TY - JOUR
T1 - Evaluation of new anti-infective drugs for the treatment of acute pelvic infections in hospitalized women
AU - Hemsell, D. L.
AU - Solomkin, J. S.
AU - Sweet, R.
AU - Tally, F.
AU - Bartlett, J. G.
N1 - Funding Information:
Financial Support: This work was supported by a contract to the Infectious Diseases Society of America from the Food and Drug Administration (no. HHS 223-88-1301). * Chair. Correspondence: Dr. David Hemsell, Department of Obstetrics and Gynecology, The University of Texas Southwestern Medical Center at Dallas, 06.226, 5323 Harry Hines Boulevard, Dallas, Texas 75235-9032. Clinical Infectious Diseases 1992;15(Suppll):S43-52 © 1992 by The University of Chicago. All rights reserved.
PY - 1992/11
Y1 - 1992/11
N2 - This set of guidelines deals with evaluation of anti-infective drugs for treatment of acute pelvic infections in hospitalized women. The clinical entities include infectious complications of cesarean section; elective hysterectomy; and septic, incomplete abortion. Conditions including endomyometritis, cuff cellulitis, pelvic cellulitis, parametritis, phlegmon, and pelvic abscesses may arise due to a variety of bacterial species, both aerobic and anaerobic, that comprise the endogenous flora of the lower reproductive tract. Anaerobic bacteria have assumed particular importance, and therapy should be directed against such organisms. The roles of enterococci, chlamydiae, and mycoplasmas remain uncertain. Culture samples must be obtained under conditions assuring minimal vaginal contamination. Before a new drug may be used for treatment of human pelvic infections, considerable information is necessary about its antimicrobial spectrum as well as its safety and efficacy. Placebo-controlled trials are considered unethical. Historical controls may be used, but concurrent active control comparative trials are preferred. Parenteral administration is recommended for at least the initial 4 days of therapy, but orally administered drugs may be evaluated for completion of longer courses. The expected cure rate is ˜90%. Uncomplicated infections should be treated for at least 4 days; more complicated infections may require prolonged therapy. Although clinical cure is paramount, microbiologic response must also be taken into account. In the final assessment, outcome will be classified as cure, failure, or indeterminate.
AB - This set of guidelines deals with evaluation of anti-infective drugs for treatment of acute pelvic infections in hospitalized women. The clinical entities include infectious complications of cesarean section; elective hysterectomy; and septic, incomplete abortion. Conditions including endomyometritis, cuff cellulitis, pelvic cellulitis, parametritis, phlegmon, and pelvic abscesses may arise due to a variety of bacterial species, both aerobic and anaerobic, that comprise the endogenous flora of the lower reproductive tract. Anaerobic bacteria have assumed particular importance, and therapy should be directed against such organisms. The roles of enterococci, chlamydiae, and mycoplasmas remain uncertain. Culture samples must be obtained under conditions assuring minimal vaginal contamination. Before a new drug may be used for treatment of human pelvic infections, considerable information is necessary about its antimicrobial spectrum as well as its safety and efficacy. Placebo-controlled trials are considered unethical. Historical controls may be used, but concurrent active control comparative trials are preferred. Parenteral administration is recommended for at least the initial 4 days of therapy, but orally administered drugs may be evaluated for completion of longer courses. The expected cure rate is ˜90%. Uncomplicated infections should be treated for at least 4 days; more complicated infections may require prolonged therapy. Although clinical cure is paramount, microbiologic response must also be taken into account. In the final assessment, outcome will be classified as cure, failure, or indeterminate.
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U2 - 10.1093/clind/15.Supplement_1.S43
DO - 10.1093/clind/15.Supplement_1.S43
M3 - Article
C2 - 1477250
AN - SCOPUS:0026452646
SN - 1058-4838
VL - 15
SP - S43-S52
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
ER -