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| ID | Type | Description | Link |
|---|---|---|---|
| HHSN275201000003I | Other Grant/Funding Number | NICHD |
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| Name | Class |
|---|---|
| The Emmes Company, LLC | INDUSTRY |
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The main purpose of this study is evaluate whether it is safe or not to use various combination of antibiotics (ampicillin, metronidazole, clindamycin, piperacillin-tazobactam, gentamicin) in treating infants with complicated intra-abdominal infections
The most commonly used antibiotics in infants with complicated intra-abdominal infections are not labeled for use in this population because safety and efficacy data are lacking. This study will provide the safety information required for labeling. In addition, the pharmacokinetics(PK) and effectiveness data will also be collected during this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (ampicillin +gentamycin +metronidazole) | Active Comparator | Ampicillin and gentamycin and metronidazole |
|
| Group 2 (ampicillin +gentamicin+clindamycin) | Active Comparator | ampicillin and gentamicin and clindamycin |
|
| Group 3 (piperacillin-tazobactam and gentamicin) | Active Comparator | piperacillin-tazobactam and gentamicin |
|
| Group 4 (metronidazole) | Active Comparator | Per standard of care antibiotics, and Metronidazole |
|
| Group 5 (metronidazole/clindamycin/piperacillin-tazobactam) | Active Comparator | metronidazole, clindamycin, or piperacillin-tazobactam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ampicillin and metronidazole and gentamicin | Drug | IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA) |
| Measure | Description | Time Frame |
|---|---|---|
| Death | Number of Participants who experienced Death | Within 30 days after last dose of study drug, up to 40 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Therapeutic Success at Day 30 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Feeding Intolerance | Feeding intolerance confirmed by documentation of any feedings held for >24 consecutive hours in infants being fed | 90 days after last dose of study drug |
| Number of Participants With Grade 3 and/or Grade 4 Intraventricular Hemorrhage (IVH) |
Inclusion Criteria:
Exclusion Criteria*
History of anaphylaxis in response to study drugs (Groups 1-5)
Serum creatinine >2 mg/dL within 48 hours on measurement prior to and closest to randomization /first study drug dose (Groups 1- 5)**
Known ALT >250 U/L or AST >500 U/L on measurement closest to the time of randomization or first study drug dose (Groups 1-5)**
Any condition that, in the judgment of the investigator, precludes participation because it could affect participant safety (Groups 1-5)
Do not apply for Group 5 participants receiving drug per standard of care
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| Name | Affiliation | Role |
|---|---|---|
| Micheal Cohen-Wolkowiez, MD, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Arkansas Children's Hospital/Univ of Arkansas for Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33902072 | Derived | Smith MJ, Boutzoukas A, Autmizguine J, Hudak ML, Zinkhan E, Bloom BT, Heresi G, Lavery AP, Courtney SE, Sokol GM, Cotten CM, Bliss JM, Mendley S, Bendel C, Dammann CEL, Weitkamp JH, Saxonhouse MA, Mundakel GT, Debski J, Sharma G, Erinjeri J, Gao J, Benjamin DK Jr, Hornik CP, Smith PB, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Antibiotic Safety and Effectiveness in Premature Infants With Complicated Intraabdominal Infections. Pediatr Infect Dis J. 2021 Jun 1;40(6):550-555. doi: 10.1097/INF.0000000000003034. |
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One participant was enrolled but did not receive any dose of study drug. The participant is excluded from study result data analysis
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | Group 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ampicillin and gentamicin and clindamycin | Drug | IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA) |
|
| gentamicin and Piperacillin- tazobactam | Drug | IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA) |
|
| standard of care antibiotics and metronidazole | Drug | 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) |
|
| metronidazole, clindamycin, or piperacillin-tazobactam | Drug | 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) |
|
| 30 days after last dose of study drug |
Grade 3 IVH: Subependymal hemorrhage with extension into lateral ventricles with ventricular enlargement Grade 4 IVH: Intraparenchymal hemorrhage |
| 90 days after last dose of study drug |
| Number of Participants With Short Bowel Syndrome | 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 | 90 days after last dose of study drug |
| Number of Participants With Intestinal Perforation | 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 | 90 days after last dose of study drug |
| Number of Participants With Intestinal Stricture | 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 | 90 days after last dose of study drug |
| Number of Participants Progressed to a Higher Stage of Necrotizing Enterocolitis (NEC), if NEC is the Cause of the Complicated Intra-abdominal Infection | Progression is determined by the clinical NEC scoring | 90 days after last dose of study drug |
| Number of Participants With Gastrointestinal Surgeries | Determined by medical history and confirmed with hospital records. (Laparotomy) | 90 days after last dose of study drug |
| Number of Participants With Seizure | documented seizure(s) in hospital records | 90 days after last dose of study drug |
| Number of Participants With Positive Blood Cultures | Positive blood culture (bacterial or fungal) | 90 days after last dose of study drug |
| Little Rock |
| Arkansas |
| 72202 |
| United States |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
| Stanford University School of Medicine | Palo Alto | California | 94304 | United States |
| Rady Children's Hospital and Health Center | San Diego | California | 92123 | United States |
| University of California San Diego Medical Center | San Diego | California | 92123 | United States |
| Sharp Mary Birch | San Diego | California | 92131 | United States |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States |
| University of Florida Jacksonville Healthcare, Inc. | Jacksonville | Florida | 32209 | United States |
| Wolfson Children's Hospital, Shands Medical Center | Jacksonville | Florida | 32209 | United States |
| Georgia Regents University | Augusta | Georgia | 30912 | United States |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | United States |
| Riley Hospital | Indianapolis | Indiana | 46202 | United States |
| Wesley Medical Center | Wichita | Kansas | 67214 | United States |
| University of Kentucky Hospital | Lexington | Kentucky | 40536 | United States |
| Louisana State University Health Sciences Center | Shreveport | Louisiana | 71103 | United States |
| University of Maryland Hospital | Baltimore | Maryland | 21201 | United States |
| Floating Hospital for Children at Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| University of Minnesota Fairview University Medical Center | Minneapolis | Minnesota | 55455 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Kings County Hospital | Brooklyn | New York | 11203 | United States |
| Brookdale University Hospital | Brooklyn | New York | 11212 | United States |
| New York University School of Medicine | New York | New York | 10016 | United States |
| Columbia University Neonatology | New York | New York | 10032 | United States |
| Westchester Medical Center - New York Medical College | Valhalla | New York | 10595 | United States |
| University of North Carolina Hospital | Chapel Hill | North Carolina | 27514 | United States |
| Levine Children's Hospital | Charlotte | North Carolina | 28232 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| WakeMed Faculty Neonatology | Raleigh | North Carolina | 27610 | United States |
| New Hanover Reginal Medical Center | Wilmington | North Carolina | 28403 | United States |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
| Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | United States |
| University of Oklahoma Health Science Center | Oklahoma City | Oklahoma | 73104 | United States |
| Penn State Hershey Children's Hospital | Hershey | Pennsylvania | 17033 | United States |
| Womens and Infant Hospital of Rhode Island | Providence | Rhode Island | 02905 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| Intermountain Medical Center | Salt Lake City | Utah | 84108 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| Carilion Roanoke Memorial Hospital | Roanoke | Virginia | 24014 | United States |
| University of Alberta - Royal Alexandra Hospital | Edmonton | Alberta | T5H 3V9 | Canada |
| University of British Columbia - British Columbia Women's Hospital | Vancouver | British Columbia | V6H 3V4 | Canada |
| Manitoba Institute of Child Health | Winnipeg | Manitoba | R3P 2C1 | Canada |
| Children's Hospital of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | Canada |
| Hospital Sainte-Justine | Montreal | Quebec | T3T 1C5 | Canada |
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) |
| FG002 | 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) |
| FG003 | 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) |
| FG004 | 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) |
| COMPLETED |
|
| NOT COMPLETED |
|
count of participants
Note: the overall numbers above were based on "Per protocol population", defined as participants who received at least 1 study dose of each study drug of the enrolled treatment group.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | 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) |
| BG002 | 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) |
| BG003 | 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) |
| BG004 | 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) |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Gestational Age (weeks) |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | count of participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Death | Number of Participants who experienced Death | Full intent-to-treat population (patients who received at least 1 dose of any study drug) | Posted | Count of Participants | Participants | Within 30 days after last dose of study drug, up to 40 days |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Therapeutic Success at Day 30 | 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 | Participants who received at least 1 dose of each study drug. Does not apply to Group 5. | Posted | Count of Participants | Participants | 30 days after last dose of study drug |
| ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Feeding Intolerance | Feeding intolerance confirmed by documentation of any feedings held for >24 consecutive hours in infants being fed | Participant who received at least 1 dose of each study drug | Posted | Count of Participants | Participants | 90 days after last dose of study drug |
| ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Grade 3 and/or Grade 4 Intraventricular Hemorrhage (IVH) | Grade 3 IVH: Subependymal hemorrhage with extension into lateral ventricles with ventricular enlargement Grade 4 IVH: Intraparenchymal hemorrhage | Participant who received at least 1 dose of each study drug | Posted | Count of Participants | Participants | 90 days after last dose of study drug |
| ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Short Bowel Syndrome | 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 | Participant who received at least 1 dose of each study drug | Posted | Count of Participants | Participants | 90 days after last dose of study drug |
| ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Intestinal Perforation | 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 | Participant who received at least 1 dose of each study drug | Posted | Count of Participants | Participants | 90 days after last dose of study drug |
| ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Intestinal Stricture | 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 | Participant who received at least 1 dose of each study drug | Posted | Count of Participants | Participants | 90 days after last dose of study drug |
| ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants Progressed to a Higher Stage of Necrotizing Enterocolitis (NEC), if NEC is the Cause of the Complicated Intra-abdominal Infection | Progression is determined by the clinical NEC scoring | Participant who received at least 1 dose of each study drug | Posted | Count of Participants | Participants | 90 days after last dose of study drug |
| ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Gastrointestinal Surgeries | Determined by medical history and confirmed with hospital records. (Laparotomy) | Participant who received at least 1 dose of each study drug | Posted | Count of Participants | Participants | 90 days after last dose of study drug |
| ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Seizure | documented seizure(s) in hospital records | Participant who received at least 1 dose of each study drug | Posted | Count of Participants | Participants | 90 days after last dose of study drug |
| ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Positive Blood Cultures | Positive blood culture (bacterial or fungal) | Participant who received at least 1 dose of each study drug | Posted | Count of Participants | Participants | 90 days after last dose of study drug |
|
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
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) | 5 | 62 | 19 | 62 | 10 | 62 |
| EG001 | 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) | 5 | 46 | 10 | 46 | 6 | 46 |
| EG002 | 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) | 7 | 70 | 12 | 70 | 10 | 70 |
| EG003 | 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) | 1 | 55 | 3 | 55 | 4 | 55 |
| EG004 | 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) | 0 | 24 | 3 | 24 | 9 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Cardiopulmonary failure | Cardiac disorders | Systematic Assessment |
| ||
| Patent ductus arteriosus | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Retinal detachment | Eye disorders | Systematic Assessment |
| ||
| Retinopathy of prematurity | Eye disorders | Systematic Assessment |
| ||
| Gastrointestinal necrosis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Necrotising colitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oesophageal perforation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Organ failure | General disorders | Systematic Assessment |
| ||
| Bacterial sepsis | Infections and infestations | Systematic Assessment |
| ||
| Candida infection | Infections and infestations | Systematic Assessment |
| ||
| Candida sepsis | Infections and infestations | Systematic Assessment |
| ||
| Cytomegalovirus infection | Infections and infestations | Systematic Assessment |
| ||
| Enterococcal sepsis | Infections and infestations | Systematic Assessment |
| ||
| Escherichia infection | Infections and infestations | Systematic Assessment |
| ||
| Escherichia sepsis | Infections and infestations | Systematic Assessment |
| ||
| Fungal endocarditis | Infections and infestations | Systematic Assessment |
| ||
| Fungal infection | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Pseudomonal bacteraemia | Infections and infestations | Systematic Assessment |
| ||
| Pseudomonal sepsis | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Septic shock | Infections and infestations | Systematic Assessment |
| ||
| Staphylococcal sepsis | Infections and infestations | Systematic Assessment |
| ||
| Endotracheal intubation complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Haemorrhage intracranial | Nervous system disorders | Systematic Assessment |
| ||
| Hydrocephalus | Nervous system disorders | Systematic Assessment |
| ||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Infantile apnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Neonatal respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Debridement | Surgical and medical procedures | Systematic Assessment |
| ||
| Patent ductus arteriosus repair | Surgical and medical procedures | Systematic Assessment |
| ||
| Extremity necrosis | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Shock haemorrhagic | Vascular disorders | Systematic Assessment |
| ||
| Venous occlusion | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Jaundice cholestatic | Hepatobiliary disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Intraventricular haemorrhage neonatal | Nervous system disorders | Systematic Assessment |
| ||
| Skin disorder | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Agitation | Psychiatric disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Cohen-Wolkowiez, M.D | Duke University Medical Center | 9196688812 | michael.cohenwolkowiez@duke.edu |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D008795 | Metronidazole |
| D005839 | Gentamicins |
| D002981 | Clindamycin |
| D000077725 | Piperacillin, Tazobactam Drug Combination |
| ID | Term |
|---|---|
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D000078142 | Tazobactam |
| D010397 | Penicillanic Acid |
| D010878 | Piperacillin |
| D013450 | Sulfones |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
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)
| OG003 | 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) |
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| 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) |
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| OG003 |
| 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) |
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| OG003 | 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) |
|
|
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)
| OG003 | 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) |
|
|
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)
| OG003 | 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) |
|
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| OG003 |
| 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) |
|
|
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) |
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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)
|
|
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) |
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