Once-Daily Oral Gatifloxacin versus Oral Levofloxacin in Treatment of Uncomplicated Skin and Soft Tissue Infections: Double-Blind, Multicenter, Randomized Study

ABSTRACT This was a double-blind, multicenter study in which 410 adults (≥18 years of age) with uncomplicated skin and soft tissue infections (SSTIs) were randomized to receive either 400 mg of gatifloxacin orally once daily or 500 mg of levofloxacin orally once daily for 7 to 10 days. The study protocol called for four assessments—before and during treatment, at the end of treatment, and posttreatment. Efficacy evaluations included clinical response and bacterial eradication rates. Of 407 treated patients, 202 (108 women, 94 men) received gatifloxacin and 205 (111 women, 94 men) received levofloxacin. For clinically evaluable patients, the cure rates were 91% for gatifloxacin and 84% for levofloxacin (95% confidence interval [CI] for the difference, −2.0 to 15.2%). Clinical cure rates for microbiologically evaluable patients were 93% for gatifloxacin and 88% for levofloxacin (95% CI for the difference, −6.5 to 16.8%). The bacterial eradication rate was 92% for each group, with gatifloxacin eradicating 93% of the methicillin-susceptible Staphylococcus aureus isolates and levofloxacin eradicating 91% of them. Both drugs were well tolerated. Most of the adverse events were mild to moderate, and nausea was the most common adverse event in each treatment arm. Once-daily oral gatifloxacin (400 mg) is clinically efficacious and well tolerated compared with once-daily levofloxacin (500 mg) for the treatment of patients with uncomplicated SSTIs.

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Dirithromycin: A New Macrolide

Annals of Pharmacotherapy ◽

10.1177/106002809603001014 ◽

1996 ◽

Vol 30 (10) ◽

pp. 1141-1149 ◽

Cited By ~ 7

Author(s):

Susan M. Wintermeyer ◽

Susan M. Abdel-Rahman ◽

Milap C. Nahata

Keyword(s):

Adverse Effect ◽

Soft Tissue ◽

Drug Interactions ◽

Clinical Efficacy ◽

Special Role ◽

Soft Tissue Infections ◽

Tissue Concentrations ◽

Double Blind ◽

Once Daily ◽

Tract Infections

OBJECTIVE: To review the clinical microbiology and therapeutic use of dirithromycin, emphasizing comparative data between dirithromycin and the standard macrolide erythromycin, as well as clarithromycin and azithromycin. DATA SOURCES: A MEDLINE search of English-language literature during the years 1966–1996, and an extensive review of journals were conducted to prepare this article. DATA EXTRACTION: The data on pharmacokinetics, adverse effects, and drug interactions were obtained from open and controlled studies. Controlled single- or double-blind studies were evaluated to assess the efficacy of dirithromycin in the treatment of various upper and lower respiratory tract infections, as well as skin and soft tissue infections. DATA SYNTHESIS: The spectrum of activity of dirithromycin is similar to that of erythromycin, clarithromycin, or azithromycin, with some notable exceptions. Dirithromycin was more active in vitro against Campylobacter jejuni and Borrelia burgdorferi than was erythromycin or clarithromycin, but in general demonstrated less activity than erythromycin, clarithromycin, or azithromycin against a majority of microorganisms. The pharmacokinetic profile of dirithromycin offers the advantages of once-daily dosing and high and prolonged tissue concentrations; dosing adjustments are not needed in the elderly or in patients with renal or mild hepatic impairment. Clinical efficacy and bacteriologic eradication rates with dirithromycin and erythromycin are comparable for the treatment of respiratory and skin and soft tissue infections due to susceptible pathogens. Dirithromycin appears to have adverse effect profiles similar to those of the other macrolides, with reported problems most often related to the gastrointestinal tract. Dirithromycin does not seem to cause clinically important interactions with drugs such as theophylline, oral contraceptives, cyclosporine, or terfenadine. CONCLUSIONS: Dirithromycin offers some attractive pharmacokinetic properties. The long elimination half-life of dirithromycin allows once-daily dosing and higher and more prolonged tissue concentrations than are achievable with erythromycin. The spectrum of activity, adverse effect profile, clinical efficacy, and bacteriologic eradication rate of dirithromycin may be similar to those of erythromycin. No significant drug interactions with dirithromycin have been reported. Based on available data, dirithromycin may not offer any unique clinical advantage over clarithromycin or azithromycin. Future clinical trials may reveal a special role for dirithromycin in patient care.

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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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Rezafungin versus Caspofungin in a Phase 2, Randomized, Double-Blind Study for the Treatment of Candidemia and Invasive Candidiasis- The STRIVE Trial

Clinical Infectious Diseases ◽

10.1093/cid/ciaa1380 ◽

2020 ◽

Author(s):

George R Thompson ◽

Alex Soriano ◽

Athanasios Skoutelis ◽

Jose A Vazquez ◽

Patrick M Honore ◽

...

Keyword(s):

Invasive Candidiasis ◽

Double Blind Study ◽

Phase 2 ◽

Double Blind ◽

Once Daily ◽

Secondary Endpoints ◽

Intent To Treat ◽

Cure Rates ◽

Treat Population

Abstract Background Rezafungin (RZF) is a novel echinocandin exhibiting distinctive pharmacokinetics/pharmacodynamics. STRIVE was a phase 2, double-blind, randomized trial designed to compare the safety and efficacy of RZF once weekly (QWk) to caspofungin (CAS) once daily for treatment of candidemia and/or invasive candidiasis (IC). Methods Adults with systemic signs and mycological confirmation of candidemia and/or IC were randomized to RZF 400 mg QWk (400 mg), RZF 400 mg on week 1 then 200 mg QWk (400/200 mg), or CAS 70 mg as a loading dose followed by 50 mg daily for ≤ 4 weeks. Efficacy assessments included overall cure (resolution of signs of candidemia/IC + mycological eradication) at day 14 (primary endpoint), investigator-assessed clinical response at day 14, and 30-day all-cause mortality (ACM) (secondary endpoints), and time to negative blood culture. Safety was evaluated by adverse events and ACM through follow-up. Results Of 207 patients enrolled, 183 were in the microbiological intent-to-treat population (~21% IC). Overall cure rates were 60.5% (46/76) for RZF 400 mg, 76.1% (35/46) for RZF 400/200 mg, and 67.2% (41/61) for CAS; investigator-assessed clinical cure rates were 69.7% (53/76), 80.4% (37/46), and 70.5% (43/61), respectively. 30-day ACM was 15.8% for RZF 400 mg, 4.4% for RZF 400/200 mg, and 13.1% for CAS. Candidemia was cleared in 19.5 and 22.8 hours in RZF and CAS patients, respectively. No concerning safety trends were observed; ACM through follow-up was 15.2% (21/138) for RZF and 18.8% (13/69) for CAS. Conclusions RZF was safe and efficacious in the treatment of candidemia and/or IC.

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Two-Year Results of Envarsus (Once-Daily MeltDose Tacrolimus Tablets) vs Prograf (Twice-Daily Tacrolimus Capsules): A Phase 3, Double-Blind, Double-Dummy, Multi-Center, Prospective, Randomized Study.

Transplantation Journal ◽

10.1097/00007890-201407151-02240 ◽

2014 ◽

Vol 98 ◽

pp. 661-662 ◽

Cited By ~ 1

Author(s):

L. Rostaing ◽

K. Ciechanowski ◽

S. Bunnapradist ◽

H. Silva ◽

J. Grinyo ◽

...

Keyword(s):

Randomized Study ◽

Prospective Randomized Study ◽

Phase 3 ◽

Double Blind ◽

Once Daily

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Efficacy of Celecoxib in Treating Symptoms of Viral Pharyngitis: A Double-Blind, Randomized Study of Celecoxib versus Diclofenac

Journal of International Medical Research ◽

10.1177/147323000203000212 ◽

2002 ◽

Vol 30 (2) ◽

pp. 185-194 ◽

Cited By ~ 8

Author(s):

LLM Weckx ◽

JE Ruiz ◽

J Duperly ◽

GA Martínez Mendizabal ◽

MBG Rausis ◽

...

Keyword(s):

Quality Of Life ◽

Adverse Events ◽

Randomized Study ◽

Specific Inhibitor ◽

Symptomatic Treatment ◽

Double Blind ◽

Once Daily ◽

Daily Group ◽

Throat Pain

This study compared the efficacy and safety of the cyclooxygenase-2 specific inhibitor celecoxib with the conventional non-steroidal anti-inflammatory drug diclofenac in the symptomatic treatment of viral pharyngitis. Adult patients from 27 study centers in Latin America were treated with oral doses of celecoxib 200 mg once daily or 200 mg twice daily, or diclofenac 75 mg twice daily for 5 days in a double-blind, randomized study. The primary efficacy assessment was ‘Throat Pain on Swallowing’ on day 3. In addition, secondary quality-of-life assessments were performed on days 3 and 5. All adverse events and treatment-emergent signs and symptoms were recorded. Data from 313 patients were evaluable for efficacy (105 celecoxib 200 mg once daily, 107 celecoxib 200 mg twice daily, 101 diclofenac 75 mg twice daily). The upper 95% confidence limits for the visual analog scale of ‘Throat Pain on Swallowing’ on day 3 for celecoxib 200 mg once daily relative to diclofenac 75 mg twice daily, and celecoxib 200 mg twice daily relative to diclofenac 75 mg twice daily were 9.26 and 7.83, respectively. All secondary efficacy and quality-of-life measures were clinically similar for the three treatment groups, and no statistically significant differences were detected. The incidences of treatment-emergent adverse events and withdrawals due to adverse events were similar for all groups, but numerically higher among patients taking diclofenac than celecoxib. More patients in the diclofenac group reported gastrointestinal complaints (7.3%) compared with those in the celecoxib groups (4.3% in the celecoxib 200 mg once-daily group and 3.4% in the celecoxib 200 mg twice-daily group). In conclusion, 5 days of treatment with celecoxib 200 mg once daily is as effective as diclofenac 75 mg twice daily in the symptomatic treatment of viral pharyngitis. Celecoxib 200 mg once daily is also as effective as celecoxib 200 mg twice daily in this condition.

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The lack of sustained effect of bright light in non-seasonal major depression

Psychological Medicine ◽

10.1017/s0033291706008105 ◽

2006 ◽

Vol 36 (9) ◽

pp. 1247-1252 ◽

Cited By ~ 16

Author(s):

KLAUS MARTINY ◽

MARIANNE LUNDE ◽

MOGENS UNDÉN ◽

HENRIK DAM ◽

PER BECH

Keyword(s):

Major Depression ◽

Randomized Study ◽

Bright Light ◽

Light Therapy ◽

Treated Group ◽

Bright Light Therapy ◽

Double Blind ◽

Sustained Effect ◽

The Difference

Background. Recently accumulated evidence has demonstrated that bright-light therapy in combination with antidepressants is effective in patients with non-seasonal major depression. Whether bright light has a sustained effect after discontinuation is, however, poorly investigated.Method. In this double-blind randomized study we report the results from a 4-week follow-up period in patients with major non-seasonal depression who had been treated for 5 weeks with sertraline combined with bright-light therapy or sertraline combined with dim-light therapy. At the beginning of the follow-up period the light therapy was stopped while sertraline treatment continued for 4 weeks.Results. Depression scores decreased substantially in both groups, resulting in high response and remission rates in both groups after 9 weeks of treatment. The difference in depression scores at week 5, favouring the bright-light-treated group, disappeared gradually in the 4-week follow-up period, resulting in similar end-point scores.Conclusions. Bright light did not have a sustained effect after discontinuation. The offset of effect was complete after 4 weeks.

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Randomized Study of Phentolamine Mesylate for Reversal of Local Anesthesia

Journal of Dental Research ◽

10.1177/154405910808700717 ◽

2008 ◽

Vol 87 (7) ◽

pp. 635-639 ◽

Cited By ~ 21

Author(s):

M. Laviola ◽

S.K. McGavin ◽

G.A. Freer ◽

G. Plancich ◽

S.C. Woodbury ◽

...

Keyword(s):

Soft Tissue ◽

Local Anesthetic ◽

Dental Treatment ◽

Randomized Study ◽

Study Drug ◽

Negative Consequences ◽

Double Blind ◽

Dental Procedures ◽

Phase 2 Study ◽

Pulpal Anesthesia

Local anesthetic solutions frequently contain vasoconstrictors to increase the depth and/or duration of anesthesia. Generally, the duration of soft-tissue anesthesia exceeds that of pulpal anesthesia. Negative consequences of soft-tissue anesthesia include accidental lip and tongue biting as well as difficulty in eating, drinking, speaking, and smiling. A double-blind, randomized, multicenter, Phase 2 study tested the hypothesis that local injection of the vasodilator phentolamine mesylate would shorten the duration of soft-tissue anesthesia following routine dental procedures. Participants (122) received one or two cartridges of local anesthetic/vasoconstrictor prior to dental treatment. Immediately after treatment, 1.8 mL of study drug (containing 0.4 mg phentolamine mesylate or placebo) was injected per cartridge of local anesthetic used. The phentolamine was well-tolerated and reduced the median duration of soft-tissue anesthesia in the lip from 155 to 70 min (p < 0.0001).

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Clinafloxacin versus Piperacillin-Tazobactam in Treatment of Patients with Severe Skin and Soft Tissue Infections

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.45.2.525-531.2001 ◽

2001 ◽

Vol 45 (2) ◽

pp. 525-531 ◽

Cited By ~ 48

Author(s):

G. Siami ◽

N. Christou ◽

I. Eiseman ◽

K. J. Tack

Keyword(s):

Soft Tissue ◽

Adverse Events ◽

Clinical Cure ◽

Wound Infections ◽

Soft Tissue Infections ◽

Pathogenic Species ◽

Treatment Groups ◽

Diabetic Foot Infections ◽

Cure Rates ◽

To Receive

ABSTRACT Patients (n = 409) with severe skin and soft tissue infections (SSTIs) were randomized to receive clinafloxacin or piperacillin-tazobactam (plus optional vancomycin for methicillin-resistant cocci), administered intravenously, with the option to switch to oral medication. Most patients had cellulitis, wound infections, or diabetic foot infections. Staphylococcus aureus, Enterococcus faecalis, and Pseudomonas aeruginosa were the most common baseline pathogens. Fewer baseline pathogens were resistant to clinafloxacin (1.8%) than to piperacillin-tazobactam (6.2%) (P = 0.001). The clinafloxacin and piperacillin-tazobactam groups did not differ significantly in clinical cure rates (68.8 and 65.2%, respectively) or microbiologic eradication rates (61.5 and 57.2%). Clinafloxacin yielded higher eradication rates for all three of the most common pathogenic species, although no differences were statistically significant. Within the power of this study, the overall frequency of adverse events was similar (P = 0.577) in the two treatment groups. Drug-associated adverse events (P = 0.050) and treatment discontinuations (P = 0.052) were marginally more frequent in the clinafloxacin group, primarily due to phototoxicity in outpatients receiving clinafloxacin. Although most cases of phototoxicity were mild to moderate, four cases were reported as severe. In summary, clinafloxacin monotherapy was equivalent in effectiveness to therapy with piperacillin-tazobactam plus optional vancomycin in the treatment of hospitalized patients with severe SSTIs.

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