Study to Compare TP-434 and Ertapenem in Community-acquired Complicated Intra-abdominal Infections

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01265784
• Date of registration: 21/12/2010
• Prospective Registration: Yes
• Primary sponsor: Tetraphase Pharmaceuticals, Inc.
• Public title: Study to Compare TP-434 and Ertapenem in Community-acquired Complicated Intra-abdominal Infections
• Scientific title: A Phase 2, Randomized, Double-Blind, Double-Dummy, Multicenter, Prospective Study to Assess the Efficacy, Safety, and PK of 2 Dose Regimens of TP-434 Compared With Ertapenem in Adult Community-Acquired Complicated Intra-abdominal Infections
• Date of first enrolment: January 2011
• Target sample size: 143
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01265784
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Bulgaria, India, Latvia, Lithuania, Romania, United States

Contacts

• Name: Patrick T Horn, MD, PhD
• Affiliation: Tetraphase Pharmaceuticals, Inc.

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Complicated Intra-abdominal Infection

Intervention(s)

Drug: Ertapenem

Drug: Placebo

Drug: TP-434

Primary Outcome(s)

Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Test-of-Cure Visit [Time Frame: TOC Visit (10-14 days after last dose of study drug)]

Secondary Outcome(s)

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)]

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)]

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)]

Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the EOT Visit [Time Frame: 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 TOC Visit [Time Frame: TOC Visit (10-14 days after last dose of study drug)]

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)]

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)]

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)]

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)]

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)]

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)]

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)]

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)]

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)]

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]

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)]

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]

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)]

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)]

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)]

Secondary ID(s)

TP-434-P2-cIAI-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/09/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01265784