methods: Six studies were identified in the peer-reviewed literature. All were randomized single-blind (investigator-blind) or open-label trials in outpatients diagnosed with acute maxillary sinusitis. A total of 1580 patients were enrolled, of whom 1194 were clinically evaluable. The total daily dose of clarithromycin was 1000 mg; the total daily dose of amoxicillin (with or without clavulanate potassium) was either 1500 or 2000 mg. The duration of study drug treatment varied from 8 to 14 days. Endpoints comprised clinical and radiological success within 48 h of the end of study drug treatment plus bacteriologic cure and eradication. Success and cure rate differences were analyzed using fixed- and random-effect models. The absence of between-study heterogeneity was tested using Cochran’s Q-test. Results: Clinical success rates varied between 85.8% and 97.9% for clarithromycin and between 84.2% and 96.8% for amoxicillin. The combined rate difference in clinical success rates between clarithromycin and amoxicillin was +1.9% (P=0.14). Radiological success rates (four studies) varied from 78.2% to 94.0% for clarithromycin and 79.7% to 95.0% for amoxicillin, with a combined rate difference of zero (P=1.00). Bacteriologic cure rates (four studies) were 87.1–94.6% for clarithromycin, compared with 89.8–98.1% for amoxicillin, with a combined difference in cure rates of –3.2% (P=0.16). Overall bacterial eradication rates were comparable between the two treatments (clarithromycin, 89.3%; amoxicillin, 92.1%). Conclusion: These data, with their limitations properly acknowledged, identify clarithromycin as a valid and viable alternative to amoxicillin for the treatment of acute maxillary sinusitis in adults.

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Sulphadiazine/Trimethoprim Once Daily in Maxillary Sinusitis: A Randomized Double-Blind Comparison with Sulphamethoxazole/Trimethoprim B.I.D.

Journal of International Medical Research ◽

10.1177/030006058100900609 ◽

1981 ◽

Vol 9 (6) ◽

pp. 478-481 ◽

Cited By ~ 1

Author(s):

Pierre Federspil ◽

Peter Bamberg

Keyword(s):

Maxillary Sinusitis ◽

Favourable Result ◽

Double Blind Study ◽

Double Blind ◽

Once Daily ◽

Days Of Therapy ◽

Significant Difference ◽

Blind Comparison ◽

Cure Rates

In a randomized double-blind study fifty-four patients suffering from acute maxillary sinusitis were treated for 10 days with daily doses of sulphadiazine/trimethopim (1 g) and sulphamethoxazole/trimethoprim (1.92 g), respectively. The efficacy was evaluated clinically at two follow-up visits. X-ray investigations were performed at admission and after the therapy. Of thirty-nine patients finally evaluated, thirty-seven showed a favourable result. After 6–8 days of therapy there was significant difference in cure rates in favour of sulphadiazine/trimethoprim (p < 0.05) while the outcome as evaluated after treatment was similar for both drugs.

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A Double-Blind Parallel Evaluation of the Efficacy and Safety of a Single Dose of Ketoprofen in Cancer Pain

The Journal of Clinical Pharmacology ◽

10.1002/j.1552-4604.1988.tb05975.x ◽

1988 ◽

Vol 28 ◽

pp. S34-S39 ◽

Cited By ~ 27

Author(s):

John Stambaugh ◽

Janet Drew

Keyword(s):

Single Dose ◽

Cancer Pain ◽

Efficacy And Safety ◽

Double Blind ◽

Parallel Evaluation

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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

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.01614-13 ◽

2013 ◽

Vol 58 (4) ◽

pp. 1847-1854 ◽

Cited By ~ 69

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.)

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Ceftobiprole Compared With Vancomycin Plus Aztreonam in the Treatment of Acute Bacterial Skin and Skin Structure Infections: Results of a Phase 3, Randomized, Double-blind Trial (TARGET)

Clinical Infectious Diseases ◽

10.1093/cid/ciaa974 ◽

2020 ◽

Cited By ~ 1

Author(s):

J Scott Overcash ◽

Charles Kim ◽

Richard Keech ◽

Illia Gumenchuk ◽

Borislav Ninov ◽

...

Keyword(s):

Clinical Response ◽

Clinical Success ◽

Laboratory Data ◽

European Medicines Agency ◽

Success Rates ◽

Phase 3 ◽

Gram Positive ◽

Double Blind ◽

Gram Negative ◽

Skin Structure

Abstract Background The development of novel broad-spectrum antibiotics, with efficacy against both gram-positive and gram-negative bacteria, has the potential to enhance treatment options for acute bacterial skin and skin structure infections (ABSSSIs). Ceftobiprole is an advanced-generation intravenous cephalosporin with broad in vitro activity against gram-positive (including methicillin-resistant Staphylococcus aureus) and gram-negative pathogens. Methods TARGET was a randomized, double-blind, active-controlled, parallel-group, multicenter, phase 3 noninferiority study that compared ceftobiprole with vancomycin plus aztreonam. The Food and Drug Administration-defined primary efficacy endpoint was early clinical response 48–72 hours after treatment initiation in the intent-to-treat (ITT) population and the European Medicines Agency-defined primary endpoint was investigator-assessed clinical success at the test-of-cure (TOC) visit. Noninferiority was defined as the lower limit of the 95% CI for the difference in success rates (ceftobiprole minus vancomycin/aztreonam) >−10%. Safety was assessed through adverse event and laboratory data collection. Results In total, 679 patients were randomized to ceftobiprole (n = 335) or vancomycin/aztreonam (n = 344). Early clinical success rates were 91.3% and 88.1% in the ceftobiprole and vancomycin/aztreonam groups, respectively, and noninferiority was demonstrated (adjusted difference: 3.3%; 95% CI: −1.2, 7.8). Investigator-assessed clinical success at the TOC visit was similar between the 2 groups, and noninferiority was demonstrated for both the ITT (90.1% vs 89.0%) and clinically evaluable (97.9% vs 95.2%) populations. Both treatment groups displayed similar microbiological success and safety profiles. Conclusions TARGET demonstrated that ceftobiprole is noninferior to vancomycin/aztreonam in the treatment of ABSSSIs, in terms of early clinical response and investigator-assessed clinical success at the TOC visit. Clinical Trials Registration NCT03137173.

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