Complicated Intra-abdominal InfectionPhase 2NCT01265784
Study to Compare TP-434 and Ertapenem in Community-acquired Complicated Intra-abdominal Infections
A Phase 2 study testing TP-434 and Ertapenem in people with Complicated Intra-abdominal Infection, run by Tetraphase Pharmaceuticals, Inc at 38 sites in 6 countries.
Trial 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 (cIAIs). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Complicated Intra-abdominal Infection
- What is being tested?
- TP-434 and Ertapenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 38 sitesin 6 countries
- Study dates
- Jan 2011to May 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 IAI requiring urgent surgical or percutaneous intervention and not expected to require antibacterial therapy for longer than 14 days
- Body mass index (BMI) of ≤ 30 kilograms per square meter (kg/m^2)
- Able to provide informed consent. If the participant is unable to provide informed consent, the participant'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 (for example, 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
Who cannot join
- Symptoms related to diagnosis of complicated appendicitis (if current diagnosis) for < 24 hours 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
- Acute Physiology and Chronic Health Evaluation (APACHE) II score > 25
- Unlikely to survive the 6-8 week study period
Show all 24Show fewer
- 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 grams per deciliter (g/dL)
- Neutropenia with absolute neutrophil count < 1000 cells per cubic millimeter (mm^3)
- Platelet count < 50,000/mm3
- Abnormal coagulation tests or participant on anticoagulants
- Immunocompromised condition, including known human immunodeficiency virus (HIV) positivity or acquired immune deficiency syndrome (AIDS), organ (bone marrow) transplant recipients, and hematological malignancy. Immunosuppressive therapy, including use of high-dose corticosteroids (for example, > 40 milligrams [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 hours duration of systemic antibiotic coverage for current condition
- Received ertapenem or any other carbapenem, or tigecycline for the current infection
- 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
Trial locations and contacts
38 sites in 6 countries.
38 sites in 6 countries
India9 sites
HCG-Medisurge Hospitals Pvt. Ltd.
Ahmedabad, 380006
Santosh Hospital
Bangalore, 560005
K.R. Hospital
Bangalore, 560050
M.S. Ramalah Medical College and Hospitals
Bangalore, 560054
Bangalore Medical College and Research Institute, Victoria Hospital
Fort Mumbai, Bangalore, 560002
Sai Vani Hospitals, Ltd.
Hyderabad, 500029
S.R. Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan
Amrita Institute of Medical Sciences and Research Centre
Kochi, Kerala, 682041
Sahyadri Munot Hospital
Pune, Maharashtra, 411042
Bulgaria8 sites
MHAT "Yulia Vrevska - Byala" EOOD, Byala
Byala, 7100
UMHAT "Dr. Georgi Stranski" EAD, Pleven
Pleven, 5800
UMHAT "Sveti Georgi" EAD, Plovdiv
Plovdiv, 4000
MHAT "Russe" AD, Russe
Rousse, 7002
MHAT "Tokuda Hospital Sofia" AD, Sofia
Sofia, 1407
UMHAT "Tzaritza Yoanna" EAD, Sofia
Sofia, 1527
UMHATEM "N.I. Pirogov" EAD, Sofia
Sofia, 1606
UMHATEM "N.I.Pirogov" EAD, Sofia
Sofia, 1606
Lithuania6 sites
Kaunas Hospital
Kaunas, LT-45130
Kaunas Clinical Hospital
Kaunas, LT-47144
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, LT-50009
Klaipeda University Hospital
Klaipėda, LT-92288
Vilnius University Hospital Santariskiu Clinics
Vilnius, LT-08661
Vilnius City Clinical Hospital
Vilnius, LT-10207
Romania6 sites
"Dr. Carol Davila" Clinical Nephrology Hospital General Surgery Clinic
Bucharest, 010701
Emergency Clinical Hospital Bucharest
Bucharest, 014461
Coltea Clinical Hospital
Bucharest, 030171
:Sfantul loan" Clinical Emergency Hospital
Bucharest, 042122
University Emergency Hospital Bucharest
Bucharest, 050098
Emergency Clinical City Hospital
Timișoara, Timiș County, 300079
United States5 sites
Mercury Street Medical Group
Butte, Montana, 59701
Denver Health Medical Center
Denver, Colorado, 80204
Henry Ford Hospital
Detroit, Michigan, 48202
Long Beach VA Medical Center
Long Beach, California, 90822
Barnes Jewish Hospital
St Louis, Missouri, 63110
Latvia4 sites
Daugavpils Regional Hospital
Daugavpils, LV-5417
Jekabpils Regional Hospital
Jēkabpils, LV 5201
Rezeknes Hospital
Rēzekne, LV-4601
Vidzeme Hospital
Valmiera, LV-4201
About this study
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
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).
- Conditions
- Complicated Intra-abdominal Infection
- Being tested
- TP-434, Ertapenem, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TP-434Drug
Also called Eravacycline
ErtapenemDrug
Also called Invanz
PlaceboDrug
Administered IV to maintain the blind.
| Study group | Role | What they receive |
|---|---|---|
| TP-434, 1.5 mg/kg q24h | Experimental | TP-434 was administered intravenously (IV) at a dose of 1.5 milligrams per kilogram of body weight (mg/kg) every 24 hours (q24h) for a minimum of 4 days and a maximum of 14 days (7 days for participants in India). TP-434 treatment was to be stopped when symptoms of complicated intra-abdominal infection (cIAI) resolved, there was treatment failure, or the maximum allowed number of infusion days was reached. Receives: Drug: TP-434; Drug: Placebo |
| TP-434, 1.0 mg/kg q12h | Experimental | TP-434 was administered IV at a dose of 1.0 mg/kg every 12 hours (q12h) for a minimum of 4 days and a maximum of 14 days (7 days for participants in India). TP-434 treatment was to be stopped when symptoms of cIAI resolved, there was treatment failure, or the maximum allowed number of infusion days was reached. Receives: Drug: TP-434; Drug: Placebo |
| Ertapenem, 1 g q24h | Active comparator | Ertapenem was administered IV at a dose of 1 gram (g) q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India). Ertapenem treatment was to be stopped when symptoms of cIAI resolved, there was treatment failure, or the maximum allowed number of infusion days was reached. Receives: Drug: Ertapenem; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Test-of-Cure Visit
Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection [cIAI], persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (Test-of-Cure [TOC] assessment was not available, death unrelated to cIAI, or some other reason).
Measured: TOC Visit (10-14 days after last dose of study drug)
Secondary outcomes (20)
Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the End-of-Treatment (EOT) Visit
Measured: EOT Visit (4-14 days after first dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at TOC Visit
Measured: TOC Visit (10-14 days after last dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the Follow-up Visit
Measured: Follow-up Visit (28-42 days after last dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the EOT Visit
Measured: EOT Visit (4-14 days after first dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the TOC Visit
Measured: TOC Visit (10-14 days after last dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the Follow-up Visit
Measured: Follow-up Visit (28-42 days after last dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the EOT Visit
Measured: EOT Visit (4-14 days after first dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the TOC Visit
Measured: TOC Visit (10-14 days after last dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the Follow-up Visit
Measured: Follow-Up Visit (28-42 days after last dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the EOT Visit
Measured: EOT Visit (4-14 days after first dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the TOC Visit
Measured: TOC Visit (10-14 days after last dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the Follow-up Visit
Measured: Follow-up Visit (28-42 days after last dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the EOT Visit
Measured: EOT Visit (4-14 days after first dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Follow-up Visit
Measured: Follow-up Visit (28-42 days after last dose of study drug)
Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the EOT Visit
Microbiological response was classified as favorable (eradication or presumed eradication), unfavorable (persistence, presumed persistence, superinfection, or new infection), or indeterminate (assessment not possible).
Measured: EOT Visit (4-14 days after first dose of study drug)
Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the TOC Visit
Measured: TOC Visit (10-14 days after last dose of study drug)
Microbiologic Response to TP-434 and Ertapenem in the ME Population at the EOT Visit
Measured: EOT Visit (4-14 days after first dose of study drug)
Microbiologic Response to TP-434 and Ertapenem in the ME Population at the TOC Visit
Measured: TOC Visit (10-14 days after last dose of study drug)
Pharmacokinetics: Maximum Concentration (Cmax) of TP-434
Measured: Prior to first infusion and 1, 3, 7, 12, 48, and 108 hours after start of first infusion
Pharmacokinetics: Area Under the Concentration Time Curve From Time 0 to 12 Hours (AUC[0-12]) of TP-434
Measured: Prior to first infusion and 1, 3, 7, 12, 48, and 108 hours after start of first infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complicated Intra-abdominal InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tetraphase Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick T Horn, MD, PhD, Study director, Tetraphase Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265784
- Sponsor's protocol ID
- TP-434-P2-cIAI-1
- Status last verified
- Dec 2021
- First submitted
- 21 Dec 2010
- Last updated
- 6 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Solomkin JS, Ramesh MK, Cesnauskas G, Novikovs N, Stefanova P, Sutcliffe JA, Walpole SM, Horn PT. Phase 2, randomized, double-blind study of the efficacy and safety of two dose regimens of eravacycline versus ertapenem for adult community-acquired complicated intra-abdominal infections. Antimicrob Agents Chemother. 2014;58(4):1847-54. doi: 10.1128/AAC.01614-13. Epub 2013 Dec 16.
PubMed 24342651
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01265784
- Acronym / sponsor ID
- TP-434-P2-cIAI-1
- Conditions
- Complicated Intra-abdominal Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Tetraphase Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 23 Dec 2010 (estimated)
- Results
- Posted 4 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TP-434, 1.5 mg/kg q24h | Experimental | Drug: TP-434, Drug: PlaceboTP-434 was administered intravenously (IV) at a dose of 1.5 milligrams per kilogram of body weight (mg/kg) every 24 hours (q24h) for a minimum of 4 days and a maximum of 14 days (7 days for participants in India). TP-434 treatment was to be stopped when symptoms of complicated intra-abdominal infection (cIAI) resolved, there was treatment failure, or the maximum allowed number of infusion days was reached. |
| TP-434, 1.0 mg/kg q12h | Experimental | Drug: TP-434, Drug: PlaceboTP-434 was administered IV at a dose of 1.0 mg/kg every 12 hours (q12h) for a minimum of 4 days and a maximum of 14 days (7 days for participants in India). TP-434 treatment was to be stopped when symptoms of cIAI resolved, there was treatment failure, or the maximum allowed number of infusion days was reached. |
| Ertapenem, 1 g q24h | Active comparator | Drug: Ertapenem, Drug: PlaceboErtapenem was administered IV at a dose of 1 gram (g) q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India). Ertapenem treatment was to be stopped when symptoms of cIAI resolved, there was treatment failure, or the maximum allowed number of infusion days was reached. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 IAI requiring urgent surgical or percutaneous intervention and not expected to require antibacterial therapy for longer than 14 days
- Body mass index (BMI) of ≤ 30 kilograms per square meter (kg/m^2)
Key exclusion criteria (24 listed)
- Symptoms related to diagnosis of complicated appendicitis (if current diagnosis) for < 24 hours 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
- Acute Physiology and Chronic Health Evaluation (APACHE) II score > 25
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TP-434Also: Eravacycline | Drug | TP-434, 1.0 mg/kg q12h, TP-434, 1.5 mg/kg q24h |
| ErtapenemAlso: Invanz | Drug | Ertapenem, 1 g q24h |
| PlaceboAdministered IV to maintain the blind. | Drug | Ertapenem, 1 g q24h, TP-434, 1.0 mg/kg q12h, TP-434, 1.5 mg/kg q24h |
Primary outcome
Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Test-of-Cure Visit
Time frame: TOC Visit (10-14 days after last dose of study drug)
Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection [cIAI], persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (Test-of-Cure [TOC] assessment was not available, death unrelated to cIAI, or some other reason).
20 secondary outcomes
Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the End-of-Treatment (EOT) Visit
Time frame: EOT Visit (4-14 days after first dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at TOC Visit
Time frame: TOC Visit (10-14 days after last dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the Follow-up Visit
Time frame: Follow-up Visit (28-42 days after last dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the EOT Visit
Time frame: EOT Visit (4-14 days after first dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the TOC Visit
Time frame: TOC Visit (10-14 days after last dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the Follow-up Visit
Time frame: Follow-up Visit (28-42 days after last dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the EOT Visit
Time frame: EOT Visit (4-14 days after first dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the TOC Visit
Time frame: TOC Visit (10-14 days after last dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the Follow-up Visit
Time frame: Follow-Up Visit (28-42 days after last dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the EOT Visit
Time frame: EOT Visit (4-14 days after first dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the TOC Visit
Time frame: TOC Visit (10-14 days after last dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the Follow-up Visit
Time frame: Follow-up Visit (28-42 days after last dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the EOT Visit
Time frame: EOT Visit (4-14 days after first dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Follow-up Visit
Time frame: Follow-up Visit (28-42 days after last dose of study drug)
Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the EOT Visit
Time frame: EOT Visit (4-14 days after first dose of study drug)
Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the TOC Visit
Time frame: TOC Visit (10-14 days after last dose of study drug)
Microbiologic Response to TP-434 and Ertapenem in the ME Population at the EOT Visit
Time frame: EOT Visit (4-14 days after first dose of study drug)
Microbiologic Response to TP-434 and Ertapenem in the ME Population at the TOC Visit
Time frame: TOC Visit (10-14 days after last dose of study drug)
Pharmacokinetics: Maximum Concentration (Cmax) of TP-434
Time frame: Prior to first infusion and 1, 3, 7, 12, 48, and 108 hours after start of first infusion
Pharmacokinetics: Area Under the Concentration Time Curve From Time 0 to 12 Hours (AUC[0-12]) of TP-434
Time frame: Prior to first infusion and 1, 3, 7, 12, 48, and 108 hours after start of first infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24342651Solomkin JS, Ramesh MK, Cesnauskas G, Novikovs N, Stefanova P, Sutcliffe JA, Walpole SM, Horn PT. Phase 2, randomized, double-blind study of the efficacy and safety of two dose regimens of eravacycline versus ertapenem for adult community-acquired complicated intra-abdominal infections. Antimicrob Agents Chemother. 2014;58(4):1847-54. doi: 10.1128/AAC.01614-13. Epub 2013 Dec 16.
Related trials for Complicated Intra-abdominal Infection
RecruitingPhase 2
Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections
Gram-negative Bacterial Infections
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
RecruitingObservational study
A Study to Learn About the Study Medicine Zavicefta After it is Released Into the Markets in Korea
Complicated Intra-abdominal Infection, Complicated Urinary Tract Infection
RecruitingObservational study
Exclusive Enteral Nutrition Therapy for Active and Complicated Crohn's Disease
Crohn's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick T Horn, MD, PhD study director
Tetraphase Pharmaceuticals, Inc
38 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TP-434 and Ertapenem in people with Complicated Intra-abdominal Infection, run by Tetraphase Pharmaceuticals, Inc at 38 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in India, Bulgaria, Lithuania, Romania, United States and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Test-of-Cure Visit (time frame: TOC Visit (10-14 days after last dose of study drug)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01265784, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2022.