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Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cIAI

Last updated on March 14, 2019

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Study Location
Multiple Cities, , Taiwan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Abdominal Abscess
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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 treatment with
chemotherapy, immunotherapy, radiation therapy or antineoplastic therapy within the
past 3 months, or any metastatic malignancy to the abdomen with life expectancy less
than 6 months.

- Anticipated length of antibiotic therapy less than 5 days.

NCT00488306
Pfizer
Completed
Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cIAI

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