Protocol for an evaluative study of the protective effect of isolation systems and decontamination in patients with high susceptibility to infection

Abstract

In the fall of 1968 Dr. T. M. Fliedner (University of Ulm, Germany) took the initiative to invite a number of clinicians and scientists working in the field of gnotobiology to discuss the necessity of cooperation. Since it would require many years for each individual clinical unit to evaluate the benefit of the isolation as well as antibiotic decontamination of the digestive tract of patients with a strong immune suppression, it was generally recognized that only co-operation could lead to a conclusive study. A close contact between clinicians and scientists experienced in gnotobiology would be of help since a number of questions arising in the clinical application, could be investigated first in experimental animals. This original nucleus extended rapidly. In the course of 2 years the protocol, published here, was prepared in a series of eight meetings. During this period the group was recognized as an official project group of the European Organization for Research on Treatment of Cancer (EORTC). Since the final version of the protocol in January 1971, 22 patients have been randomized. Not all units are at this moment in the position to isolate patients, but are expected to do so within the first half of 1972.