Archive for January 4, 2006

Original Article – Safety and Efficacy of a Pentavalent Human–Bovine (WC3) Reassortant Rotavirus Vaccine

Source: N Engl J Med Jan.5 2006 v.354  N.1 p.23-33

Timo Vesikari, M.D., David O. Matson, M.D., Ph.D., Penelope Dennehy, M.D., Pierre Van Damme, M.D., Ph.D., Mathuram Santosham, M.D., M.P.H., Zoe Rodriguez, M.D., Michael J. Dallas, Ph.D., Joseph F. Heyse, Ph.D., Michelle G. Goveia, M.D., M.P.H., Steven B. Black, M.D., Henry R. Shinefield, M.D., Celia D.C. Christie, M.D., M.P.H., Samuli Ylitalo, M.D., Robbin F. Itzler, Ph.D., Michele L. Coia, B.A., Matthew T. Onorato, B.S., Ben A. Adeyi, M.P.H., Gary S. Marshall, M.D., Leif Gothefors, M.D., Dirk Campens, M.D., Aino Karvonen, M.D., James P. Watt, M.D., M.P.H., Katherine L. O’Brien, M.D., M.P.H., Mark J. DiNubile, M.D., H Fred Clark, D.V.M., Ph.D., John W. Boslego, M.D., Paul A. Offit, M.D., Penny M. Heaton, M.D., for the Rotavirus Efficacy and Safety Trial (REST) Study Team

ABSTRACT

Background Rotavirus is a leading cause of childhood gastroenteritis and death worldwide.

Methods We studied healthy infants approximately 6 to 12 weeks old who were randomly assigned to receive three oral doses of live pentavalent human–bovine (WC3 strain) reassortant rotavirus vaccine containing human serotypes G1, G2, G3, G4, and P[8] or placebo at 4-to-10-week intervals in a blinded fashion. Active surveillance was used to identify subjects with serious adverse and other events.

Results The 34,035 infants in the vaccine group and 34,003 in the placebo group were monitored for serious adverse events. Intussusception occurred in 12 vaccine recipients and 15 placebo recipients within one year after the first dose including six vaccine recipients and five placebo recipients within 42 days after any dose (relative risk, 1.6; 95 percent confidence interval, 0.4 to 6.4). The vaccine reduced hospitalizations and emergency department visits related to G1–G4 rotavirus gastroenteritis occurring 14 or more days after the third dose by 94.5 percent (95 percent confidence interval, 91.2 to 96.6 percent). In a nested substudy, efficacy against any G1–G4 rotavirus gastroenteritis through the first full rotavirus season after vaccination was 74.0 percent (95 percent confidence interval, 66.8 to 79.9 percent); efficacy against severe gastroenteritis was 98.0 percent (95 percent confidence interval, 88.3 to 100 percent). The vaccine reduced clinic visits for G1–G4 rotavirus gastroenteritis by 86.0 percent (95 percent confidence interval, 73.9 to 92.5 percent).

Conclusions This vaccine was efficacious in preventing rotavirus gastroenteritis, decreasing severe disease and health care contacts. The risk of intussusception was similar in vaccine and placebo recipients. (ClinicalTrials.gov number, NCT00090233 [ClinicalTrials.gov] .)
FREE ACCESS Full text of this article     www.nejm.org

 

January 4, 2006 at 11:39 pm Leave a comment

Original Article – Safety and Efficacy of an Attenuated Vaccine against Severe Rotavirus Gastroenteritis

Source: N Engl J Med Jan.5 2006 v.354  N.1 p.11-22

Guillermo M. Ruiz-Palacios, M.D., Irene Pérez-Schael, M.Sc., F. Raúl Velázquez, M.D., Hector Abate, M.D., Thomas Breuer, M.D., SueAnn Costa Clemens, M.D., Brigitte Cheuvart, Ph.D., Felix Espinoza, M.D., Paul Gillard, M.D., Bruce L. Innis, M.D., Yolanda Cervantes, M.D., Alexandre C. Linhares, M.D., Pío López, M.D., Mercedes Macías-Parra, M.D., Eduardo Ortega-Barría, M.D., Vesta Richardson, M.D., Doris Maribel Rivera-Medina, M.D., Luis Rivera, M.D., Belén Salinas, M.D., Noris Pavía-Ruz, M.D., Jorge Salmerón, M.D., Ricardo Rüttimann, M.D., Juan Carlos Tinoco, M.D., Pilar Rubio, M.D., Ernesto Nuñez, M.D., M. Lourdes Guerrero, M.D., Juan Pablo Yarzábal, M.D., Silvia Damaso, M.Sc., Nadia Tornieporth, M.D., Xavier Sáez-Llorens, M.D., Rodrigo F. Vergara, M.D., Timo Vesikari, M.D., Alain Bouckenooghe, M.D., Ralf Clemens, M.D., Ph.D., Béatrice De Vos, M.D., Miguel O’Ryan, M.D., for the Human Rotavirus Vaccine Study Group

ABSTRACT

Background The safety and efficacy of an attenuated G1P[8] human rotavirus (HRV) vaccine were tested in a randomized, double-blind, phase 3 trial.

Methods We studied 63,225 healthy infants from 11 Latin American countries and Finland who received two oral doses of either the HRV vaccine (31,673 infants) or placebo (31,552 infants) at approximately two months and four months of age. Severe gastroenteritis episodes were identified by active surveillance. The severity of disease was graded with the use of the 20-point Vesikari scale. Vaccine efficacy was evaluated in a subgroup of 20,169 infants (10,159 vaccinees and 10,010 placebo recipients).

Results The efficacy of the vaccine against severe rotavirus gastroenteritis and against rotavirus-associated hospitalization was 85 percent (PConclusions Two oral doses of the live attenuated G1P[8] HRV vaccine were highly efficacious in protecting infants against severe rotavirus gastroenteritis, significantly reduced the rate of severe gastroenteritis from any cause, and were not associated with an increased risk of intussusception. (ClinicalTrials.gov numbers, NCT00139347 [ClinicalTrials.gov] and NCT00263666 [ClinicalTrials.gov] .)
FREE ACCESS Full text of this article    www.nejm.org

January 4, 2006 at 11:37 pm Leave a comment

Review Article – Community-Acquired Bacterial Meningitis in Adults

Source: N Engl J Med Jan.5 2006 v.354  N.1 p.44-53

Current Concepts

Diederik van de Beek, M.D., Ph.D., Jan de Gans, M.D., Ph.D., Allan R. Tunkel, M.D., Ph.D., and Eelco F.M. Wijdicks, M.D., Ph.D.

Bacterial meningitis is a medical, neurologic, and sometimes neurosurgical emergency that requires a multidisciplinary approach. Bacterial meningitis has an annual incidence of 4 to 6 cases per 100,000 adults (defined as patients older than 16 years of age), and Streptococcus pneumoniae and Neisseria meningitidis are responsible for 80 percent of all cases.1,2 A diagnosis of bacterial meningitis is often considered, but the disease can be difficult to recognize.1,2,3,4,5,6,7,8 Recommendations for antimicrobial therapy are changing as a result of the emergence of antimicrobial . . .

FREEE ACCESS Full Text of this Article   www.nejm.org

January 4, 2006 at 11:35 pm Leave a comment

Viridans Streptococci Isolated by Culture from Blood of Cancer Patients: Clinical and Microbiologic Analysis of 50 Cases

Source: Journal of Clinical Microbiology Jan 2006 p.160-165 Vol.44 N.1

Xiang Y. Han,1* Mallika Kamana,2 and Kenneth V. I. Rolston2

Section of Clinical Microbiology,1 Infectious Diseases, The University of Texas M. D. Anderson Cancer Center, Houston, Texas2

Clinical and microbiologic studies of 50 cases of viridans streptococcal bacteremia in cancer patients were performed. The bacteria were identified to species level by sequencing analysis of the 16S rRNA gene.

At least nine Streptococcus spp. were found, including S. mitis (25 strains, 50.0% of 50); currently unnamed Streptococcus spp. (11 strains); S. parasanguis (five strains); S. anginosus (three strains); S. salivarius (two strains); and one strain each of S. gordonii, S. sanguis, S. sobrinus, and S. vestibularis. There were no S. oralis strains. Among 11 antibiotics of nine classes tested, no resistance to vancomycin, linezolid, or quinupristin-dalfopristin was seen.

Resistance to penicillin (MIC, 4 to 12 µg/ml) was noted only among S. mitis strains (28.0%, 7/25) and not non-S. mitis strains (0/25) (P = 0.004).

Significantly more S. mitis strains than non-S. mitis strains were resistant to fluoroquinolones and to 3 classes of antibiotics. Isolation of quinolone-resistant organisms was associated with the prior usage of quinolones (P = 0.002). Quantitative blood cultures showed that the strains resistant to levofloxacin or gatifloxacin were associated with higher colony counts than were their corresponding nonresistant strains.

The young and elderly patients also had higher levels of bacteremia caused predominantly by S. mitis. Septic shock was present in 17 (34.0% of 50) patients, and 13 of those cases were caused by S. mitis (P = 0.007). These results suggest that S. mitis is the most common cause of viridans streptococcal bacteremia in cancer patients and is more resistant to antibiotics than other species.

* Corresponding author. Mailing address: Section of Clinical Microbiology, The University of Texas M. D. Anderson Cancer Center, Unit 84, 1515 Holcombe Boulevard, Houston, TX 77030. Phone: (713) 792-3515. Fax: (713) 792-0936. E-mail: xhan@mdanderson.org.

January 4, 2006 at 1:48 am Leave a comment

Characterization of a Strain of Community-Associated Methicillin-Resistant Staphylococcus aureus Widely Disseminated in the United States

Source: Journal of Clinical Microbiology Jan 2006 p.108-118 Vol.44 N.1

Fred C. Tenover,1* Linda K. McDougal,1 Richard V. Goering,2 George Killgore,1 Steven J. Projan,3 Jean B. Patel,1 and Paul M. Dunman4

Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia 30333,1 Department of Medical Microbiology, Creighton University, Omaha, Nebraska 68178,2 Genomics—Cambridge, Wyeth Research, Cambridge, Massachusetts 02140,3 Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha, Nebraska 681984

A highly stable strain of Staphylococcus aureus with a pulsed-field gel electrophoresis type of USA300 and multilocus sequence type 8 has been isolated from patients residing in diverse geographic regions of the United States. This strain, designated USA300-0114, is a major cause of skin and soft tissue infections among persons in community settings, including day care centers and correctional facilities, and among sports teams, Native Americans, men who have sex with men, and military recruits. The organism is typically resistant to penicillin, oxacillin, and erythromycin (the latter mediated by msrA) and carries SCCmec type IVa. This strain is variably resistant to tetracycline [mediated by tet(K)]; several recent isolates have decreased susceptibility to fluoroquinolones. S. aureus USA300-0114 harbors the genes encoding the Panton-Valentine leucocidin toxin. DNA sequence analysis of the direct repeat units within the mec determinant of 30 USA300-0114 isolates revealed differences in only a single isolate. Plasmid analysis identified a common 30-kb plasmid that hybridized with blaZ and msrA probes and a 3.1-kb cryptic plasmid. A 4.3-kb plasmid encoding tet(K) and a 2.6-kb plasmid encoding ermC were observed in a few isolates. DNA microarray analysis was used to determine the genetic loci for a series of virulence factors and genes associated with antimicrobial resistance.

Comparative genomics between USA300-0114 and three other S. aureus lineages (USA100, USA400, and USA500) defined a set of USA300-0114-specific genes, which may facilitate the strain's pathogenesis within diverse environments.

* Corresponding author. Mailing address: Division of Healthcare Quality Promotion (G08), Centers for Disease Control and Prevention, 1600 Clifton Rd., Atlanta, GA 30333. Phone: (404) 639-3375. Fax: (404) 639-1381. E-mail: fnt1@cdc.gov.

January 4, 2006 at 1:40 am Leave a comment

Association between Preterm Birth and Vaginal Colonization by Mycoplasmas in Early Pregnancy

Source: Journal of Clinical Microbiology Jan 2006 p.51-55 Vol.44 N. 1

Soromon Kataoka, Takashi Yamada,* Kazutoshi Chou, Ryutaro Nishida, Mamoru Morikawa, Mashiho Minami, Hideto Yamada, Noriaki Sakuragi, and Hisanori Minakami

Departments of Obstetrics and Gynecology, Hokkaido University Graduate School of Medicine, Sapporo, Japan

To examine the association between colonization by two newly classified species of genital ureaplasmas (Ureaplasma parvum and U. urealyticum) in early pregnancy and subsequent late abortion or preterm birth at * Corresponding author. Mailing address: Department of Obstetrics, Hokkaido University Hospital, Kita-ku N14 W6, Sapporo 060-8638, Japan. Phone: 81-11-716-1161, ext. 5941. Fax: 81-11-706-7711. E-mail: yamataka@med.hokudai.ac.jp.

January 4, 2006 at 1:38 am Leave a comment

Prevalence and Evolution of Methicillin-Resistant Staphylococcus aureus in Spanish Hospitals between 1996 and 2002

Source: Journal of Clinical Microbiology Jan 2006 p.266-270 Vol.44 N.1

A. Vindel,1* P. Trincado,1 E. Gómez,1 R. Cabrera,1 T. Boquete,1 C. Solá,2 S. Valdezate,1 and J. A. Saez-Nieto1

Nosocomial Infectious Diseases Laboratory, Servicio de Bacteriología, Instituto de Salud Carlos III, Centro Nacional de Microbiología, 28220 Majadahonda, Madrid, Spain,1 Centro de Investigaciones en Bioquímica Clínica e Inmunología (CIBICI-CONICET), Departamento de Bioquímica Clinica, Facultad de Ciencias Químicas, Universidad Nacional de Córdoba, Ciudad Universitaria, Pabellon Argentina, 5000 Córdoba, Argentina2

Pulsed-field gel electrophoretic analysis of 2,144 methicillin-resistant Staphylococcus aureus (MRSA) strains isolated from patients in Spanish hospitals over a 7-year period revealed 17 predominant profiles. Typing showed the replacement of Iberian clone E1 (ST247-MRSA-I) by two prevalent clones, E7 and E8, that are closely related to each other and have the same genetic background as ST125-MRSA-IV.

* Corresponding author. Mailing address: Nosocomial Infectious Diseases Laboratory, Instituto de Salud Carlos III, Centro Nacional de Microbiología, 28220 Majadahonda, Madrid, Spain. Phone: 34-91-8223666. Fax: 34-91-5097966. E-mail: avindel@isciii.es.

January 4, 2006 at 1:34 am Leave a comment

Older Posts


Calendar

January 2006
M T W T F S S
 1
2345678
9101112131415
16171819202122
23242526272829
3031  

Posts by Month

Posts by Category