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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Complicated Intra-abdominal Infection

Intervention: Ceftazidime-avibactam (Drug); metronidazole (Drug); Meropenem (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Paul A Newell, MBBS, MRCP, Study Director, Affiliation: AstraZeneca

Summary

The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus Metronidazole compared to Meropenem for treating hospitalized patients with complicated intra-abdominal infections.

Clinical Details

Official title: A Phase III, Randomized, Multicenter, Double Blind, Double-Dummy, Parallel-Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-Abdominal Infections In Hospitalized Adults

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The proportion of patients with clinical cure in the clinically evaluable analysis set

Secondary outcome:

The proportion of patients with clinical cure in the microbiologically evaluable, extended microbiologically evaluable and microbiological modified intent-to-treat analysis sets

The proportion of patients with clinical cure in the clinically evaluable analysis set

The proportion of patients with a favorable per-patient microbiological response in the microbiological modified intent to treat, microbiologically evaluable and extended microbiologically evaluable analysis sets

The proportion of favorable per-pathogen microbiological response in the microbiological modified intent to treat, microbiologically evaluable and extended microbiologically evaluable analysis sets

The favorable per-pathogen microbiologic response by minimum inhibitory concentration categories in the microbiological modified intent to treat, microbiologically evaluable and extended microbiologically evaluable analysis sets

Favorable clinical response and favorable per-patient microbiological response for patients infected with ceftazidime-resistant pathogens in the microbiological modified intent to treat and (extended) microbiologically evaluable analysis sets

The proportion of patients with a favorable per-pathogen microbiological response for patients infected with ceftazidime-resistant pathogens in the microbiological modified intent to treat and (extended) microbiologically evaluable analysis sets

The time to first defervescence in the clinically evaluable, microbiologically evaluable and extended microbiologically evaluable analysis sets for patients who have fever at study entry

Safety and tolerability by incidence and severity of adverse events and serious adverse events, exposure, mortality, reasons for discontinuations of study therapy, vital signs, laboratory tests, electrocardiogram parameters and physical exams

Detailed description: A Phase III, Randomized, Multicenter, Double Blind, Double-Dummy, Parallel-Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-Abdominal Infections In Hospitalized Adults

Eligibility

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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:

- 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

Locations and Contacts

Research Site, Baotou, China

Research Site, Beijing, China

Research Site, Changsha, China

Research Site, Chengdu, China

Research Site, Chongqing, China

Research Site, Fuzhou, China

Research Site, Guangzhou, China

Research Site, Guilin, China

Research Site, Haikou, China

Research Site, Hebei, China

Research Site, Jiangyin, China

Research Site, Liaocheng, China

Research Site, Nan Chang, China

Research Site, Shanghai, China

Research Site, Tianjin, China

Research Site, Urumqi, China

Research Site, Wenzhou, China

Research Site, Wuxi, China

Research Site, Xi'an, China

Research Site, Ansan-si, Korea, Republic of

Research Site, Anyang-si, Korea, Republic of

Research Site, Busan, Korea, Republic of

Research Site, Cheongju-si, Korea, Republic of

Research Site, Daejeon, Korea, Republic of

Research Site, Gwangju, Korea, Republic of

Research Site, Jinju-si, Korea, Republic of

Research Site, Seoul, Korea, Republic of

Research Site, Wonju-si, Korea, Republic of

Research Site, Hanoi, Vietnam

Research Site, Hochiminh, Vietnam

Additional Information

Starting date: January 2013
Last updated: April 15, 2015

Page last updated: August 23, 2015

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