A prospective, multicenter, double, randomizedcomparative estimation study to evaluate the safety, tolerability, and efficacy of L-749,345 versus Ceftriaxone sodium plus metronidazole in the treatment of serious complicated intra-abdominal infections of mild to moderate severity in adults

MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 1997年12月22日最近更新: 2023年9月4日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 0 至 0（—）

入选标准

•-Patient has a clinically suspected and/or bacteriologically documented infections diagnosis appropriate for study, according to the following diagnostic criteria:
•1) intra-Abdominal Infection based on history, physical findings, and laboratory evaluation (either oral temperature >38°C or rectal temperature >38.6°C; WBC>10.5x10^3/mm3; abdominal tenderness and pain supportive of a diagnosis of intra-abdominal infection, and/or CT scan, MRI or radionuclide changes consistent with intra-abdominal infection)
•2) Infection extends or is presumed to extend beyond the wall of a hollow organ (e.g., peritonitis, gangrene, abscess, cholecystitis with inflammation outside the gallbladder). Patients diagnosed with appendicitis are eligible for inclusion only if symptoms developed outside the hospital and there is a history of symptoms for >24 hours but <72 hours, oral temperature >101.5°F or 38.6°C, and WBC>13,500/mm^, and either: a) physical exam evidence of peritoneal irritation extending beyond the local site of infection; or b) radiologic evidence of an abscess.
•3) Infection is caused or presumed to be caused by microorganisms susceptible to the intravenous study antibiotics (L-749,345 or ceftriaxone sodium and metronidazole). Patients diagnosed with infections of a hollow organ will only be considered fully evaluable if etiologic microorganisms susceptible to the intravenous study antibiotics (L-749,345 or ceftriaxone sodium and metronidazole) are isolated from an intraperitoneal source, or from the external surface of the hollow viscus (prior to incision of a hollow viscus).
•-Patient is an adult (male or female) between the ages of 18 and 75 years.
•-Absolute neutrophil count >3,000 cells/mm3.
•-Females of childbearing potential must have a negative serum pregnancy test (b-HCG) prior to enrollment into the study and subsequently until 1-month after discontinuation of study treatment use adequate birth control measures as defined by the investigator. Oral contraceptives should not be used as the sole method of birth control, because the effect of L-749,345 on the efficacy of oral contraceptives has not yet been established.
•-Patient´s infection is characterized by the investigator as serious (requiring hospitalization), complicated (requiring surgical intervention with 24 hours after diagnosis), and mild to moderate in severity (not life-threatening). Surgical intervention can be open surgery, percutaneous drainage of an abscess, or laparoscopic surgery where cultures are positive from the peritoneal surface.
•-Patient´s infection is caused or thought to be caused by microorganisms susceptible in vitro to the intravenous study antibiotic(s), in the opinion of the investigator. Patients will only be considered microbiologically evaluable if an etiologic pathogen(s) susceptible to the study antibiotic is (are) isolated from a clinically relevant specimen in the initial/pre-study culture. Patients with a polymicrobial infection where one or more pathogens are resistant in vitro to the study antibiotic may be included at the discretion of the investigator if a pathogen that is susceptible in vitro to the intravenous study antibiotic(s) has also been isolated.
•-Patient´s infection has not been treated with more than 24 hours of systemic antibiotic therapy known to be effective against the presumed etiologic pathogen(s) within the 72-hour period immediately prior to consideration for entry into the study.

排除标准

•-Failure to meet all inclusion criteria.
•-Infection diagnosis of simple cholecystitis, traumatic bowel perforation requiring surgery within 12 hours, perforation of gastroduodenal ulcers requiring surgery within 24 hours, or other intra-abdominal processes in which the primary etiology is not likely to be infectious.
•-Ischemic bowel disease.
•-History of serious allergy, hypersensitivity (e.g., anaphylaxis), or any serious reaction to carbapenem antibiotics (such as imipenem), ceftriaxone sodium, any cephalosporins or penicillins, or metronidazole and metronidazole derivatives. Patients with a history of mild rash to penicillin may be enrolled.
•-History of allergy, hypersensitivity, intolerance, or any other adverse reaction to an injectable multivitamin or any of its components.
•-Rapidly progressive or terminal illness; patients in whom a response to antibiotic therapy is considered unlikely or patients who are considered unlikely to survive the study period.
•-Pregnant women, nursing women, or fertile women not practicing adequate methods of contraception; women planning to become pregnant within 1 month of the study.
•-Treatment with a systemic antibiotic within the 72-hour period immediately prior to consideration for entry into the study, unless either:
•1) Treatment during the 72-hour period consisted of <24 hours of antibiotic dosing, and would not be expected to eradicate the infection, or
•2) The patient is considered to have failed the course of antibiotic therapy within the 72-hour period immediately prior to consideration for entry into the study. Such a patient may be eligible for admission into this study if: a) there is clinical evidence of a failure to improve after a course of therapy deemed adequate by the investigator or a progression of the infectious process requiring a change in the intravenous antibiotic regimen; b) appropriate specimens from the site of infection are taken for culture and susceptibility testing (1) after the last dose of the antibiotic on which the patient failed, and (2) either (a) prior to the first dose of intravenous study antibiotic, or (b) prior to the third day of intravenous study antibiotic if no material is available for culture until a surgical procedure is performed. As an example, if a patient is found at surgery or by percutaneous drainage to have an abscess from which organisms are recovered, prior antibiotic therapy does not invalidate the patient.
•-The need for concomitant systemic antimicrobials in addition to those designated in the two study groups.
•-Concomitant infection that would interfere with evaluation of response to the study antibiotic.
•-Presence of renal or hepatic disease defined by:
•1) Serum creatinine greater than 1.25x the upper limit of the range of normal values used by the laboratory performing the test for patients up to 65 years of age and greater than 1.0x the upper limit of the range of normal values used by the laboratory performing the test for patients 66 to 75 years of age.
•2) Liver function tests (SGOT, SGPT)>3x the upper limit of the range of normal values used by the laboratory performing the test. Exceptions will be considered for patients with infections of the biliary system in whom these abnormalities are considered due to the acute infectious process.
•-Hematocrit <30%.
•-Coagulation >1.5x upper limit of normal.
•-History of any illness that, in the opinion of the inv

研究者

发起方

MERCK SHARP & DOHME PERU S.R.L.,

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