TY - JOUR
T1 - General guidelines for the evaluation of new anti-infective drugs for the treatment of skin, skin-structure, bone, and joint infections
T2 - Evaluation of new anti-infective drugs for the treatment of selected infections of the skin and skin structure
AU - Calandra, Gary B.
AU - Norden, Carl
AU - Nelson, John D.
AU - Mader, Jon T.
N1 - Funding Information:
Financial support: This work was supported by a contract to the Infectious DiseasesSociety ofAmerica from the U.S. Food and Drug Administration (no. HHS 223-88-130 I). Correspondence: Dr. Gary Calandra, Clinical Research, Merck Sharp & Dohme Laboratories, West Point, Pennsylvania 19486.
PY - 1992/11
Y1 - 1992/11
N2 - No method for classifying infections of the skin and skin structure is uniformly accepted. Therefore, each protocol for the evaluation of new anti-infective drugs must include definitions of the skin and skin-structure infections to be treated. Clinical findings may suggest the etiology. Cultures should be performed by the best available technique. Because the yield of pathogens from sites of skin and skin-structure infection is often low, monitoring of the clinical response to therapy is paramount. Randomized, double-blind, active-control comparative studies are needed, and maintenance of blinding is recommended, even with a change in the route of administration of the study and/or control drugs. The period of follow-up should be defined for each type of infection.
AB - No method for classifying infections of the skin and skin structure is uniformly accepted. Therefore, each protocol for the evaluation of new anti-infective drugs must include definitions of the skin and skin-structure infections to be treated. Clinical findings may suggest the etiology. Cultures should be performed by the best available technique. Because the yield of pathogens from sites of skin and skin-structure infection is often low, monitoring of the clinical response to therapy is paramount. Randomized, double-blind, active-control comparative studies are needed, and maintenance of blinding is recommended, even with a change in the route of administration of the study and/or control drugs. The period of follow-up should be defined for each type of infection.
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U2 - 10.1093/clind/15.Supplement_1.S148
DO - 10.1093/clind/15.Supplement_1.S148
M3 - Article
C2 - 1477222
AN - SCOPUS:84963017625
SN - 1058-4838
VL - 15
SP - S148-S154
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
ER -