A Phase 3 interventional study of Eravacycline and Meropenem in Complicated Intra-abdominal Infections and Complicated Appendicitis, sponsored by Tetraphase Pharmaceuticals, Inc.. Completed at 54 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-06.
Sponsored by Tetraphase Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment
This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics (PK) of eravacycline compared with meropenem in the treatment of complicated intra-abdominal infections (cIAIs).
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 500 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Tetraphase Pharmaceuticals, Inc. is the lead sponsor of 15 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Antibiotic-related exclusions:
Drug: Eravacycline · Drug: Placebo
Drug: Meropenem · Drug: Placebo
Also known as: TP-434
Also known as: Merrem
Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population
Clinical cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no additional antibacterial therapy, surgical, or radiological intervention was required. Clinical failure was defined as death related to complicated intra-abdominal infection (cIAI), persistence of clinical symptoms of cIAI, unplanned surgical or percutaneous drainage procedures for complication or recurrence of cIAI, post-surgical wound infections requiring systemic antibiotics, or initiation of rescue antibacterial drug therapy for treatment of cIAI. Indeterminate/missing was defined as an outcome that was neither a clinical cure nor clinical failure, if the investigator did not complete an assessment, if a study visit was not conducted, or if the subject died for a cause unrelated to cIAI.
Time frame: TOC visit: 25-31 days after first dose of study drug
Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the All-Treated (MITT) Population
Clinical cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no additional antibacterial therapy, surgical, or radiological intervention was required. Clinical failure was defined as death related to complicated intra-abdominal infection (cIAI), persistence of clinical symptoms of cIAI, unplanned surgical or percutaneous drainage procedures for complication or recurrence of cIAI, post-surgical wound infections requiring systemic antibiotics, or initiation of rescue antibacterial drug therapy for treatment of cIAI. Indeterminate/missing was defined as an outcome that was neither a clinical cure nor clinical failure, if the investigator did not complete an assessment, if a study visit was not conducted, or if the subject died for a cause unrelated to cIAI.
Time frame: TOC visit: 25-31 days after first dose of study drug
Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population
Clinical cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no additional antibacterial therapy, surgical, or radiological intervention was required. Clinical failure was defined as death related to complicated intra-abdominal infection (cIAI), persistence of clinical symptoms of cIAI, unplanned surgical or percutaneous drainage procedures for complication or recurrence of cIAI, post-surgical wound infections requiring systemic antibiotics, or initiation of rescue antibacterial drug therapy for treatment of cIAI.
Time frame: TOC visit: 25-31 days after first dose of study drug
Subjects with a diagnosis of complicated intra-abdominal infection (cIAI) requiring surgery were recruited into this study. Subjects were recruited in 65 centers worldwide. The first subject enrolled on 13 October 2016 and the last subject completed on 19 May 2017.
| Milestone | Eravacycline | Meropenem |
|---|---|---|
| Started | 250 | 250 |
| Treated | 250 | 249 |
| Completed | 237 | 241 |
| Not completed | 13 | 9 |
| Withdrew: Adverse event | 4 | 2 |
| Withdrew: Lost to follow-up | 6 | 4 |
| Withdrew: Withdrawal by subject | 1 | 3 |
| Withdrew: Subject non compliance | 2 | 0 |
Clinical cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no additional antibacterial therapy, surgical, or radiological intervention was required. Clinical failure was defined as death related to complicated intra-abdominal infection (cIAI), persistence of clinical symptoms of cIAI, unplanned surgical or percutaneous drainage procedures for complication or recurrence of cIAI, post-surgical wound infections requiring systemic antibiotics, or initiation of rescue antibacterial drug therapy for treatment of cIAI. Indeterminate/missing was defined as an outcome that was neither a clinical cure nor clinical failure, if the investigator did not complete an assessment, if a study visit was not conducted, or if the subject died for a cause unrelated to cIAI.
| Participants | Eravacycline | Meropenem |
|---|---|---|
| Clinical Cure | 177 | 187 |
| Clinical Failure | 7 | 7 |
| Indeterminate/missing | 11 | 11 |
Clinical cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no additional antibacterial therapy, surgical, or radiological intervention was required. Clinical failure was defined as death related to complicated intra-abdominal infection (cIAI), persistence of clinical symptoms of cIAI, unplanned surgical or percutaneous drainage procedures for complication or recurrence of cIAI, post-surgical wound infections requiring systemic antibiotics, or initiation of rescue antibacterial drug therapy for treatment of cIAI. Indeterminate/missing was defined as an outcome that was neither a clinical cure nor clinical failure, if the investigator did not complete an assessment, if a study visit was not conducted, or if the subject died for a cause unrelated to cIAI.
| Participants | Eravacycline | Meropenem |
|---|---|---|
| Clinical Cure | 231 | 228 |
| Clinical Failure | 7 | 9 |
| Indeterminate/missing | 12 | 12 |
Clinical cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no additional antibacterial therapy, surgical, or radiological intervention was required. Clinical failure was defined as death related to complicated intra-abdominal infection (cIAI), persistence of clinical symptoms of cIAI, unplanned surgical or percutaneous drainage procedures for complication or recurrence of cIAI, post-surgical wound infections requiring systemic antibiotics, or initiation of rescue antibacterial drug therapy for treatment of cIAI.
| Participants | Eravacycline | Meropenem |
|---|---|---|
| Clinical Cure | 218 | 222 |
| Clinical Failure | 7 | 9 |
Collected over 52 days. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Eravacycline | 4/250 (1.6%) | 15/250 (6%) | 29/250 (11.6%) |
| Meropenem | 1/249 (0.4%) | 16/249 (6.4%) | 8/249 (3.2%) |
| Event | Eravacycline | Meropenem |
|---|---|---|
| PneumoniaInfections and infestations | 2/250 | 1/249 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/250 | 1/249 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/250 | 1/249 |
| Atrial fibrillationCardiac disorders | 0/250 | 1/249 |
| Cardiac arrestCardiac disorders | 0/250 | 1/249 |
| Cholecystitis acuteHepatobiliary disorders | 0/250 | 1/249 |
| Duodenal ulcerGastrointestinal disorders | 0/250 | 1/249 |
| Duodenal ulcer haemorrhageGastrointestinal disorders | 0/250 | 1/249 |
| Gallbladder cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/250 | 1/249 |
| HypotensionVascular disorders | 0/250 | 1/249 |
| Event | Eravacycline | Meropenem |
|---|---|---|
| NauseaGastrointestinal disorders | 12/250 | 2/249 |
| VomitingGastrointestinal disorders | 9/250 | 5/249 |
| Infusion site phlebitisGeneral disorders | 8/250 | 1/249 |
Modified Intent-to-Treat Population: all randomized subjects who receive any amount of study drug.
| Age, Categorical(Participants) | Eravacycline | Meropenem | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 180 | 174 | 354 |
| >=65 years | 70 | 75 | 145 |
| Age, Continuous(years) | Eravacycline | Meropenem | Total |
|---|---|---|---|
| Mean | 52.1 ± 17.69 | 52.8 ± 18.24 | 52.4 ± 17.931 |
| Sex: Female, Male(Participants) | Eravacycline | Meropenem | Total |
|---|---|---|---|
| Female | 111 | 120 | 231 |
| Male | 139 | 129 | 268 |
| Ethnicity (NIH/OMB)(Participants) | Eravacycline | Meropenem | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 0 | 4 |
| Not Hispanic or Latino | 239 | 238 | 477 |
| Unknown or Not Reported | 7 | 11 | 18 |
| Race (NIH/OMB)(Participants) | Eravacycline | Meropenem | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 249 | 249 | 498 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Eravacycline | Meropenem | Total |
|---|---|---|---|
| Latvia | 34 | 33 | 67 |
| Romania | 23 | 34 | 57 |
| Hungary | 10 | 20 | 30 |
| United States | 8 | 4 | 12 |
| Czechia | 13 | 16 | 29 |
| Ukraine | 39 | 43 | 82 |
| Georgia | 8 | 16 | 24 |
| Bulgaria | 52 | 41 | 93 |
| Lithuania | 22 | 18 | 40 |
| Estonia | 20 | 11 | 31 |
| Russia | 21 | 13 | 34 |
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Tetraphase Pharmaceuticals, Inc.