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

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ClinicalTrials.gov Identifier: NCT00752219
Recruitment Status : Completed
First Posted : September 15, 2008
Results First Posted : July 3, 2018
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Complicated Intra-abdominal Infections Drug: ceftazidime/NXL104 + metronidazole Drug: meropenem Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 31, 2009
Actual Primary Completion Date : November 30, 2009
Actual Study Completion Date : December 31, 2009


Arm Intervention/treatment
Experimental: NXL104/CAZ/MTZ
NXL104/ceftazidime + metronidazole
Drug: ceftazidime/NXL104 + metronidazole
IV TID

Active Comparator: Meropenem Drug: meropenem
IV TID
Other Name: merrem




Primary Outcome Measures :
  1. Number of Participants With Clinical Response at the Test of Cure (TOC) Visit [ Time Frame: 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.

  2. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 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 :
  1. Number of Participants With Clinical Response at the End of Intravenous (IV) Therapy [ Time Frame: 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.

  2. Number of Participants With Clinical Response at the Late Follow-up Visit [ Time Frame: 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.

  3. Number of Participants With Microbiological Response at the Test of Cure Visit [ Time Frame: 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.

  4. Number of Participants With Microbiological Response at the End of IV Therapy [ Time Frame: 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.

  5. Number of Participants With Microbiological Response at the Late Follow-up Visit [ Time Frame: 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)

  6. Number of Participants With Clinical Response in Clinically Evaluable (CE) Participants at the Test of Cure Visit [ Time Frame: 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.

  7. Number of Participants With Clinical Response in CE Participants at the End of IV Therapy [ Time Frame: 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.

  8. Number of Participants With Clinical Response in CE Participants at the Late Follow-up Visit [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00752219


  Show 45 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00752219     History of Changes
Other Study ID Numbers: NXL-104/2002
C3591014 ( Other Identifier: Alias Study Number )
First Posted: September 15, 2008    Key Record Dates
Results First Posted: July 3, 2018
Last Update Posted: July 3, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Ceftazidime
Avibactam
Infection
Communicable Diseases
Intraabdominal Infections
Metronidazole
Meropenem
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action