Role of medical thoracoscopy in the treatment of complicated parapneumonic effusions.

OBJECTIVE: The role of medical thoracoscopy in the treatment of pleural infections is increasingly being recognized. This study was done to assess the role of medical thoracoscopy in the management of carefully selected subset of patients with complicated parapneumonic effusions (PPEs). MATERIALS AND METHODS: We analyzed retrospective data of 164 thoracoscopic procedures performed at our center on patients with complicated PPE in the past 10 years. Patients were subjected to medical thoracoscopy based on ultrasonographic stratification and a computed tomography (CT) thorax. Medical thoracoscopy was performed after an intercostal block under conscious sedation with midazolam (2 mg) and fentanyl (50 mcg) and local anesthesia with lignocaine 2% (10-15 ml), through a single port 10 mm diameter thoracoscope. RESULTS: A total of 164 patients (119 males and 45 females) underwent medical thoracoscopy during the study period. The mean age was 47.4 ± 15.9 (median, 50; range, 16-86). The final diagnosis by thoracoscopy was bacterial empyema in 93 patients and tuberculosis in 71 patients. Medical thoracoscopy was successful without subsequent intervention in 160 (97.5%) patients, two patients underwent a second procedure, in the form of decortication, and two patients died due to sepsis. There were no major procedure-related complications that required intervention. CONCLUSION: Early adhesiolysis and drainage of fluid using medical thoracoscopy should be considered in patients with multiloculated complicated PPE after careful radiological (ultrasonography and CT) stratification, as a more cost-effective and safe method of management.

Comparison of a Novel Human Rabies Monoclonal Antibody to Human Rabies Immunoglobulin for Postexposure Prophylaxis: A Phase 2/3, Randomized, Single-Blind, Noninferiority, Controlled Study.

Background: Lack of access to rabies immunoglobulin (RIG) contributes to high rabies mortality. A recombinant human monoclonal antibody (SII RMAb) was tested in a postexposure prophylaxis (PEP) regimen in comparison with a human RIG (HRIG)-containing PEP regimen. Methods: This was a phase 2/3, randomized, single-blind, noninferiority study conducted in 200 participants with World Health Organization category III suspected rabies exposures. Participants received either SII RMAb or HRIG (1:1 ratio) in wounds and, if required, intramuscularly on day 0, along with 5 doses of rabies vaccine intramuscualarly on days 0, 3, 7, 14 and 28. The primary endpoint was the ratio of the day 14 geometric mean concentration (GMC) of rabies virus neutralizing activity (RVNA) as measured by rapid fluorescent focus inhibition test for SII RMAb recipients relative to HRIG recipients. Results: One hundred ninety-nine participants received SII RMAb (n = 101) or HRIG (n = 98) and at least 1 dose of vaccine. The day 14 GMC ratio of RVNA for the SII RMAb group relative to the HRIG group was 4.23 (96.9018% confidence interval [CI], 2.59-6.94) with a GMC of of 24.90 IU/mL (95% CI, 18.94-32.74) for SII RMAb recipients and 5.88 IU/mL (95% CI, 4.11-8.41) for HRIG recipients. The majority of local injection site and systemic adverse reactions reported from both groups were mild to moderate in severity. Conclusions: A PEP regimen containing SII RMAb was safe and demonstrated noninferiority to HRIG PEP in RVNA production. The novel monoclonal potentially offers a safe and potent alternative for the passive component of PEP and could significantly improve the management of bites from suspected rabid animals. Clincical Trials Registration: CTRI/2012/05/002709.

A randomized non-inferiority clinical study to assess post-exposure prophylaxis by a new purified vero cell rabies vaccine (Rabivax-S) administered by intramuscular and intradermal routes.

BACKGROUND: Rabies is a 100% fatal disease but preventable with vaccines and immunoglobulins. We have developed a new purified vero cell rabies vaccine (Rabivax-S) and evaluated its safety and immunogenicity in post-exposure prophylaxis by intramuscular (IM) and intradermal (ID) routes. METHODS: This was a randomized active-controlled non-inferiority study in 180 individuals (age 5years and above) with suspected rabies exposure (90 each with WHO Category II and Category III exposures). The participants received either Rabivax-S (1mL IM; five doses), Rabivax-S (0.1mL ID; eight doses) or purified chick embryo cell vaccine (PCEC, Rabipur®) (1mL IM; five doses). The IM doses were given on Day 0, 3, 7, 14 and 28 while the ID doses were given on days 0, 3, 7 and 28. Category III patients also received a human rabies immunoglobulin (HRIG) on Day 0. Adverse events (AEs) were recorded with diary cards till day 42. Rabies neutralizing antibody levels were measured on day 0, 7, 14, 28 and 42. RESULTS: In both the category II and III patients, the geometric mean concentration (GMC) ratios of Rabivax-S IM and Rabivax-S ID groups to PCEC IM were more than 1, thus proving the non-inferiority. GMCs were similar or higher in Rabivax-S groups at all the time points. Seroresponse against rabies (RFFIT titre⩾0.5IU/mL) was achieved in all participants. Mostly mild local and systemic adverse events were reported across the three groups and all resolved without sequelae. CONCLUSIONS: Rabivax-S was well tolerated and showed immunogenicity comparable to a licensed rabies vaccine by both IM and ID routes in post-exposure prophylaxis. Registry No.: CTRI/2012/11/003135.

Comparative study on the immunogenicity and safety of a purified chick embryo cell rabies vaccine (PCECV) administered according to two different simulated post exposure intramuscular regimens (Zagreb versus Essen).

Despite availability of effective rabies vaccines, India has the highest global mortality rate for rabies. Low socio-economic communities are most affected due to lack of awareness of the disease and poor compliance to post-exposure prophylactic regimens. Currently, the only approved intramuscular regimen for post-exposure prophylaxis (PEP) against rabies in India is the Essen regimen, which consists of 5 injections administered over 5 separate days in a period of one month. The high number of doses and clinical visits, however, are major reasons for non-compliance, and thus a shorter regimen would be beneficial. In a simulated PEP trial in healthy, adult subjects, this study evaluated whether purified chick embryo cell vaccine (PCECV), administered according to the WHO-recommended 4-dose/3 visit Zagreb vaccination regimen is of equal immunogenicity and safety as the standard Essen regimen in Indian subjects. Two hundred and 50 healthy adults were enrolled and randomized into a Zagreb or Essen group, each receiving PCECV according to their respective regimen. Blood samples were collected on Days 0, 7, 14 and 42 and analyzed using the rapid fluorescent focus inhibition test (RFFIT). By Day 14, all subjects across both groups attained rabies virus neutralizing antibody (RVNA) concentrations of ≥ 0.5IU/ml. The Zagreb regimen was then demonstrated to be immunologically non-inferior to the Essen regimen by Day 14, which was the primary endpoint of the study. No safety issues were noted and the occurrence of adverse events was similar in both groups (17% and 15%, respectively). NCT01365494. CTRI No.: CTRI/2011/07/001857.

A coverage evaluation survey of JE vaccination in two districts of Karnataka.

A coverage evaluation survey was conducted in Mandya and Koppal districts of Karnataka state following the Japanese Encephalitis (JE) vaccination campaign. The purposes of the survey were to assess coverage of children in target age group by JE vaccination and to assess adverse events following immunisation against JE, the knowledge of health care providers and community about JE & mass vaccination for JE. The study design consisted of both quantitative and qualitative methods. The quantitative data was used to know the coverage levels for children. The qualitative data collected through interviews of head of the family in the sample households, selected health care workers using a structured pretested questionnaire. The standard cluster sampling method was used for selecting the sample of children to be evaluated. In Mandya district the evaluation showed 92% coverage in the selected sample of 313 children against the reported 83.85%. In Koppal district the evaluation showed 70% coverage, among the selected sample of 251 children, against the reported coverage of 69.8%. The incidence of adverse events was 4% in Mandya sample and 6.37% in Koppal sample. In Mandya district, about 42% of households had knowledge of JE. About 68% of households had prior knowledge of the immunization day. In Koppal district, the survey has revealed that only 19.85% of the heads of household had the knowledge of JE and 48.53% had the knowledge of JE vaccination before the day of vaccination campaign.

Ultra low dose aprotinin decreases blood loss and transfusion requirements in high risk two valve replacement surgery.

The efficacy of ultra-low-dose-aprotinin (ULDA) in 'high-risk' two valve replacement surgery, was evaluated in this prospective, randomized, double-blind study. Forty adult high-risk patients undergoing elective two valve replacement surgery, were included. The patients were divided into 2 groups of 20 each. In Group I, aprotinin in a dose of 1,000,000 KIU was administered from the end of anaesthesia induction to the time of sternotomy after a 1 ml of test dose. In Group II (control), 100 ml of normal saline was administered in a similar fashion. Coagulation parameters, blood loss, and amount of transfusion of blood / blood products were measured at specific intervals. The postoperative chest tube drainage in the first 24 hours was significantly less 203+/-35 ml (p<0.05) in Group I as compared with 490+/-104 ml in group II and consequently, Group I patients received significantly less (p<0.05) red cell concentrates and platelet transfusion. There was a significant decrease in the length of postoperative elective ventilation, intensive care unit (ICU) stay and direct costs involved in the hospital expenses with the use of ULDA. We conclude that ULDA is safe and effective in 'high-risk' two-valve replacement surgery to reduce postoperative bleeding, postoperative length of intubation and ICU stay; use of ULDA is associated with significant direct cost savings.