Complicated Intra-abdominal Infection
Conditions
Brief summary
This is a Phase 2, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of two dose regimens of TP-434 compared with ertapenem in the treatment of adult community-acquired complicated intra-abdominal infections (cIAIs).
Interventions
DRUGTP-434
DRUGErtapenem
DRUGPlacebo
Administered IV to maintain the blind.
Sponsors
Tetraphase Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Abdominal pain/discomfort with onset prior to hospitalization * Evidence of a systemic inflammatory response * Physical findings consistent with intra-abdominal infection (IAI) * Clinical diagnosis of community-acquired IAI requiring urgent surgical or percutaneous intervention and not expected to require antibacterial therapy for longer than 14 days * Body mass index (BMI) of ≤ 30 kilograms per square meter (kg/m\^2) * Able to provide informed consent. If the participant is unable to provide informed consent, the participant's legally acceptable representative may provide written consent in accordance with institutional guidelines * If female, not pregnant or nursing or, if of child-bearing potential either: will commit to use at least two medically accepted, effective methods of birth control (for example, condom, oral contraceptive, indwelling intrauterine device, hormonal implant/patch, injections, approved cervical ring) during study drug dosing and for 90 days following last study drug dose or practicing sexual abstinence
Exclusion criteria
* Symptoms related to diagnosis of complicated appendicitis (if current diagnosis) for \< 24 hours prior to current hospitalization * Previously hospitalized or admitted to a healthcare facility within the last 6 months * Managed by Staged Abdominal Repair or other open abdomen technique * Known at study entry to have an IAI caused by a pathogen(s) resistant to both study drug antibiotics * Acute Physiology and Chronic Health Evaluation (APACHE) II score \> 25 * Unlikely to survive the 6-8 week study period * Any rapidly-progressing disease or immediately life-threatening illness, including acute hepatic failure, respiratory failure and septic shock * Requirement for vasopressors at therapeutic dosages * Renal failure * Presence or possible signs of hepatic disease * Hematocrit \< 25% or hemoglobin \< 8 grams per deciliter (g/dL) * Neutropenia with absolute neutrophil count \< 1000 cells per cubic millimeter (mm\^3) * Platelet count \< 50,000/mm3 * Abnormal coagulation tests or participant on anticoagulants * Immunocompromised condition, including known human immunodeficiency virus (HIV) positivity or acquired immune deficiency syndrome (AIDS), organ (bone marrow) transplant recipients, and hematological malignancy. Immunosuppressive therapy, including use of high-dose corticosteroids (for example, \> 40 milligrams \[mg\] prednisone or equivalent per day for greater than 2 weeks) * History of hypersensitivity reactions to tetracyclines or carbapenems * Participation in any investigational drug or device study within 30 days prior to study entry * Known or suspected central nervous system (CNS) disorder that may predispose to seizures or lower seizure threshold * Previously received TP-434 in a clinical trial * More than 24 hours duration of systemic antibiotic coverage for current condition * Received ertapenem or any other carbapenem, or tigecycline for the current infection * Need for concomitant systemic antimicrobial agents other than study drug or received systemic (IV or oral) antibiotics in the last 3 months * Refusal of mechanical ventilation, dialysis or hemofiltration, cardioversion or any other resuscitative measures and drug/fluid therapy at time of consent * Known or suspected inflammatory bowel disease or associated visceral abscess
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Test-of-Cure Visit | TOC Visit (10-14 days after last dose of study drug) | Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection \[cIAI\], persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (Test-of-Cure \[TOC\] assessment was not available, death unrelated to cIAI, or some other reason). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at TOC Visit | TOC Visit (10-14 days after last dose of study drug) | — |
| Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the Follow-up Visit | Follow-up Visit (28-42 days after last dose of study drug) | — |
| Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the EOT Visit | EOT Visit (4-14 days after first dose of study drug) | — |
| Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the TOC Visit | TOC Visit (10-14 days after last dose of study drug) | — |
| Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the Follow-up Visit | Follow-up Visit (28-42 days after last dose of study drug) | — |
| Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the EOT Visit | EOT Visit (4-14 days after first dose of study drug) | — |
| Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the TOC Visit | TOC Visit (10-14 days after last dose of study drug) | — |
| Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the Follow-up Visit | Follow-Up Visit (28-42 days after last dose of study drug) | — |
| Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the EOT Visit | EOT Visit (4-14 days after first dose of study drug) | — |
| Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the End-of-Treatment (EOT) Visit | EOT Visit (4-14 days after first dose of study drug) | — |
| Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the Follow-up Visit | Follow-up Visit (28-42 days after last dose of study drug) | — |
| Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the EOT Visit | EOT Visit (4-14 days after first dose of study drug) | — |
| Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Follow-up Visit | Follow-up Visit (28-42 days after last dose of study drug) | — |
| Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the EOT Visit | EOT Visit (4-14 days after first dose of study drug) | Microbiological response was classified as favorable (eradication or presumed eradication), unfavorable (persistence, presumed persistence, superinfection, or new infection), or indeterminate (assessment not possible). |
| Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the TOC Visit | TOC Visit (10-14 days after last dose of study drug) | — |
| Microbiologic Response to TP-434 and Ertapenem in the ME Population at the EOT Visit | EOT Visit (4-14 days after first dose of study drug) | — |
| Microbiologic Response to TP-434 and Ertapenem in the ME Population at the TOC Visit | TOC Visit (10-14 days after last dose of study drug) | — |
| Pharmacokinetics: Maximum Concentration (Cmax) of TP-434 | Prior to first infusion and 1, 3, 7, 12, 48, and 108 hours after start of first infusion | — |
| Pharmacokinetics: Area Under the Concentration Time Curve From Time 0 to 12 Hours (AUC[0-12]) of TP-434 | Prior to first infusion and 1, 3, 7, 12, 48, and 108 hours after start of first infusion | — |
| Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the TOC Visit | TOC Visit (10-14 days after last dose of study drug) | — |
Countries
Bulgaria, India, Latvia, Lithuania, Romania, United States
Participant flow
Pre-assignment details
Randomization was stratified by site of infection (complicated appendicitis versus all other diagnoses).
Participants by arm
| Arm | Count |
|---|---|
| TP-434, 1.5 mg/kg q24h TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India). | 56 |
| TP-434, 1.0 mg/kg q12h TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India). | 57 |
| Ertapenem 1 g q24h Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India). | 30 |
| Total | 143 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 |
| Overall Study | Death | 3 | 0 | 0 |
| Overall Study | Incorrectly Randomized | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 5 | 3 | 2 |
| Overall Study | Physician Decision | 1 | 0 | 1 |
| Overall Study | Protocol Violation | 2 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 5 | 0 |
Baseline characteristics
| Characteristic | TP-434, 1.5 mg/kg q24h | TP-434, 1.0 mg/kg q12h | Ertapenem 1 g q24h | Total |
|---|---|---|---|---|
| Age, Continuous | 43.6 years STANDARD_DEVIATION 18.39 | 42.1 years STANDARD_DEVIATION 17.16 | 41.8 years STANDARD_DEVIATION 17.6 | 42.6 years STANDARD_DEVIATION 17.64 |
| Region of Enrollment Bulgaria | 9 participants | 6 participants | 3 participants | 18 participants |
| Region of Enrollment India | 16 participants | 20 participants | 9 participants | 45 participants |
| Region of Enrollment Latvia | 8 participants | 9 participants | 4 participants | 21 participants |
| Region of Enrollment Lithuania | 17 participants | 13 participants | 7 participants | 37 participants |
| Region of Enrollment Romania | 6 participants | 9 participants | 6 participants | 21 participants |
| Region of Enrollment United States | 0 participants | 0 participants | 1 participants | 1 participants |
| Sex: Female, Male Female | 18 Participants | 14 Participants | 8 Participants | 40 Participants |
| Sex: Female, Male Male | 38 Participants | 43 Participants | 22 Participants | 103 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 53 | 10 / 56 | 7 / 30 |
| serious Total, serious adverse events | 6 / 53 | 1 / 56 | 1 / 30 |
Outcome results
Primary
Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Test-of-Cure Visit
Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection \[cIAI\], persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (Test-of-Cure \[TOC\] assessment was not available, death unrelated to cIAI, or some other reason).
Time frame: TOC Visit (10-14 days after last dose of study drug)
Population: All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, had a baseline pathogen identified, and had a microbiological response assessed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Test-of-Cure Visit | Cure | 39 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Test-of-Cure Visit | Indeterminate | 0 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Test-of-Cure Visit | Failure | 3 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Test-of-Cure Visit | Failure | 0 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Test-of-Cure Visit | Indeterminate | 0 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Test-of-Cure Visit | Cure | 41 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Test-of-Cure Visit | Failure | 2 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Test-of-Cure Visit | Indeterminate | 0 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Test-of-Cure Visit | Cure | 24 participants |
Secondary
Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the EOT Visit
Time frame: EOT Visit (4-14 days after first dose of study drug)
Population: All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and for whom sufficient information was available to determine the participant's outcome with no confounding factors present that interfered with the assessment of that outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the EOT Visit | Failure | 2 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the EOT Visit | Cure | 47 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the EOT Visit | Indeterminate | 0 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the EOT Visit | Failure | 1 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the EOT Visit | Indeterminate | 0 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the EOT Visit | Cure | 47 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the EOT Visit | Failure | 1 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the EOT Visit | Indeterminate | 0 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the EOT Visit | Cure | 27 participants |
Secondary
Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the Follow-up Visit
Time frame: Follow-up Visit (28-42 days after last dose of study drug)
Population: All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and for whom sufficient information was available to determine the participant's outcome with no confounding factors present that interfered with the assessment of that outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the Follow-up Visit | Failure | 4 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the Follow-up Visit | Cure | 41 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the Follow-up Visit | Indeterminate | 4 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the Follow-up Visit | Failure | 1 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the Follow-up Visit | Cure | 45 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the Follow-up Visit | Indeterminate | 2 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the Follow-up Visit | Cure | 23 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the Follow-up Visit | Indeterminate | 3 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the Follow-up Visit | Failure | 2 participants |
Secondary
Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the TOC Visit
Time frame: TOC Visit (10-14 days after last dose of study drug)
Population: All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and for whom sufficient information was available to determine the participant's outcome with no confounding factors present that interfered with the assessment of that outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the TOC Visit | Cure | 46 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the TOC Visit | Failure | 3 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the TOC Visit | Indeterminate | 0 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the TOC Visit | Cure | 47 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the TOC Visit | Failure | 1 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the TOC Visit | Indeterminate | 0 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the TOC Visit | Failure | 2 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the TOC Visit | Cure | 26 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the TOC Visit | Indeterminate | 0 participants |
Secondary
Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the EOT Visit
Time frame: EOT Visit (4-14 days after first dose of study drug)
Population: All randomized participants who received at least 1 dose of study drug and met the minimal disease definition of intra-abdominal infection (IAI). The minimal disease definition included all IAI, whether complicated or not. Identification of a baseline pathogen was not required for this population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the EOT Visit | Failure | 2 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the EOT Visit | Cure | 49 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the EOT Visit | Indeterminate | 3 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the EOT Visit | Failure | 1 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the EOT Visit | Cure | 52 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the EOT Visit | Indeterminate | 3 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the EOT Visit | Cure | 28 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the EOT Visit | Indeterminate | 0 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the EOT Visit | Failure | 1 participants |
Secondary
Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the Follow-up Visit
Time frame: Follow-up Visit (28-42 days after last dose of study drug)
Population: All randomized participants who received at least 1 dose of study drug and met the minimal disease definition of IAI. The minimal disease definition included all IAI, whether complicated or not. Identification of a baseline pathogen was not required for this population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the Follow-up Visit | Failure | 4 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the Follow-up Visit | Cure | 41 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the Follow-up Visit | Indeterminate | 9 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the Follow-up Visit | Failure | 1 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the Follow-up Visit | Indeterminate | 10 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the Follow-up Visit | Cure | 45 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the Follow-up Visit | Cure | 24 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the Follow-up Visit | Indeterminate | 3 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the Follow-up Visit | Failure | 2 participants |
Secondary
Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the TOC Visit
Time frame: TOC Visit (10-14 days after last dose of study drug)
Population: All randomized participants who received at least 1 dose of study drug and met the minimal disease definition of IAI. The minimal disease definition included all IAI, whether complicated or not. Identification of a baseline pathogen was not required for this population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the TOC Visit | Failure | 3 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the TOC Visit | Cure | 46 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the TOC Visit | Indeterminate | 5 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the TOC Visit | Failure | 1 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the TOC Visit | Cure | 47 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the TOC Visit | Indeterminate | 8 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the TOC Visit | Cure | 26 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the TOC Visit | Indeterminate | 1 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the TOC Visit | Failure | 2 participants |
Secondary
Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the EOT Visit
Time frame: EOT Visit (4-14 days after first dose of study drug)
Population: All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, had a baseline pathogen identified, and had a microbiological response assessed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the EOT Visit | Failure | 2 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the EOT Visit | Cure | 40 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the EOT Visit | Indeterminate | 0 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the EOT Visit | Failure | 0 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the EOT Visit | Cure | 41 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the EOT Visit | Indeterminate | 0 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the EOT Visit | Cure | 25 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the EOT Visit | Indeterminate | 0 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the EOT Visit | Failure | 1 participants |
Secondary
Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Follow-up Visit
Time frame: Follow-up Visit (28-42 days after last dose of study drug)
Population: All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, had a baseline pathogen identified, and had a microbiological response assessed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Follow-up Visit | Failure | 4 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Follow-up Visit | Cure | 36 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Follow-up Visit | Indeterminate | 2 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Follow-up Visit | Failure | 0 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Follow-up Visit | Cure | 39 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Follow-up Visit | Indeterminate | 2 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Follow-up Visit | Cure | 21 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Follow-up Visit | Indeterminate | 3 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Follow-up Visit | Failure | 2 participants |
Secondary
Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the EOT Visit
Time frame: EOT Visit (4-14 days after first dose of study drug)
Population: All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and had a baseline pathogen identified. The minimal disease definition of cIAI included IAI that extended beyond the hollow viscus of origin into the peritoneal space and was associated with either abscess formation or peritonitis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the EOT Visit | Cure | 41 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the EOT Visit | Indeterminate | 2 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the EOT Visit | Failure | 2 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the EOT Visit | Failure | 0 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the EOT Visit | Indeterminate | 3 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the EOT Visit | Cure | 44 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the EOT Visit | Failure | 1 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the EOT Visit | Indeterminate | 0 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the EOT Visit | Cure | 26 participants |
Secondary
Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the Follow-up Visit
Time frame: Follow-Up Visit (28-42 days after last dose of study drug)
Population: All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and had a baseline pathogen identified. The minimal disease definition of cIAI included IAI that extended beyond the hollow viscus of origin into the peritoneal space and was associated with either abscess formation or peritonitis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the Follow-up Visit | Failure | 4 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the Follow-up Visit | Cure | 36 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the Follow-up Visit | Indeterminate | 5 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the Follow-up Visit | Failure | 0 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the Follow-up Visit | Indeterminate | 8 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the Follow-up Visit | Cure | 39 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the Follow-up Visit | Failure | 2 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the Follow-up Visit | Cure | 22 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the Follow-up Visit | Indeterminate | 3 participants |
Secondary
Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the TOC Visit
Time frame: TOC Visit (10-14 days after last dose of study drug)
Population: All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and had a baseline pathogen identified. The minimal disease definition of cIAI included IAI that extended beyond the hollow viscus of origin into the peritoneal space and was associated with either abscess formation or peritonitis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the TOC Visit | Failure | 3 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the TOC Visit | Cure | 39 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the TOC Visit | Indeterminate | 3 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the TOC Visit | Failure | 0 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the TOC Visit | Cure | 41 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the TOC Visit | Indeterminate | 6 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the TOC Visit | Cure | 24 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the TOC Visit | Indeterminate | 1 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the TOC Visit | Failure | 2 participants |
Secondary
Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the End-of-Treatment (EOT) Visit
Time frame: EOT Visit (4-14 days after first dose of study drug)
Population: All randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the End-of-Treatment (EOT) Visit | Failure | 2 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the End-of-Treatment (EOT) Visit | Cure | 49 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the End-of-Treatment (EOT) Visit | Indeterminate | 3 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the End-of-Treatment (EOT) Visit | Failure | 1 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the End-of-Treatment (EOT) Visit | Cure | 52 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the End-of-Treatment (EOT) Visit | Indeterminate | 3 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the End-of-Treatment (EOT) Visit | Cure | 28 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the End-of-Treatment (EOT) Visit | Indeterminate | 0 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the End-of-Treatment (EOT) Visit | Failure | 1 participants |
Secondary
Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the Follow-up Visit
Time frame: Follow-up Visit (28-42 days after last dose of study drug)
Population: All randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the Follow-up Visit | Failure | 4 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the Follow-up Visit | Cure | 41 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the Follow-up Visit | Indeterminate | 9 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the Follow-up Visit | Failure | 1 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the Follow-up Visit | Cure | 45 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the Follow-up Visit | Indeterminate | 10 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the Follow-up Visit | Cure | 24 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the Follow-up Visit | Indeterminate | 3 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the Follow-up Visit | Failure | 2 participants |
Secondary
Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at TOC Visit
Time frame: TOC Visit (10-14 days after last dose of study drug)
Population: All randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at TOC Visit | Indeterminate | 5 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at TOC Visit | Failure | 3 participants |
| TP-434, 1.5 mg/kg q24h | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at TOC Visit | Cure | 46 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at TOC Visit | Failure | 1 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at TOC Visit | Cure | 47 participants |
| TP-434, 1.0 mg/kg q12h | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at TOC Visit | Indeterminate | 8 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at TOC Visit | Indeterminate | 1 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at TOC Visit | Failure | 2 participants |
| Ertapenem 1 g q24h | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at TOC Visit | Cure | 26 participants |
Secondary
Microbiologic Response to TP-434 and Ertapenem in the ME Population at the EOT Visit
Time frame: EOT Visit (4-14 days after first dose of study drug)
Population: All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, had a baseline pathogen identified, and had a microbiological response assessed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TP-434, 1.5 mg/kg q24h | Microbiologic Response to TP-434 and Ertapenem in the ME Population at the EOT Visit | Favorable | 40 participants |
| TP-434, 1.5 mg/kg q24h | Microbiologic Response to TP-434 and Ertapenem in the ME Population at the EOT Visit | Indeterminate | 0 participants |
| TP-434, 1.5 mg/kg q24h | Microbiologic Response to TP-434 and Ertapenem in the ME Population at the EOT Visit | Unfavorable | 2 participants |
| TP-434, 1.0 mg/kg q12h | Microbiologic Response to TP-434 and Ertapenem in the ME Population at the EOT Visit | Favorable | 41 participants |
| TP-434, 1.0 mg/kg q12h | Microbiologic Response to TP-434 and Ertapenem in the ME Population at the EOT Visit | Unfavorable | 0 participants |
| TP-434, 1.0 mg/kg q12h | Microbiologic Response to TP-434 and Ertapenem in the ME Population at the EOT Visit | Indeterminate | 0 participants |
| Ertapenem 1 g q24h | Microbiologic Response to TP-434 and Ertapenem in the ME Population at the EOT Visit | Favorable | 25 participants |
| Ertapenem 1 g q24h | Microbiologic Response to TP-434 and Ertapenem in the ME Population at the EOT Visit | Indeterminate | 0 participants |
| Ertapenem 1 g q24h | Microbiologic Response to TP-434 and Ertapenem in the ME Population at the EOT Visit | Unfavorable | 1 participants |
Secondary
Microbiologic Response to TP-434 and Ertapenem in the ME Population at the TOC Visit
Time frame: TOC Visit (10-14 days after last dose of study drug)
Population: All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, had a baseline pathogen identified, and had a microbiological response assessed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TP-434, 1.5 mg/kg q24h | Microbiologic Response to TP-434 and Ertapenem in the ME Population at the TOC Visit | Unfavorable | 3 participants |
| TP-434, 1.5 mg/kg q24h | Microbiologic Response to TP-434 and Ertapenem in the ME Population at the TOC Visit | Favorable | 39 participants |
| TP-434, 1.5 mg/kg q24h | Microbiologic Response to TP-434 and Ertapenem in the ME Population at the TOC Visit | Indeterminate | 0 participants |
| TP-434, 1.0 mg/kg q12h | Microbiologic Response to TP-434 and Ertapenem in the ME Population at the TOC Visit | Unfavorable | 0 participants |
| TP-434, 1.0 mg/kg q12h | Microbiologic Response to TP-434 and Ertapenem in the ME Population at the TOC Visit | Favorable | 41 participants |
| TP-434, 1.0 mg/kg q12h | Microbiologic Response to TP-434 and Ertapenem in the ME Population at the TOC Visit | Indeterminate | 0 participants |
| Ertapenem 1 g q24h | Microbiologic Response to TP-434 and Ertapenem in the ME Population at the TOC Visit | Favorable | 24 participants |
| Ertapenem 1 g q24h | Microbiologic Response to TP-434 and Ertapenem in the ME Population at the TOC Visit | Indeterminate | 0 participants |
| Ertapenem 1 g q24h | Microbiologic Response to TP-434 and Ertapenem in the ME Population at the TOC Visit | Unfavorable | 2 participants |
Secondary
Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the EOT Visit
Microbiological response was classified as favorable (eradication or presumed eradication), unfavorable (persistence, presumed persistence, superinfection, or new infection), or indeterminate (assessment not possible).
Time frame: EOT Visit (4-14 days after first dose of study drug)
Population: All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and had a baseline pathogen identified. The minimal disease definition of cIAI included IAI that extended beyond the hollow viscus of origin into the peritoneal space and was associated with either abscess formation or peritonitis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TP-434, 1.5 mg/kg q24h | Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the EOT Visit | Unfavorable | 2 participants |
| TP-434, 1.5 mg/kg q24h | Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the EOT Visit | Favorable | 41 participants |
| TP-434, 1.5 mg/kg q24h | Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the EOT Visit | Indeterminate | 2 participants |
| TP-434, 1.0 mg/kg q12h | Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the EOT Visit | Favorable | 44 participants |
| TP-434, 1.0 mg/kg q12h | Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the EOT Visit | Indeterminate | 3 participants |
| TP-434, 1.0 mg/kg q12h | Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the EOT Visit | Unfavorable | 0 participants |
| Ertapenem 1 g q24h | Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the EOT Visit | Indeterminate | 0 participants |
| Ertapenem 1 g q24h | Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the EOT Visit | Unfavorable | 1 participants |
| Ertapenem 1 g q24h | Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the EOT Visit | Favorable | 26 participants |
Secondary
Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the TOC Visit
Time frame: TOC Visit (10-14 days after last dose of study drug)
Population: All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and had a baseline pathogen identified. The minimal disease definition of cIAI included IAI that extended beyond the hollow viscus of origin into the peritoneal space and was associated with either abscess formation or peritonitis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TP-434, 1.5 mg/kg q24h | Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the TOC Visit | Unfavorable | 3 participants |
| TP-434, 1.5 mg/kg q24h | Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the TOC Visit | Favorable | 39 participants |
| TP-434, 1.5 mg/kg q24h | Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the TOC Visit | Indeterminate | 3 participants |
| TP-434, 1.0 mg/kg q12h | Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the TOC Visit | Unfavorable | 0 participants |
| TP-434, 1.0 mg/kg q12h | Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the TOC Visit | Favorable | 42 participants |
| TP-434, 1.0 mg/kg q12h | Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the TOC Visit | Indeterminate | 5 participants |
| Ertapenem 1 g q24h | Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the TOC Visit | Favorable | 24 participants |
| Ertapenem 1 g q24h | Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the TOC Visit | Indeterminate | 1 participants |
| Ertapenem 1 g q24h | Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the TOC Visit | Unfavorable | 2 participants |
Secondary
Pharmacokinetics: Area Under the Concentration Time Curve From Time 0 to 12 Hours (AUC[0-12]) of TP-434
Time frame: Prior to first infusion and 1, 3, 7, 12, 48, and 108 hours after start of first infusion
Population: All randomized participants without significant protocol deviations who received at least 1 dose of TP-434 and had evaluable AUC(0-12) data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TP-434, 1.5 mg/kg q24h | Pharmacokinetics: Area Under the Concentration Time Curve From Time 0 to 12 Hours (AUC[0-12]) of TP-434 | 4349.900 nanogram*hours per milliliter (ng*h/mL) | Standard Deviation 2186.791 |
| TP-434, 1.0 mg/kg q12h | Pharmacokinetics: Area Under the Concentration Time Curve From Time 0 to 12 Hours (AUC[0-12]) of TP-434 | 3240.724 nanogram*hours per milliliter (ng*h/mL) | Standard Deviation 1732.172 |
Secondary
Pharmacokinetics: Maximum Concentration (Cmax) of TP-434
Time frame: Prior to first infusion and 1, 3, 7, 12, 48, and 108 hours after start of first infusion
Population: All randomized participants without significant protocol deviations who received at least 1 dose of TP-434 and had evaluable Cmax data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TP-434, 1.5 mg/kg q24h | Pharmacokinetics: Maximum Concentration (Cmax) of TP-434 | 1445.625 nanograms per milliliter (ng/mL) | Standard Deviation 1168.029 |
| TP-434, 1.0 mg/kg q12h | Pharmacokinetics: Maximum Concentration (Cmax) of TP-434 | 952.608 nanograms per milliliter (ng/mL) | Standard Deviation 759.754 |