30 closest matches · ranked by relevance
Complicated Appendicitis · Acute Appendicitis
Primary: Feasibility of the Use of Antibiotic Solution Instillation Following Intraoperative Diagnosis of Complex Appendicitis as Assessed by Percentage of Eligible Participants…
Infection
Primary: Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population — 315; 324; 37; 23 participants
Abdominal (ABD) Infection
Primary: Extended-Spectrum Days of Antibacterial Therapy (ES-DOT) Per Empiric Day — 68616; 68679; 76605; 50001 Extended-Spectrum Days-of-Therapy
Healthcare Associated Infections · Methicillin Resistant Staphylococcus Aureus · Multi Drug Resistant Organisms
Primary: MRSA and VRE Clinical Cultures — 0.87; 0.79 Hazard Ratio (Intervention vs Baseline) — p=0.17
Intraabdominal Infections
Primary: Number of Subjects With Adverse Events — 175; 82; 20; 6 Subjects
Abdominal Surgery · Colon Surgery · Post-Op Infection
Primary: The Combined Infection and Mortality Rate Within 30 Days Post Index Surgery — 24; 10 Participants — p=0.0086
Pneumonia, Ventilator-Associated · Pneumonia, Bacterial · Pneumonia
Primary: Patients With Incidence of Treatment-emergent Adverse Events (TEAEs). — 42; 13; 37; 15 participants
Intestinal Obstruction · Colorectal Cancer · Post-Op Complication
Primary: Change in Number of Participants With Post-operative Infectious and Inflammatory Complications — 43; 47; 25; 17 Participants
Intra-abdominal Infections
Primary: Clinical Response: Response Rate (Data Review Committee Assessment) — 96.6; 96.7 percentage of participants
Complicated Intra-Abdominal Infection
Primary: Clinical Response at the Test of Cure (TOC) Visit in the Microbiologically Modified Intent-To-Treat (mMITT) Analysis Set (Primary Outcome for FDA). — 337; 349; 37; 30…
Open Abdomen
Primary: Primary Closure Rate — 75; 67 % of participants
Abdominal Abscess · Pelvic Abscess
Primary: Percentage of Patients Requiring Surgical Debridement for a Persistent Abscess Within 30 Days Following Initial Drainage — 3; 7 participants
Complicated Urinary Tract Infection · Complicated Intra-abdominal Infection
Primary: Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set — 6; 8; 129; 132 Participant
Intra-abdominal Infection
Primary: Clinical Response at the Test-of-Cure (TOC) Assessment Within the Clinically Evaluable (CE) Population — 89.9; 96.6; 10.1; 3.4 percentage of participants — p=0.0008
Complicated Intra-abdominal Infection
Primary: Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Test-of-Cure Visit — 39; 41; 24; 3 participants
Complicated Intra-abdominal Infections
Primary: Number of Participants With Clinical Response at the Test of Cure (TOC) Visit — 62; 71 participants
Acinetobacter Baumannii-calcoaceticus Complex · Hospital-acquired Bacterial Pneumonia · Ventilator-associated Bacterial Pneumonia
Primary: Proportion of Patients With All-Cause Mortality in CRABC m-MITT Population — 12; 20 Participants
Intra Abdominal Infections
Primary: Percentage of Participants With Clinical Success — 85.5; 90.2 percentage of participants
Surgical Site Infection · Colon Surgery · Abdominal Surgery
Primary: To Assess the Anti-infective Efficacy of D-PLEX Over a Period of 30 Days Post Operation, by Preventing Surgical Site Infection (SSI), Defined as Superficial and Deep…
Complicated Intra-abdominal Infections
Primary: Clinical Response of Eravacycline and Ertapenem Treatment Arms at the Test-of-cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population — 191; 198…
Abscess
Primary: Number of Participants With Abscess Resolution — 11; 9 Participants
Necrotizing Soft Tissue Infections
Primary: Number of Subjects With One or More Adverse Events (AEs) During the Treatment Period — 14; 16; 9 Participants
Secondary Peritonitis
Primary: Peritonitis Resolved — 26; 29 participants — p=<0.05
Antibiotic Resistant Infection · Infection
Primary: Percentage of Appropriate Antimicrobial Prescriptions Recommended — 90 percentage of prescriptions appropriate
Complicated Intra-abdominal Infection
Primary: The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) Analysis Set. — 166; 173; 11; 11 Number of patients…
Appendicitis · Appendicitis; Perforation
Primary: Length of Hospital Stay — 121.55; 131.69 hours
Abscesses
Primary: Treatment Failures at 7 Days — 15; 27 participants
Complicated Intra-Abdominal Infection
Primary: Duration of Hospitalization — 14.1 Days
Pain, Postoperative
Primary: Total Morphine Milliequivalent (MME) Use Postoperatively After Cesarean Delivery — 52; 68 Morphine milligram equivalents
Abscess
Primary: Sensitivity and Specificity of Bedside Emergency Ultrasound When Added to the Clinical Examination Compared With Clinical Examination Alone. — 94.7; 93.1; 84.2; 81.4…