| Primary | Number of Participants With Clinical Response at the Test of Cure (TOC) Visit | 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. | ME set:clinically evaluable(CE)subset with atleast 1 etiologic pathogen isolated from a clinically relevant specimen in initial culture susceptible in both study agents. CE set:participants diagnosed with intraperitoneal infection confirmed by operative findings with adequate therapy and information to determine clinical outcome at specified visit. | Posted | | Number | | participants | | Test of cure visit: 2 weeks post-therapy (Day 28) | | | | ID | Title | Description |
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| OG000 | NXL104/Ceftazidime + Metronidazole | Participants received intravenous dose of 500 milligram (mg) of NXL104, 2000 mg of ceftazidime and 500 mg of metronidazole every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy. | | OG001 | Meropenem | Participants received intravenous dose of 1000 mg of meropenem every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy. |
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| Secondary | Number of Participants With Clinical Response at the End of Intravenous (IV) Therapy | 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. | ME population: A subset of CE population with at least 1 etiologic pathogen isolated from a clinically relevant specimen in initial culture susceptible in both study agents. | Posted | | Number | | participants | | End of IV therapy: From Day 5 to Day 14 | | | | ID | Title | Description |
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| OG000 | NXL104/Ceftazidime + Metronidazole | Participants received intravenous dose of 500 milligram (mg) of NXL104, 2000 mg of ceftazidime and 500 mg of metronidazole every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy. | | OG001 | Meropenem | Participants received intravenous dose of 1000 mg of meropenem every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy. |
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| Secondary | Number of Participants With Clinical Response at the Late Follow-up Visit | 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. | ME population: A subset of CE population with at least 1 etiologic pathogen isolated from a clinically relevant specimen in initial culture susceptible in both study agents. | Posted | | Number | | participants | | Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks) | | | | ID | Title | Description |
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| OG000 | NXL104/Ceftazidime + Metronidazole | Participants received intravenous dose of 500 milligram (mg) of NXL104, 2000 mg of ceftazidime and 500 mg of metronidazole every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy. | | OG001 | Meropenem | Participants received intravenous dose of 1000 mg of meropenem every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy. |
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| Secondary | Number of Participants With Microbiological Response at the Test of Cure Visit | 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. | ME population: A subset of CE population with at least 1 etiologic pathogen isolated from a clinically relevant specimen in initial culture susceptible in both study agents. | Posted | | Number | | participants | | Test of cure visit: 2 weeks post-therapy (Day 28) | | | | ID | Title | Description |
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| OG000 | NXL104/Ceftazidime + Metronidazole | Participants received intravenous dose of 500 milligram (mg) of NXL104, 2000 mg of ceftazidime and 500 mg of metronidazole every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy. | | OG001 | Meropenem | Participants received intravenous dose of 1000 mg of meropenem every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy. |
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| Secondary | Number of Participants With Microbiological Response at the End of IV Therapy | 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. | ME population: A subset of CE population with at least 1 etiologic pathogen isolated from a clinically relevant specimen in initial culture susceptible in both study agents. | Posted | | Number | | participants | | End of IV therapy: From Day 5 to Day 14 | | | | ID | Title | Description |
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| OG000 | NXL104/Ceftazidime + Metronidazole | Participants received intravenous dose of 500 milligram (mg) of NXL104, 2000 mg of ceftazidime and 500 mg of metronidazole every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy. | | OG001 | Meropenem | Participants received intravenous dose of 1000 mg of meropenem every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy. |
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| Secondary | Number of Participants With Microbiological Response at the Late Follow-up Visit | 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) | ME population: A subset of CE population with at least 1 etiologic pathogen isolated from a clinically relevant specimen in initial culture susceptible in both study agents. | Posted | | Number | | participants | | Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks) | | | | ID | Title | Description |
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| OG000 | NXL104/Ceftazidime + Metronidazole | Participants received intravenous dose of 500 milligram (mg) of NXL104, 2000 mg of ceftazidime and 500 mg of metronidazole every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy. | | OG001 | Meropenem | Participants received intravenous dose of 1000 mg of meropenem every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy. |
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| Secondary | Number of Participants With Clinical Response in Clinically Evaluable (CE) Participants at the Test of Cure Visit | 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. | CE population included all randomized participants diagnosed with intraperitoneal infection confirmed by operative findings, received adequate therapy and had information to determine clinical outcome at specified visit. | Posted | | Number | | participants | | Test of cure visit: 2 weeks post-therapy (Day 28) | | | | ID | Title | Description |
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| OG000 | NXL104/Ceftazidime + Metronidazole | Participants received intravenous dose of 500 milligram (mg) of NXL104, 2000 mg of ceftazidime and 500 mg of metronidazole every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy. | | OG001 | Meropenem | Participants received intravenous dose of 1000 mg of meropenem every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy. |
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| Secondary | Number of Participants With Clinical Response in CE Participants at the End of IV Therapy | 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. | CE population included all randomized participants diagnosed with intraperitoneal infection confirmed by operative findings, received adequate therapy and had information to determine clinical outcome at specified visit. | Posted | | Number | | participants | | End of IV therapy: From Day 5 to Day 14 | | | | ID | Title | Description |
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| OG000 | NXL104/Ceftazidime + Metronidazole | Participants received intravenous dose of 500 milligram (mg) of NXL104, 2000 mg of ceftazidime and 500 mg of metronidazole every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy. | | OG001 | Meropenem | Participants received intravenous dose of 1000 mg of meropenem every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy. |
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| Secondary | Number of Participants With Clinical Response in CE Participants at the Late Follow-up Visit | 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. | CE population included all randomized participants diagnosed with intraperitoneal infection confirmed by operative findings, received adequate therapy and had information to determine clinical outcome at specified visit. | Posted | | Number | | participants | | Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks) | | | | ID | Title | Description |
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| OG000 | NXL104/Ceftazidime + Metronidazole | Participants received intravenous dose of 500 milligram (mg) of NXL104, 2000 mg of ceftazidime and 500 mg of metronidazole every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy. | | OG001 | Meropenem | Participants received intravenous dose of 1000 mg of meropenem every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy. |
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| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Safety population included all participants who received at least one dose of study treatment. | Posted | | Number | | participants | | Baseline up to 6 weeks after last dose of study treatment (up to a maximum of 8 weeks) | | | | ID | Title | Description |
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| OG000 | NXL104/Ceftazidime + Metronidazole | Participants received intravenous dose of 500 milligram (mg) of NXL104, 2000 mg of ceftazidime and 500 mg of metronidazole every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy. | | OG001 | Meropenem | Participants received intravenous dose of 1000 mg of meropenem every 8 hour, for up to a maximum duration of 14 days. Participants were followed up to a maximum of 6 weeks post therapy. |
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