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Compare Ceftazidime-Avibactam + Metronidazole Versus Meropenem for Hospitalized Adults With Complicated Intra-Abdominal Infections

Last updated on February 20, 2019

FOR MORE INFORMATION
Study Location
Research Site
Chula Vista, California, United States
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.
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- 18 to 90 years of age inclusive

- Female patient is authorized to participate if at least one of the following criteria
are met:

1. Surgical sterilization

2. Age ≥50 years and postmenopausal as defined by amenorrhea for 12 months or more
following cessation of all exogenous hormonal treatments

3. Age the postmenopausal range PLUS amenorrhea for 12 months or more following
cessation of all exogenous hormonal treatments

4. Patient has a negative serum pregnancy test (serum ß-human chorionic gonadotropin
[ß-hCG]) within 1 day prior to study entry, and agrees to use highly effective
contraception methods during treatment and for at least 7 days after last dose of
IV study therapy

- Intraoperative/postoperative enrollment with 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 response; 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.
Show details

- 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

- 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

NCT01499290
Pfizer
Completed
Compare Ceftazidime-Avibactam + Metronidazole Versus Meropenem for Hospitalized Adults With Complicated Intra-Abdominal Infections

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now