Immunization of burned patients against Pseudomonas aeruginosa infection at Safdarjang Hospital, New Delhi.

Patients (746) aged one to 60 years admitted to Safdarjang Hospital with full skin-thickness burns over 5%-70% of their body surface were randomly allocated to a group in a controlled clinical trial in which polyvalent pseudomonas vaccine (PEV-01), antipseudomonas human immunoglobulin, pseudomonas vaccine and immunoglobulin, or no immunologic prophylaxis was administered. The mortality rate for 297 patients immunized with PEV-01 was reduced fourfold in adults and more than twofold in children as compared with that for the 263 patients who received no immunoprophylaxis. Children particularly benefited from prophylaxis with immunoglobulin; the mortality rate for children who received PEV-01 was more than twofold less than that for a control group of unimmunized children. In both children and adults, immunoprophylaxis with PEV-01 plus immunoglobulin was less effective in reducing mortality than was PEV-01 or immunoglobulin administered alone. Antibodies measured by passive hemagglutination and by passive protection tests failed to correlate with one another, but all three immunologic regimens enhanced the bactericidal capacity of whole blood against Pseudomonas aeruginosa. Klebsiella pneumoniae emerged as the dominant gram-negative bacterial species causing bacteremia in patients receiving immunoprophylaxis against P. aeruginosa.

RCT Entities:   Population Interventions Outcomes