TY - JOUR
T1 - General guidelines for the evaluation of new anti-infective drugs for the treatment of intraabdominal and pelvic infections
T2 - Evaluation of new anti-infective drugs for the treatment of intraabdominal infections
AU - Solomkin, Joseph S.
AU - Hemsell, David L.
AU - Sweet, Richard
AU - Tally, Frank
AU - Bartlett, John
N1 - Funding Information:
Financial support: This work was supported by a contract to the Infectious Disease Society of America from the U.S. Food and Drug Administration (no. HHS 223-88-1301). These guidelines are endorsed by the Surgical Infection Society. * Chair. Correspondence: Dr. John Bartlett, Department of Internal Medicine, Johns Hopkins Hospital, 600 North Wolfe Streeet, Baltimore, Maryland 21205.
PY - 1992/11
Y1 - 1992/11
N2 - These guidelines deal with the evaluation of anti-infective drugs for the treatment of intraabdominal infections. The clinical entities consist of infections arising from any part of the gastrointestinal tract, from the distal esophagus to the colon. These include surgical infections of the bowel, biliary tree, liver, spleen, and pancreas. Virtually all intraabdominal infections are due to multiple microorganisms resident in the gastrointestinal tract; these include aerobes and facultative and obligate anaerobes. Infections are classified as complicated (requiring an operative procedure), uncomplicated (managed medically), and postoperative wound (the operative procedure should be curative, but anti-infective drugs are used to prevent further infection at the site). Clinical criteria are paramount for entry into a study and for evaluation of efficacy. For complicated infections an adequate operation is an important determinant of outcome and needs assessment. Cultures of purulent intraabdominal fluid or abscess material are the only valid microbiologic indicators of infection. The acute physiology and chronic health evaluation score is useful in defining the severity of acute illness. The control regimen should consist of effective, established drugs and surgical procedures for the condition. Duration of therapy for complicated infections is usually 5-14 days; for uncomplicated infections, 3-7 days; and for postoperative wound infection, 2-5 days. Periodic assessment of safety and efficacy must be conducted during therapy. The outcome at final assessment is cure, failure, or indeterminate.
AB - These guidelines deal with the evaluation of anti-infective drugs for the treatment of intraabdominal infections. The clinical entities consist of infections arising from any part of the gastrointestinal tract, from the distal esophagus to the colon. These include surgical infections of the bowel, biliary tree, liver, spleen, and pancreas. Virtually all intraabdominal infections are due to multiple microorganisms resident in the gastrointestinal tract; these include aerobes and facultative and obligate anaerobes. Infections are classified as complicated (requiring an operative procedure), uncomplicated (managed medically), and postoperative wound (the operative procedure should be curative, but anti-infective drugs are used to prevent further infection at the site). Clinical criteria are paramount for entry into a study and for evaluation of efficacy. For complicated infections an adequate operation is an important determinant of outcome and needs assessment. Cultures of purulent intraabdominal fluid or abscess material are the only valid microbiologic indicators of infection. The acute physiology and chronic health evaluation score is useful in defining the severity of acute illness. The control regimen should consist of effective, established drugs and surgical procedures for the condition. Duration of therapy for complicated infections is usually 5-14 days; for uncomplicated infections, 3-7 days; and for postoperative wound infection, 2-5 days. Periodic assessment of safety and efficacy must be conducted during therapy. The outcome at final assessment is cure, failure, or indeterminate.
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U2 - 10.1093/clind/15.Supplement_1.S33
DO - 10.1093/clind/15.Supplement_1.S33
M3 - Article
C2 - 1477248
AN - SCOPUS:84963044003
SN - 1058-4838
VL - 15
SP - S33-S42
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
ER -