SOLITAIRE-ORAL: Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia

Sponsor

Melinta Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01756339

Collaborator

(none)

860

Enrollment

118

Locations

Arms

Duration (Months)

7.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.

Condition or Disease	Intervention/Treatment	Phase
Community-acquired Bacterial Pneumonia	Drug: Solithromycin Drug: Moxifloxacin Other: Placebo to match solithromycin	Phase 3

Detailed Description

Community-acquired bacterial pneumonia (CABP) 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 against CABP pathogens. Solithromycin is a fourth generation macrolide antibiotic with excellent activity against resistant S. pneumoniae and other key typical and atypical bacterial respiratory pathogens. A completed Phase 2 study showed comparable efficacy to levofloxacin in adults with CABP.

Study Design

Study Type:

Interventional

Actual Enrollment :

860 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in the Treatment of Adult Patients With Community-Acquired Bacterial Pneumonia

Study Start Date :

Dec 1, 2012

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Solithromycin Solithromycin 800 mg orally (PO) on Day 1 followed by 400 mg PO daily on Days 2 through 5, followed by placebo on Days 6 and 7	Drug: Solithromycin Other Names: CEM-101 Other: Placebo to match solithromycin
Active Comparator: Moxifloxacin Moxifloxacin 400 mg PO daily on Day 1 through Day 7	Drug: Moxifloxacin Other Names: Avelox

Arm

Intervention/Treatment

Experimental: Solithromycin

Solithromycin 800 mg orally (PO) on Day 1 followed by 400 mg PO daily on Days 2 through 5, followed by placebo on Days 6 and 7

Drug: Solithromycin

Other Names:

CEM-101

Other: Placebo to match solithromycin

Active Comparator: Moxifloxacin

Moxifloxacin 400 mg PO daily on Day 1 through Day 7

Drug: Moxifloxacin

Other Names:

Avelox

Outcome Measures

Primary Outcome Measures

Early clinical response rate in the Intent to Treat (ITT) population [72 [±12] hours after the first dose of study drug]
To determine noninferiority (NI) in early clinical response rate, in at least 2 of the following 4 cardinal symptoms: cough, shortness of breath, chest pain, and sputum production.

Secondary Outcome Measures

Early clinical response rate in the microITT population [72 [±12] hours after the first dose of study drug]
To determine NI in early clinical response rate of oral solithromycin compared to oral moxifloxacin in the mITT population
Clinical success rates in the ITT and Clincally Evaluable (CE) populations [5 to 10 days after the last dose of study drug]
To determine the overall clinical success rates of oral solithromycin compared to moxifloxacin

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male and female patients ≥ 18 years of age
An acute onset of at least 3 of the following signs and symptoms (new or worsening):

Cough
Production of purulent sputum
Shortness of breath (dyspnea)
Chest pain due to pneumonia

At least 1 of the following:

Fever
Hypothermia
Presence of pulmonary rales and/or evidence of pulmonary consolidation

PORT Risk Class II, III, or IV
Presence of lobar, multilobar, or patchy parenchymal infiltrate(s) consistent with acute bacterial pneumonia on a pulmonary imaging study
Not received any systemic antibiotics during the prior 7 days

Exclusion Criteria:

Ventilator-associated pneumonia
Known anatomical or pathological bronchial obstruction or a history of bronchiectasis or documented severe chronic obstructive pulmonary disease
Hospitalization within 90 days or residence in a long-term care facility within 30 days prior to the onset of symptoms
Presence of known:

Viral or fungal pneumonia
Pneumocystis jiroveci pneumonia
Aspiration pneumonia
Other non-infectious causes of pulmonary infiltrates (e.g. pulmonary embolism, hypersensitivity pneumonia, congestive heart failure)
Primary or metastatic lung cancer
Cystic fibrosis
Active or suspected tuberculosis

Known HIV or myasthesia gravis

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Glendale	California	United States	91206
2	Los Angeles	California	United States	90015
3	Mission Hills	California	United States	91345
4	Oxnard	California	United States	93030
5	Pasadena	California	United States	91105
6	Sylmar	California	United States	91342
7	Torrance	California	United States	90502
8	Debary	Florida	United States	32713
9	DeLand	Florida	United States	32720
10	Miami	Florida	United States	33126
11	Miami	Florida	United States	33144
12	St Cloud	Florida	United States	34769
13	Tampa	Florida	United States	33606
14	Duluth	Georgia	United States	30096
15	New Bedford	Massachusetts	United States	02740
16	Butte	Montana	United States	59701
17	Columbus	Ohio	United States	43035
18	Downingtown	Pennsylvania	United States	19335
19	Summerville	South Carolina	United States	29485
20	Rapid City	South Dakota	United States	57702
21	Houston	Texas	United States	77011
22	Houston	Texas	United States	77030
23	Houston	Texas	United States	77070
24	Houston	Texas	United States	77093
25	Splendora	Texas	United States	77372
26	La Plata	Buenos Aires	Argentina	B1900AVG
27	Tandil	Buenos Aires	Argentina	B7000AXD
28	Loma Hermosa	Provincia de Buenos Aires	Argentina	B1657BHD
29	Rosario	Santa Fe	Argentina	S2000CVB
30	San Miguel De Tucuman	Tucuman	Argentina	T4000IAR
31	Caba		Argentina	C1120AAF
32	Ciudad Autonoma de Buenos Aires		Argentina	1426
33	Ciudad Autonoma de Buenos Aires		Argentina	C1425BEA
34	Cordoba		Argentina	X5000JRD
35	Santa Fe		Argentina	S3000EOZ
36	Pernik		Bulgaria	2300
37	Ruse		Bulgaria	7002
38	Sofia		Bulgaria	1233
39	Sofia		Bulgaria	1336
40	Sofia		Bulgaria	1431
41	Sofia		Bulgaria	1709
42	Edmonton	Alberta	Canada	T6G 2B7
43	Vancouver	British Columbia	Canada	V1Y 1S1
44	Cornwall	Ontario	Canada	K6H 4M4
45	Montreal	Quebec	Canada	H1T 2M4
46	Beroun		Czech Republic	266 01
47	Santo Domingo		Dominican Republic	10205
48	Santo Domingo		Dominican Republic	10511
49	Guayaquil	Guayas	Ecuador	EC090103
50	Guayaquil		Ecuador
51	Quito		Ecuador
52	Tallinn		Estonia	10617
53	Tallinn		Estonia	13619
54	Tartu		Estonia	51014
55	Hofheim	De-he	Germany	65719
56	Rotenburg (Wuemme)	De-ni	Germany	27356
57	Hannover		Germany	30173
58	Budapest		Hungary	1121
59	Budapest		Hungary	1122
60	Budapest		Hungary	1125
61	Kecskemet		Hungary	6000
62	Nyiregyhaza		Hungary	4400
63	Daugavpils		Latvia	LV5417
64	Liepaja		Latvia	LV 3414
65	Riga		Latvia	LV-1002
66	Riga		Latvia	LV-1057
67	Krakow		Poland	31011
68	Lodz		Poland	90153
69	Lublin		Poland	20090
70	Zgierz		Poland	95100
71	San Juan		Puerto Rico	00921
72	Bucharest		Romania	010825
73	Bucharest		Romania	021659
74	Bucharest		Romania	030303
75	Craiova		Romania	200515
76	Iasi		Romania	700115
77	Timisoara		Romania	300310
78	St Petersburg	Leningrad Region	Russian Federation	194354
79	St Petersburg	Leningrad Region	Russian Federation	196211
80	St Petersburg	Leningrad Region	Russian Federation	198205
81	Smolensk	Smolensk Region	Russian Federation	214019
82	Chelyabinsk		Russian Federation	454008
83	Moscow		Russian Federation	109240
84	Moscow		Russian Federation	111539
85	Moscow		Russian Federation	115446
86	Moscow		Russian Federation	119991
87	Moscow		Russian Federation	123182
88	Moscow		Russian Federation	125206
89	Moscow		Russian Federation	125284
90	Smolensk		Russian Federation	214019
91	St Petersburg		Russian Federation	193312
92	St. Petersburg		Russian Federation	192242
93	St. Petersburg		Russian Federation	194354
94	St. Petersburg		Russian Federation	195271
95	St. Petersburg		Russian Federation	196247
96	St. Petersburg		Russian Federation	197022
97	St. Petersburg		Russian Federation	199106
98	Thabazimbi	Limpopo	South Africa	0380
99	Halfway House	Midrand	South Africa	1685
100	Middelburg	Mpumalanga	South Africa	1055
101	Witbank	Mpumalanga	South Africa	1035
102	Korsten	Port Elizabeth	South Africa	6014
103	Hillcrest	Pretoria	South Africa	0083
104	Benoni		South Africa	1500
105	Bloemfontein		South Africa	9300
106	Cape Town		South Africa	7530
107	Cape Town		South Africa	7570
108	Cape Town		South Africa	7764
109	Krugersdorp		South Africa	1739
110	Pretoria		South Africa	0001
111	Worcester		South Africa	6850
112	Badalona	Barcelona	Spain	08916
113	Majadahonda	Madrid	Spain	28222
114	Barcelona		Spain	08036
115	Madrid		Spain	28046
116	Madrid		Spain	28850
117	Mataro		Spain	08304
118	Valencia		Spain	46026