Efficacy and Safety Study of Oral CEM-101 Compared to Oral Levofloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia

• Sponsor: Melinta Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01168713
• Collaborator: (none)
• Enrollment: 132
• Locations: 55
• Arms: 2
• Duration (Months): 11
• Patients Per Site: 2.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Study to evaluate the safety and efficacy of oral CEM-101 compared to oral Levofloxacin in the treatment of adults with moderate to moderately severe community-acquired bacterial pneumonia.

Condition or Disease	Intervention/Treatment	Phase
Community-Acquired Bacterial Pneumonia	Drug: Levofloxacin; Drug: CEM-101	Phase 2

Detailed Description

Community-acquired bacterial pneumonia is an acute infection of the pulmonary parenchyma with symptoms such as fever or hypothermia, chills, rigors, chest pain, and/or dyspnea. The widespread emergence of antibiotic resistant pathogens, including the macrolide-resistant Streptococcus pneumoniae, has resulted in a need for new and effective antibiotics that have activity again CABP pathogens. CEM-101 is the first fluoroketolide with excellent in vitro and in vivo activity against resistant S. pneumoniae and other key typical and atypical bacterial respiratory pathogens.

Study Design

• Study Type: Interventional
• Actual Enrollment: 132 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Oral CEM-101 Compared to Oral Levofloxacin in the Treatment of Patients With Community-Acquired Bacterial Pneumonia
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Levofloxacin	Drug: Levofloxacin; Levofloxacin once daily for 5 days: Levofloxacin 750 mg PO Days 1-5; Other Names: Levaquin
Experimental: CEM-101	Drug: CEM-101; CEM-101 once daily for 5 days: CEM-101 800 mg PO Day 1 CEM-101 400 mg PO Days 2-5; Other Names: Solithromycin

Outcome Measures

Primary Outcome Measures

1. Clinical Success in the Intent to Treat (ITT) population at the Treatment of Cure (TOC) visit [5 to 10 days after the last dose of study drug]

   Clinical Success defined as continued improvement or complete resolution of baseline signs and symptoms and if available, an improved/stable chest radiograph after the end of treatment

2. Clinical Success in the Clinically Evaluable (CE) population at the Treatment of Cure (TOC) Visit [5 to 10 days after the last dose of study drug]

   Clinical Success defined as continued improvement or complete resolution of baseline signs and symptoms and if available, an improved/stable chest radiograph after the end of treatment

Secondary Outcome Measures

1. By Patient Microbiological Response in the Microbiological Intent to Treat (microlITT) population at the end of treatment (EOT) [5 days of study drug treatment]

   Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen.

2. By Patient Microbiological Response in the Microbiological Intent to Treat (microlITT) population at the Treatment of Cure (TOC) visit [5 to 10 days after the last dose of study drug]

   Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen

3. By-patient Microbiological Response in the Microbiologically Evaluable (ME) populations at the end of treatment (EOT) [5 days of study drug treatment]

   Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen

4. By-patient Microbiological Response in the Microbiologically Evaluable (ME) populations at Treatment of Cure (TOC) visit [5 to 10 days after the last dose of study drug]

   Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen

5. Clinical Response in the Intent to Treat (ITT) population at End of Treatment (EOT) [5 days of study drug treatment]

   Clinical Success is defined as complete or near-complete resolution of the baseline signs and symptoms of community acquired bacterial pneumonia (CABP); no further study drug for treatment of CABP

6. Clinical Response in the microbiological intent to treat (microlITT) population at the end of treatment (EOT) [5 days of study drug treatment]

   Clinical Success is defined as complete or near-complete resolution of the baseline signs and symptoms of community acquired bacterial pneumonia (CABP); no further study drug for treatment of CABP

7. Clinical Response in the clinically evaluable (CE) population at the end of treatment (EOT) [5 days of study drug treatment]

   Clinical Success is defined as complete or near-complete resolution of the baseline signs and symptoms of community acquired bacterial pneumonia (CABP); no further study drug for treatment of CABP

8. Clinical REsponse in the Microbiologically Evaluable (ME) population at the end of treatment (EOT) [5 days of study drug treatment]

   Clinical Success is defined as complete or near-complete resolution of the baseline signs and symptoms of community acquired bacterial pneumonia (CABP); no further study drug for treatment of CABP

9. Early Clinical Response in the intent to treat (ITT) population at Day 3 [3 days of study drug treatment]

   Clinical success is defined as being both clinically stable and showing clinical improvement based on the symptoms of community acquired bacterial pneumonia (CABP)

10. Percentage of patients at each visit who have resolution of all baseline signs and symptoms in the clinically evaluable (CE) population [Day 3, Day 5 (end of treatment), and 5 to 10 days after the last dose of study drug (test of cure visit)]

    Resolution of all baseline signs and symptoms in the clinically evaluable (CE) population

11. Percentage of patients at Day 3 who have resolution of cough, dyspnea, chest pain due to pneumonia and sputum production [3 days of study drug treatment]

    Resolution of cough, dyspnea, chest pain due to pneumonia and sputum production

12. Percentage of patients at the end of treatment (EOT) who have resolution of cough, dyspnea, chest pain due to pneumonia and sputum production [5 days of study drug treatment]

    resolution of cough, dyspnea, chest pain due to pneumonia and sputum production

13. Percentage of patients at Day 3 who are clinically stable [3 days of study drug treatment]

    clinical stability defined as: Temperature <=37.8°C Heart rate <=100 beats/min Systolic blood pressure ≥90 mm Hg Ability to maintain oral intake Normal mental status (oriented to person, place or time)

14. Percentage of patients at the end of treatment (EOT) who are clinically stable [5 days of study drug treatment]

    Clinically stable defined as: Temperature ≤37.8°C Heart rate ≤100 beats/min Systolic blood pressure ≥90 mm Hg Ability to maintain oral intake Normal mental status (oriented to person, place or time)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Diagnosis of community acquired bacterial pneumonia (e.g. cough with purulent sputum or change in character of sputum consistent with bacterial infection, dyspnea or tachypnea, chest pain due to pneumonia, fever, presence of rales and/or signs of consolidation).

2. No prior systemic antibacterial therapy, unless failed other therapy.

3. Chest Xray shows new lobar or multilobar infiltrate(s) consistent with acute bacterial pneumonia.

4. PORT Risk Class II, III, or IV <=105

5. Ability to take oral medication.

Exclusion Criteria:

1. Severe chronic obstructive pulmonary disease FEV1 <30%.

2. Hospitalization within 90 days or residence in a long-term-care facility within 30 days prior to the onset of symptoms

3. Chemotherapy or radiation therapy within the previous 3 months.

4. Significant hepatic, hematological, renal abnormalities.

5. Any concomitant condition that, in the opinion of the Investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy and follow-up could be completed (e.g. life expectancy <30 days).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States	35242
2		Flagstaff	Arizona	United States	86001
3		Bell Gardens	California	United States	90201
4		Chula Vista	California	United States	91911
5		LeMesa	California	United States	91942
6		Los Angeles	California	United States	90015
7		Montclaire	California	United States	91763
8		Norwalk	California	United States	90650
9		Oceanside	California	United States	92056
10		Oxnard	California	United States	93030
11		Pasadena	California	United States	91105
12		Torrence	California	United States	90501
13		Waterbury	Connecticut	United States	06708
14		Debary	Florida	United States	32713
15		Gainesville	Florida	United States	32605
16		Hialeah	Florida	United States	33012
17		Kissimmee	Florida	United States	34741
18		Orlando	Florida	United States	32837
19		Blue Ridge	Georgia	United States	30513
20		Columbus	Georgia	United States	31904
21		Savannah	Georgia	United States	31406
22		Idaho Falls	Idaho	United States	83404
23		Morton	Illinois	United States	61550
24		Dubuque	Iowa	United States	52001
25		New Orleans	Louisiana	United States	70112
26		Fall River	Massachusetts	United States	02720
27		New Bedford	Massachusetts	United States	02740
28		Detroit	Michigan	United States	48202
29		Traverse City	Michigan	United States	49684
30		Butte	Montana	United States	59701
31		Las Vegas	Nevada	United States	89109
32		Akron	Ohio	United States	44304
33		Carlisle	Ohio	United States	45005
34		Eugene	Oregon	United States	97404
35		West Reading	Pennsylvania	United States	19611
36		Simpsonville	South Carolina	United States	29681
37		Rapid City	South Dakota	United States	57702
38		Franklin	Tennessee	United States	37067
39		Corsicana	Texas	United States	75110
40		Houston	Texas	United States	77002
41		Houston	Texas	United States	77093
42		San Antonio	Texas	United States	78238
43		Draper	Utah	United States	84020
44		Magna	Utah	United States	84044
45		Salt Lake City	Utah	United States	84121
46		Calgary	Alberta	Canada	T2N2T9
47		Hamilton	Ontario	Canada	L8N3Z5
48		Hamilton	Ontario	Canada	L8N4A6
49		Hamilton	Ontario	Canada	L8V1C3
50		Ottawa	Ontario	Canada	K1Y 4E9
51		Toronto	Ontario	Canada	M9W 4L6
52		Chicoutimi	Quebec	Canada	G7H-5H6
53		Sherbrooke	Quebec	Canada	J1H5N4
54		St. Jerome	Quebec	Canada	J7Z5T3
55		Trios-Rivieres	Quebec	Canada	G8Z3R9

Sponsors and Collaborators

• Melinta Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Melinta Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT01168713
• Other Study ID Numbers: CE01-200
• First Posted: Jul 23, 2010
• Last Update Posted: Mar 3, 2017
• Last Verified: Mar 1, 2017

• Keywords provided by Melinta Therapeutics, Inc.: Adults with Community-Acquired Bacterial Pneumonia
• Additional relevant MeSH terms: Pneumonia; Pneumonia, Bacterial; Levofloxacin; Ofloxacin; Solithromycin

Study Results

No Results Posted as of Mar 3, 2017