chapter  18
12 Pages

Microbiological Testing During Clinical Trials

ByJan N. Faergemann

Microbiological testing is very important in all clinical trials where microorganisms are involved. In principle, the same approach is used in bacterial, fungal, and viral infections. It is important that the laboratory meets the standard for good clinical practice to insure the quality of microbiological testing and increase the importance and credibility of the whole trial. Sampling should be performed at the start and the end of the trial and sometimes during the trial, especially if one treatment is expected to have a higher efficacy than the other treatment. The goal of this chapter is to discuss how microbiological testing may be used in clinical trials for bacterial and fungal skin infections. A quantitative or semiquantitative culture procedure is necessary when determining the number of microorganisms is important. This is discussed in more detail in clinical trials of atopic dermatis as well as in the treatment of dandruff or seborrheic dermatitis.