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Clinical Trials/EUCTR2010-022548-19-BG
EUCTR2010-022548-19-BG
Active, not recruiting
Not Applicable

A Phase 2, Randomized, Double-Blind, Double-Dummy, Multicenter,Prospective Study to Assess the Efficacy, Safety and Pharmacokinetics of 2Dose Regimens of TP-434 Compared with Ertapenem in Adult Community-Acquired Complicated Intra-abdominal Infections

Tetraphase Pharmaceuticals, Inc.0 sites200 target enrollmentMarch 2, 2011
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ConditionsCommunity-acquired complicated intra-abdominal infectionMedDRA version: 12.1Level: LLTClassification code 10056570Term: Intra-abdominal infection
DrugsInvanz

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Community-acquired complicated intra-abdominal infection
Sponsor
Tetraphase Pharmaceuticals, Inc.
Enrollment
200
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 2, 2011
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Subjects must meet all of the following criteria:
  • •1\. Abdominal pain/discomfort with onset prior to hospitalization.
  • •2\. Evidence of a systemic inflammatory response with at least one of the following:
  • •a. Fever (oral temperature \> 100\.4°F / 38°C) or hypothermia (oral temperature \<
  • •35°C / 95°F)
  • •b. Elevated WBC ( \> 10,500/mm3\)
  • •c. Tachycardia (Heart rate \> 90 beats/min)
  • •d. Tachypnea ( \> 20 breaths/min)
  • •3\. Physical findings consistent with intra\-abdominal infection (IAI), defined as localized or diffuse abdominal tenderness (Other supportive findings include presence of a mass, ileus, or rebound tenderness)
  • •4\. Clinical diagnosis of community\-acquired intra\-abdominal infection requiring urgent

Exclusion Criteria

  • •1\. Symptoms related to diagnosis of complicated appendicitis (if current diagnosis) for \< 24 hrs prior to current hospitalization
  • •2\. Previously hospitalized or admitted to a healthcare facility (includes nursing or
  • •convalescent home) within the last 6 months
  • •3\. Managed by Staged Abdominal Repair or other open abdomen technique
  • •4\. Known at study entry to have an IAI caused by a pathogen(s) resistant to one of the study drug antibiotics
  • •5\. Acute Physiology and Chronic Health Evaluation (APACHE) II score \> 25
  • •6\. Considered unlikely to survive the 6\-8 week study period
  • •7\. Any rapidly\-progressing disease or immediately life\-threatening illness, including acute hepatic failure, respiratory failure and septic shock
  • •8\. Requirement for vasopressors at therapeutic dosages (i.e., dopamine greater than 5
  • •µg/kg/min, any dose of norepinephrine, epinephrine or phenylephrine) to maintain a systolic blood pressure \> 90 mm Hg or a mean arterial pressure \> 70 mm Hg

Outcomes

Primary Outcomes

Not specified

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