A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI

October 31, 2018 updated by: Synthetic Biologics Inc.

A Double-Blind, Placebo-Controlled, Multicenter Study of SYN-004 Compared to Placebo for the Prevention of C.Diff in Patients With a Diagnosis of a Lower Respiratory Tract Infection

A Phase 2b Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study of SYN-004 Compared to Placebo for the Prevention of Clostridium difficile Infection (CDI) in Hospitalized Patients receiving IV ceftriaxone with a Diagnosis of a Lower Respiratory Tract Infection (LRTI).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase 2b, randomized, double-blind, placebo controlled, parallel-group, multi-center proof-of-concept study to assess the potential of SYN-004 in the prevention of CDI and the unwanted side effects of IV antibiotic treatment in at risk patients who are hospitalized for LRTI and receiving IV ceftriaxone alone or in combination with a macrolide. Subjects will be 50 years or older. The entire duration of the study may be up to 59 days. All patients will be evaluated for the occurrence of CDI and AAD by testing according to local diagnostic standards and monitoring for diarrhea (3 or more unformed stools per 24 hour period).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
413

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Gabrovo, Bulgaria
        • Synthetic Biologics Investigational Site
      • Kyustendil, Bulgaria
        • Synthetic Biologics Investigational Site
      • Lovech, Bulgaria
        • Synthetic Biologics Investigational Site
      • Multiple Locations, Bulgaria
        • Synthetic Biologics Investigational Site
      • Ruse, Bulgaria
        • Synthetic Biologics Investigational Site
      • Sevlievo, Bulgaria
        • Synthetic Biologics Investigational Site
      • Sofia, Bulgaria
        • Synthetic Biologics Investigational Site
      • Tărgovište, Bulgaria
        • Synthetic Biologics Investigational Site
  • Canada
      • Sherbrooke, Canada
        • Synthetic Biologics Investigational Site
      • Toronto, Canada
        • Synthetic Biologics Investigational Site
  • Hungary
      • Balassagyarmat, Hungary
        • Synthetic Biologics Investigational Site
      • Budapest, Hungary
        • Synthetic Biologics Investigational Site
      • Veszprém, Hungary
        • Synthetic Biologics Investigational Site
  • Poland
      • Białystok, Poland
        • Synthetic Biologics Investigational Site
      • Bochnia, Poland
        • Synthetic Biologics Investigational Site
      • Bydgoszcz, Poland
        • Synthetic Biologics Investigational Site
      • Chodzież, Poland
        • Synthetic Biologics Investigational Site
      • Oława, Poland
        • Synthetic Biologics Investigational Site
      • Pomorskie, Poland
        • Synthetic Biologics Investigational Site
      • Siedlce, Poland
        • Synthetic Biologics Investigational Site
      • Tarnów, Poland
        • Synthetic Biologics Investigational Site
      • Tychy, Poland
        • SyntheticBiologics Investigational Site
      • Warszawice, Poland
        • Synthetic Biologics Investigational Site
      • Łódź, Poland
        • Synthetic Biologics Investigational Site
  • Romania
      • Arad, Romania
        • Synthetic Biologics Investigational Site
      • Braşov, Romania
        • Synthetic Biologics Investigational Site
      • Bucharest, Romania
        • Synthetic Biologics Investigational Site
      • Cluj-Napoca, Romania
        • Synthetic Biologics Investigational Site
      • Oradea, Romania
        • Synthetic Biologics Investigational Site
      • Otopeni, Romania
        • Synthetic Biologics Investigational Site
      • Timişoara, Romania
        • Synthetic Biologics Investigational Site
  • Serbia
      • Belgrade, Serbia
        • Synthetic Biologics Investigational Site
      • Gornji Matejevac, Serbia
        • Synthetic Biologics Investigational Site
      • Kragujevac, Serbia
        • Synthetic Biologics Investigational Site
      • Novi Sad, Serbia
        • Synthetic Biologics Investigational Site
      • Užice, Serbia
        • Synthetic Biologics Investigational Site
      • Čačak, Serbia
        • Synthetic Biologics Investigational Site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Synthetic Biologics Investigational Site
    • California
      • Torrance, California, United States, 90502
        • Synthetic Biologics Investigational Site
    • Florida
      • DeLand, Florida, United States, 32720
        • Synthetic Biologics Investigational Site
    • Louisiana
      • Będzin, Louisiana, United States, 71457
        • Synthetic Biologics Investigational Site
      • Debrecen, Louisiana, United States, 71457
        • Synthetic Biologics Investigational Site
      • Natchitoches, Louisiana, United States, 71457
        • Synthetic Biologics Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Expected minimum hospital stay of 5 days
  • Expected ≥5 day course of intravenous (IV) ceftriaxone alone or in combination with a macrolide
  • Clinical diagnosis of moderate to severe lower respiratory tract infection consisting of signs and symptoms of a lower respiratory tract infection and Pneumonia Severity Index (PSI/PORT) score for CAP of 90-130, inclusive. Evidence of a new or progressive infiltrate on chest x-ray is recommended.

Exclusion Criteria:

  • Presence of a diarrheal illness within 72 hours prior to randomization
  • Current treatment for CDAD or ongoing active CDI, as evidenced by clinical signs of diarrhea along with the presence of toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool
  • Number of previous CDAD episodes >1 within 12 weeks of randomization and no C. difficile infection (CDI) within 4 weeks of randomization
  • Use of antibiotics within 1 month of start of study drug except for the current illness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Matching placebo
Drug: Placebo
Experimental: SYN-004
SYN-004 150 mg
Drug: SYN-004

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Patients With Clostridium Difficile Infection at 4- Weeks of Follow-up.
Time Frame: Day 1 to the 4 week Follow-up Visit.
Percentage of subjects with CDI, based on the protocol definition of CDI (defined as 3 or more unformed stools per 24 hour period and a stool sample being positive for C. difficile toxin A and/or B [or their respective genes, tcdA and/or tcdB], based on the clinical site local laboratory results) from Day 1 to the 4-week Follow-up Visit in the SYN-004 treatment group compared to the placebo group, imputing early termination without CDI as not being treatment failures.
Day 1 to the 4 week Follow-up Visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Synthetic Biologics Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Michael Kaleko, MD, Synthetic Biologics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SB-2-004-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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