Trial Outcomes & Findings for Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal Infections (NCT NCT00752219)
NCT ID: NCT00752219
Last Updated: 2018-07-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
204 participants
Primary outcome timeframe
Test of cure visit: 2 weeks post-therapy (Day 28)
Results posted on
2018-07-03
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
102
|
|
Overall Study
Treated
|
101
|
102
|
|
Overall Study
COMPLETED
|
91
|
96
|
|
Overall Study
NOT COMPLETED
|
11
|
6
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Clinical failure
|
0
|
1
|
|
Overall Study
Adverse Event
|
5
|
3
|
|
Overall Study
Protocol deviation
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Randomized but not treated
|
1
|
0
|
|
Overall Study
Other
|
3
|
0
|
Baseline Characteristics
Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal Infections
Baseline characteristics by cohort
| Measure |
NXL104/Ceftazidime + Metronidazole
n=101 Participants
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.
|
Meropenem
n=102 Participants
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.
|
Total
n=203 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.0 years
STANDARD_DEVIATION 15.93 • n=5 Participants
|
42.6 years
STANDARD_DEVIATION 18.09 • n=7 Participants
|
42.8 years
STANDARD_DEVIATION 17.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Test of cure visit: 2 weeks post-therapy (Day 28)Population: 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.
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.
Outcome measures
| Measure |
NXL104/Ceftazidime + Metronidazole
n=68 Participants
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.
|
Meropenem
n=76 Participants
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.
|
|---|---|---|
|
Number of Participants With Clinical Response at the Test of Cure (TOC) Visit
|
62 participants
|
71 participants
|
PRIMARY outcome
Timeframe: Baseline up to 6 weeks after last dose of study treatment (up to a maximum of 8 weeks)Population: Safety population included all participants who received at least one dose of study treatment.
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.
Outcome measures
| Measure |
NXL104/Ceftazidime + Metronidazole
n=101 Participants
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.
|
Meropenem
n=102 Participants
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.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
65 participants
|
59 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
9 participants
|
11 participants
|
SECONDARY outcome
Timeframe: End of IV therapy: From Day 5 to Day 14Population: 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.
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.
Outcome measures
| Measure |
NXL104/Ceftazidime + Metronidazole
n=68 Participants
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.
|
Meropenem
n=76 Participants
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.
|
|---|---|---|
|
Number of Participants With Clinical Response at the End of Intravenous (IV) Therapy
|
66 participants
|
74 participants
|
SECONDARY outcome
Timeframe: Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)Population: 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.
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.
Outcome measures
| Measure |
NXL104/Ceftazidime + Metronidazole
n=68 Participants
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.
|
Meropenem
n=76 Participants
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.
|
|---|---|---|
|
Number of Participants With Clinical Response at the Late Follow-up Visit
|
62 participants
|
71 participants
|
SECONDARY outcome
Timeframe: Test of cure visit: 2 weeks post-therapy (Day 28)Population: 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.
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.
Outcome measures
| Measure |
NXL104/Ceftazidime + Metronidazole
n=68 Participants
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.
|
Meropenem
n=76 Participants
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.
|
|---|---|---|
|
Number of Participants With Microbiological Response at the Test of Cure Visit
|
62 participants
|
71 participants
|
SECONDARY outcome
Timeframe: End of IV therapy: From Day 5 to Day 14Population: 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.
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.
Outcome measures
| Measure |
NXL104/Ceftazidime + Metronidazole
n=68 Participants
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.
|
Meropenem
n=76 Participants
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.
|
|---|---|---|
|
Number of Participants With Microbiological Response at the End of IV Therapy
|
66 participants
|
74 participants
|
SECONDARY outcome
Timeframe: Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)Population: 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.
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)
Outcome measures
| Measure |
NXL104/Ceftazidime + Metronidazole
n=68 Participants
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.
|
Meropenem
n=76 Participants
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.
|
|---|---|---|
|
Number of Participants With Microbiological Response at the Late Follow-up Visit
|
62 participants
|
71 participants
|
SECONDARY outcome
Timeframe: Test of cure visit: 2 weeks post-therapy (Day 28)Population: 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.
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.
Outcome measures
| Measure |
NXL104/Ceftazidime + Metronidazole
n=87 Participants
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.
|
Meropenem
n=90 Participants
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.
|
|---|---|---|
|
Number of Participants With Clinical Response in Clinically Evaluable (CE) Participants at the Test of Cure Visit
|
80 participants
|
85 participants
|
SECONDARY outcome
Timeframe: End of IV therapy: From Day 5 to Day 14Population: 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.
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.
Outcome measures
| Measure |
NXL104/Ceftazidime + Metronidazole
n=87 Participants
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.
|
Meropenem
n=89 Participants
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.
|
|---|---|---|
|
Number of Participants With Clinical Response in CE Participants at the End of IV Therapy
|
84 participants
|
87 participants
|
SECONDARY outcome
Timeframe: Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)Population: 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.
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.
Outcome measures
| Measure |
NXL104/Ceftazidime + Metronidazole
n=86 Participants
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.
|
Meropenem
n=89 Participants
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.
|
|---|---|---|
|
Number of Participants With Clinical Response in CE Participants at the Late Follow-up Visit
|
79 participants
|
84 participants
|
Adverse Events
NXL104/Ceftazidime + Metronidazole
Serious events: 9 serious events
Other events: 41 other events
Deaths: 0 deaths
Meropenem
Serious events: 11 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NXL104/Ceftazidime + Metronidazole
n=101 participants at risk
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.
|
Meropenem
n=102 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.98%
1/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cardiac Arrest
|
0.99%
1/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.99%
1/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
2/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastric Perforation
|
0.99%
1/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Localised Intraabdominal Fluid Collection
|
0.99%
1/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.98%
1/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Volvulus
|
0.99%
1/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Multi-Organ Failure
|
0.99%
1/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.99%
1/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.98%
1/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Postoperative Abscess
|
0.99%
1/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.98%
1/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sepsis
|
0.99%
1/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Septic Shock
|
0.99%
1/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Wound Secretion
|
0.00%
0/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.98%
1/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Hepatic Enzyme Increased
|
0.99%
1/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Platelet Count Decreased
|
0.00%
0/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.98%
1/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.98%
1/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.98%
1/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Disorder
|
0.00%
0/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.98%
1/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.99%
1/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheo-Oesophageal Fistula
|
0.00%
0/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.98%
1/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
NXL104/Ceftazidime + Metronidazole
n=101 participants at risk
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.
|
Meropenem
n=102 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
13.9%
14/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.9%
5/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
9.9%
10/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.9%
6/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal Pain
|
7.9%
8/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.9%
3/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
8.9%
9/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.8%
11/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Aspartate Aminotransferase Increased
|
8.9%
9/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.7%
15/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Alanine Aminotransferase Increased
|
7.9%
8/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.7%
13/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Blood Alkaline Phosphatase Increased
|
8.9%
9/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.9%
7/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Platelet Count Increased
|
4.0%
4/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.9%
7/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
White Blood Cell Count Increased
|
5.0%
5/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.9%
6/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
4.0%
4/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.9%
6/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
6/101
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.9%
4/102
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER