Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cIAI (NCT00488306) | Clinical Trial Compass
CompletedPhase 4
Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cIAI
Taiwan50 participantsStarted 2006-08
Plain-language summary
In light of tigecycline's activity against these resistant bacteria, tigecycline may represent a viable new therapy for complicated intra-abdominal infections.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Hospitalized male or female patients greater than or equal to 18 years of age.
* Patients must be a candidate for or have had a laparotomy, or laparoscopy of an intra-abdominal abscess.
* Patients with a complicated intra-abdominal infection such as:
* an intra-abdominal abscess;
* an intra-abdominal abscess (including liver and spleen) that develops in a post-operative patient after receiving \> 48 hours and less than or equal to 5 days of a non-study antibiotic. An intra-abdominal culture must be obtained from the infected site.
* appendicitis complicated by perforation (grossly visible) and abscess and/or periappendiceal abscess;
* perforated diverticulitis complicated by abscess formation or fecal contamination;
* complicated cholecystitis with evidence of perforation or empyema;
* perforation of the large or small intestine with abscess, or fecal contamination;
* purulent peritonitis or peritonitis associated with fecal contamination;
* gastric or duodenal ulcer perforation with symptoms lasting at least 24 hours prior to operation;
* traumatic bowel perforation with symptoms lasting at least 12 hours prior to operation.
Exclusion Criteria:
* Patients with any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up visits could be completed.
* Active or treated leukemia or systemic malignancy that required…
What they're measuring
1
The primary efficacy endpoint will be clinical response within the clinically evaluable population at the test-of-cure assessment.
Trial details
NCT IDNCT00488306
SponsorWyeth is now a wholly owned subsidiary of Pfizer