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 |
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Recruitment Status :
Completed
First Posted : September 15, 2008
Results First Posted : July 3, 2018
Last Update Posted : July 3, 2018
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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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 |
| 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 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: NXL104/CAZ/MTZ
NXL104/ceftazidime + metronidazole
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Drug: ceftazidime/NXL104 + metronidazole
IV TID |
| Active Comparator: Meropenem |
Drug: meropenem
IV TID
Other Name: merrem |
Primary Outcome Measures :
- 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.
- 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 :
- 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.
- 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.
- 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.
- 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.
- 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)
- 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.
- 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.
- 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
Locations
Show 45 study locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00752219 |
| 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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Infections Communicable Diseases Intraabdominal Infections Disease Attributes Pathologic Processes Metronidazole Meropenem Ceftazidime |
Avibactam Anti-Infective Agents Anti-Bacterial Agents Antiprotozoal Agents Antiparasitic Agents beta-Lactamase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |