Trial Outcomes & Findings for Efficacy of Betalactam Antibiotics in Prolonged Infusion Compared to Intermittent in Pediatric Patients With Sepsis (NCT NCT03019965)
NCT ID: NCT03019965
Last Updated: 2021-08-05
Results Overview
Resolution. Disappearance of all signs and symptoms related to the infection. Failure. Insufficient lessening of the signs and symptoms of infection to qualify as improvement, including death or indeterminate (no evaluation possible, for any reason).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
426 participants
Primary outcome timeframe
Number of participants with clinical response at 14 days after antibiotic cessation, up to an average of 28 days or the day of your discharge if this occurred before 14 days after antibiotic cessation.
Results posted on
2021-08-05
Participant Flow
the pre-specified intent was to only compare "Intermittent" and "Prolonged" Arm/Groups with the grouping of betalactam antibiotics (imipenem, meropenem and piperacillin/tazobactam)
Participant milestones
| Measure |
Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem
Piperacillin/tazobactam 300mg/kg/day, divided into 4 doses/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 30 minutes infusion every 6 hours.
Intermittent Piperacillin/tazobactam: Piperacillin/tazobactam administered in 30 minutes infusion.
Imipenem 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes infusion every 6 hours.
Intermittent Imipenem: Imipenem administered in 60 minutes infusion. Meropenem 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes every 8 hours.
Intermittent Meropenem: Meropenem administered in 60 minutes infusion.
|
Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem
Piperacillin/tazobactam initial doses 75mg/kg in 30 minutes infusion, immediately thereafter continue 300mg/kg/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 24 hours infusion every 24 hours, as determined by antibiotic stability at room temperature.
Continuous Piperacillin/tazobactam: Piperacillin/tazobactam administered in 24 hours infusion.
Imipenem initial doses 20mg/kg in 60 minutes infusion, immediately thereafter continue 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 6 hours infusion every 6 hours, as determined by antibiotic stability at room temperature.
Extended Imipenem: Imipenem administered in 6 hours infusion.
Meropenem initial doses 35mg/kg in 60 minutes infusion, immediately thereafter continue 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution at a concentration of 7mg/ml, to be administered in 8 hours infusion every 8 hours, as determined by antibiotic stability at room temperature.
Extended Meropenem: Meropenem administered in 8 hours infusion.
|
|---|---|---|
|
Overall Study
STARTED
|
211
|
215
|
|
Overall Study
COMPLETED
|
201
|
202
|
|
Overall Study
NOT COMPLETED
|
10
|
13
|
Reasons for withdrawal
| Measure |
Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem
Piperacillin/tazobactam 300mg/kg/day, divided into 4 doses/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 30 minutes infusion every 6 hours.
Intermittent Piperacillin/tazobactam: Piperacillin/tazobactam administered in 30 minutes infusion.
Imipenem 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes infusion every 6 hours.
Intermittent Imipenem: Imipenem administered in 60 minutes infusion. Meropenem 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes every 8 hours.
Intermittent Meropenem: Meropenem administered in 60 minutes infusion.
|
Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem
Piperacillin/tazobactam initial doses 75mg/kg in 30 minutes infusion, immediately thereafter continue 300mg/kg/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 24 hours infusion every 24 hours, as determined by antibiotic stability at room temperature.
Continuous Piperacillin/tazobactam: Piperacillin/tazobactam administered in 24 hours infusion.
Imipenem initial doses 20mg/kg in 60 minutes infusion, immediately thereafter continue 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 6 hours infusion every 6 hours, as determined by antibiotic stability at room temperature.
Extended Imipenem: Imipenem administered in 6 hours infusion.
Meropenem initial doses 35mg/kg in 60 minutes infusion, immediately thereafter continue 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution at a concentration of 7mg/ml, to be administered in 8 hours infusion every 8 hours, as determined by antibiotic stability at room temperature.
Extended Meropenem: Meropenem administered in 8 hours infusion.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
3
|
|
Overall Study
viral or fungal infection
|
3
|
4
|
|
Overall Study
acute liver failure in the first 24 hours of randomization
|
4
|
5
|
|
Overall Study
Physician Decision
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem
n=201 Participants
Piperacillin/tazobactam 300mg/kg/day, divided into 4 doses/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 30 minutes infusion every 6 hours.
Intermittent Piperacillin/tazobactam: Piperacillin/tazobactam administered in 30 minutes infusion.
Imipenem 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes infusion every 6 hours.
Intermittent Imipenem: Imipenem administered in 60 minutes infusion.
Meropenem 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes every 8 hours.
Intermittent Meropenem: Meropenem administered in 60 minutes infusion.
|
Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem
n=202 Participants
Piperacillin/tazobactam initial doses 75mg/kg in 30 minutes infusion, immediately thereafter continue 300mg/kg/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 24 hours infusion every 24 hours, as determined by antibiotic stability at room temperature.
Continuous Piperacillin/tazobactam: Piperacillin/tazobactam administered in 24 hours infusion.
Imipenem initial doses 20mg/kg in 60 minutes infusion, immediately thereafter continue 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 6 hours infusion every 6 hours, as determined by antibiotic stability at room temperature.
Extended Imipenem: Imipenem administered in 6 hours infusion.
Meropenem initial doses 35mg/kg in 60 minutes infusion, immediately thereafter continue 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution at a concentration of 7mg/ml, to be administered in 8 hours infusion every 8 hours, as determined by antibiotic stability at room temperature.
Extended Meropenem: Meropenem administered in 8 hours infusion.
|
Total
n=403 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
201 Participants
n=201 Participants
|
202 Participants
n=202 Participants
|
403 Participants
n=403 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=201 Participants
|
0 Participants
n=202 Participants
|
0 Participants
n=403 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=201 Participants
|
0 Participants
n=202 Participants
|
0 Participants
n=403 Participants
|
|
Age, Continuous
|
6 years
n=201 Participants
|
6 years
n=202 Participants
|
6 years
n=403 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=201 Participants
|
91 Participants
n=202 Participants
|
182 Participants
n=403 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=201 Participants
|
111 Participants
n=202 Participants
|
221 Participants
n=403 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Mexico
|
201 participants
n=201 Participants
|
202 participants
n=202 Participants
|
403 participants
n=403 Participants
|
|
Comorbidity
|
196 Participants
n=201 Participants
|
187 Participants
n=202 Participants
|
383 Participants
n=403 Participants
|
|
Comorbid conditions
Neoplastic
|
125 Participants
n=196 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
133 Participants
n=187 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
258 Participants
n=383 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
|
Comorbid conditions
Gastrointestinal
|
20 Participants
n=196 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
15 Participants
n=187 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
35 Participants
n=383 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
|
Comorbid conditions
Neurological
|
8 Participants
n=196 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
11 Participants
n=187 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
19 Participants
n=383 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
|
Comorbid conditions
Neonatal
|
2 Participants
n=196 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
3 Participants
n=187 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
5 Participants
n=383 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
|
Comorbid conditions
Cardiovascular
|
15 Participants
n=196 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
8 Participants
n=187 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
23 Participants
n=383 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
|
Comorbid conditions
Respiratory
|
2 Participants
n=196 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
2 Participants
n=187 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
4 Participants
n=383 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
|
Comorbid conditions
Hematologic/immunologic
|
11 Participants
n=196 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
4 Participants
n=187 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
15 Participants
n=383 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
|
Comorbid conditions
Metabolic
|
1 Participants
n=196 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
1 Participants
n=187 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
2 Participants
n=383 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
|
Comorbid conditions
Renal
|
1 Participants
n=196 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
0 Participants
n=187 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
1 Participants
n=383 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
|
Comorbid conditions
Genetic
|
11 Participants
n=196 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
9 Participants
n=187 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
20 Participants
n=383 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
|
Comorbid conditions
Stem cell transplant
|
0 Participants
n=196 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
1 Participants
n=187 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
1 Participants
n=383 Participants • Comorbidity only was in 196 patients in intermittent infusion group and 187 patients in prolonged infusion group.
|
|
Hospital stay prior to enrollment to the study protocol
|
113 Participants
n=201 Participants
|
122 Participants
n=202 Participants
|
235 Participants
n=403 Participants
|
|
septic shock at enrollment
|
49 Participants
n=201 Participants
|
61 Participants
n=202 Participants
|
110 Participants
n=403 Participants
|
|
B-lactam antibiotic
piperacillin/tazobactam
|
109 Participants
n=201 Participants
|
108 Participants
n=202 Participants
|
217 Participants
n=403 Participants
|
|
B-lactam antibiotic
imipenem
|
39 Participants
n=201 Participants
|
42 Participants
n=202 Participants
|
81 Participants
n=403 Participants
|
|
B-lactam antibiotic
meropenem
|
53 Participants
n=201 Participants
|
52 Participants
n=202 Participants
|
105 Participants
n=403 Participants
|
|
type of infection
febrile neutropenia
|
69 Participants
n=201 Participants
|
55 Participants
n=202 Participants
|
124 Participants
n=403 Participants
|
|
type of infection
intraabdominal
|
40 Participants
n=201 Participants
|
55 Participants
n=202 Participants
|
95 Participants
n=403 Participants
|
|
type of infection
respiratory tract
|
34 Participants
n=201 Participants
|
27 Participants
n=202 Participants
|
61 Participants
n=403 Participants
|
|
type of infection
bacteremia
|
30 Participants
n=201 Participants
|
35 Participants
n=202 Participants
|
65 Participants
n=403 Participants
|
|
type of infection
skin and soft tissue
|
11 Participants
n=201 Participants
|
10 Participants
n=202 Participants
|
21 Participants
n=403 Participants
|
|
type of infection
unknown
|
11 Participants
n=201 Participants
|
14 Participants
n=202 Participants
|
25 Participants
n=403 Participants
|
|
type of infection
urinary tract
|
6 Participants
n=201 Participants
|
6 Participants
n=202 Participants
|
12 Participants
n=403 Participants
|
|
Number of participants with organisms identified
|
75 Participants
n=201 Participants
|
86 Participants
n=202 Participants
|
161 Participants
n=403 Participants
|
PRIMARY outcome
Timeframe: Number of participants with clinical response at 14 days after antibiotic cessation, up to an average of 28 days or the day of your discharge if this occurred before 14 days after antibiotic cessation.Population: The efficacy of the maneuver was evaluated by frequency of clinical response and calculation of the absolute risk reduction and the number needed to treat.
Resolution. Disappearance of all signs and symptoms related to the infection. Failure. Insufficient lessening of the signs and symptoms of infection to qualify as improvement, including death or indeterminate (no evaluation possible, for any reason).
Outcome measures
| Measure |
Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem
n=201 Participants
Piperacillin/tazobactam 300mg/kg/day, divided into 4 doses/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 30 minutes infusion every 6 hours.
Intermittent Piperacillin/tazobactam: Piperacillin/tazobactam administered in 30 minutes infusion.
Imipenem 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes infusion every 6 hours.
Intermittent Imipenem: Imipenem administered in 60 minutes infusion.
Meropenem 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes every 8 hours.
Intermittent Meropenem: Meropenem administered in 60 minutes infusion.
|
Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem
n=202 Participants
Piperacillin/tazobactam initial doses 75mg/kg in 30 minutes infusion, immediately thereafter continue 300mg/kg/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 24 hours infusion every 24 hours, as determined by antibiotic stability at room temperature.
Continuous Piperacillin/tazobactam: Piperacillin/tazobactam administered in 24 hours infusion.
Imipenem initial doses 20mg/kg in 60 minutes infusion, immediately thereafter continue 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 6 hours infusion every 6 hours, as determined by antibiotic stability at room temperature.
Extended Imipenem: Imipenem administered in 6 hours infusion.
Meropenem initial doses 35mg/kg in 60 minutes infusion, immediately thereafter continue 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution at a concentration of 7mg/ml, to be administered in 8 hours infusion every 8 hours, as determined by antibiotic stability at room temperature.
Extended Meropenem: Meropenem administered in 8 hours infusion.
|
|---|---|---|
|
Number of Participants With Clinical Response
|
178 Participants
|
169 Participants
|
SECONDARY outcome
Timeframe: Number of participants with adverse events evaluated by an physician at the time of administration of antibiotics, up to an average to 24 hours after the study drug cessation.Population: evaluation of the safety of the intervention with analysis of the frequency of adverse events by treatment group
Any harmful, undesirable, potentially serious and life threatening effects occurring during or after administration of the antibiotics proposed in this study (piperacillin / tazobactam, imipenem or meropenem), was evaluated as: none or adverse event classified according to the intensity of the clinical manifestation (severity) as: mild, moderate or severe and for each antibiotic.
Outcome measures
| Measure |
Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem
n=201 Participants
Piperacillin/tazobactam 300mg/kg/day, divided into 4 doses/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 30 minutes infusion every 6 hours.
Intermittent Piperacillin/tazobactam: Piperacillin/tazobactam administered in 30 minutes infusion.
Imipenem 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes infusion every 6 hours.
Intermittent Imipenem: Imipenem administered in 60 minutes infusion.
Meropenem 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes every 8 hours.
Intermittent Meropenem: Meropenem administered in 60 minutes infusion.
|
Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem
n=202 Participants
Piperacillin/tazobactam initial doses 75mg/kg in 30 minutes infusion, immediately thereafter continue 300mg/kg/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 24 hours infusion every 24 hours, as determined by antibiotic stability at room temperature.
Continuous Piperacillin/tazobactam: Piperacillin/tazobactam administered in 24 hours infusion.
Imipenem initial doses 20mg/kg in 60 minutes infusion, immediately thereafter continue 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 6 hours infusion every 6 hours, as determined by antibiotic stability at room temperature.
Extended Imipenem: Imipenem administered in 6 hours infusion.
Meropenem initial doses 35mg/kg in 60 minutes infusion, immediately thereafter continue 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution at a concentration of 7mg/ml, to be administered in 8 hours infusion every 8 hours, as determined by antibiotic stability at room temperature.
Extended Meropenem: Meropenem administered in 8 hours infusion.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
1 Participants
|
3 Participants
|
Adverse Events
Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem
Serious events: 0 serious events
Other events: 1 other events
Deaths: 17 deaths
Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem
Serious events: 0 serious events
Other events: 3 other events
Deaths: 19 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem
n=201 participants at risk
Piperacillin/tazobactam 300mg/kg/day, divided into 4 doses/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 30 minutes infusion every 6 hours.
Intermittent Piperacillin/tazobactam: Piperacillin/tazobactam administered in 30 minutes infusion.
Imipenem 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes infusion every 6 hours.
Intermittent Imipenem: Imipenem administered in 60 minutes infusion.
Meropenem 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes every 8 hours.
Intermittent Meropenem: Meropenem administered in 60 minutes infusion.
|
Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem
n=202 participants at risk
Piperacillin/tazobactam initial doses 75mg/kg in 30 minutes infusion, immediately thereafter continue 300mg/kg/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 24 hours infusion every 24 hours, as determined by antibiotic stability at room temperature.
Continuous Piperacillin/tazobactam: Piperacillin/tazobactam administered in 24 hours infusion.
Imipenem initial doses 20mg/kg in 60 minutes infusion, immediately thereafter continue 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 6 hours infusion every 6 hours, as determined by antibiotic stability at room temperature.
Extended Imipenem: Imipenem administered in 6 hours infusion.
Meropenem initial doses 35mg/kg in 60 minutes infusion, immediately thereafter continue 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution at a concentration of 7mg/ml, to be administered in 8 hours infusion every 8 hours, as determined by antibiotic stability at room temperature.
Extended Meropenem: Meropenem administered in 8 hours infusion.
|
|---|---|---|
|
Gastrointestinal disorders
moderate adverse event
|
0.50%
1/201 • Number of events 1 • adverse events by the mode of administration: intermittent or prolonged, evaluated during the time of administration, up to an average 24 hours after administration of the antibiotics proposed.
pre-specified intent was to only compare "Intermittent" and "Prolonged" Arm/Groups with the grouping of antibiotics betalactam (imipenem, meropenem and piperacillin/tazobactam)
|
1.5%
3/202 • Number of events 3 • adverse events by the mode of administration: intermittent or prolonged, evaluated during the time of administration, up to an average 24 hours after administration of the antibiotics proposed.
pre-specified intent was to only compare "Intermittent" and "Prolonged" Arm/Groups with the grouping of antibiotics betalactam (imipenem, meropenem and piperacillin/tazobactam)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place