Outbreak of B.cepacia bacteremia following use of contaminated drug vials in a tertiary care centre.

PURPOSE: We report an outbreak of Burkholderia cepacia bacteremia related to contaminated drug vials. MATERIALS AND METHODS: All patients having fever post coronary angiography were analysed from February 12, 2019 to March 18, 2019. A thorough inspection of the cath lab was done by the infection control team. Surveillance cultures were taken from various places including swabs from the all the drug vials used for the patients. RESULTS: During the above period, a total of 898 cases had been taken up for angiographic procedures in all the four cath labs, out of which 72 were for neurological issues. Among these patients only 60 patients reported fever. No fever was reported among those who underwent angiograms for neurological issues. Of the 60 patients who had fever, 38 patients satisfied the case definition. Blood cultures were sent for 7(18.4%) patients and 17(44.7%) had been started on antibiotics. After identification of 2 cases with the positive culture and following the news that a drug manufacturing company had recalled a particular batch of drug (diltiazem), the source of the outbreak was thought to be contaminated diltiazem vials. Retrospectively it was noted that the 38 patients had received the diltiazem from three different batches. Subsequently the same organism was isolated from the drug vials also. Both the isolates were phenotypically the same. There were no patients with fever post procedure reported the week after the batch of diltiazem was recalled. CONCLUSION: The outbreak was thus linked to the contaminated diltiazem vials. Physicians should thus be aware of such outbreaks that can cause bacteremias.

Safety and Immunogenicity of a novel three-dose recombinant nanoparticle rabies G protein vaccine administered as simulated post exposure immunization: A randomized, comparator controlled, multicenter, phase III clinical study.

BACKGROUND: Rabies vaccines are lifesaving in human post animal exposure. However, the compliance to the complete course of vaccine is found to be only 60%. Hence, there is a need for safe and immunogenic, shorter course vaccine that can enhance the compliance and effectively prevent the disease. OBJECTIVES: To establish a noninferiority of a novel three-dose recombinant rabies G protein vaccine to be administered as simulated postexposure prophylaxis when compared to five-dose WHO prequalified vaccine for better safety and immunogenicity. METHODS: A multi-centric, open label, assessor blind, center-specific block randomized, parallel design, phase III clinical study was conducted among 800 subjects. The eligible subjects were randomized in 2:1 ratio for recombinant rabies G protein vaccine and the reference vaccine. Subjects in recombinant rabies G protein vaccine arm received three doses of vaccine on days 0, 3, and 7, while subjects in reference vaccine arm received five doses of WHO prequalified vaccine on days 0, 3, 7, 14, and 28. RESULTS: The socio-demographic characteristics of the two arms were comparable. About 9.9% subjects in recombinant rabies G protein vaccine arm and 17.2% subjects in reference arm reported adverse events. The sero-protection on day 14 was found to be 99.24% and 97.72% in recombinant rabies G protein vaccine arm and reference vaccine arm respectively and the difference was statistically nonsignificant. CONCLUSION: The novel three-dose recombinant rabies G protein vaccine administered as simulated postexposure prophylaxis was noninferior to five dose WHO prequalified vaccine in terms of safety and immunogenicity.

Profile of Infective Endocarditis: At a Tertiary Care Referral Centre.

BACKGROUND: Infective endocarditis (IE) remains a serious challenge with a persistently high morbidity and mortality despite the availability of improved diagnostic and treatment amenities in the developing world. Data on the clinical and microbiological profile of IE in India is still limited. The emergence of modern risk factors such as hospitalization and device insertion has changed the epidemiology of the disease in the western world, whereas in India and other parts of the developing world the situation is more complex because of the concomitant burden of rheumatic heart disease and congenital heart defects. We therefore attempted to describe the changing epidemiology of the disease in a cohort of patients with definite IE admitted to a tertiary care centre. METHODS: 145 cases were identified as IE during the period January 2010-December 2015 (6 years) of which 120 'definite' cases of IE according to the modifies Dukes' criteria were analysed. RESULTS: The mean age of patients was 53 years ± 15 years (age range 18 to 79 years) with a male preponderance of 72%. Native valve disease was seen in 103 cases and 17 cases had prosthetic valve infections. IE was classified as community acquired in 87 (72.5%) cases and healthcare associated in 33(27.5%) events. Predisposing factors contributing to healthcare associated events included hemodialysis in 8.3%, recent surgical intervention which included urological instrumentation with urosepsis and gastrointestinal procedures in 5.8% events. Postpartum IE was seen in 1.7% cases. There was evidence of remote abscess, prior bacteraemia or septic foci in the preceding 3 months of presentation with IE in 8.3% of patients and 3.3% patients underwent prior dental procedure. Prior structural heart disease was present in 47.5% of cases of which Rheumatic heart disease (RHD) was seen in 15%. A previous episode of infective endocarditis was observed in significantly more patients with PVE (29.4%) than with NVE (1.9%). Blood cultures were negative in 50 (41.7%) of cases of whom 60% had received antibiotics prior to admission. Nine of 17 patients with PVE (52.9%) were culture negative. In the 70(58.3% of all patients) patients with positive blood cultures, Streptococcus sp were the commonest bacteria isolated in 15.8%, of which Viridans group Streptococci (VGS) was seen in majority of the cases (13.3%) followed by Staphylococcus sp (14.2%) with methicillin resistant staphylococcus was seen in 3.3% and Enterococcus sp in 13.3%. Gram negative bacteraemia were seen in 8.3%. In addition, ESBL E coli constituted 4% of our culture positive cases, perhaps representing a complication of this common community acquired bacteraemia and increasing resistance in E coli. Tissue / valve cultures in patients who underwent surgery was positive in four cases, 3 of whom where blood culture negative The mortality rate was higher among PVE (33%) compared to 10% in NVE. The most common cause of death in IE was usually congestive cardiac failure. CONCLUSIONS: Thought Rheumatic heart disease continues to be the most common predisposing factor, degenerative heart diseases and healthcare associated IE are also gradually increasing. Use of antibiotics prior to sending blood cultures remains a significant cause of culture negativity. Viridans streptococci continue to be the commonest pathogen and though ESBL E coli constituted a significant minority it could expound the changing epidemiology and risk factors for Gramnegative endocarditis especially non-HACEK group necessitating an updated review of this subject.