No need for biopsies: comparison of three sample techniques for wound microbiota determination.

The aim of the study was to compare three sampling techniques used in routine diagnostics to identify the microbiota in chronic venous leg ulcers. A total of 46 patients with persisting venous leg ulcers were included in the study. At inclusion, swab, biopsy and filter paper pad samples were collected. After 4 weeks, additional biopsy and filter paper pad samples were collected. Bacteria were isolated and identified at species level by standard methods. The most common bacterial species detected was Staphylococcus aureus found in 89% of the ulcers. No methicillin-resistant S. aureus isolates were found. We did not find any significant differences regarding the bacterial species isolated between the three sampling techniques. However, using multiple techniques led to identification of more species. Our study suggests that it is sufficient to use swab specimens to identify the bacterial species present in chronic wounds, thus avoiding complications during and after biopsy sampling.

Nosocomial infection in a Danish Neonatal Intensive Care Unit: a prospective study.

AIM: The aim of this study was to estimate the incidence and identify independent risk factors for nosocomial infections in a Danish Neonatal Intensive Care Unit and to compare these findings with international results. METHODS: The study was performed prospectively from January 1, 2005 to December 31, 2005 in the Neonatal Intensive Care Unit at Rigshospitalet, Copenhagen. Specific criteria for blood stream infection and respiratory tract infection adapted for neonates in our ward were worked out. RESULTS: Six hundred and eighty-three patients were included. The overall incidence of nosocomial infection was 8.8/1000 hospital days. Blood stream infection was the most frequent type of infection, with an incidence of 5.1/1000 hospital days. Multivariate analysis showed gestational age and heart disease to be significant independent risk factors for both first time blood stream infection and respiratory tract infection, and central venous catheter and parenteral nutrition risk factors for first time blood stream infection. CONCLUSION: This first prospective study of nosocomial infection in a Danish Neonatal Intensive Care Unit found an overall incidence of 8.8/1000 hospital days, which is low or similar compared to other studies. Further Danish multicentre studies are needed, and we suggest that procedures related to central venous catheters should be a future focus area.

A randomised, double-blind, non-inferiority clinical trial on the safety and immunogenicity of a tetanus, diphtheria and monocomponent acellular pertussis (TdaP) vaccine in comparison to a tetanus and diphtheria (Td) vaccine when given as booster vaccinations to healthy adults.

BACKGROUND: Increasing incidence of pertussis in adolescents and adults has stimulated the development of safe and immunogenic acellular pertussis vaccines for booster vaccination of adolescents and adults. PURPOSE: To obtain clinical documentation of the safety and immunogenicity of a tetanus, diphtheria and monocomponent acellular pertussis combination vaccine (TdaP), when given as a booster vaccination to adults. METHODS: The trial was double-blind, controlled and randomised. 802 healthy adults, aged 18-55 years who had completed childhood vaccination with diphtheria, tetanus and whole cell pertussis vaccine (DTwP), were booster vaccinated with TdaP or Td. Blood samples were taken before and one month after the vaccination for serological analysis and adverse events were recorded during the one-month-follow-up period. RESULTS: The monocomponent acellular pertussis vaccine (aP) in the TdaP vaccine was immunogenic in adults with 92.0% of TdaP vaccinated subjects obtaining an anti-pertussis toxin (anti-PT) antibody booster response. TdaP was non-inferior to Td in eliciting seroprotective anti-tetanus and diphtheria antibody concentrations with more than 98% of subjects obtaining post-vaccination seroprotective concentrations (≥ 0.1 IU/mL). T and d booster response rates were 93.0% and 97.5%, respectively. The frequencies of solicited local adverse reactions were low and comparable between TdaP and Td vaccinees. In the TdaP group, 30.7% reported pain, 4.2% swelling and 2.0% erythema at the injection site. The most frequent solicited general symptoms were headache (20.4%), fatigue (17.0%) and myalgia (10.0%). In the Td group, 35.7% reported pain, 2.5% swelling and 3.2% erythema at the injection site, whereas headache, fatigue and myalgia were reported by 15.7%, 14.5% and 12.5%, respectively. In conclusion, TdaP Vaccine SSI was safe and immunogenic when given as a booster vaccination to adults.

Safety and immunogenicity of a DTaP-IPV(Vero) (serum-free) combination vaccine in comparison to DTaP-IPV(Mkc) when administered simultaneously with Haemophilus influenzae type B conjugate vaccine (PRP-T) in children at 2, 3.5, 5 and 16 months of age.

In a phase III, double blind, randomized, noninferiority, multi-centre clinical trial, 817 infants were included and randomly assigned to vaccination with DTaP-IPV(Vero) (N=410) or DTaP-IPV(Mkc) (N=407) vaccines (Statens Serum Institut (SSI), Denmark) in the right thigh. All infants were vaccinated with Act-HIB (Sanofi Pasteur, France) in the left thigh at the same time. The vaccination schedule was 2, 3.5, 5 and 16 months and serum samples were obtained at 6, 16 and 17 months. The primary objective was to demonstrate noninferiority of DTaP-IPV(Vero) to DTaP-IPV(Mkc) as regards immunological protection against polio virus types 1, 2 and 3. Furthermore, the immunogenicity of all vaccine antigens and the safety profile of the vaccines were assessed. The study demonstrated that DTaP-IPV(Vero) was noninferior to DTaP-IPV(Mkc). All antibody concentrations/titres remained at an acceptable level from the end of the primary vaccination series (i.e. 2, 3.5 and 5 months) until the time of the booster vaccination at 16 months. A good booster response was, furthermore, demonstrated for all antigens. No vaccine-related serious adverse events and no injection site granulomas or swelling of the entire thigh occurred. The frequencies of local injection site erythema and swelling as well as systemic adverse events such as fever, irritability, somnolence and decreased appetite were low and acceptable in both treatment groups. In conclusion, DTaP-IPV(Vero) is immunogenic and safe for primary vaccination and for booster vaccination of healthy children.

Safety and immunogenicity of a booster dose of inactivated poliovirus vaccine produced in vero-cells.

Statens Serum Institut has developed a new vero-cell culturing technique for the manufacturing of inactivated poliovirus vaccine (IPV). This technique implies that the cultivation of cells and poliovirus is performed in a medium free of materials of animal origin and free of antibiotics. In a double-blind randomised clinical trial, IPV(vero) manufactured by this new technique was compared to conventionally produced IPV(mkc). One hundred and twenty-nine (129) healthy adult volunteers were given booster vaccinations of IPV(vero) (65) or IPV(mkc) (64). Both vaccines were well tolerated and resulted in excellent booster responses. No statistically significant differences were seen between the study groups.