| 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). | 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. | Posted | | Number | | participants | | TOC Visit (10-14 days after last dose of study drug) | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
| | | Title | Denominators | Categories |
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| Cure | | | | Failure | | |
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| Secondary | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the End-of-Treatment (EOT) Visit | | All randomized participants who received at least 1 dose of study drug. | Posted | | Number | | participants | | EOT Visit (4-14 days after first dose of study drug) | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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| Secondary | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at TOC Visit | | All randomized participants who received at least 1 dose of study drug. | Posted | | Number | | participants | | TOC Visit (10-14 days after last dose of study drug) | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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| Secondary | Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the Follow-up Visit | | All randomized participants who received at least 1 dose of study drug. | Posted | | Number | | participants | | Follow-up Visit (28-42 days after last dose of study drug) | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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| Secondary | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the EOT Visit | | 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. | Posted | | Number | | participants | | EOT Visit (4-14 days after first dose of study drug) | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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| Secondary | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the TOC Visit | | 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. | Posted | | Number | | participants | | TOC Visit (10-14 days after last dose of study drug) | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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| Secondary | Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the Follow-up Visit | | 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. | Posted | | Number | | participants | | Follow-up Visit (28-42 days after last dose of study drug) | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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| Secondary | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the EOT Visit | | 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. | Posted | | Number | | participants | | EOT Visit (4-14 days after first dose of study drug) | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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| Secondary | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the TOC Visit | | 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. | Posted | | Number | | participants | | TOC Visit (10-14 days after last dose of study drug) | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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| Secondary | Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the Follow-up Visit | | 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. | Posted | | Number | | participants | | Follow-Up Visit (28-42 days after last dose of study drug) | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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| Secondary | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the EOT Visit | | 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. | Posted | | Number | | participants | | EOT Visit (4-14 days after first dose of study drug) | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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| Secondary | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the TOC Visit | | 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. | Posted | | Number | | participants | | TOC Visit (10-14 days after last dose of study drug) | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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| Secondary | Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the Follow-up Visit | | 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. | Posted | | Number | | participants | | Follow-up Visit (28-42 days after last dose of study drug) | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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| Secondary | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the EOT Visit | | 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. | Posted | | Number | | participants | | EOT Visit (4-14 days after first dose of study drug) | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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| Secondary | Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Follow-up Visit | | 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. | Posted | | Number | | participants | | Follow-up Visit (28-42 days after last dose of study drug) | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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| 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). | 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. | Posted | | Number | | participants | | EOT Visit (4-14 days after first dose of study drug) | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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| Secondary | Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the TOC Visit | | 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. | Posted | | Number | | participants | | TOC Visit (10-14 days after last dose of study drug) | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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| Secondary | Microbiologic Response to TP-434 and Ertapenem in the ME Population at the EOT Visit | | 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. | Posted | | Number | | participants | | EOT Visit (4-14 days after first dose of study drug) | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
| |
| Secondary | Microbiologic Response to TP-434 and Ertapenem in the ME Population at the TOC Visit | | 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. | Posted | | Number | | participants | | TOC Visit (10-14 days after last dose of study drug) | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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| Secondary | Pharmacokinetics: Maximum Concentration (Cmax) of TP-434 | | All randomized participants without significant protocol deviations who received at least 1 dose of TP-434 and had evaluable Cmax data. | Posted | | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | | Prior to first infusion and 1, 3, 7, 12, 48, and 108 hours after start of first infusion | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). |
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| Secondary | Pharmacokinetics: Area Under the Concentration Time Curve From Time 0 to 12 Hours (AUC[0-12]) of TP-434 | | All randomized participants without significant protocol deviations who received at least 1 dose of TP-434 and had evaluable AUC(0-12) data. | Posted | | Mean | Standard Deviation | nanogram*hours per milliliter (ng*h/mL) | | Prior to first infusion and 1, 3, 7, 12, 48, and 108 hours after start of first infusion | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). |
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