Community-Acquired Bacterial Pneumonia (CABP)Phase 2NCT02903836
Phase II Study of Oral Nafithromycin in CABP
A Phase 2 study testing Nafithromycin 800 mg 3 days, Nafithromycin 800 mg 5 days and Moxifloxacin 400 mg in people with Community-Acquired Bacterial Pneumonia (CABP), run by Wockhardt at 6 sites in United States.
Trial summary
Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Oral Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia (CABP) in Adults Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-Acquired Bacterial Pneumonia (CABP)
- What is being tested?
- Nafithromycin 800 mg 3 days, Nafithromycin 800 mg 5 days and Moxifloxacin 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 6 sitesUnited States
- Study dates
- 18 Nov 2016to 8 Jul 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the clinical criteria for CABP based on following:
- Clinical symptoms (new or worsening)
- Vital sign abnormalities
- Laboratory abnormalities
- Radiographic evidence of CABP
- PORT score
Who cannot join
- Subjects with any of the following confirmed or suspected types of pneumonia:
- Aspiration pneumonia
- Hospital-acquired bacterial pneumonia (HABP)
- Healthcare-associated bacterial pneumonia (HCAP)
- Ventilator-associated bacterial pneumonia (VABP)
- Pneumonia that may be caused by pathogen(s) resistant to either study drug
Show all 9Show fewer
- Receipt of 1 or more dose(s) of a potentially effective systemic antibacterial treatment for treatment of the current CABP
- Suspected or confirmed non-infectious causes of pulmonary infiltrates
- Subjects requiring concomitant adjunctive or additional potentially-effective systemic antibacterial treatment for management of CABP
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
HCI Metromedic Walkin Medical Center
Bedford, Massachusetts, 02740-6634
Health Concepts
Bedford, South Dakota, 57702
A & L Clinical research
Miami, Florida, 33126
A Plus Research Inc.
Miami, Florida, 33144
RM Medical Research, Inc.
Miami, Florida, 33175
Empire Clinical Research, LLC
Miami Lakes, Florida, 33016
About this study
Official title: A Phase II, Randomized, Double-Blind, Multicenter, Comparative Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Oral Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia (CABP) in Adults
Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Oral Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia (CABP) in Adults
- Being tested
- Nafithromycin 800 mg 3 days, Nafithromycin 800 mg 5 days, Moxifloxacin 400 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nafithromycin 800 mg 3 daysDrug
Nafithromycin 800 mg 5 daysDrug
Moxifloxacin 400 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Nafithromycin 800 mg 3 days | Experimental | PO q24h for 3 days; subjects will receive matching placebo , to maintain the blind Receives: Drug: Nafithromycin 800 mg 3 days |
| Nafithromycin 800 mg 5 days | Experimental | PO q24h for 5 days; subjects will receive matching placebo, to maintain the blind Receives: Drug: Nafithromycin 800 mg 5 days |
| Moxifloxacin 400 mg | Active comparator | PO q24h for 7 days;subjects will also receive two nafithromycin placebo tablets PO q24h on Days 1 through Day 7 to maintain the blind Receives: Drug: Moxifloxacin 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response in the ITT Population
The primary efficacy endpoint was clinical response (response, non-response, or indeterminate) at Day 4, tested in the ITT population. Clinical response was determined programmatically using the investigator's assessment of CABP symptoms entered into the eCRF. The severity of the subject CABP symptoms of dyspnea (shortness of breath), cough, production of purulent sputum, and pleuritic chest pain were evaluated on a 4-point scale (absent, mild, moderate, or severe) based upon the CABP Symptom Severity Guidance
Measured: Day 4 from start of drug administration
Secondary outcomes (1)
Clinical Response in the Micro-ITT Population
Clinical response (response, non-response, or indeterminate) at Day 4 was also tested in the micro-ITT population as a secondary efficacy endpoint. Clinical response was determined programmatically using the investigator's assessment of CABP symptoms entered into the eCRF. The severity of the subject CABP symptoms of dyspnea (shortness of breath), cough, production of purulent sputum, and pleuritic chest pain were evaluated on a 4-point scale (absent, mild, moderate, or severe) based upon the CABP Symptom Severity Guidance
Measured: Day 4 from start of drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study start18 Nov 2016
- Primary completionJul 2017
- Study completion8 Jul 2017
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.
- Other trials for Community-Acquired Bacterial Pneumonia (CABP)Studies 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wockhardt
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ACM
- Responsible party
- Sponsor
- Investigators
- Ashima Bhatia, MD PDCR, Study director, Wockhardt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903836
- Sponsor's protocol ID
- W-4873-201
- Status last verified
- Dec 2019
- First submitted
- 13 Sep 2016
- Last updated
- 20 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Blind, Multicenter, Comparative Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Oral Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia (CABP) in Adults
- ClinicalTrials.gov ID
- NCT02903836
- Acronym / sponsor ID
- W-4873-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- WockhardtIndustry (pharma, biotech, devices)
- Collaborators
- ACM
- Study start
- 18 Nov 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- 8 Jul 2017 (actual)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Posted 20 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Oral Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia (CABP) in Adults
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nafithromycin 800 mg 3 days | Experimental | Drug: Nafithromycin 800 mg 3 daysPO q24h for 3 days; subjects will receive matching placebo , to maintain the blind |
| Nafithromycin 800 mg 5 days | Experimental | Drug: Nafithromycin 800 mg 5 daysPO q24h for 5 days; subjects will receive matching placebo, to maintain the blind |
| Moxifloxacin 400 mg | Active comparator | Drug: Moxifloxacin 400 mgPO q24h for 7 days;subjects will also receive two nafithromycin placebo tablets PO q24h on Days 1 through Day 7 to maintain the blind |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical symptoms (new or worsening)
- Vital sign abnormalities
- Laboratory abnormalities
- Radiographic evidence of CABP
- PORT score
Key exclusion criteria (9 listed)
- Subjects with any of the following confirmed or suspected types of pneumonia:
- Receipt of 1 or more dose(s) of a potentially effective systemic antibacterial treatment for treatment of the current CABP
- Suspected or confirmed non-infectious causes of pulmonary infiltrates
- Subjects requiring concomitant adjunctive or additional potentially-effective systemic antibacterial treatment for management of CABP
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 |
|---|---|---|
| Nafithromycin 800 mg 3 days | Drug | Nafithromycin 800 mg 3 days |
| Nafithromycin 800 mg 5 days | Drug | Nafithromycin 800 mg 5 days |
| Moxifloxacin 400 mg | Drug | Moxifloxacin 400 mg |
Primary outcome
Clinical Response in the ITT Population
Time frame: Day 4 from start of drug administration
The primary efficacy endpoint was clinical response (response, non-response, or indeterminate) at Day 4, tested in the ITT population. Clinical response was determined programmatically using the investigator's assessment of CABP symptoms entered into the eCRF. The severity of the subject CABP symptoms of dyspnea (shortness of breath), cough, production of purulent sputum, and pleuritic chest pain were evaluated on a 4-point scale (absent, mild, moderate, or severe) based upon the CABP Symptom Severity Guidance
1 secondary outcome
Clinical Response in the Micro-ITT Population
Time frame: Day 4 from start of drug administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Ashima Bhatia, MD PDCR study director
Wockhardt
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nafithromycin 800 mg 3 days, Nafithromycin 800 mg 5 days and Moxifloxacin 400 mg in people with Community-Acquired Bacterial Pneumonia (CABP), run by Wockhardt at 6 sites 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 6 inclusion and 9 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 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Yes. Results are posted in the registry (first posted 20 Dec 2019). 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 in the ITT Population (time frame: Day 4 from start of drug administration). 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 20 Dec 2019.