A Prospective, Multicenter, Double-blind, Randomized, Comparative Study to Estimate the Safety, Tolerability and Efficacy of NXL104/Ceftazidime Plus Metronidazole vs. Meropenem in the Treatment of Complicated Intra-abdominal Infections in Hospitalized Adults

Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal Infections

Sponsors

Lead sponsor: Pfizer

Source Pfizer
Brief Summary

The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the treatment of complicated intra-abdominal infections as compared to a comparator group.

Overall Status Completed
Start Date March 31, 2009
Completion Date December 31, 2009
Primary Completion Date November 30, 2009
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of Participants With Clinical Response at the Test of Cure (TOC) Visit Test of cure visit: 2 weeks post-therapy (Day 28)
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Baseline up to 6 weeks after last dose of study treatment (up to a maximum of 8 weeks)
Secondary Outcome
Measure Time Frame
Number of Participants With Clinical Response at the End of Intravenous (IV) Therapy End of IV therapy: From Day 5 to Day 14
Number of Participants With Clinical Response at the Late Follow-up Visit Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
Number of Participants With Microbiological Response at the Test of Cure Visit Test of cure visit: 2 weeks post-therapy (Day 28)
Number of Participants With Microbiological Response at the End of IV Therapy End of IV therapy: From Day 5 to Day 14
Number of Participants With Microbiological Response at the Late Follow-up Visit Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
Number of Participants With Clinical Response in Clinically Evaluable (CE) Participants at the Test of Cure Visit Test of cure visit: 2 weeks post-therapy (Day 28)
Number of Participants With Clinical Response in CE Participants at the End of IV Therapy End of IV therapy: From Day 5 to Day 14
Number of Participants With Clinical Response in CE Participants at the Late Follow-up Visit Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
Enrollment 204
Condition
Intervention

Intervention type: Drug

Intervention name: ceftazidime/NXL104 + metronidazole

Description: IV TID

Arm group label: NXL104/CAZ/MTZ

Intervention type: Drug

Intervention name: meropenem

Description: IV TID

Arm group label: Meropenem

Other name: merrem

Eligibility

Criteria:

Inclusion Criteria:

- complicated intra-abdominal infections

Exclusion Criteria:

- infections limited to hollow viscus

- ischemic bowel disease without perforation

- acute suppurative cholangitis

- acute necrotizing pancreatitis

- pts to undergo stated abdominal repair, open abdomen technique or marsupialization

- Apache II >25

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Pfizer CT.gov Call Center Study Director Pfizer
Location
facility
University of Southern California | Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center Dept of Surgery | Los Angeles, California, United States
Michael S. Somero Research Division | Palm Springs, California, United States
Henry Ford Health System | Detroit, Michigan, United States
Mercury Street Medical Group | Butte, Montana, United States
South Jersey Infectious Disease | Somers Point, New Jersey, United States
Summa Health Systems | Akron, Ohio, United States
Remington-Daviss Inc | Columbus, Ohio, United States
ID Clinical Research Ltd | Toledo, Ohio, United States
UMHAT Sveti Georgi 3rd Clinical of Surgery | Plovdiv, Bulgaria
MHAT Rousse, 2nd Clinical of Surgery | Rousse, Bulgaria
CCB Ministry of Interior Clinical of Surgery | Sofia, Bulgaria
Multiprofile Hospital for Active Trt Emergency Med | Sofia, Bulgaria
UMHAT Queen Joanna-ISUL, Clinical of Surgery | Sofia, Bulgaria
Hospital Saint Joseph Marseille | Marseille, France
Hospital L'Archet II | Nice, France
CHU Nimes | Nimes, France
Medisurge Hospital Ahmedabad | Ahmedabad, India
Medisys Clinisearch India Pvt Ltd | Bangalore, India
MS Ramaiah Memorial Hospital Bangalore | Bangalore, India
Victoria Hospital Bangalore | Bangalore, India
Amrita Institute of Medical Sciences, Cochin | Cochin, India
Suyash Hospital Indore | Indore, India
SR Kalla General and Gastro Hospital | Jaipur, India
Lucknow Cancer Institute Lucknow | Lucknow, India
Al-Zahraa university Hospital | Beirut, Lebanon
Makassed General Hospital | Beirut, Lebanon
Rafik Heriri University Hospital | Beirut, Lebanon
Hammound Hospital University Medical Center | Saida, Lebanon
Labib Medical Center | Saida, Lebanon
Slaski Uniwersytet Medyczny | Katowice, Poland
Pomorskie Centrum Traumatologii | Nowe Ogrody, Poland
Katedra i Klinika Chirurgii Ogolnej | Warszawa, Poland
Samodzielny Publiczny | Warszawa, Poland
Akademicki Szpital Kliniczn | Wroclaw, Poland
Coltea Clinical Hospital | Bucharest, Romania
Floreasca Clinical Emergency Hospital | Bucharest, Romania
Fundeni Clinical Institute | Bucharest, Romania
University Emergency Hospital Bucharest | Bucharest, Romania
City Clinical Hospital # 13 | Moscow, Russian Federation
City Clinical Hospital # 1 | Moscow, Russian Federation
FGU National Medical Surgery | Moscow, Russian Federation
Moscow City Clinical Hospital # 31 | Moscow, Russian Federation
SMO of Clinical Trials | Smolensk, Russian Federation
North-Ossetian Medical Academy | Vladikavkas, Russian Federation
Location Countries

Bulgaria

France

India

Lebanon

Poland

Romania

Russian Federation

United States

Verification Date

June 2018

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: NXL104/CAZ/MTZ

Arm group type: Experimental

Description: NXL104/ceftazidime + metronidazole

Arm group label: Meropenem

Arm group type: Active Comparator

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov