Trial Outcomes & Findings for Antibiotic Safety (SCAMP) (NCT NCT01994993)
NCT ID: NCT01994993
Last Updated: 2019-05-30
Results Overview
Number of Participants who experienced Death
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
260 participants
Primary outcome timeframe
Within 30 days after last dose of study drug, up to 40 days
Results posted on
2019-05-30
Participant Flow
One participant was enrolled but did not receive any dose of study drug. The participant is excluded from study result data analysis
Participant milestones
| Measure |
Group 1
Ampicillin and gentamycin and metronidazole
ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 2
ampicillin and gentamicin and clindamycin
ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 3
piperacillin-tazobactam and gentamicin
gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 4
Per standard of care antibiotics, and Metronidazole
standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 5
metronidazole, clindamycin, or piperacillin-tazobactam
metronidazole, clindamycin, or piperacillin-tazobactam: IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
63
|
47
|
70
|
55
|
24
|
|
Overall Study
COMPLETED
|
28
|
12
|
23
|
9
|
22
|
|
Overall Study
NOT COMPLETED
|
35
|
35
|
47
|
46
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Antibiotic Safety (SCAMP)
Baseline characteristics by cohort
| Measure |
Group 1
n=62 Participants
Ampicillin and gentamycin and metronidazole
ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 2
n=46 Participants
ampicillin and gentamicin and clindamycin
ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 3
n=70 Participants
piperacillin-tazobactam and gentamicin
gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 4
n=55 Participants
Per standard of care antibiotics, and Metronidazole
standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 5
n=24 Participants
metronidazole, clindamycin, or piperacillin-tazobactam
metronidazole, clindamycin, or piperacillin-tazobactam: IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Total
n=257 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
27.3 Gestational Age (weeks)
STANDARD_DEVIATION 2.6 • n=5 Participants
|
27.8 Gestational Age (weeks)
STANDARD_DEVIATION 3.0 • n=7 Participants
|
27.5 Gestational Age (weeks)
STANDARD_DEVIATION 2.9 • n=5 Participants
|
36.4 Gestational Age (weeks)
STANDARD_DEVIATION 2.1 • n=4 Participants
|
28.9 Gestational Age (weeks)
STANDARD_DEVIATION 4.9 • n=21 Participants
|
29.5 Gestational Age (weeks)
STANDARD_DEVIATION 4.6 • n=8 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
114 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
143 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
47 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
190 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
67 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
144 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
|
Region of Enrollment
Canada
|
4 count of participants
n=5 Participants
|
0 count of participants
n=7 Participants
|
0 count of participants
n=5 Participants
|
0 count of participants
n=4 Participants
|
1 count of participants
n=21 Participants
|
5 count of participants
n=8 Participants
|
|
Region of Enrollment
United States
|
58 count of participants
n=5 Participants
|
46 count of participants
n=7 Participants
|
70 count of participants
n=5 Participants
|
55 count of participants
n=4 Participants
|
23 count of participants
n=21 Participants
|
252 count of participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Within 30 days after last dose of study drug, up to 40 daysPopulation: Full intent-to-treat population (patients who received at least 1 dose of any study drug)
Number of Participants who experienced Death
Outcome measures
| Measure |
Group 1
n=63 Participants
Ampicillin and gentamycin and metronidazole
ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 2
n=47 Participants
ampicillin and gentamicin and clindamycin
ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 3
n=70 Participants
piperacillin-tazobactam and gentamicin
gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 4
n=56 Participants
Per standard of care antibiotics, and Metronidazole
standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 5
n=24 Participants
metronidazole, clindamycin, or piperacillin-tazobactam
metronidazole, clindamycin, or piperacillin-tazobactam: IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
|---|---|---|---|---|---|
|
Death
|
5 Participants
|
5 Participants
|
7 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 days after last dose of study drugPopulation: Participants who received at least 1 dose of each study drug. Does not apply to Group 5.
Confirmed by 1).Alive, 2).Negative bacterial blood cultures, and 3). Clinical cure score \>4. Clinical cure score =1 for each of the following elements: FiO2 ≤ baseline FiO2; Urine output ≥1 mL/kg/h for 24-hour period prior to assessment; Absence of inotropic support at time of assessment; Absence of mechanical ventilation at time of assessment; No seizure in 24-hour period prior to assessment; pH ≥7.25 or not measured in 24 hours prior to assessment
Outcome measures
| Measure |
Group 1
n=62 Participants
Ampicillin and gentamycin and metronidazole
ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 2
n=46 Participants
ampicillin and gentamicin and clindamycin
ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 3
n=70 Participants
piperacillin-tazobactam and gentamicin
gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 4
n=55 Participants
Per standard of care antibiotics, and Metronidazole
standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 5
metronidazole, clindamycin, or piperacillin-tazobactam
metronidazole, clindamycin, or piperacillin-tazobactam: IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
|---|---|---|---|---|---|
|
Number of Participants With Therapeutic Success at Day 30
|
45 Participants
|
39 Participants
|
52 Participants
|
52 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 days after last dose of study drugPopulation: Participant who received at least 1 dose of each study drug
Feeding intolerance confirmed by documentation of any feedings held for \>24 consecutive hours in infants being fed
Outcome measures
| Measure |
Group 1
n=62 Participants
Ampicillin and gentamycin and metronidazole
ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 2
n=46 Participants
ampicillin and gentamicin and clindamycin
ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 3
n=70 Participants
piperacillin-tazobactam and gentamicin
gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 4
n=55 Participants
Per standard of care antibiotics, and Metronidazole
standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 5
metronidazole, clindamycin, or piperacillin-tazobactam
metronidazole, clindamycin, or piperacillin-tazobactam: IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
|---|---|---|---|---|---|
|
Number of Participants With Feeding Intolerance
|
24 Participants
|
19 Participants
|
21 Participants
|
18 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 days after last dose of study drugPopulation: Participant who received at least 1 dose of each study drug
Grade 3 IVH: Subependymal hemorrhage with extension into lateral ventricles with ventricular enlargement Grade 4 IVH: Intraparenchymal hemorrhage
Outcome measures
| Measure |
Group 1
n=62 Participants
Ampicillin and gentamycin and metronidazole
ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 2
n=46 Participants
ampicillin and gentamicin and clindamycin
ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 3
n=70 Participants
piperacillin-tazobactam and gentamicin
gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 4
n=55 Participants
Per standard of care antibiotics, and Metronidazole
standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 5
metronidazole, clindamycin, or piperacillin-tazobactam
metronidazole, clindamycin, or piperacillin-tazobactam: IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
|---|---|---|---|---|---|
|
Number of Participants With Grade 3 and/or Grade 4 Intraventricular Hemorrhage (IVH)
|
2 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 days after last dose of study drugPopulation: Participant who received at least 1 dose of each study drug
Short bowel syndrome: Operative reports documenting resection of bowel, estimated bowel length, and absence/presence of the ileocecal valve. Total parenteral nutrition for \>42 consecutive days after bowel resection, or a residual small bowel length of less than 25% expected for gestational age
Outcome measures
| Measure |
Group 1
n=62 Participants
Ampicillin and gentamycin and metronidazole
ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 2
n=46 Participants
ampicillin and gentamicin and clindamycin
ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 3
n=70 Participants
piperacillin-tazobactam and gentamicin
gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 4
n=55 Participants
Per standard of care antibiotics, and Metronidazole
standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 5
metronidazole, clindamycin, or piperacillin-tazobactam
metronidazole, clindamycin, or piperacillin-tazobactam: IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
|---|---|---|---|---|---|
|
Number of Participants With Short Bowel Syndrome
|
5 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 days after last dose of study drugPopulation: Participant who received at least 1 dose of each study drug
Intestinal perforation: Radiological reports leading to the diagnosis of intestinal perforation. These include plain chest x-rays, plain abdominal x-rays, ultra-sonograms of the abdomen, contrast studies, and computed tomography scans of the abdomen and pelvis. Operative reports documenting surgical procedures leading to the diagnosis and/or treatment of intestinal perforation. These include placement of a surgical drain, laparotomy, intestinal resection, and ostomy placement
Outcome measures
| Measure |
Group 1
n=62 Participants
Ampicillin and gentamycin and metronidazole
ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 2
n=46 Participants
ampicillin and gentamicin and clindamycin
ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 3
n=70 Participants
piperacillin-tazobactam and gentamicin
gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 4
n=55 Participants
Per standard of care antibiotics, and Metronidazole
standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 5
metronidazole, clindamycin, or piperacillin-tazobactam
metronidazole, clindamycin, or piperacillin-tazobactam: IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
|---|---|---|---|---|---|
|
Number of Participants With Intestinal Perforation
|
2 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 days after last dose of study drugPopulation: Participant who received at least 1 dose of each study drug
Intestinal stricture: Radiology reports leading to the diagnosis of intestinal stricture. These include plain abdominal x-rays, upper gastrointestinal series with small bowel follow-through, contrast enema studies, and computed tomography scans of the abdomen and pelvis. Operative reports documenting surgical procedures leading to the diagnosis and/or treatment of intestinal stricture. These procedures include endoscopy, laparotomy, stricture dilatation, intestinal resection, and ostomy placement
Outcome measures
| Measure |
Group 1
n=62 Participants
Ampicillin and gentamycin and metronidazole
ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 2
n=46 Participants
ampicillin and gentamicin and clindamycin
ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 3
n=70 Participants
piperacillin-tazobactam and gentamicin
gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 4
n=55 Participants
Per standard of care antibiotics, and Metronidazole
standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 5
metronidazole, clindamycin, or piperacillin-tazobactam
metronidazole, clindamycin, or piperacillin-tazobactam: IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
|---|---|---|---|---|---|
|
Number of Participants With Intestinal Stricture
|
3 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 days after last dose of study drugPopulation: Participant who received at least 1 dose of each study drug
Progression is determined by the clinical NEC scoring
Outcome measures
| Measure |
Group 1
n=62 Participants
Ampicillin and gentamycin and metronidazole
ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 2
n=46 Participants
ampicillin and gentamicin and clindamycin
ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 3
n=70 Participants
piperacillin-tazobactam and gentamicin
gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 4
n=55 Participants
Per standard of care antibiotics, and Metronidazole
standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 5
metronidazole, clindamycin, or piperacillin-tazobactam
metronidazole, clindamycin, or piperacillin-tazobactam: IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
|---|---|---|---|---|---|
|
Number of Participants Progressed to a Higher Stage of Necrotizing Enterocolitis (NEC), if NEC is the Cause of the Complicated Intra-abdominal Infection
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 days after last dose of study drugPopulation: Participant who received at least 1 dose of each study drug
Determined by medical history and confirmed with hospital records. (Laparotomy)
Outcome measures
| Measure |
Group 1
n=62 Participants
Ampicillin and gentamycin and metronidazole
ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 2
n=46 Participants
ampicillin and gentamicin and clindamycin
ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 3
n=70 Participants
piperacillin-tazobactam and gentamicin
gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 4
n=55 Participants
Per standard of care antibiotics, and Metronidazole
standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 5
metronidazole, clindamycin, or piperacillin-tazobactam
metronidazole, clindamycin, or piperacillin-tazobactam: IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
|---|---|---|---|---|---|
|
Number of Participants With Gastrointestinal Surgeries
|
27 Participants
|
15 Participants
|
26 Participants
|
10 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 days after last dose of study drugPopulation: Participant who received at least 1 dose of each study drug
documented seizure(s) in hospital records
Outcome measures
| Measure |
Group 1
n=62 Participants
Ampicillin and gentamycin and metronidazole
ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 2
n=46 Participants
ampicillin and gentamicin and clindamycin
ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 3
n=70 Participants
piperacillin-tazobactam and gentamicin
gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 4
n=55 Participants
Per standard of care antibiotics, and Metronidazole
standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 5
metronidazole, clindamycin, or piperacillin-tazobactam
metronidazole, clindamycin, or piperacillin-tazobactam: IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
|---|---|---|---|---|---|
|
Number of Participants With Seizure
|
4 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 days after last dose of study drugPopulation: Participant who received at least 1 dose of each study drug
Positive blood culture (bacterial or fungal)
Outcome measures
| Measure |
Group 1
n=62 Participants
Ampicillin and gentamycin and metronidazole
ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 2
n=46 Participants
ampicillin and gentamicin and clindamycin
ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 3
n=70 Participants
piperacillin-tazobactam and gentamicin
gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 4
n=55 Participants
Per standard of care antibiotics, and Metronidazole
standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 5
metronidazole, clindamycin, or piperacillin-tazobactam
metronidazole, clindamycin, or piperacillin-tazobactam: IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
|---|---|---|---|---|---|
|
Number of Participants With Positive Blood Cultures
|
8 Participants
|
4 Participants
|
12 Participants
|
5 Participants
|
—
|
Adverse Events
Group 1
Serious events: 19 serious events
Other events: 10 other events
Deaths: 5 deaths
Group 2
Serious events: 10 serious events
Other events: 6 other events
Deaths: 5 deaths
Group 3
Serious events: 12 serious events
Other events: 10 other events
Deaths: 7 deaths
Group 4
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Group 5
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=62 participants at risk
Ampicillin and gentamycin and metronidazole
ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 2
n=46 participants at risk
ampicillin and gentamicin and clindamycin
ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 3
n=70 participants at risk
piperacillin-tazobactam and gentamicin
gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 4
n=55 participants at risk
Per standard of care antibiotics, and Metronidazole
standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 5
n=24 participants at risk
metronidazole, clindamycin, or piperacillin-tazobactam
metronidazole, clindamycin, or piperacillin-tazobactam: IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
1.6%
1/62 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/62 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
1.8%
1/55 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
1.6%
1/62 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
1.4%
1/70 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Eye disorders
Retinal detachment
|
0.00%
0/62 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
1.8%
1/55 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Eye disorders
Retinopathy of prematurity
|
1.6%
1/62 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
1.6%
1/62 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Gastrointestinal disorders
Necrotising colitis
|
1.6%
1/62 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
2.2%
1/46 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Gastrointestinal disorders
Oesophageal perforation
|
1.6%
1/62 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
General disorders
Organ failure
|
0.00%
0/62 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
1.4%
1/70 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Infections and infestations
Bacterial sepsis
|
1.6%
1/62 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
1.4%
1/70 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Infections and infestations
Candida infection
|
0.00%
0/62 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
2.2%
1/46 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Infections and infestations
Candida sepsis
|
1.6%
1/62 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
2.2%
1/46 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Infections and infestations
Cytomegalovirus infection
|
1.6%
1/62 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/62 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
1.4%
1/70 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Infections and infestations
Escherichia infection
|
1.6%
1/62 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/62 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
1.4%
1/70 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Infections and infestations
Fungal endocarditis
|
0.00%
0/62 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
2.2%
1/46 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Infections and infestations
Fungal infection
|
0.00%
0/62 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
1.4%
1/70 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Infections and infestations
Pneumonia
|
1.6%
1/62 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.00%
0/62 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
2.2%
1/46 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/62 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
1.4%
1/70 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Infections and infestations
Sepsis
|
0.00%
0/62 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
1.4%
1/70 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Infections and infestations
Septic shock
|
1.6%
1/62 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/62 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
1.4%
1/70 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
1.6%
1/62 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/62 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
2.2%
1/46 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/62 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
1.4%
1/70 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Nervous system disorders
Hydrocephalus
|
1.6%
1/62 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/62 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
2.2%
1/46 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Respiratory, thoracic and mediastinal disorders
Infantile apnoea
|
0.00%
0/62 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
1.8%
1/55 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory failure
|
0.00%
0/62 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
2.2%
1/46 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/62 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
4.2%
1/24 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.6%
1/62 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
1.4%
1/70 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.6%
1/62 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/62 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
2.2%
1/46 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
4.2%
1/24 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Surgical and medical procedures
Debridement
|
0.00%
0/62 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
4.2%
1/24 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Surgical and medical procedures
Patent ductus arteriosus repair
|
1.6%
1/62 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
2.2%
1/46 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Vascular disorders
Extremity necrosis
|
1.6%
1/62 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Vascular disorders
Hypotension
|
1.6%
1/62 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Vascular disorders
Shock haemorrhagic
|
1.6%
1/62 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Vascular disorders
Venous occlusion
|
0.00%
0/62 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
1.4%
1/70 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
Other adverse events
| Measure |
Group 1
n=62 participants at risk
Ampicillin and gentamycin and metronidazole
ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 2
n=46 participants at risk
ampicillin and gentamicin and clindamycin
ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 3
n=70 participants at risk
piperacillin-tazobactam and gentamicin
gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 4
n=55 participants at risk
Per standard of care antibiotics, and Metronidazole
standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
Group 5
n=24 participants at risk
metronidazole, clindamycin, or piperacillin-tazobactam
metronidazole, clindamycin, or piperacillin-tazobactam: IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.5%
4/62 • Number of events 5 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
6.5%
3/46 • Number of events 3 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
5.7%
4/70 • Number of events 4 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
4.2%
1/24 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Blood and lymphatic system disorders
Anaemia
|
4.8%
3/62 • Number of events 7 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
1.4%
1/70 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
5.5%
3/55 • Number of events 3 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
1.6%
1/62 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
5.7%
4/70 • Number of events 4 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/24 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/62 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
2.2%
1/46 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
1.4%
1/70 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
1.8%
1/55 • Number of events 1 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
8.3%
2/24 • Number of events 2 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Nervous system disorders
Intraventricular haemorrhage neonatal
|
0.00%
0/62 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
4.3%
2/46 • Number of events 2 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
8.3%
2/24 • Number of events 2 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
3.2%
2/62 • Number of events 2 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
8.3%
2/24 • Number of events 2 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
|
Psychiatric disorders
Agitation
|
0.00%
0/62 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/46 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/70 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
0.00%
0/55 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
8.3%
2/24 • Number of events 2 • 90 days post last study dose
Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
|
Additional Information
Michael Cohen-Wolkowiez, M.D
Duke University Medical Center
Phone: 9196688812
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place