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

Information source: Tetraphase Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Complicated Intra-Abdominal Infection

Intervention: TP-434 (Drug); Ertapenem (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Tetraphase Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
Patrick T Horn, MD, PhD, Study Director, Affiliation: Tetraphase Pharmaceuticals, Inc.


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.

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Clinical response of TP-434 and ertapenem in the microbiologically evaluable population

Secondary outcome:

Clinical response of TP-434 and ertapenem

Determine microbiologic response of TP-434 and ertapenem

Assess Safety and Tolerability of TP-434 (Adverse Events, Physical Exams, Vital Signs, ECGs, Lab Data)

Explore the PK of TP-434 and ertapenem


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


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 intra-abdominal infection requiring urgent

surgical or percutaneous intervention and not expected to require antibacterial therapy for longer than 14 days

- Body mass index (BMI) of ≤ 30 kg/m2

- Able to provide informed consent. If the patient is unable to provide informed

consent, the patient'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 (e. g., 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 hrs 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

- 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 g/dL

- Neutropenia with absolute neutrophil count < 1000/mm3

- Platelet count < 50,000/mm3

- Abnormal coagulation tests or patient on anticoagulants

- Immunocompromised condition, including known HIV positivity or AIDS, organ (bone

marrow) transplant recipients, and hematological malignancy. Immunosuppressive therapy, including use of high-dose corticosteroids (e. g., > 40 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 hrs duration of systemic antibiotic coverage for current condition or

received ertapenem or any other carbapenem, or tigecycline for the current infection or

- 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

Locations and Contacts

MHAT "Yulia Vrevska - Byala" EOOD, Byala, Byala 7100, Bulgaria

UMHAT "Dr. Georgi Stranski" EAD, Pleven, Pleven 5800, Bulgaria

UMHAT "Sveti Georgi" EAD, Plovdiv, Plovdiv 4000, Bulgaria

MHAT "Russe" AD, Russe, Russe 7002, Bulgaria

MHAT "Tokuda Hospital Sofia" AD, Sofia, Sofia 1407, Bulgaria

UMHAT "Tzaritza Yoanna" EAD, Sofia, Sofia 1527, Bulgaria

UMHATEM "N.I. Pirogov" EAD, Sofia, Sofia 1606, Bulgaria

UMHATEM "N.I.Pirogov" EAD, Sofia, Sofia 1606, Bulgaria

HCG-Medisurge Hospitals Pvt. Ltd., Ahmedabad 380006, India

K.R. Hospital, Bangalore 560050, India

M.S. Ramalah Medical College and Hospitals, Bangalore 560054, India

Santosh Hospital, Bangalore 560005, India

Sai Vani Hospitals, Ltd., Hyderabad 500029, India

Daugavpils Regional Hospital, Daugavpils LV-5417, Latvia

Jekabpils Regional Hospital, Jekabpils LV 5201, Latvia

Rezeknes Hospital, Rezekne LV-4601, Latvia

Vidzeme Hospital, Valmiera LV-4201, Latvia

Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Kaunas LT-50009, Lithuania

Kaunas Clinical Hospital, Kaunas LT-47144, Lithuania

Kaunas Hospital, Kaunas LT-45130, Lithuania

Klaipeda University Hospital, Klaipeda LT-92288, Lithuania

Vilnius City Clinical Hospital, Vilnius LT-10207, Lithuania

Vilnius University Hospital Santariskiu Clinics, Vilnius LT-08661, Lithuania

"Dr. Carol Davila" Clinical Nephrology Hospital General Surgery Clinic, Bucharest 010701, Romania

:Sfantul loan" Clinical Emergency Hospital, Bucharest 042122, Romania

Coltea Clinical Hospital, Bucharest 030171, Romania

Emergency Clinical Hospital Bucharest, Bucharest 014461, Romania

University Emergency Hospital Bucharest, Bucharest 050098, Romania

Bangalore Medical College and Research Institute, Victoria Hospital, Fort, Bangalore 560002, India

Long Beach VA Medical Center, Long Beach, California 90822, United States

Denver Health Medical Center, Denver, Colorado 80204, United States

Amrita Institute of Medical Sciences and Research Centre, Kochi, Kerala 682041, India

Sahyadri Munot Hospital, Pune, Maharashtra 411042, India

Henry Ford Hospital, Detroit, Michigan 48202, United States

Barnes Jewish Hospital, St. Louis, Missouri 63110, United States

Mercury Street Medical Group, Butte, Montana 59701, United States

S.R. Kalla Memorial Gastro & General Hospital, Jaipur, Rajasthan, India

Emergency Clinical City Hospital, Timisoara, Timis 300079, Romania

Additional Information

Starting date: March 2011
Last updated: July 5, 2012

Page last updated: August 23, 2015

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