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

Phase 2

Completed

Conditions: Complicated Intra-abdominal Infections

Interventions: Drug: ceftazidime/NXL104 + metronidazole
Drug: meropenem

Registration Number: NCT00752219

Lead Sponsor: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 204

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NXL104/CAZ/MTZ	ceftazidime/NXL104 + metronidazole	NXL104/ceftazidime + metronidazole
Meropenem	meropenem	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clinical Response at the Test of Cure (TOC) Visit	Test of cure visit: 2 weeks post-therapy (Day 28)	Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were microbiologically evaluable (ME) at baseline.
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)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 weeks after last dose of study treatment that were absent before treatment or that worsened relative to pretreatment state.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Clinical Response at the End of Intravenous (IV) Therapy	End of IV therapy: From Day 5 to Day 14	Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were ME at baseline.
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)	Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were ME at baseline.
Number of Participants With Microbiological Response at the Test of Cure Visit	Test of cure visit: 2 weeks post-therapy (Day 28)	Microbiological response was defined as eradication of pathogen identified (absence of causative pathogens from appropriately obtained specimens at site of infection) or presumptive eradication of pathogens (absence of material to culture in a participant who had responded clinically to treatment). This clinical response was measured in participants who were ME at baseline.
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	Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required.
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)	Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required.
Number of Participants With Microbiological Response at the End of IV Therapy	End of IV therapy: From Day 5 to Day 14	Microbiological response was defined as eradication of pathogen identified (absence of causative pathogens from appropriately obtained specimens at site of infection) or presumptive eradication of pathogens (absence of material to culture in a participant who had responded clinically to treatment). This clinical response was measured in participants who were ME at baseline.
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)	Favorable: eradication (absence of causative pathogens from appropriately obtained specimens at site of infection) or presumptive eradication (absence of material to culture in a patient who had responded clinically to treatment)
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)	Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required.

Trial Locations

Locations (45): Cedars-Sinai Medical Center Dept of Surgery
🇺🇸
Los Angeles, California, United States
Henry Ford Health System
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Detroit, Michigan, United States
University of Southern California
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Los Angeles, California, United States
Mercury Street Medical Group
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Butte, Montana, United States
Michael S. Somero Research Division
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Palm Springs, California, United States
CCB Ministry of Interior Clinical of Surgery
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Sofia, Bulgaria
UMHAT Queen Joanna-ISUL, Clinical of Surgery
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Sofia, Bulgaria
South Jersey Infectious Disease
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Somers Point, New Jersey, United States
Summa Health Systems
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Akron, Ohio, United States
University Emergency Hospital Bucharest
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Bucharest, Romania
FGU National Medical Surgery
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Moscow, Russian Federation
Amrita Institute of Medical Sciences, Cochin
🇮🇳
Cochin, India
Lucknow Cancer Institute Lucknow
🇮🇳
Lucknow, India
Remington-Daviss Inc
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Columbus, Ohio, United States
ID Clinical Research Ltd
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Toledo, Ohio, United States
UMHAT Sveti Georgi 3rd Clinical of Surgery
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Plovdiv, Bulgaria
MHAT Rousse, 2nd Clinical of Surgery
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Rousse, Bulgaria
CHU Nimes
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Nimes, France
Hospital Saint Joseph Marseille
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Marseille, France
Hospital L'Archet II
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Nice, France
Multiprofile Hospital for Active Trt Emergency Med
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Sofia, Bulgaria
Medisurge Hospital Ahmedabad
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Ahmedabad, India
Labib Medical Center
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Saida, Lebanon
Victoria Hospital Bangalore
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Bangalore, India
SR Kalla General and Gastro Hospital
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Jaipur, India
Suyash Hospital Indore
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Indore, India
Slaski Uniwersytet Medyczny
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Katowice, Poland
Al-Zahraa university Hospital
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Beirut, Lebanon
Hammound Hospital University Medical Center
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Saida, Lebanon
Makassed General Hospital
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Beirut, Lebanon
Rafik Heriri University Hospital
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Beirut, Lebanon
Samodzielny Publiczny
🇵🇱
Warszawa, Poland
Pomorskie Centrum Traumatologii
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Nowe Ogrody, Poland
Katedra i Klinika Chirurgii Ogolnej
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Warszawa, Poland
Akademicki Szpital Kliniczn
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Wroclaw, Poland
Coltea Clinical Hospital
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Bucharest, Romania
Floreasca Clinical Emergency Hospital
🇷🇴
Bucharest, Romania
Fundeni Clinical Institute
🇷🇴
Bucharest, Romania
City Clinical Hospital # 13
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Moscow, Russian Federation
Moscow City Clinical Hospital # 31
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Moscow, Russian Federation
City Clinical Hospital # 1
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Moscow, Russian Federation
SMO of Clinical Trials
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Smolensk, Russian Federation
North-Ossetian Medical Academy
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Vladikavkas, Russian Federation
Medisys Clinisearch India Pvt Ltd
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Bangalore, India
MS Ramaiah Memorial Hospital Bangalore
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Bangalore, India