Overview

This trial is active, not recruiting.

Condition complicated intra-abdominal infections
Treatments eravacycline, ertapenem
Phase phase 3
Sponsor Tetraphase Pharmaceuticals, Inc.
Start date August 2013
End date January 2015
Trial size 536 participants
Trial identifier NCT01844856, TP-434-008

Summary

This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of eravacycline compared with ertapenem in the treatment of adult complicated intra-abdominal infections (cIAI).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Eravacycline, 1.0 mg/kg q12h administered via IV infusion, plus saline placebo
eravacycline TP-434
Eravacycline reconstituted and administered via an IV infusion
(Active Comparator)
Ertapenem, 1 g q24h administered via IV infusion, plus saline placebo
ertapenem Invanz®
Ertapenem reconstituted and administered via an IV infusion

Primary Outcomes

Measure
Clinical response of eravacycline and ertapenem treatment arms at the test-of-cure (TOC) visit in the microbiological intent-to-treat (micro-ITT) population
time frame: TOC: 25-31 days after the first dose of study drug

Secondary Outcomes

Measure
Clinical response of eravacycline and ertapenem treatment arms at the end-of-treatment (EOT), TOC, and follow-up(FU) visits
time frame: EOT: within 24 hours of last dose; TOC: 25-31 days after first dose; FU: 38-50 days after first dose
Microbiologic response of eravacycline and ertapenem treatment arms at the EOT and TOC visits
time frame: EOT: within 24 hours of last dose; TOC: 25-31 days after first dose
Assess safety and tolerability of eravacycline (Adverse Events, Physical Exams, Vital signs, ECGs, Lab Data) in the safety population
time frame: Screening, Days 1-14, EOT, TOC, FU
Explore pharmacokinetic parameters after eravacycline infusion
time frame: Day 1

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Male or female subject hospitalized for complicated intra-abdominal infection 2. At least 18 years of age (and not over 65 years of age for subjects in India) 3. Evidence of a systemic inflammatory response 4. Abdominal pain or flank pain (with or without rebound tenderness), or pain caused by cIAI that is referred to another anatomic area 5. Able to provide informed consent 6. If male: must agree to use an effective barrier method of contraception during the study and for 90 days following the last dose if sexually active with a female of childbearing potential 7. If female, not pregnant or nursing or, if of childbearing 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: 1. Unlikely to survive the 6-8 week study period 2. Renal failure 3. Presence or possible signs of hepatic disease 4. Immunocompromised condition, including known HIV positivity (requiring anti-retroviral therapy or with CD4 count <300), 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) 5. History of hypersensitivity reactions to tetracyclines, carbapenems, β-lactam antibiotics or to excipients contained in the study drug formulations 6. Participation in any investigational drug or device study within 30 days prior to study entry 7. Known or suspected current Central Nervous System disorder that may predispose to seizures or lower seizure threshold 8. Previously received eravacycline in a clinical trial 9. Antibiotic-related exclusions: 1. Receipt of effective antibacterial drug therapy for cIAI for a continuous duration of > 24-h during the 72-h preceding enrollment (however, subjects with documented cIAI (i.e., known baseline pathogen) who have received at least 72-h of antibiotic therapy and are considered treatment failures may be enrolled. Treatment failure is defined as persistent fever and/or clinical symptoms; or the development of a new intra-abdominal abscess after ≥ 72-h of antibiotic therapy), or 2. Receipt of ertapenem or any other carbapenem, or tigecycline for the current infection or 3. Need for concomitant systemic antimicrobial agents other than study drug 10. Refusal of mechanical ventilation, dialysis or hemofiltration, cardioversion or any other resuscitative measures and drug/fluid therapy at time of consent 11. Known or suspected inflammatory bowel disease or associated visceral abscess 12. The anticipated need for systemic antibiotics for a duration of more than 14 days 13. Systemic malignancy that required chemotherapy, immunotherapy, radiation therapy or antineoplastic therapy within the previous 3 months or that is anticipated to begin prior to the TOC visit

Additional Information

Official title A Phase 3, Randomized, Double-Blind, Double-Dummy, Multicenter, Prospective Study to Assess the Efficacy and Safety of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Tetraphase Pharmaceuticals, Inc..