AzTrials
AzTrials

Community-acquired Bacterial PneumoniaPhase 3SOLITAIRE-IVNCT01968733

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

A Phase 3 study testing Solithromycin and Moxifloxacin in people with Community-acquired Bacterial Pneumonia, run by Melinta Therapeutics, Inc. at 270 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Community-acquired Bacterial Pneumonia
What is being tested?
Solithromycin and Moxifloxacin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
863 participants
Where
270 sitesin 26 countries
Study dates
Nov 2013to Sep 2015
Phase
Phase 3
Are there results?
None posted in the registry

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

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • Other non-infectious causes of pulmonary infiltrates
  • Primary or metastatic lung cancer
  • Cystic fibrosis
  • Active or suspected tuberculosis
  • HIV or myasthenia gravis

Trial locations and contacts

270 sites in 26 countries.

270 sites in 26 countries

United States62 sites

  • Study site

    Akron, Ohio, 44304

  • Study site

    Augusta, Georgia, 30912

  • Study site

    Bay Pines, Florida, 33744

  • Study site

    Bethleham, Pennsylvania, 18015

  • Study site

    Blue Ridge, Georgia, 30513

  • Study site

    Buffalo, New York, 14215

  • Study site

    Butte, Montana, 59701

  • Study site

    Charlottesville, Virginia, 22905-2877

  • Study site

    Chicago, Illinois, 60611

  • Study site

    Chino, California, 91710

  • Study site

    Cincinnati, Ohio, 45267

  • Study site

    Cleveland, Ohio, 44106

  • Study site

    Columbus, Ohio, 43210

  • Study site

    Council Bluffs, Iowa, 51503

  • Study site

    Dayton, Ohio, 45402

  • Study site

    Decatur, Georgia, 30033

  • Study site

    DeLand, Florida, 32720

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Doral, Florida, 33166

  • Study site

    Duluth, Minnesota, 55805

  • Study site

    Farmington Hills, Michigan, 48334

  • Study site

    Glendale, California, 91206

  • Study site

    Hazard, Kentucky, 41701

  • Study site

    Houston, Texas, 77011

  • Study site

    Houston, Texas, 77024

  • Study site

    Houston, Texas, 77030

  • Study site

    Houston, Texas, 77093

  • Study site

    Jamaica, New York, 11418

  • Study site

    Johnson City, New York, 13790

  • Study site

    Kissimmee, Florida, 34741

  • Study site

    Lafayette, Louisiana, 70503

  • Study site

    Laguna Hills, California, 92653

  • Study site

    Lima, Ohio, 45801

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Los Angeles, California, 90015

  • Study site

    Louisville, Kentucky, 40202

  • Study site

    Louisville, Kentucky, 40206

  • Study site

    Miami, Florida, 33144

  • Study site

    Miami, Florida, 33156

  • Study site

    Mobile, Alabama, 36607

  • Study site

    Mobile, Alabama, 36609

  • Study site

    Nashville, Tennessee, 37232

  • Study site

    New York, New York, 10003

  • Study site

    Newark, Delaware, 19713

  • Study site

    Newark, New Jersey, 07102

  • Study site

    Owensboro, Kentucky, 42303

  • Study site

    Pasadena, California, 91105

  • Study site

    Philadelphia, Pennsylvania, 19141

  • Study site

    Rapid City, South Dakota, 57702

  • Study site

    Royal Oak, Michigan, 48073

  • Study site

    Sacramento, California, 95817

  • Study site

    Shreveport, Louisiana, 71103

  • Study site

    Somers Point, New Jersey, 08244

  • Study site

    Splendora, Texas, 77372

  • Study site

    Spokane, Washington, 99202

  • Study site

    Springfield, Illinois, 62702

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Sylmar, California, 91342

  • Study site

    Torrance, California, 90502

  • Study site

    West Palm Beach, Florida, 33401

  • Study site

    Winston-Salem, North Carolina, 27103

  • Study site

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Taiwan16 sites

  • Study site

    Changhua Country, 500

  • Study site

    Hualien City, 970

  • Study site

    Kaohsiung City, 807

  • Study site

    Kaohsiung City, 82445

  • Study site

    Kaohsiung City, 83301

  • Study site

    New Taipei City, 220

  • Study site

    Taichung, R.o. C., 40447

  • Study site

    Taichung, R.o. C., 407

  • Study site

    Taichung, 402

  • Study site

    Taichung, 40705

  • Study site

    Tainan, 704

  • Study site

    Tainan, 710

  • Study site

    Taipei, R.o. C., 116

  • Study site

    Taipei, 100

  • Study site

    Taipei, 11217

  • Study site

    Taipei, 114

Other trials in Taiwan

Romania15 sites

  • Study site

    Bragadiru, Judet Ilfov, 769764

  • Study site

    Bucharest, Bucharest, 011461

  • Study site

    Bucharest, Sector 1, 010824

  • Study site

    Bucharest, Sector 2, 021105

  • Study site

    Bucharest, Sector 2, 021661

  • Study site

    Bucharest, Sector 3, 030303

  • Study site

    Bucharest, Sector 5, 050159

  • Study site

    Cluj-Napoca, Cluj, 400371

  • Study site

    Constanța, Constanța County, 900002

  • Study site

    Craiova, Dolj, 200515

  • Study site

    Marghita, Bihor County, 415300

  • Study site

    Ploieşti, Prahova, 10097

  • Study site

    Suceava, Judetual Suceava, 720284

  • Study site

    Suceava, Suceava, 720284

  • Study site

    Timișoara, Timiș County, 300310

Other trials in Romania

Hungary13 sites

  • Study site

    Budapest, H-1097

  • Study site

    Budapest, H-1121

  • Study site

    Budapest, H-1125

  • Study site

    Budapest, H-1145

  • Study site

    Budapest, H-115

  • Study site

    Debrecen, H-1051

  • Study site

    Győr, H-9024

  • Study site

    Kaposvár, H-7400

  • Study site

    Nagykanizsa, H-8800

  • Study site

    Nyíregyháza, H-4412

  • Study site

    Pécs, H-7623

  • Study site

    Székesfehérvár, H-8000

  • Study site

    Törökbálint, H-2045

Other trials in Hungary

Peru13 sites

  • Study site

    Bellavista, Provincia Constitucional del Callao, Callao

  • Study site

    Cercado, Lima 1, Lima 1

  • Study site

    Cercado, Lima, Lima01

  • Study site

    Ica, Ica

  • Study site

    Iquitos, Loreto

  • Study site

    Jesus Maria, Lima11, Lima11

  • Study site

    Lima Cercado, Lima1, Lima1

  • Study site

    Miraflores, Lima 18, Lima 18

  • Study site

    San Borja, Lima 41, Lima 41

  • Study site

    San Juán de Miraflores, Lima 29, Lima 29

  • Study site

    San Martín de Porres, Lima 31, Lima 31

  • Study site

    San Miguel, Lima 32, Lima 32

  • Study site

    Santiago de Surco, Lima 33, Lima 33

Other trials in Peru

Russia13 sites

  • Study site

    Barnaul, 656045

  • Study site

    Chelyabinsk, 454021

  • Study site

    Moscow, 119991

  • Study site

    Moscow, 123182

  • Study site

    Moscow, 127206

  • Study site

    Novosibirsk, 195271

  • Study site

    Penza, 440067

  • Study site

    Saint Petersburg, 194354

  • Study site

    Saint Petersburg, 195030

  • Study site

    Saint Petersburg, 195271

  • Study site

    Saint Petersburg, 198205

  • Study site

    Smolensk, 214019

  • Study site

    Tomsk, 634063

Other trials in Russia

Argentina12 sites

  • Study site

    Caba, Buenos Aires, C1093AAS

  • Study site

    Córdoba, Córdoba Province, X5000JRD

  • Study site

    Florencia Varela, Buenos Aires, B1887FWB

  • Study site

    La Plata, Buenos Aires, 1900

  • Study site

    La Plata, Buenos Aires, B1900AVG

  • Study site

    Loma Hermosa, Buenos Aires, B1657BHD

  • Study site

    Mar del Plata, Buenos Aires, B7600GNY

  • Study site

    Rosario, Santa Fe Province, S2000CVB

  • Study site

    Salta, Salta Province, 4400

  • Study site

    San Juan Bautista, Buenos Aires, 1888

  • Study site

    San Miguel de Tucumán, Tucumán Province, T4000IFL

  • Study site

    Vicente López, Buenos Aires, B1602DOH

Other trials in Argentina

South Korea12 sites

  • Study site

    Ansan-si, Gyeonggi-do, 425-707

  • Study site

    Anyang-si, Gyenggi-do, 431-796

  • Study site

    Goyang-si, Gyeonggi-do, 410-719

  • Study site

    Goyang-si, Gyeonggi-do, 411-706

  • Study site

    Jeonju, Jeollabuk-do, 561-712

  • Study site

    Seoul, Gyenggi, 135-710

  • Study site

    Seoul, Gyenggi, 138-736

  • Study site

    Seoul, Gyenggi, 156-707

  • Study site

    Seoul, Gyenggi, 158-710

  • Study site

    Seoul, Gyeonggi-do, 136-705

  • Study site

    Seoul, Gyeonggi-do, 143-729

  • Study site

    Seoul, Gyeonggi-do, 150-950

Other trials in South Korea

Ukraine12 sites

  • Study site

    Chernivtsi, 58000

  • Study site

    Ivano Frakivsk, 76018

  • Study site

    Kharkiv, 61103

  • Study site

    Kharkiv, 61106

  • Study site

    Kharkiv, 61124

  • Study site

    Kherson, 73000

  • Study site

    Kiev, 01133

  • Study site

    Kremenchuk, 39617

  • Study site

    Sumy, 40022

  • Study site

    Vinnytsia, 21029

  • Study site

    Zaporizhzhya, 69035

  • Study site

    Zaporizhzhya, 69065

Other trials in Ukraine

Malaysia11 sites

  • Study site

    Alor Star, Kedah, 05460

  • Study site

    Ampang, Selangor, 68000

  • Study site

    Batu Caves, Selangor, 68100

  • Study site

    Cheras, Kuala Lumpur, 56000

  • Study site

    George Town, Pulau Pinang, 10400

  • Study site

    George Town, Pulau Pinang, 10990

  • Study site

    Jalan Pahang, Kuala Lumpur, 50586

  • Study site

    Kota Bharu, Kelantan, 15586

  • Study site

    Malacca, Melaka, 75400

  • Study site

    Miri, Sarawak, 98000

  • Study site

    Sungai Buloh, Selangor, 47000

Other trials in Malaysia

Spain11 sites

  • Study site

    Alicante, 03010

  • Study site

    Badalona, Barcelona, 08916

  • Study site

    Barcelona, Barcelona, 08003

  • Study site

    Barcelona, Barcelona, 08035

  • Study site

    Barcelona, Barcelona, 08036

  • Study site

    Barcelona, 08221

  • Study site

    Granada, Granada, 18014

  • Study site

    Madrid, Madrid, 28040

  • Study site

    Madrid, 28046

  • Study site

    Mataró, Barcelona, 08304

  • Study site

    Torrejón de Ardoz, Madrid, 28850

Other trials in Spain

Bulgaria9 sites

  • Study site

    Kozloduy, 3320

  • Study site

    Montana, 3400

  • Study site

    Pernik, 2300

  • Study site

    Rousse, 7002

  • Study site

    Samokov, 2000

  • Study site

    Sofia, 1431

  • Study site

    Sofia, 1606

  • Study site

    Vidin, 3700

  • Study site

    Vratsa, 3000

Other trials in Bulgaria

Canada8 sites

  • Study site

    Chicoutimi, Quebec, G7H5H6

  • Study site

    Edmonton, Alberta, T6G2B7

  • Study site

    Greenfield Park, Quebec, J4V2H1

  • Study site

    Montreal, Quebec, H2W 1T8

  • Study site

    Sherbrooke, Quebec, JIH-5N4

  • Study site

    Surrey, British Columbia, V3V 1Z2

  • Study site

    Vancouver, British Columbia, V6Z 1Y6

  • Study site

    Winnipeg, Manitoba, R3E0J9

Other trials in Canada

Georgia8 sites

  • Study site

    Batumi, 6004

  • Study site

    Rustavi, 3700

  • Study site

    Tbilisi, 0101

  • Study site

    Tbilisi, 0112

  • Study site

    Tbilisi, 0144

  • Study site

    Tbilisi, 0159

  • Study site

    Tbilisi, 0160

  • Study site

    Tbilisi, 0186

Other trials in Georgia

Poland8 sites

  • Study site

    Chrzanów, 32-500

  • Study site

    Krakow, 31-011

  • Study site

    Krakow, 31-209

  • Study site

    Lodz, 90-153

  • Study site

    Poznan, 60-569

  • Study site

    Warsaw, 01-138

  • Study site

    Warsaw, 02-507

  • Study site

    Wroclaw, 21-162

Other trials in Poland

Germany7 sites

  • Study site

    Bochum, 44789

  • Study site

    Bonn, 53105

  • Study site

    Dresden, 01307

  • Study site

    Greifswald, 17475

  • Study site

    Hanover, 30625

  • Study site

    Lübeck, 23538

  • Study site

    Rostock, 18055

Other trials in Germany

South Africa7 sites

  • Study site

    Benoni, Gauteng, 1501

  • Study site

    Johannesburg, Gauteng, 2113

  • Study site

    Krugersdorp, Gauteng, 1739

  • Study site

    Middleburg, Mpumalanga, 1055

  • Study site

    Newcastle, KwaZulu-Natal, 2940

  • Study site

    Observatory, Western Cape, 7925

  • Study site

    Thabazimbi, Limpopo, 0380

Other trials in South Africa

Philippines6 sites

  • Study site

    Cebu City, 6000

  • Study site

    EDSA Caloocan City, National Capital Region, 1400

  • Study site

    Iloilo City, 5000

  • Study site

    Lipa City, Batangas, 4217

  • Study site

    Quezon City, 1100

  • Study site

    Quezon City, 1109

Other trials in Philippines

Serbia5 sites

  • Study site

    Belgrade, 11000

  • Study site

    Belgrade, 11080

  • Study site

    Kamenitz, 21204

  • Study site

    Kragujevac, 34000

  • Study site

    Niš, 18000

Other trials in Serbia

Chile4 sites

  • Study site

    Providencia, RM, 7500710

  • Study site

    Talca, Maule Region, 3465584

  • Study site

    Temuco, 4800997

  • Study site

    Viña del Mar, Valparaiso, 2540364

Other trials in Chile

Latvia4 sites

  • Study site

    Balvi, LV-4501

  • Study site

    Daugavpils, LV-5417

  • Study site

    Liepāja, LV-3414

  • Study site

    Valmiera, LV-4201

Other trials in Latvia

Guatemala3 sites

  • Study site

    Guatemala City, Departamento de Guatemala, 01010

  • Study site

    Guatemala City, Departamento de Guatemala, 01016

  • Study site

    Guatemala City, 01010

Other trials in Guatemala

Netherlands3 sites

  • Study site

    Breda, North Brabant, 4818 CK

  • Study site

    Maastricht, Limburg, 6229 HX

  • Study site

    Utrecht, Utrecht, 3584 CX

Other trials in Netherlands

Slovakia3 sites

  • Study site

    Kosice-Saca, Slovakia, 04015

  • Study site

    Lučenec, Slovakia, 98401

  • Study site

    Trebišov, 07501

Other trials in Slovakia

Slovenia3 sites

  • Study site

    Golnik, 4204

  • Study site

    Ljubljana, 1000

  • Study site

    Topolšica, 3326

Other trials in Slovenia

Colombia2 sites

  • Study site

    Cali, Valle del Cauca Department

  • Study site

    Medellín, Antioquia

Other trials in Colombia

About this study

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

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

Read the 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.

Being tested
Solithromycin, Moxifloxacin
Keywords
Pneumonia, CABP, CAP, Macrolide
Medical subject headings
Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SolithromycinDrug

    Also called CEM-101

  • MoxifloxacinDrug

    Also called Avelox

Study groups in NCT01968733
Study groupRoleWhat they receive
MoxifloxacinActive comparatorIntravenous with the potential step-down to oral moxifloxacin
Receives: Drug: Moxifloxacin
SolithromycinExperimentalIntravenous with potential step-down to oral solithromycin
Receives: Drug: Solithromycin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Early clinical response rate in the Intent to Treat (ITT) population.

    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

    Measured: 72 [±12] hours after the first dose of study drug

Secondary outcomes (2)

  1. Early clinical response rate in the microITT population

    To determine NI in early clinical response rate of intravenous to oral solithromycin compared to intravenous to oral moxifloxacin in the mITT population

    Measured: 72 [±12] hours after the first dose of study drug

  2. Clinical success rates in the ITT and Clinically Evaluable (CE) populations

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

    Measured: 5 to 10 days after the last dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionJul 2015
  4. Study completionSep 2015

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
863 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01968733
Sponsor's protocol ID
CE01-301
Acronym
SOLITAIRE-IV
Status last verified
Mar 2017
First submitted
21 Oct 2013
Last updated
3 Mar 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • File TM Jr, Rewerska B, Vucinic-Mihailovic V, Gonong JRV, Das AF, Keedy K, Taylor D, Sheets A, Fernandes P, Oldach D, Jamieson BD. SOLITAIRE-IV: A Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of Intravenous-to-Oral Solithromycin to Intravenous-to-Oral Moxifloxacin for Treatment of Community-Acquired Bacterial Pneumonia. Clin Infect Dis. 2016 Oct 15;63(8):1007-1016. doi: 10.1093/cid/ciw490. Epub 2016 Jul 22.

    PubMed 27448679

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Solithromycin and Moxifloxacin in people with Community-acquired Bacterial Pneumonia, run by Melinta Therapeutics, Inc. at 270 sites in 26 countries.

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 13 inclusion and 11 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 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 270 sites in United States, Taiwan, Romania, Hungary, Peru and 21 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Early clinical response rate in the Intent to Treat (ITT) population. (time frame: 72 [±12] hours after the first dose of study drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01968733, which also lists 1 linked publication.

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 3 Mar 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in