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Community-Acquired Bacterial PneumoniaPhase 2NCT01168713

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

A Phase 2 study testing Levofloxacin and CEM-101 in people with Community-Acquired Bacterial Pneumonia, run by Melinta Therapeutics, Inc. at 55 sites in 2 countries.

Completed

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

Official record
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Trial 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. 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?
Levofloxacin and CEM-101
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
55 sitesin 2 countries
Study dates
Aug 2010to Jul 2011
Phase
Phase 2
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

  • 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).
  • No prior systemic antibacterial therapy, unless failed other therapy.
  • Chest Xray shows new lobar or multilobar infiltrate(s) consistent with acute bacterial pneumonia.
  • PORT Risk Class II, III, or IV <=105
  • Ability to take oral medication.

Who cannot join

  • Severe chronic obstructive pulmonary disease FEV1 <30%.
  • Hospitalization within 90 days or residence in a long-term-care facility within 30 days prior to the onset of symptoms
  • Chemotherapy or radiation therapy within the previous 3 months.
  • Significant hepatic, hematological, renal abnormalities.
  • 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).

Trial locations and contacts

55 sites in 2 countries.

55 sites in 2 countries

United States45 sites

  • Study site

    Akron, Ohio, 44304

  • Study site

    Bell Gardens, California, 90201

  • Study site

    Birmingham, Alabama, 35242

  • Study site

    Blue Ridge, Georgia, 30513

  • Study site

    Butte, Montana, 59701

  • Study site

    Carlisle, Ohio, 45005

  • Study site

    Chula Vista, California, 91911

  • Study site

    Columbus, Georgia, 31904

  • Study site

    Corsicana, Texas, 75110

  • Study site

    DeBary, Florida, 32713

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Draper, Utah, 84020

  • Study site

    Dubuque, Iowa, 52001

  • Study site

    Eugene, Oregon, 97404

  • Study site

    Fall River, Massachusetts, 02720

  • Study site

    Flagstaff, Arizona, 86001

  • Study site

    Franklin, Tennessee, 37067

  • Study site

    Gainesville, Florida, 32605

  • Study site

    Hialeah, Florida, 33012

  • Study site

    Houston, Texas, 77002

  • Study site

    Houston, Texas, 77093

  • Study site

    Idaho Falls, Idaho, 83404

  • Study site

    Kissimmee, Florida, 34741

  • Study site

    Las Vegas, Nevada, 89109

  • Study site

    LeMesa, California, 91942

  • Study site

    Los Angeles, California, 90015

  • Study site

    Magna, Utah, 84044

  • Study site

    Montclaire, California, 91763

  • Study site

    Morton, Illinois, 61550

  • Study site

    New Bedford, Massachusetts, 02740

  • Study site

    New Orleans, Louisiana, 70112

  • Study site

    Norwalk, California, 90650

  • Study site

    Oceanside, California, 92056

  • Study site

    Orlando, Florida, 32837

  • Study site

    Oxnard, California, 93030

  • Study site

    Pasadena, California, 91105

  • Study site

    Rapid City, South Dakota, 57702

  • Study site

    Salt Lake City, Utah, 84121

  • Study site

    San Antonio, Texas, 78238

  • Study site

    Savannah, Georgia, 31406

  • Study site

    Simpsonville, South Carolina, 29681

  • Study site

    Torrence, California, 90501

  • Study site

    Traverse City, Michigan, 49684

  • Study site

    Waterbury, Connecticut, 06708

  • Study site

    West Reading, Pennsylvania, 19611

Other trials in United States

Canada10 sites

  • Study site

    Calgary, Alberta, T2N2T9

  • Study site

    Chicoutimi, Quebec, G7H-5H6

  • Study site

    Hamilton, Ontario, L8N3Z5

  • Study site

    Hamilton, Ontario, L8N4A6

  • Study site

    Hamilton, Ontario, L8V1C3

  • Study site

    Ottawa, Ontario, K1Y 4E9

  • Study site

    Saint-Jérôme, Quebec, J7Z5T3

  • Study site

    Sherbrooke, Quebec, J1H5N4

  • Study site

    Toronto, Ontario, M9W 4L6

  • Study site

    Trios-Rivieres, Quebec, G8Z3R9

Other trials in Canada

About this study

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 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.

Read the 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.

Being tested
Levofloxacin, CEM-101
Keywords
Adults with Community-Acquired Bacterial Pneumonia

What participants receive

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

  • LevofloxacinDrug

    Also called Levaquin

    Levofloxacin once daily for 5 days:

    Levofloxacin 750 mg PO Days 1-5

  • CEM-101Drug

    Also called Solithromycin

    CEM-101 once daily for 5 days:

    CEM-101 800 mg PO Day 1

    CEM-101 400 mg PO Days 2-5

Study groups in NCT01168713
Study groupRoleWhat they receive
LevofloxacinActive comparatorNot described
Receives: Drug: Levofloxacin
CEM-101ExperimentalNot described
Receives: Drug: CEM-101

What is being measured

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

  1. Clinical Success in the Intent to Treat (ITT) population at the Treatment of Cure (TOC) visit

    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

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

  2. Clinical Success in the Clinically Evaluable (CE) population at the Treatment of Cure (TOC) Visit

    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

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

Secondary outcomes (14)

  1. By Patient Microbiological Response in the Microbiological Intent to Treat (microlITT) population at the end of treatment (EOT)

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

    Measured: 5 days of study drug treatment

  2. By Patient Microbiological Response in the Microbiological Intent to Treat (microlITT) population at the Treatment of Cure (TOC) visit

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

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

  3. By-patient Microbiological Response in the Microbiologically Evaluable (ME) populations at the end of treatment (EOT)

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

    Measured: 5 days of study drug treatment

  4. By-patient Microbiological Response in the Microbiologically Evaluable (ME) populations at Treatment of Cure (TOC) visit

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

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

  5. Clinical Response in the Intent to Treat (ITT) population at End of Treatment (EOT)

    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

    Measured: 5 days of study drug treatment

  6. Clinical Response in the microbiological intent to treat (microlITT) population at the end of treatment (EOT)

    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

    Measured: 5 days of study drug treatment

  7. Clinical Response in the clinically evaluable (CE) population at the end of treatment (EOT)

    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

    Measured: 5 days of study drug treatment

  8. Clinical REsponse in the Microbiologically Evaluable (ME) population at the end of treatment (EOT)

    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

    Measured: 5 days of study drug treatment

  9. Early Clinical Response in the intent to treat (ITT) population at Day 3

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

    Measured: 3 days of study drug treatment

  10. Percentage of patients at each visit who have resolution of all baseline signs and symptoms in the clinically evaluable (CE) population

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

    Measured: Day 3, Day 5 (end of treatment), and 5 to 10 days after the last dose of study drug (test of cure visit)

  11. Percentage of patients at Day 3 who have resolution of cough, dyspnea, chest pain due to pneumonia and sputum production

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

    Measured: 3 days of study drug treatment

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

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

    Measured: 5 days of study drug treatment

  13. Percentage of patients at Day 3 who are clinically stable

    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)

    Measured: 3 days of study drug treatment

  14. Percentage of patients at the end of treatment (EOT) who are clinically stable

    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)

    Measured: 5 days of study drug treatment

Timeline

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

  1. First posted23 Jul 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionJul 2011
  4. Study completionJul 2011

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01168713
Sponsor's protocol ID
CE01-200
Status last verified
Mar 2017
First submitted
22 Jul 2010
Last updated
3 Mar 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Oldach D, Clark K, Schranz J, Das A, Craft JC, Scott D, Jamieson BD, Fernandes P. Randomized, double-blind, multicenter phase 2 study comparing the efficacy and safety of oral solithromycin (CEM-101) to those of oral levofloxacin in the treatment of patients with community-acquired bacterial pneumonia. Antimicrob Agents Chemother. 2013 Jun;57(6):2526-34. doi: 10.1128/AAC.00197-13. Epub 2013 Mar 18.

    PubMed 23507282

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Levofloxacin and CEM-101 in people with Community-Acquired Bacterial Pneumonia, run by Melinta Therapeutics, Inc. at 55 sites in 2 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 5 inclusion and 5 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 55 sites in United States, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Clinical Success in the Intent to Treat (ITT) population at the Treatment of Cure (TOC) visit (time frame: 5 to 10 days after the last dose of study drug). The study lists 2 primary outcomes in all. 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 NCT01168713, 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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