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

Sponsor
Melinta Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01968733
Collaborator
(none)
863
Enrollment
269
Locations
2
Arms
22
Duration (Months)
3.2
Patients Per Site
0.1
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
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 :
863 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 Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in the Treatment of Adult Patients With Community-Acquired Bacterial Pneumonia
Study Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Jul 1, 2015
Actual Study Completion Date :
Sep 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Moxifloxacin

Intravenous with the potential step-down to oral moxifloxacin

Drug: Moxifloxacin
Other Names:
  • Avelox

    		•
    Experimental: Solithromycin

    Intravenous with potential step-down to oral solithromycin

    Drug: Solithromycin
    Other Names:
  • CEM-101

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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 intravenous to oral solithromycin compared to intravenous to oral moxifloxacin in the mITT population

    2. Clinical success rates in the ITT and Clinically Evaluable (CE) populations [5 to 10 days after the last dose of study drug]

      To determine the overall clinical success rates of intravenous to oral solithromycin compared to moxifloxacin

    Eligibility Criteria

    Criteria

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

    1. Cough

    2. Production of purulent sputum

    3. Shortness of breath (dyspnea)

    4. Chest pain due to pneumonia

    • At least 1 of the following:

    1. Fever

    2. Hypothermia

    3. 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

    • Fungal pneumonia

    • Pneumocystis jiroveci pneumonia

    • Aspiration pneumonia

    • Other non-infectious causes of pulmonary infiltrates

    • Primary or metastatic lung cancer

    • Cystic fibrosis

    • Active or suspected tuberculosis

    • HIV or myasthenia gravis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mobile Alabama United States 36607
    2 Mobile Alabama United States 36609
    3 Little Rock Arkansas United States 72205
    4 Chino California United States 91710
    5 Glendale California United States 91206
    6 Laguna Hills California United States 92653
    7 Los Angeles California United States 90015
    8 Pasadena California United States 91105
    9 Sacramento California United States 95817
    10 Sylmar California United States 91342
    11 Torrance California United States 90502
    12 Newark Delaware United States 19713
    13 Bay Pines Florida United States 33744
    14 DeLand Florida United States 32720
    15 Doral Florida United States 33166
    16 Kissimmee Florida United States 34741
    17 Miami Florida United States 33144
    18 Miami Florida United States 33156
    19 West Palm Beach Florida United States 33401
    20 Augusta Georgia United States 30912
    21 Blue Ridge Georgia United States 30513
    22 Decatur Georgia United States 30033
    23 Chicago Illinois United States 60611
    24 Springfield Illinois United States 62702
    25 Council Bluffs Iowa United States 51503
    26 Hazard Kentucky United States 41701
    27 Louisville Kentucky United States 40202
    28 Louisville Kentucky United States 40206
    29 Owensboro Kentucky United States 42303
    30 Lafayette Louisiana United States 70503
    31 Shreveport Louisiana United States 71103
    32 Detroit Michigan United States 48202
    33 Farmington Hills Michigan United States 48334
    34 Royal Oak Michigan United States 48073
    35 Duluth Minnesota United States 55805
    36 St. Louis Missouri United States 63110
    37 Butte Montana United States 59701
    38 Newark New Jersey United States 07102
    39 Somers Point New Jersey United States 08244
    40 Buffalo New York United States 14215
    41 Jamaica New York United States 11418
    42 Johnson City New York United States 13790
    43 New York New York United States 10003
    44 Winston-Salem North Carolina United States 27103
    45 Akron Ohio United States 44304
    46 Cincinnati Ohio United States 45267
    47 Cleveland Ohio United States 44106
    48 Columbus Ohio United States 43210
    49 Dayton Ohio United States 45402
    50 Lima Ohio United States 45801
    51 Bethleham Pennsylvania United States 18015
    52 Philadelphia Pennsylvania United States 19141
    53 Wyomissing Pennsylvania United States 19610
    54 Rapid City South Dakota United States 57702
    55 Nashville Tennessee United States 37232
    56 Houston Texas United States 77011
    57 Houston Texas United States 77024
    58 Houston Texas United States 77030
    59 Houston Texas United States 77093
    60 Splendora Texas United States 77372
    61 Charlottesville Virginia United States 22905-2877
    62 Spokane Washington United States 99202
    63 Caba Buenos Aires Argentina C1093AAS
    64 Florencia Varela Buenos Aires Argentina B1887FWB
    65 Florencio Varela Buenos Aires Argentina 1888
    66 La Plata Buenos Aires Argentina 1900
    67 La Plata Buenos Aires Argentina B1900AVG
    68 Loma Hermosa Buenos Aires Argentina B1657BHD
    69 Mar del Plata Buenos Aires Argentina B7600GNY
    70 Vicente Lopez Buenos Aires Argentina B1602DOH
    71 Rosario Santa Fe Argentina S2000CVB
    72 San Miguel de Tucuman Tucuman Argentina T4000IFL
    73 Cordoba Argentina X5000JRD
    74 Salta Argentina 4400
    75 Kozloduy Bulgaria 3320
    76 Montana Bulgaria 3400
    77 Pernik Bulgaria 2300
    78 Russe Bulgaria 7002
    79 Samokov Bulgaria 2000
    80 Sofia Bulgaria 1431
    81 Sofia Bulgaria 1606
    82 Vidin Bulgaria 3700
    83 Vratsa Bulgaria 3000
    84 Edmonton Alberta Canada T6G2B7
    85 Surrey British Columbia Canada V3V 1Z2
    86 Vancouver British Columbia Canada V6Z 1Y6
    87 Winnipeg Manitoba Canada R3E0J9
    88 Chicoutimi Quebec Canada G7H5H6
    89 Greenfield Park Quebec Canada J4V2H1
    90 Montreal Quebec Canada H2W 1T8
    91 Sherbrooke Quebec Canada JIH-5N4
    92 Providencia RM Chile 7500710
    93 Vina del Mar V Region Chile 2540364
    94 Talca VII Region Chile 3465584
    95 Temuco Chile 4800997
    96 Medellin Antioquia Colombia
    97 Cali Valle del Cauca Colombia
    98 Batumi Georgia 6004
    99 Rustavi Georgia 3700
    100 Tbilisi Georgia 0101
    101 Tbilisi Georgia 0112
    102 Tbilisi Georgia 0144
    103 Tbilisi Georgia 0159
    104 Tbilisi Georgia 0160
    105 Tbilisi Georgia 0186
    106 Bochum Germany 44789
    107 Bonn Germany 53105
    108 Dresden Germany 01307
    109 Greifswald Germany 17475
    110 Hannover Germany 30625
    111 Lubeck Germany 23538
    112 Rostock Germany 18055
    113 Guatemala Guatemala 01010
    114 Guatemala Guatemala 01016
    115 Budapest Hungary H-1097
    116 Budapest Hungary H-1121
    117 Budapest Hungary H-1125
    118 Budapest Hungary H-1145
    119 Budapest Hungary H-115
    120 Debrecen Hungary H-1051
    121 Gyor Hungary H-9024
    122 Kaposvar Hungary H-7400
    123 Nagykanizsa Hungary H-8800
    124 Nyiregyhaza Hungary H-4412
    125 Pecs Hungary H-7623
    126 Szekesfehervar Hungary H-8000
    127 Torokbalint Hungary H-2045
    128 Anyang-si Gyenggi-do Korea, Republic of 431-796
    129 Seoul Gyenggi Korea, Republic of 135-710
    130 Seoul Gyenggi Korea, Republic of 138-736
    131 Seoul Gyenggi Korea, Republic of 156-707
    132 Seoul Gyenggi Korea, Republic of 158-710
    133 Ansan-si Gyeonggi-do Korea, Republic of 425-707
    134 Goyang-si Gyeonggi-do Korea, Republic of 410-719
    135 Goyang-si Gyeonggi-do Korea, Republic of 411-706
    136 Seoul Gyeonggi Korea, Republic of 136-705
    137 Seoul Gyeonggi Korea, Republic of 143-729
    138 Seoul Gyeonggi Korea, Republic of 150-950
    139 Jeonju-si Jeollabuk-do Korea, Republic of 561-712
    140 Balvi Latvia LV-4501
    141 Daugavpils Latvia LV-5417
    142 Liepaja Latvia LV-3414
    143 Valmiera Latvia LV-4201
    144 Alor Setar Kedah Malaysia 05460
    145 Kota Bharu Kelantan Malaysia 15586
    146 Cheras Kuala Lumpur Malaysia 56000
    147 Jalan Pahang Kuala Lumpur Malaysia 50586
    148 Georgetown Penang Malaysia 10400
    149 George Town Pulau Pinang Malaysia 10990
    150 Miri Sarawak Malaysia 98000
    151 Ampang Selangor Malaysia 68000
    152 Batu Caves Selangor Malaysia 68100
    153 Sungai Buloh Selangor Malaysia 47000
    154 Melaka Malaysia 75400
    155 Maastricht Limburg Netherlands 6229 HX
    156 Breda Noord-Brabant Netherlands 4818 CK
    157 Utrecht Netherlands 3584 CX
    158 Bellavista Callao Peru Callao
    159 Miraflores Lima 18 Peru Lima 18
    160 Cercado Lima 1 Peru Lima 1
    161 San Juan de Miraflores Lima 29 Peru Lima 29
    162 San Martin de Porres Lima 31 Peru Lima 31
    163 San Miguel Lima 32 Peru Lima 32
    164 Santiago de Surco Lima 33 Peru Lima 33
    165 San Borja Lima 41 Peru Lima 41
    166 Jesus Maria Lima11 Peru Lima11
    167 Cercado de Lima Lima1 Peru Lima1
    168 Cercado Lima Peru Lima01
    169 Iquitos Loreto Peru
    170 Ica Peru
    171 Lipa City Batangas Philippines 4217
    172 EDSA Caloocan City Metro Manila Philippines 1400
    173 Cebu City Philippines 6000
    174 Iloilo City Philippines 5000
    175 Quezon City Philippines 1100
    176 Quezon City Philippines 1109
    177 Chrzanow Poland 32-500
    178 Krakow Poland 31-011
    179 Krakow Poland 31-209
    180 Lodz Poland 90-153
    181 Poznan Poland 60-569
    182 Warszawa Poland 01-138
    183 Warszawa Poland 02-507
    184 Wroclaw Poland 21-162
    185 Marghita Bihor Romania 415300
    186 Cluj-Napoca Cluj Romania 400371
    187 Craiova Dolj Romania 200515
    188 Bragadiru judet Ilfov Romania 769764
    189 Suceava Judetual Suceava Romania 720284
    190 Suceava Judetul Suceava Romania 720284
    191 Ploiesti Prahova Romania 10097
    192 Bucuresti Sector 1 Romania 010824
    193 Bucuresti Sector 2 Romania 021105
    194 Bucuresti Sector 2 Romania 021661
    195 Bucuresti Sector 3 Romania 030303
    196 Bucuresti Sector 5 Romania 050159
    197 Timisoara Timis Romania 300310
    198 Bucuresti Romania 011461
    199 Constanta Romania 900002
    200 Barnaul Russian Federation 656045
    201 Chelyabinsk Russian Federation 454021
    202 Moscow Russian Federation 119991
    203 Moscow Russian Federation 123182
    204 Moscow Russian Federation 127206
    205 Novosibirsk Russian Federation 195271
    206 Penza Russian Federation 440067
    207 Saint-Petersburg Russian Federation 195030
    208 Saint-Petersburg Russian Federation 198205
    209 Smolensk Russian Federation 214019
    210 St. Petersburg Russian Federation 194354
    211 St. Petersburg Russian Federation 195271
    212 Tomsk Russian Federation 634063
    213 Belgrade Serbia 11000
    214 Belgrade Serbia 11080
    215 Kragujevac Serbia 34000
    216 Nis Serbia 18000
    217 Sremska Kamenica Serbia 21204
    218 Kosice-Saca Slovakia 04015
    219 Lucenec Slovakia 98401
    220 Trebisov Slovakia 07501
    221 Golnik Slovenia 4204
    222 Ljubljana Slovenia 1000
    223 Topolsica Slovenia 3326
    224 Benoni Gauteng South Africa 1501
    225 Johannesburg Gauteng South Africa 2113
    226 Krugersdorp Gauteng South Africa 1739
    227 Newcastle Kwazulu, Natal South Africa 2940
    228 Thabazimbi Limpopo South Africa 0380
    229 Middleburg Mpumalanga South Africa 1055
    230 Observatory Western Cape South Africa 7925
    231 Badalona Barcelona Spain 08916
    232 Mataro Barcelona Spain 08304
    233 Torrejon de Ardoz Madrid Spain 28850
    234 Alicante Spain 03010
    235 Barcelona Spain 08003
    236 Barcelona Spain 08035
    237 Barcelona Spain 08036
    238 Barcelona Spain 08221
    239 Granada Spain 18014
    240 Madrid Spain 28040
    241 Madrid Spain 28046
    242 Taichung R.o. C. Taiwan 40447
    243 Taichung R.o. C. Taiwan 407
    244 Taipei City R.o. C. Taiwan 116
    245 Changhua Country Taiwan 500
    246 Hualien Taiwan 970
    247 Kaohsiung City Taiwan 82445
    248 Kaohsiung Taiwan 807
    249 Kaohsiung Taiwan 83301
    250 New Taipei City Taiwan 220
    251 Taichung Taiwan 402
    252 Taichung Taiwan 40705
    253 Tainan City Taiwan 710
    254 Tainan Taiwan 704
    255 Taipei City Taiwan 11217
    256 Taipei Taiwan 100
    257 Taipei Taiwan 114
    258 Chernivtsi Ukraine 58000
    259 Ivano Frakivsk Ukraine 76018
    260 Kharkiv Ukraine 61103
    261 Kharkiv Ukraine 61106
    262 Kharkiv Ukraine 61124
    263 Kherson Ukraine 73000
    264 Kiev Ukraine 01133
    265 Kremenchuk Ukraine 39617
    266 Sumy Ukraine 40022
    267 Vinnytsia Ukraine 21029
    268 Zaporizhzhia Ukraine 69035
    269 Zaporizhzhia Ukraine 69065

    Sponsors and Collaborators

    • Melinta Therapeutics, Inc.

    Investigators

    • Study Director: Brian D Jamieson, MD, Melinta Therapeutics, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Melinta Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT01968733
    Other Study ID Numbers:
    • CE01-301
    First Posted:
    Oct 24, 2013
    Last Update Posted:
    Mar 3, 2017
    Last Verified:
    Mar 1, 2017
    Keywords provided by Melinta Therapeutics, Inc.
    Pneumonia
    CABP
    CAP
    Macrolide
    Additional relevant MeSH terms:
    Pneumonia
    Pneumonia, Bacterial
    Moxifloxacin
    Solithromycin

    Study Results

    No Results Posted as of Mar 3, 2017