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Compare Ceftazidime-Avibactam + Metronidazole vs Meropenem for Hospitalized Adults With Complicated Intra-Abd Infections (RECLAIM3)

This study is currently recruiting participants.
Verified March 2013 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01726023
First received: November 5, 2012
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Complicated Intra-abdominal Infection
 Drug: Ceftazidime-avibactam
Drug: metronidazole
Drug: Meropenem
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The proportion of patients with clinical cure in the clinically evaluable analysis set [ Time Frame: at the test of cure visit (Day 28 to35) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of patients with clinical cure in the microbiologically evaluable, extended microbiologically evaluable and microbiological modified intent-to-treat analysis sets [ Time Frame: at the end of treatment (within 24 hours of last IV dose), test of cure (Day 28 to 35) and late follow up visits (Day 42 to 49) ] [ Designated as safety issue: No ]
  • The proportion of patients with clinical cure in the clinically evaluable analysis set [ Time Frame: at the end of treatment (within 24 hours of last IV dose) and late follow up visits (Day 42 to 49) ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: at the end of treatment (within 24 hours of last IV dose), test of cure (Day 28 to 35) and late follow up visits (Day 42 to 49) ] [ Designated as safety issue: No ]
  • The proportion of favorable per-pathogen microbiological response in the microbiological modified intent to treat, microbiologically evaluable and extended microbiologically evaluable analysis sets [ Time Frame: at the end of treatment (within 24 hours of last IV dose), test of cure (Day 28 to 35) and late follow up visits (Day 42 to 49) ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: at the end of treatment (within 24 hours of last IV dose), test of cure (Day 28 to 35) and late follow up visits (Day 42 to 49) ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: at the test of cure visit (Day 28 to 35) ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: at the test of cure visit (Day 28 to 35) ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: while on study therapy (from Day 1 to Day 14) ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: study duration (from screening to Day 49 LFU visit) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 404
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ceftazidime-Avibactam plus metronidazole Drug: Ceftazidime-avibactam
Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg
Drug: metronidazole
Metronidazole 500mg/100ml solution for infusion
Active Comparator: Meropenem Drug: Meropenem
Meropenem powder for solution for infusion 1000mg

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726023

Contacts
Contact: AstraZeneca Clinical Study Information 800-236-9933 information.center@astrazeneca.com

Locations
Korea, Republic of
Research Site Recruiting
Ansansi, Korea, Republic of
Research Site Recruiting
Anyangsi, Korea, Republic of
Research Site Recruiting
Incheon, Korea, Republic of
Research Site Recruiting
Seoul, Korea, Republic of
Research Site Recruiting
Suwonsi, Korea, Republic of
Research Site Recruiting
Wonjusi, Korea, Republic of
Vietnam
Research Site Not yet recruiting
Hanoi, Vietnam
Research Site Not yet recruiting
Ho Chi Minh, Vietnam
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Paul A Newell, MBBS, MRCP AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01726023     History of Changes
Other Study ID Numbers: D4280C00018, 2011-003893-97
Study First Received: November 5, 2012
Last Updated: March 18, 2013
Health Authority: China: Food and Drug Administration
Korea: Food and Drug Administration
Vietnam: Ministry of Health

Keywords provided by AstraZeneca:
Ceftazidime-avibactam,
Metronidazole,
Meropenem,
Anti-Bacterial Agents,
 Anti-Infective Agents,
Therapeutic Uses,
Pharmacologic Actions,
Physiological Effects of Drugs

Additional relevant MeSH terms:
Meropenem
Anti-Infective Agents
Ceftazidime
Metronidazole
Physiological Effects of Drugs
Therapeutic Uses
 Pharmacologic Actions
Anti-Bacterial Agents
Radiation-Sensitizing Agents
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 22, 2013