title: Evaluation of new anti-infective drugs for the treatment of chronic carriage of Salmonella. Infectious Diseases Society of America and the Food and Drug Administration.
abstract: The chronic carriage of salmonellae is defined as the shedding of a Salmonella species for > or = 1 year, as documented by an initial positive culture of a stool sample obtained at least 1 month after resolution of the acute illness and repeated positive cultures for at least 1 year. Clinical trials of investigational anti-infective drugs for the treatment of the salmonella carrier state may be conducted with a placebo control or an active concurrent control. A crossover design also may be employed for establishing efficacy. Patients should generally receive therapy for at least 6 weeks. Outcome will be assessed only by microbiological criteria. Determination of the interval required for the suppression of salmonellae and follow-up for 6 months after completion of therapy are recommended.
authors: Division of Anti-Infectives, Robert Wood Johnson Pharmaceutical Institute, Raritan, New Jersey.
authors: M L
authors: ML
authors: Corrado
authors: H L
authors: HL
authors: DuPont
authors: M
authors: M
authors: Cooperstock
authors: R
authors: R
authors: Fekety
authors: D M
authors: DM
authors: Murray
mesh_terms: D000890:Anti-Infective Agents / Q000627:therapeutic use*; D002353:Carrier State / Q000188:drug therapy*; D002908:Chronic Disease; D002985:Clinical Protocols / Q000592:standards; D002986:Clinical Trials as Topic / Q000592:standards*; D017321:Clinical Trials, Phase I as Topic / Q000592:standards; D017322:Clinical Trials, Phase II as Topic / Q000592:standards; D017326:Clinical Trials, Phase III as Topic / Q000592:standards; D006801:Humans; D012107:Research Design; D012480:Salmonella Infections / Q000188:drug therapy*
chemical_list: D000890:Anti-Infective Agents