Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal Infections
CompletedPhase 2Results postedLast updated 3 July 2018
What this trial tests
Phase 2 trial testing ceftazidime/NXL104 + metronidazole in Complicated Intra-abdominal Infections in 204 participants. Completed in 31 December 2009.
Adults 18 to 65, any sex, with Complicated Intra-abdominal Infections. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Clinical Response at the Test of Cure (TOC) VisitPrimary· 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.
Group
Value
95% CI
NXL104/Ceftazidime + Metronidazole
62
Meropenem
71
Number of Participants With Clinical Response at the End of Intravenous (IV) TherapySecondary· 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.
Group
Value
95% CI
NXL104/Ceftazidime + Metronidazole
66
Meropenem
74
Number of Participants With Clinical Response at the Late Follow-up VisitSecondary· 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.
Group
Value
95% CI
NXL104/Ceftazidime + Metronidazole
62
Meropenem
71
Number of Participants With Microbiological Response at the Test of Cure VisitSecondary· 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.
Group
Value
95% CI
NXL104/Ceftazidime + Metronidazole
62
Meropenem
71
Number of Participants With Microbiological Response at the End of IV TherapySecondary· 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.
Group
Value
95% CI
NXL104/Ceftazidime + Metronidazole
66
Meropenem
74
Number of Participants With Microbiological Response at the Late Follow-up VisitSecondary· 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)
Group
Value
95% CI
NXL104/Ceftazidime + Metronidazole
62
Meropenem
71
Number of Participants With Clinical Response in Clinically Evaluable (CE) Participants at the Test of Cure VisitSecondary· 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.
Group
Value
95% CI
NXL104/Ceftazidime + Metronidazole
80
Meropenem
85
Number of Participants With Clinical Response in CE Participants at the End of IV TherapySecondary· 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.
Group
Value
95% CI
NXL104/Ceftazidime + Metronidazole
84
Meropenem
87
Number of Participants With Clinical Response in CE Participants at the Late Follow-up VisitSecondary· 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.
Group
Value
95% CI
NXL104/Ceftazidime + Metronidazole
79
Meropenem
84
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)Primary· 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 p
AEs
Group
Value
95% CI
NXL104/Ceftazidime + Metronidazole
65
Meropenem
59
SAEs
Group
Value
95% CI
NXL104/Ceftazidime + Metronidazole
9
Meropenem
11
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 3 July 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00752219.