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| Name | Class |
|---|---|
| ACM | UNKNOWN |
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nafithromycin 800 mg 3 days | Experimental | PO q24h for 3 days; subjects will receive matching placebo , to maintain the blind |
|
| Nafithromycin 800 mg 5 days | Experimental | PO q24h for 5 days; subjects will receive matching placebo, to maintain the blind |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nafithromycin 800 mg 3 days | Drug |
| ||
| Nafithromycin 800 mg 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 4 from start of drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Meet the clinical criteria for CABP based on following:
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Ashima Bhatia, MD PDCR | Wockhardt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A & L Clinical research | Miami | Florida | 33126 | United States | ||
| A Plus Research Inc. |
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2 subjects withdrew consent prior to receiving study drug and 7 subjects whose PK results showed no detectable level of either nafithromycin or moxifloxacin hence 9 subjects excluded from the Safety population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nafithromycin 800 mg 3 Days | PO q24h for 3 days; subjects will receive matching placebo , to maintain the blind Nafithromycin 800 mg 3 days |
| FG001 | Nafithromycin 800 mg 5 Days | PO q24h for 5 days; subjects will receive matching placebo, to maintain the blind Nafithromycin 800 mg 5 days |
| FG002 | Moxifloxacin 400 mg | 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 Moxifloxacin 400 mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nafithromycin 800 mg 3 Days | PO q24h for 3 days; subjects will receive matching placebo , to maintain the blind Nafithromycin 800 mg 3 days |
| BG001 | Nafithromycin 800 mg 5 Days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Day 4 from start of drug administration |
|
From signing of Informed Consent Form to Follow up Visit (Day 31)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nafithromycin 800 mg 3 Days | PO q24h for 3 days; subjects will receive matching placebo , to maintain the blind Nafithromycin 800 mg 3 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ischemic Stroke | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Manishkumar D Shah | Wockhardt | 02226534444 | 6893 | manish.shah@wockhardt.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 10, 2016 | Feb 25, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C000627038 | nafithromycin |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Drug |
|
| Moxifloxacin 400 mg | Drug |
|
| Day 4 from start of drug administration |
| Miami |
| Florida |
| 33144 |
| United States |
| RM Medical Research, Inc. | Miami | Florida | 33175 | United States |
| Empire Clinical Research, LLC | Miami Lakes | Florida | 33016 | United States |
| HCI Metromedic Walkin Medical Center | Bedford | Massachusetts | 02740-6634 | United States |
| Health Concepts | Bedford | South Dakota | 57702 | United States |
PO q24h for 5 days; subjects will receive matching placebo, to maintain the blind
Nafithromycin 800 mg 5 days
| BG002 | Moxifloxacin 400 mg 7 Days | 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 Moxifloxacin 400 mg 7 days |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Nafithromycin 800 mg 5 Days |
PO q24h for 5 days; subjects will receive matching placebo, to maintain the blind Nafithromycin 800 mg 5 days |
| OG002 | Moxifloxacin 400 mg | 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 Moxifloxacin 400 mg |
|
|
| Secondary | 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 | The micro-ITT population included all ITT subjects who had at least one baseline Gram-positive or atypical bacterial pathogen known to cause CABP. | Posted | Count of Participants | Participants | Day 4 from start of drug administration |
|
|
|
| 0 |
| 74 |
| 1 |
| 74 |
| 11 |
| 74 |
| EG001 | Nafithromycin 800 mg 5 Days | PO q24h for 5 days; subjects will receive matching placebo, to maintain the blind Nafithromycin 800 mg 5 days | 0 | 72 | 1 | 72 | 9 | 72 |
| EG002 | Moxifloxacin 400 mg 7 Days | 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 Moxifloxacin 400 mg 7 days | 1 | 76 | 2 | 76 | 6 | 76 |
| Epilepsy | Nervous system disorders | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Cor pulmonale | Cardiac disorders | Systematic Assessment |
|
| Hypertrophic cardiomyopathy | Congenital, familial and genetic disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
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| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |