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Compare Ceftazidime-Avibactam + Metronidazole vs Meropenem for Hospitalized Adults With Complicated Intra-Abd Infections

Last updated on March 14, 2019

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Study Location
Research Site
Baotou, , China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Complicated Intra-abdominal Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-90 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patient must be 18 to 90 years of age, inclusive,

- Female patients can participate if they are surgically sterilized or postmenopausal
for at least 1 year or her sexual partner has had a vasectomy

- Female of childbearing potential has had normal menstrual periods for 3 months and
negative serum pregnancy test and agree to practice highly effective methods of birth
control during treatment and for at least 7 days after last dose

- Intraoperative/postoperative enrollment with visual confirmation (presence of pus
within the abdominal cavity) of an intra-abdominal infection associated with
peritonitis

- Confirmation of infection by surgical intervention within 24 hours of entry: evidence
of systemic inflammatory indicators; physical findings consistent with intra-abdominal
infection; supportive radiologic imaging findings of intra-abdominal infections

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Patient is diagnosed with traumatic bowel perforation undergoing surgery within 12
hours; perforation of gastroduodenal ulcers undergoing surgery within 24 hours. Other
intra-abdominal processes in which primary etiology is not likely to be infectious

- Patient has abdominal wall abscess or bowel obstruction without perforation or
ischemic bowel without perforation

- Patients whose surgery will include staged abdominal repair, or "open abdomen"
technique, or marsupialization

- Patient has suspected intra-abdominal infections due to fungus, parasites, virus or
tuberculosis

- Patient is considered unlikely to survive the 6- to 8-week study period or has a
rapidly progressive or terminal illness, including septic shock that is associated
with a high risk of mortality

NCT01726023
Pfizer
Completed
Compare Ceftazidime-Avibactam + Metronidazole vs Meropenem for Hospitalized Adults With Complicated Intra-Abd Infections

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