Protective isolation and antimicrobial decontamination in patients with high susceptibility to infection - A prospective cooperative study of gnotobiotic care in acute leukemia patients; I. Clinical results

The efficiency of protective isolation and protective isolation plus gastrointestinal decontamination on the control of infectious complications in patients with decreased defence capacity was investigated prospectively in a cooperative trial with the participation of clinical centers in several European countries (European Organization for Research on Treatment of Cancer, Gnotobiotic Project Group). The study was performed in patients with acute leukemia under remission-induction therapy on the basis of the frequency of such patients in the participating centers. Over a period of five years, 137 cases of acute leukemia were randomly allocated to three different treatment groups as follows: Group A: strict protective isolation in plastic isolation systems or laminar air flow isolators and prophylactic antimicrobial decontamination by non-absorbable antibiotics, Group B: strict isolation alone in one or the other type of isolator, and Group C: routine hospital ward. The results demonstrated that the incidence of contamination and colonization with new bacteria could be decreased significantly by strict protective isolation alone and even more markedly by strict protective isolation and antimicrobial decontamination. They also demonstrated that in Group A there were less frequent episodes of severe infection. More specifically, the incidence of pulmonary infection was reduced significantly in both Groups A and B in comparison with Group C. The remission rate of acute leukemia was higher in patients of Groups A and B versus Group C (69%, 61%, 49%), although this result was not significant. However, the microbiological investigations and the outcome of the study suggest that the techniques of protective isolation and antimicrobial decontamination have to be improved to decrease further the incidence of infection in the compromised host. © Verlagsgesellschaft Otto Spatz 1977