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Last Updated: December 9, 2024

CLINICAL TRIALS PROFILE FOR ERAVACYCLINE DIHYDROCHLORIDE


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All Clinical Trials for Eravacycline Dihydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01265784 ↗ Study to Compare TP-434 and Ertapenem in Community-acquired Complicated Intra-abdominal Infections Completed Tetraphase Pharmaceuticals, Inc. Phase 2 2011-01-01 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 (cIAIs).
NCT01844856 ↗ Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections Completed Tetraphase Pharmaceuticals, Inc. Phase 3 2013-08-01 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).
NCT01941446 ↗ A Thorough QT/QTc Study to Evaluate the Effects of an Intravenous Infusion of Eravacycline (TP-434) on Cardiac Repolarization Completed Tetraphase Pharmaceuticals, Inc. Phase 1 2013-03-01 This is a randomized, placebo- and positive-controlled (moxifloxacin), 3-period, 3-way crossover thorough QT study, which includes a Screening Period, Treatment Periods (1 through 3), and a Follow-up Visit. Subjects will be confined to the investigational site for 4 nights/3 days during Period 1 and for 3 nights/2 days during Periods 2 and 3. There will be a minimum of a 14 day washout between treatments.
NCT01978938 ↗ Efficacy and Safety Study of Eravacycline Compared With Levofloxacin in Complicated Urinary Tract Infections Completed Tetraphase Pharmaceuticals, Inc. Phase 3 2014-10-06 This is a phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy and safety of eravacycline compared with levofloxacin in participants with complicated urinary tract infections (cUTI).
NCT01989949 ↗ Safety and Pharmacokinetic (PK) Study to Assess Bronchopulmonary Disposition of IV Eravacycline (TP-434) in Healthy Men and Women Completed Department of Health and Human Services Phase 1 2012-11-01 This is a phase 1, open-label, randomized pharmacokinetic and safety study in healthy adult subjects, who will undergo bronchoscopy and bronchoalveolar lavage (BAL) after receiving seven (7) doses of 1.0 mg/kg IV TP-434.
NCT01989949 ↗ Safety and Pharmacokinetic (PK) Study to Assess Bronchopulmonary Disposition of IV Eravacycline (TP-434) in Healthy Men and Women Completed Tetraphase Pharmaceuticals, Inc. Phase 1 2012-11-01 This is a phase 1, open-label, randomized pharmacokinetic and safety study in healthy adult subjects, who will undergo bronchoscopy and bronchoalveolar lavage (BAL) after receiving seven (7) doses of 1.0 mg/kg IV TP-434.
NCT02135276 ↗ A Phase 1, Open-Label Study to Assess the Single-Dose Pharmacokinetics of Eravacycline in Subjects With End Stage Renal Disease and Healthy Subjects Completed Tetraphase Pharmaceuticals, Inc. Phase 1 2013-12-01 This is a multi-center, open-label clinical study to assess the single-dose PK of eravacycline in subjects with renal impairment and healthy subjects conducted at approximately 2 sites in the United States. This study includes an up to 21-day Screening Period, a 5-day Treatment Period, and an End of Study Visit occurring approximately 2 weeks (±2 days) after study drug administration. Approximately 12 subjects will be enrolled: 6 subjects with ESRD and 6 healthy subjects with normal renal function. Healthy subjects will be matched to renally impaired subjects in gender, age, and body mass index (BMI). All subjects will be administered a single IV dose of eravacycline (1.5 mg/kg).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Eravacycline Dihydrochloride

Condition Name

Condition Name for Eravacycline Dihydrochloride
Intervention Trials
Complicated Intra-abdominal Infections 2
Complicated Urinary Tract Infections (cUTI) 1
cUTI 1
End Stage Renal Disease 1
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Condition MeSH

Condition MeSH for Eravacycline Dihydrochloride
Intervention Trials
Infection 6
Infections 5
Communicable Diseases 5
Intraabdominal Infections 3
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Clinical Trial Locations for Eravacycline Dihydrochloride

Trials by Country

Trials by Country for Eravacycline Dihydrochloride
Location Trials
United States 46
Romania 6
India 5
Bulgaria 5
Latvia 5
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Trials by US State

Trials by US State for Eravacycline Dihydrochloride
Location Trials
California 6
Ohio 4
Nevada 4
Florida 3
Indiana 3
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Clinical Trial Progress for Eravacycline Dihydrochloride

Clinical Trial Phase

Clinical Trial Phase for Eravacycline Dihydrochloride
Clinical Trial Phase Trials
Phase 3 4
Phase 2 2
Phase 1 5
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Clinical Trial Status

Clinical Trial Status for Eravacycline Dihydrochloride
Clinical Trial Phase Trials
Completed 9
Not yet recruiting 1
Unknown status 1
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Clinical Trial Sponsors for Eravacycline Dihydrochloride

Sponsor Name

Sponsor Name for Eravacycline Dihydrochloride
Sponsor Trials
Tetraphase Pharmaceuticals, Inc. 10
Department of Health and Human Services 1
West Virginia University 1
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Sponsor Type

Sponsor Type for Eravacycline Dihydrochloride
Sponsor Trials
Industry 10
Other 1
U.S. Fed 1
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