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Corey G.R.,Duke University | Kabler H.,Sunrise Medical | Mehra P.,Sharp Chula Vista Medical Center | Gupta S.,Hospital and Research Center | And 8 more authors.
New England Journal of Medicine | Year: 2014

BACKGROUND: Oritavancin is a lipoglycopeptide with bactericidal activity against gram-positive bacteria. Its concentration-dependent activity and prolonged half-life allow for single-dose treatment. METHODS: We conducted a randomized, double-blind trial in which adults with acute bacterial skin and skin-structure infections received either a single intravenous dose of 1200 mg of oritavancin or a regimen of intravenous vancomycin twice daily for 7 to 10 days. Three efficacy end points were tested for noninferiority. The primary composite end point was defined as cessation of spreading or reduction in lesion size, absence of fever, and no need for administration of a rescue antibiotic 48 to 72 hours after administration of oritavancin. Secondary end points were clinical cure 7 to 14 days after the end of treatment, as determined by a study investigator, and a reduction in lesion size of 20% or more 48 to 72 hours after administration of oritavancin. RESULTS: The modified intention-to-treat population comprised 475 patients who received oritavancin and 479 patients who received vancomycin. All three efficacy end points met the prespecified noninferiority margin of 10 percentage points for oritavancin versus vancomycin: primary end point, 82.3% versus 78.9% (95% confidence interval [CI] for the difference, -1.6 to 8.4 percentage points); investigator-assessed clinical cure, 79.6% versus 80.0% (95% CI for the difference, -5.5 to 4.7 percentage points); and proportion of patients with a reduction in lesion area of 20% or more, 86.9% versus 82.9% (95% CI for the difference, -0.5 to 8.6 percentage points). Efficacy outcomes measured according to type of pathogen, including methicillin-resistant Staphylococcus aureus, were similar in the two treatment groups. The overall frequency of adverse events was also similar, although nausea was more common among those treated with oritavancin. CONCLUSIONS: A single dose of oritavancin was noninferior to twice-daily vancomycin administered for 7 to 10 days for the treatment of acute bacterial skin and skin-structure infections caused by gram-positive pathogens. (Funded by the Medicines Company; SOLO I ClinicalTrials.gov number, NCT01252719.) Copyright © 2014 Massachusetts Medical Society.

Sharma A.,Hospital and Research Center
Oral health & preventive dentistry | Year: 2012

To test the value of submerging vital roots for the preservation of the residual ridge. The study sample consisted of 10 patients whose bone height on both submerged and control sites was measured with the help of OPG tracings and the use of grids, from the immediate post-operative period to 3 months, 6 months and 9 months post-operatively. Statistical analysis was performed using the t-test and one-way ANOVA. The amount of bone loss was significantly greater in the control area in comparison to the submerged area from the immediate post-operative period to 3 months, 6 months and 9 months post-operatively. Although the retained roots do not prevent the resorption of residual ridge, they aid in decreasing the resorptive pattern, thereby preserving the residual ridge to some extent. This may be an expedient and inexpensive way to preserve residual ridge, requiring minimal specialised training.

Chhabra A.,Hospital and Research Center
Minerva stomatologica | Year: 2011

Human mandible is related to the anatomic skull in several positions among these; centric relation is a significant spatial position. It contributes not only as a reference position to build optimal occlusion in artificial dentition, but is also related to sound periodontal health and stomatognatic function. The purpose of this article is to critically discuss the historical and current definitions of centric relation, the different methods used for recording the same and its clinical implication in the restorative dental practice.

Havale R.,Hospital and Research Center
Oral health and dental management | Year: 2013

This in vivo study aimed to assess and compare the relative clinical and radiographic success of formocresol, glutaraldehyde and ferric sulphate as medicaments following pulpotomies in primary molars at three-monthly intervals over one year. The study was carried out on 90 primary molars in 54 children aged from 3 to 9 years. Selected teeth were equally distributed and randomly assigned to formocresol, glutaraldehyde and ferric sulphate pulpotomy medicament groups (30 in each group). The teeth were then evaluated clinically and radiographically at three-monthly intervals over one year. The resulting data were tabulated and statistically analysed using the chi-square test. After one year, the clinical success rate was 100% with glutaraldehyde, 96.7% with ferric sulphate, and 86.7% with formocresol. The radiological success rate gradually decreased over the year in all pulpotomy medicament groups. Radiological success rates in formocresol, glutaraldehyde, and ferric sulphate groups were 56.7%, 83.3%, and 63.3%, respectively. Two per cent glutaraldehyde may be recommended as a more effective alternative to formocresol and ferric sulphate as a pulpotomy medicament.

Llanos-Cuentas A.,Cayetano Heredia Peruvian University | Lacerda M.V.,Fundacao de Medicina Tropical Doutor Heitor Vieira Dourado | Rueangweerayut R.,Mae Sot Hospital | Krudsood S.,Mahidol University | And 11 more authors.
The Lancet | Year: 2014

Background Clinical eff ectiveness of previous regimens to treat Plasmodium vivax infection have been hampered by compliance. We aimed to assess the dose-response, safety, and tolerability of single-dose tafenoquine plus 3-day chloroquine for P vivax malaria radical cure. Methods In this double-blind, randomised, dose-ranging phase 2b study, men and women (aged ≥16 years) with microscopically confi rmed P vivax monoinfection (parasite density >100 to <100 000 per μL blood) were enrolled from community health centres and hospitals across seven sites in Brazil, Peru, India, and Thailand. Patients with glucose- 6-phosphate dehydrogenase enzyme activity of less than 70% were excluded. Eligible patients received chloroquine (days 1-3) and were randomly assigned (1:1:1:1:1:1) by a computer-generated randomisation schedule to receive singledose tafenoquine 50 mg, 100 mg, 300 mg, or 600 mg, primaquine 15 mg for 14 days, or chloroquine alone. Randomisation was stratifi ed by baseline parasite count (≤7500 and >7500 per μL blood). The primary effi cacy endpoint was relapse-free effi cacy at 6 months from initial dose (ie, clearance of initial infection without subsequent microscopically confi rmed infection), analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT01376167. Findings Between Sept 19, 2011, and March 25, 2013, 329 patients were randomly assigned to a treatment group (chloroquine plus tafenoquine 50 mg [n=55], 100 mg [n=57], 300 mg [n=57], 600 mg [n=56]; or to chloroquine plus primaquine [n=50]; or chloroquine alone [n=54]). Relapse-free effi cacy at 6 months was 57.7% (95% CI 43-70) with tafenoquine 50 mg, 54.1% (40-66) with tafenoquine 100 mg, 89.2% (77-95) with tafenoquine 300 mg, 91.9% (80-97) with tafenoquine 600 mg, 77.3% (63-87) with primaquine, and 37.5% (23-52) with chloroquine alone. Tafenoquine 300 mg and 600 mg had better effi cacy than chloroquine alone (treatment diff erences 51.7% [95% CI 35-69], p&0.0001, with tafenoquine 300 mg and 54.5% [38-71], p <0.0001, with tafenoquine 600 mg), as did primaquine (treatment diff erence 39.9% [21-59], p=0.0004). Adverse events were similar between treatments. 29 serious adverse events occurred in 26 (8%) of 329 patients; QT prolongation was the most common serious adverse event (11 [3%] of 329), occurring in fi ve (2%) of 225 patients receiving tafenoquine, four (8%) of 50 patients receiving primaquine, and two (4%) of 54 patients receiving chloroquine alone, with no evidence of an additional eff ect on QT of chloroquine plus tafenoquine coadministration. Interpretation Single-dose tafenoquine 300 mg coadministered with chloroquine for P vivax malaria relapse prevention was more effi cacious than chloroquine alone, with a similar safety profi le. As a result, it has been selected for further clinical assessment in phase 3. Funding GlaxoSmithKline, Medicines for Malaria Venture.

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