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Community-acquired Bacterial PneumoniaPhase 3SOLITAIRE-ORALNCT01756339

Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared 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 119 sites in 17 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
860 participants
Where
119 sitesin 17 countries
Study dates
Dec 2012to Oct 2014
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
  • Presence of known:
  • Viral or fungal pneumonia
  • Pneumocystis jiroveci pneumonia
Show all 12Show fewer
  • 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

Trial locations and contacts

119 sites in 17 countries.

119 sites in 17 countries

United States25 sites

  • Study site

    Butte, Montana, 59701

  • Study site

    Columbus, Ohio, 43035

  • Study site

    DeBary, Florida, 32713

  • Study site

    DeLand, Florida, 32720

  • Study site

    Downingtown, Pennsylvania, 19335

  • Study site

    Duluth, Georgia, 30096

  • Study site

    Glendale, California, 91206

  • Study site

    Houston, Texas, 77011

  • Study site

    Houston, Texas, 77030

  • Study site

    Houston, Texas, 77070

  • Study site

    Houston, Texas, 77093

  • Study site

    Los Angeles, California, 90015

  • Study site

    Miami, Florida, 33126

  • Study site

    Miami, Florida, 33144

  • Study site

    Mission Hills, California, 91345

  • Study site

    New Bedford, Massachusetts, 02740

  • Study site

    Oxnard, California, 93030

  • Study site

    Pasadena, California, 91105

  • Study site

    Rapid City, South Dakota, 57702

  • Study site

    Saint Cloud, Florida, 34769

  • Study site

    Splendora, Texas, 77372

  • Study site

    Summerville, South Carolina, 29485

  • Study site

    Sylmar, California, 91342

  • Study site

    Tampa, Florida, 33606

  • Study site

    Torrance, California, 90502

Other trials in United States

Russia20 sites

  • Study site

    Chelyabinsk, 454008

  • Study site

    Moscow, 109240

  • Study site

    Moscow, 111539

  • Study site

    Moscow, 115446

  • Study site

    Moscow, 119991

  • Study site

    Moscow, 123182

  • Study site

    Moscow, 125206

  • Study site

    Moscow, 125284

  • Study site

    Saint Petersburg, Leningradskaya Oblast', 194354

  • Study site

    Saint Petersburg, Leningradskaya Oblast', 196211

  • Study site

    Saint Petersburg, Leningradskaya Oblast', 198205

  • Study site

    Saint Petersburg, 192242

  • Study site

    Saint Petersburg, 193312

  • Study site

    Saint Petersburg, 194354

  • Study site

    Saint Petersburg, 195271

  • Study site

    Saint Petersburg, 196247

  • Study site

    Saint Petersburg, 197022

  • Study site

    Saint Petersburg, 199106

  • Study site

    Smolensk, Smolensk Oblast, 214019

  • Study site

    Smolensk, 214019

Other trials in Russia

South Africa14 sites

  • Study site

    Benoni, 1500

  • Study site

    Bloemfontein, 9300

  • Study site

    Cape Town, 7530

  • Study site

    Cape Town, 7570

  • Study site

    Cape Town, 7764

  • Study site

    Halfway House, Midrand, 1685

  • Study site

    Hillcrest, Pretoria, 0083

  • Study site

    Korsten, Port Elizabeth, 6014

  • Study site

    Krugersdorp, 1739

  • Study site

    Middelburg, Mpumalanga, 1055

  • Study site

    Pretoria, 0001

  • Study site

    Thabazimbi, Limpopo, 0380

  • Study site

    Witbank, Mpumalanga, 1035

  • Study site

    Worcester, 6850

Other trials in South Africa

Argentina10 sites

  • Study site

    Buenos Aires, 1426

  • Study site

    Buenos Aires, C1425BEA

  • Study site

    Caba, C1120AAF

  • Study site

    Córdoba, Córdoba Province, X5000JRD

  • Study site

    La Plata, Buenos Aires, B1900AVG

  • Study site

    Loma Hermosa, Buenos Aires, B1657BHD

  • Study site

    Rosario, Santa Fe Province, S2000CVB

  • Study site

    San Miguel de Tucumán, Tucumán Province, T4000IAR

  • Study site

    Santa Fe, Santa Fe Province, S3000EOZ

  • Study site

    Tandil, Buenos Aires, B7000AXD

Other trials in Argentina

Bulgaria7 sites

  • Study site

    Pernik, Bulgaria, 2300

  • Study site

    Rousse, Bulgaria, 7002

  • Study site

    Sofia, Bulgaria, 1431

  • Study site

    Sofia, Bulgaria, 1709

  • Study site

    Sofia, 1233

  • Study site

    Sofia, 1336

  • Study site

    Sofia, 1431

Other trials in Bulgaria

Spain7 sites

  • Study site

    Badalona, Barcelona, 08916

  • Study site

    Barcelona, 08036

  • Study site

    Madrid, 28046

  • Study site

    Madrid, 28850

  • Study site

    Majadahonda, Madrid, 28222

  • Study site

    Mataró, 08304

  • Study site

    Valencia, Valencia, 46026

Other trials in Spain

Romania6 sites

  • Study site

    Bucharest, 010825

  • Study site

    Bucharest, 021659

  • Study site

    Bucharest, 030303

  • Study site

    Craiova, 200515

  • Study site

    Iași, 700115

  • Study site

    Timișoara, 300310

Other trials in Romania

Hungary5 sites

  • Study site

    Budapest, 1121

  • Study site

    Budapest, 1122

  • Study site

    Budapest, 1125

  • Study site

    Kecskemét, 6000

  • Study site

    Nyíregyháza, 4400

Other trials in Hungary

Canada4 sites

  • Study site

    Cornwall, Ontario, K6H 4M4

  • Study site

    Edmonton, Alberta, T6G 2B7

  • Study site

    Montreal, Quebec, H1T 2M4

  • Study site

    Vancouver, British Columbia, V1Y 1S1

Other trials in Canada

Latvia4 sites

  • Study site

    Daugavpils, LV5417

  • Study site

    Liepāja, LV 3414

  • Study site

    Riga, LV-1002

  • Study site

    Riga, LV-1057

Other trials in Latvia

Poland4 sites

  • Study site

    Krakow, 31011

  • Study site

    Lodz, 90153

  • Study site

    Lublin, 20090

  • Study site

    Zgierz, 95100

Other trials in Poland

Ecuador3 sites

  • Study site

    Guayaquil, Guayas, EC090103

  • Study site

    Guayaquil

  • Study site

    Quito

Other trials in Ecuador

Estonia3 sites

  • Study site

    Tallinn, 10617

  • Study site

    Tallinn, 13619

  • Study site

    Tartu, 51014

Other trials in Estonia

Germany3 sites

  • Study site

    Hanover, 30173

  • Study site

    Hofheim, De-he, 65719

  • Study site

    Rotenburg (Wümme), De-ni, 27356

Other trials in Germany

Dominican Republic2 sites

  • Study site

    Santo Domingo, 10205

  • Study site

    Santo Domingo, 10511

Other trials in Dominican Republic

Czechia1 site

  • Study site

    Beroun, 266 01

Other trials in Czechia

Puerto Rico1 site

  • Study site

    San Juan, 00921

Other trials in Puerto Rico

About this study

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

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, Placebo to match solithromycin
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

  • Placebo to match solithromycinOther

Study groups in NCT01756339
Study groupRoleWhat they receive
SolithromycinExperimentalSolithromycin 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
Receives: Drug: Solithromycin; Other: Placebo to match solithromycin
MoxifloxacinActive comparatorMoxifloxacin 400 mg PO daily on Day 1 through Day 7
Receives: Drug: Moxifloxacin

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 oral solithromycin compared 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 Clincally Evaluable (CE) populations

    To determine the overall clinical success rates of 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 posted25 Dec 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionOct 2014
  4. Study completionOct 2014

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
860 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01756339
Sponsor's protocol ID
CE01-300
Acronym
SOLITAIRE-ORAL
Status last verified
Mar 2017
First submitted
20 Dec 2012
Last updated
3 Mar 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Barrera CM, Mykietiuk A, Metev H, Nitu MF, Karimjee N, Doreski PA, Mitha I, Tanaseanu CM, Molina JM, Antonovsky Y, Van Rensburg DJ, Rowe BH, Flores-Figueroa J, Rewerska B, Clark K, Keedy K, Sheets A, Scott D, Horwith G, Das AF, Jamieson B, Fernandes P, Oldach D; SOLITAIRE-ORAL Pneumonia Team. Efficacy and safety of oral solithromycin versus oral moxifloxacin for treatment of community-acquired bacterial pneumonia: a global, double-blind, multicentre, randomised, active-controlled, non-inferiority trial (SOLITAIRE-ORAL). Lancet Infect Dis. 2016 Apr;16(4):421-30. doi: 10.1016/S1473-3099(16)00017-7. Epub 2016 Feb 5.

    PubMed 26852726

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 119 sites in 17 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 12 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 119 sites in United States, Russia, South Africa, Argentina, Bulgaria and 12 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 NCT01756339, 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.

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