30 closest matches · ranked by relevance
Infection
Primary: Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population — 315; 324; 37; 23 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…
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
Intra-abdominal Infections
Primary: Clinical Response: Response Rate (Data Review Committee Assessment) — 96.6; 96.7 percentage of participants
Intra Abdominal Infections
Primary: Percentage of Participants With Clinical Success — 85.5; 90.2 percentage of participants
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…
Complicated Intra-abdominal Infections
Primary: Number of Participants With Clinical Response at the Test of Cure (TOC) Visit — 62; 71 participants
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
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 Intra-abdominal Infections · Complicated Appendicitis
Primary: Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population — 177; 187; 7; 7…
Complicated Intra-abdominal Infections
Primary: Percentage of Participants With Clinical Response (Clinical Cure or Clinical Failure) at Test of Cure (TOC) Visit: Clinically Evaluable (CE) Population — 95.2; 93.1…
Complicated Intra-abdominal Infection
Primary: The Percentage of Subjects With Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population — 83.0; 87.3 percentage…
Abdominal (ABD) Infection
Primary: Extended-Spectrum Days of Antibacterial Therapy (ES-DOT) Per Empiric Day — 68616; 68679; 76605; 50001 Extended-Spectrum Days-of-Therapy
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
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…
Complicated Intra-Abdominal Infection
Primary: Duration of Hospitalization — 14.1 Days
Appendicitis · Cholecystitis · Cross Infection
Primary: Number of Clinically Evaluable Patients With Clinical Response of Cure at Test-of-Cure (TOC) Visit. — 133; 139 participants — p=0.009
Intraabdominal Infections
Primary: Number of Subjects With Adverse Events — 175; 82; 20; 6 Subjects
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…
Complicated Intra-abdominal Infection
Primary: Clinical Response of CXA 101/Tazobactam and Metronidazole at Test of Cure (TOC) Visit in the Microbiological Modified Intent to Treat (mMITT) Analysis Population — 83.6…
Necrotizing Enterocolitis · Intra-abdominal Infection
Primary: Efficacy Success (Alive at Efficacy Visit,Last Culture (if Obtained) From Sterile Body Fluid is Negative for Bacteria (Except Staphylococcus Species) From Start of Study…
Intra-Abdominal Hypertension
Primary: Intra-abdominal Pressure(IAP) Measurements in NICU Patients. — 1219 IAP measurements
SURGICAL SITE INFECTION
Primary: Surgical Site Infection — 6; 3 participants — p=<0.05
Intra-abdominal Infection · Complicated Intra-abdominal Infection
Primary: Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at Test of Cure (TOC) — 92.0; 8.0; 0.0 Percentage of Participants
Appendicitis · Cholecystitis · Diverticulitis
Primary: Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit — 162; 150 participants
Perforated Appendicitis
Primary: Abscess After Appendectomy — 10; 10 number of patients
Complicated Intra Abdominal Infections
Primary: Death — 5; 5; 7; 1 Participants
Acute, Perforated Appendicitis
Primary: Number of Participants With Postoperative Intra-abdominal Abscess — 6; 8 Participants
Gastrointestinal Injury · Complicated Diverticulitis
Primary: Rate of Surgical Site Infection — 5 Participants
Antibiotic Resistant Infection · Nosocomial Infection · Pathogen Transmission
Primary: Within-individual Change in SCFA Producer Level — -0.0; -1.8; 1.1 percentage of SCFA producers