Community Acquired PneumoniaPhase 2NCT00270517
Comparative Study of EDP-420 Versus Another Antibiotic in the Treatment of Community Acquired Pneumonia
A Phase 2 study testing EDP-420 / Duration of Treatment - 3 days and Telithromycin / Duration of Treatment - 7 days in people with Community Acquired Pneumonia, run by Enanta Pharmaceuticals, Inc at 1 site in United States.
Trial summary
This study will compare the efficacy, safety and tolerability of EDP-420 versus another oral antibiotic in the treatment of community acquired pneumonia Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Community Acquired Pneumonia
- What is being tested?
- EDP-420 / Duration of Treatment - 3 days and Telithromycin / Duration of Treatment - 7 days
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Jul 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent respiratory illness with signs and symptoms and chest X-ray consistent with the diagnosis of community-acquired pneumonia.
- Suitable candidate for oral antibiotic therapy and able to swallow large capsules intact
- If female, must be non-lactating and at no risk for pregnancy
Who cannot join
- Other infections
- Other pulmonary diseases requirement multiple antibacterial medications or long duration of therapy
- History of hypersensitivity, allergic or adverse reactions to macrolide, ketolide, azalide or streptogramins
- Evidence of uncontrolled clinically significant disease, malignancy, or other abnormality
- Requirement of parenteral antimicrobial therapy for treatment of pneumonia
- Currently receiving or likely to receive any known inhibitors or inducers of cytochrome P450 mediated drug metabolism
- Immunocompromised subjects
Trial locations and contacts
1 site in 1 country.
Medical Director contact
United States1 site, 1 recruiting
- Recruiting
Enanta Pharmaceuticals, Inc.
Watertown, Massachusetts, 02472
Study Director, clinical@enanta.com
About this study
Official title: A Randomized, Double-Blinded, Parallel Group, Multicenter Study of EDP-420 Versus Telithromycin for the Treatment of Community Acquired Pneumonia
This study will compare the efficacy, safety and tolerability of EDP-420 versus another oral antibiotic in the treatment of community acquired pneumonia
- Conditions
- Community Acquired Pneumonia
- Being tested
- EDP-420 / Duration of Treatment - 3 days, Telithromycin / Duration of Treatment - 7 days
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDP-420 / Duration of Treatment - 3 daysDrug
Telithromycin / Duration of Treatment - 7 daysDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Cure 7-14 days after end of therapy
Secondary outcomes (4)
Bacteriological response
Radiographic response
Change in signs and symptoms
Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2005 (estimated)
- Study startDec 2005
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired PneumoniaStudies 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
- Double blind
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- Enanta Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Study Director, Study director, Enanta Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00270517
- Sponsor's protocol ID
- EDP420-05-006
- Status last verified
- Sep 2006
- First submitted
- 23 Dec 2005
- Last updated
- 19 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Parallel Group, Multicenter Study of EDP-420 Versus Telithromycin for the Treatment of Community Acquired Pneumonia
- ClinicalTrials.gov ID
- NCT00270517
- Acronym / sponsor ID
- EDP420-05-006
- Conditions
- Community Acquired Pneumonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants
- Lead sponsor
- Enanta Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Study completion
- Jul 2007
- First posted
- 28 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the efficacy, safety and tolerability of EDP-420 versus another oral antibiotic in the treatment of community acquired pneumonia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recent respiratory illness with signs and symptoms and chest X-ray consistent with the diagnosis of community-acquired pneumonia.
- Suitable candidate for oral antibiotic therapy and able to swallow large capsules intact
- If female, must be non-lactating and at no risk for pregnancy
Key exclusion criteria (7 listed)
- Other infections
- Other pulmonary diseases requirement multiple antibacterial medications or long duration of therapy
- History of hypersensitivity, allergic or adverse reactions to macrolide, ketolide, azalide or streptogramins
- Evidence of uncontrolled clinically significant disease, malignancy, or other abnormality
- Requirement of parenteral antimicrobial therapy for treatment of pneumonia
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 |
|---|---|---|
| EDP-420 / Duration of Treatment - 3 days | Drug | – |
| Telithromycin / Duration of Treatment - 7 days | Drug | – |
Primary outcome
Clinical Cure 7-14 days after end of therapy
4 secondary outcomes
Bacteriological response
Radiographic response
Change in signs and symptoms
Safety
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2006.
Related trials for Community Acquired Pneumonia
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Not yet recruitingPhase 4
Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Active, not recruitingPhase 2/3
Inhaled Lexofloxacin vs Usual Care for Treatment of Community-Acquired Pneumonia
Community-acquired Pneumonia, CAP
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.
Medical Director contact
Study Director study director
Enanta Pharmaceuticals, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EDP-420 / Duration of Treatment - 3 days and Telithromycin / Duration of Treatment - 7 days in people with Community Acquired Pneumonia, run by Enanta Pharmaceuticals, Inc at 1 site in United States.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Medical Director (clinical@enanta.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Cure 7-14 days after end of therapy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2006.