A breach in patients' safety in randomized controlled trials of antibiotic drugs.

In a number of randomized controlled trials of antibiotic drugs the pathogens cultured from patients and their in vitro susceptibilities to the study drugs were not disclosed to the physicians during the whole course of the disease. These trials included patients with sepsis and bacteraemia. In clinical practice the information on the pathogen and its susceptibilities serves to re-evaluate the antibiotic treatment on the second or third day. As there is strong evidence that antibiotic treatment (empirical and definitive) matching the in vitro susceptibility of the pathogen reduces fatality rates in severe infections, withholding these data is a breach in patient safety. Sponsors and investigators of clinical trials of antibiotic drugs should ensure that the susceptibility of pathogens to the trial drugs are made available to clinicians in real time and taken into account when considering change in patient management, as would be the case in routine clinical practice. Members of research ethics committees should make sure that the protocols provide for this, while journals considering publication of clinical trial results should ask that details on the availability of susceptibilities to the trial antibiotics are disclosed in the methods section.