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