Trial Outcomes & Findings for Ertapenem Sodium (MK-0826) Versus Piperacillin/Tazobactam Sodium for the Treatment of Diabetic Foot Infections in Chinese Adults (MK-0826-061) (NCT NCT01370616)
NCT ID: NCT01370616
Last Updated: 2018-08-27
Results Overview
The investigator assessed participants for a favorable clinical response, defined as clinical improvement or cure. Clinical improvement means that most pretherapy signs and symptoms of the index infection, in particular fever, lympangitis, and purulent drainage had resolved, and no further IV antibiotic therapy was required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required.
COMPLETED
PHASE3
565 participants
Day 5 up to Day 28
2018-08-27
Participant Flow
Participant milestones
| Measure |
Ertapenem Sodium
Participants received 1.0 g intravenous (IV) ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
|
Piperacillin/Tazobactam Sodium
Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
|
|---|---|---|
|
Overall Study
STARTED
|
282
|
283
|
|
Overall Study
Treated
|
275
|
275
|
|
Overall Study
COMPLETED
|
220
|
216
|
|
Overall Study
NOT COMPLETED
|
62
|
67
|
Reasons for withdrawal
| Measure |
Ertapenem Sodium
Participants received 1.0 g intravenous (IV) ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
|
Piperacillin/Tazobactam Sodium
Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
|
|---|---|---|
|
Overall Study
Adverse Event
|
11
|
16
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
6
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
|
Overall Study
Physician Decision
|
6
|
6
|
|
Overall Study
Progressive Disease
|
0
|
1
|
|
Overall Study
Recovery
|
1
|
0
|
|
Overall Study
Technical Problems
|
3
|
5
|
|
Overall Study
Withdrawal by Subject
|
34
|
34
|
Baseline Characteristics
Ertapenem Sodium (MK-0826) Versus Piperacillin/Tazobactam Sodium for the Treatment of Diabetic Foot Infections in Chinese Adults (MK-0826-061)
Baseline characteristics by cohort
| Measure |
Ertapenem Sodium
n=282 Participants
Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
|
Piperacillin/Tazobactam Sodium
n=283 Participants
Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
|
Total
n=565 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.4 Years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
60.4 Years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
60.9 Years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
181 Participants
n=5 Participants
|
183 Participants
n=7 Participants
|
364 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 5 up to Day 28Population: Participants with confirmed clinical diagnosis, adequate IV study therapy, protocol-specified visit at DCIV, and no protocol-specific exclusions. A modified last-observation-carried-forward (LOCF), where only failure was carried forward, was used to impute missing data.
The investigator assessed participants for a favorable clinical response, defined as clinical improvement or cure. Clinical improvement means that most pretherapy signs and symptoms of the index infection, in particular fever, lympangitis, and purulent drainage had resolved, and no further IV antibiotic therapy was required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required.
Outcome measures
| Measure |
Ertapenem Sodium
n=219 Participants
Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
|
Piperacillin/Tazobactam Sodium
n=224 Participants
Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
|
|---|---|---|
|
Percentage of Participants With Favorable Clinical Response Assessments at Discontinuation of Intravenous (IV) Study Therapy (DCIV)
|
93.6 Percentage of participants
Interval 89.5 to 96.5
|
97.3 Percentage of participants
Interval 94.3 to 99.0
|
SECONDARY outcome
Timeframe: Day 5Population: Participants with a confirmed clinical diagnosis, adequate length of IV study therapy, protocol-specified visit at Day 5, and no documented protocol-specific exclusions. A modified LOCF, where only failure was carried forward, was used to impute missing data.
The investigator assessed participants for a favorable clinical response, defined as clinical improvement or cure. Clinical improvement means that most pretherapy signs and symptoms of the index infection, in particular fever, lympangitis, and purulent drainage had resolved, and no further IV antibiotic therapy was required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required.
Outcome measures
| Measure |
Ertapenem Sodium
n=210 Participants
Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
|
Piperacillin/Tazobactam Sodium
n=221 Participants
Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
|
|---|---|---|
|
Percentage of Participants With Favorable Clinical Response Assessments at Day 5 of IV Study Therapy
|
96.2 Percentage of participants
Interval 92.6 to 98.3
|
97.7 Percentage of participants
Interval 94.8 to 99.3
|
SECONDARY outcome
Timeframe: Day 15 up to Day 38Population: Participants with a confirmed clinical diagnosis, adequate length of IV study therapy, protocol-specified visit at FUA, and no documented protocol-specific exclusions. A modified LOCF, where only failure was carried forward, was used to impute missing data.
The investigator assessed participants for a favorable clinical response, defined as clinical improvement or cure. Clinical improvement means that most pretherapy signs and symptoms of the index infection, in particular fever, lympangitis, and purulent drainage had resolved, and no further IV antibiotic therapy was required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required.
Outcome measures
| Measure |
Ertapenem Sodium
n=193 Participants
Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
|
Piperacillin/Tazobactam Sodium
n=195 Participants
Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
|
|---|---|---|
|
Percentage of Participants With Favorable Clinical Response Assessments at Follow-up Assessment (FUA) Day 10 of Post-antibiotic Study Therapy
|
92.2 Percentage of participants
Interval 87.5 to 95.6
|
94.4 Percentage of participants
Interval 90.1 to 97.2
|
SECONDARY outcome
Timeframe: Day 15 up to Day 38Population: Participants with proper clinical diagnosis, adequate study therapy, adequate clinical assessment, appropriate antimicrobial therapy, and proper microbiological assessment. A modified LOCF, where only failure was carried forward, was used to impute missing data.
The investigator assessed participants for a favorable microbiological response, defined as eradication or presumptive eradication. Eradication means that the original pathogen was absent from the last available culture of an adequate specimen obtained from the original site of infection. Presumptive eradication means that the participant showed cure or improvement and no appropriate material is available to follow-up culture from the original site of infection, or collection of such a specimen would cause undue discomfort.
Outcome measures
| Measure |
Ertapenem Sodium
n=140 Participants
Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
|
Piperacillin/Tazobactam Sodium
n=149 Participants
Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
|
|---|---|---|
|
Percentage of Participants With Favorable Microbiological Response Assessments at FUA Day 10 of Post-antibiotic Study Therapy
|
86.4 Percentage of participants
Interval 79.6 to 91.6
|
89.9 Percentage of participants
Interval 83.9 to 94.3
|
SECONDARY outcome
Timeframe: Day 15 up to Day 38Population: Participants with proper clinical diagnosis, adequate study therapy and clinical assessment, appropriate antimicrobial therapy, and microbiological assessment. One participant from the Ertapenem arm with indeterminate clinical response, was excluded from the analysis. A modified LOCF (failure was carried forward), was used to impute missing data.
The investigator assessed participants for both a favorable clinical response (clinical improvement or cure) and a favorable microbiological response (eradication or presumptive eradication). Clinical improvement means that most pretherapy signs and symptoms of the index infection, had resolved, and no further IV antibiotic therapy is required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required. Eradication means that the original pathogen was absent from the last available culture obtained from the original site of infection. Presumptive eradication means that the participant showed cure or improvement and no appropriate material is available to follow-up culture from the original site of infection, or collection of such a specimen would cause undue discomfort.
Outcome measures
| Measure |
Ertapenem Sodium
n=139 Participants
Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
|
Piperacillin/Tazobactam Sodium
n=149 Participants
Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
|
|---|---|---|
|
Percentage of Participants With Both Favorable Clinical and Microbiological Response Assessments at FUA Day 10 of Post-antibiotic Study Therapy
|
86.3 Percentage of participants
Interval 79.5 to 91.6
|
89.9 Percentage of participants
Interval 83.9 to 94.3
|
SECONDARY outcome
Timeframe: Up to day 42Population: Participants who received at least one dose of IV study therapy
An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body that is temporally associated with the use of the investigational product, whether or not considered related to the use of the medicinal product. This also includes any change in frequency and/or intensity of a preexisting condition which is temporally associated with the use of the medicinal product.
Outcome measures
| Measure |
Ertapenem Sodium
n=275 Participants
Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
|
Piperacillin/Tazobactam Sodium
n=275 Participants
Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
|
|---|---|---|
|
Percentage of Participants With One or More Adverse Events (AEs)
|
64.0 Percentage of participants
|
56.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to day 42Population: Participants who received at least one dose of IV study therapy
A drug-related AE is any AE caused by the test drug as determined by an investigator who is a qualified physician. Drug-relatedness of the AE was assessed by evidence that the participant was actually exposed to the test drug, whether the AE followed a reasonable temporal sequence from administration of the test drug, and whether or not the AE was more reasonably explained by another source.
Outcome measures
| Measure |
Ertapenem Sodium
n=275 Participants
Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
|
Piperacillin/Tazobactam Sodium
n=275 Participants
Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
|
|---|---|---|
|
Percentage of Participants With Drug-related AEs
|
13.5 Percentage of participants
|
16.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to day 42Population: Participants who received at least one dose of IV study therapy
A SAE is an AE occurring at any dose that resulted in any of the following: death, was life threatening, a persistent or significant disability/incapacity, prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect in an offspring, was a cancer, an overdose, or other important medical events requiring medical or surgical intervention.
Outcome measures
| Measure |
Ertapenem Sodium
n=275 Participants
Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
|
Piperacillin/Tazobactam Sodium
n=275 Participants
Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
|
|---|---|---|
|
Percentage of Participants With Serious AEs (SAEs)
|
6.2 Percentage of participants
|
4.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to day 28Population: Participants who received at least one dose of IV study therapy
Participants chose to discontinue treatment or were discontinued from the study by the investigator due to any untoward effects, or for safety reasons such as an AE. The investigator determined whether or not the AE caused the test drug to be discontinued.
Outcome measures
| Measure |
Ertapenem Sodium
n=275 Participants
Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
|
Piperacillin/Tazobactam Sodium
n=275 Participants
Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
|
|---|---|---|
|
Percentage of Participants Who Discontinued Treatment Due to an AE
|
4.0 Percentage of participants
|
5.8 Percentage of participants
|
Adverse Events
Ertapenem Sodium
Piperacillin/Tazobactam Sodium
Serious adverse events
| Measure |
Ertapenem Sodium
n=275 participants at risk
Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
|
Piperacillin/Tazobactam Sodium
n=275 participants at risk
Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
|
|---|---|---|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/275 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
0.36%
1/275 • Number of events 1 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Cardiac disorders
Cardiac failure
|
0.36%
1/275 • Number of events 1 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
0.36%
1/275 • Number of events 1 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/275 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
0.36%
1/275 • Number of events 1 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Eye disorders
Choroidal detachment
|
0.36%
1/275 • Number of events 1 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
0.00%
0/275 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/275 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
0.36%
1/275 • Number of events 1 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
General disorders
Multi-organ failure
|
0.00%
0/275 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
0.36%
1/275 • Number of events 1 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
General disorders
Sudden cardiac death
|
0.36%
1/275 • Number of events 1 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
0.00%
0/275 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.36%
1/275 • Number of events 1 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
0.00%
0/275 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Infections and infestations
Gangrene
|
1.5%
4/275 • Number of events 4 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
0.00%
0/275 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/275 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
0.36%
1/275 • Number of events 1 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Infections and infestations
Pneumonia
|
0.00%
0/275 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
0.36%
1/275 • Number of events 1 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Infections and infestations
Sepsis
|
0.00%
0/275 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
0.36%
1/275 • Number of events 1 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/275 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
0.36%
1/275 • Number of events 1 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.36%
1/275 • Number of events 1 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
0.00%
0/275 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Investigations
White blood cell count decreased
|
0.00%
0/275 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
0.73%
2/275 • Number of events 2 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.36%
1/275 • Number of events 1 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
0.00%
0/275 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.36%
1/275 • Number of events 1 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
0.00%
0/275 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.36%
1/275 • Number of events 1 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
0.00%
0/275 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Nervous system disorders
Cerebral infarction
|
0.73%
2/275 • Number of events 2 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
0.00%
0/275 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/275 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
0.36%
1/275 • Number of events 1 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Nervous system disorders
Cerebrovascular accident
|
0.36%
1/275 • Number of events 1 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
0.00%
0/275 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Nervous system disorders
Syncope
|
0.36%
1/275 • Number of events 1 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
0.00%
0/275 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/275 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
0.36%
1/275 • Number of events 1 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/275 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
0.36%
1/275 • Number of events 1 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.36%
1/275 • Number of events 1 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
0.00%
0/275 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Vascular disorders
Shock
|
0.36%
1/275 • Number of events 1 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
0.00%
0/275 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
Other adverse events
| Measure |
Ertapenem Sodium
n=275 participants at risk
Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
|
Piperacillin/Tazobactam Sodium
n=275 participants at risk
Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
5.8%
16/275 • Number of events 17 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
5.1%
14/275 • Number of events 17 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Gastrointestinal disorders
Diarrhoea
|
5.8%
16/275 • Number of events 17 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
4.0%
11/275 • Number of events 11 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
General disorders
Pyrexia
|
7.6%
21/275 • Number of events 27 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
7.6%
21/275 • Number of events 29 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Infections and infestations
Upper respiratory tract infection
|
1.8%
5/275 • Number of events 5 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
5.8%
16/275 • Number of events 16 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Investigations
Alanine aminotransferase increased
|
12.7%
35/275 • Number of events 36 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
6.9%
19/275 • Number of events 19 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Investigations
Aspartate aminotransferase increased
|
11.6%
32/275 • Number of events 32 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
6.9%
19/275 • Number of events 19 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.8%
16/275 • Number of events 19 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
5.8%
16/275 • Number of events 20 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.6%
10/275 • Number of events 13 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
5.8%
16/275 • Number of events 18 • Through 14-Day follow-up (up to Day 42)
Participants who received at least one dose of IV study therapy
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER