Community-acquired Bacterial PneumoniaPhase 2/3NCT02605122
Safety and Efficacy of Solithromycin in Adolescents and Children With Community-Acquired Bacterial Pneumonia
A Phase 2/3 study testing Solithromycin in people with Community-acquired Bacterial Pneumonia, run by Melinta Therapeutics, Inc. at 58 sites in 6 countries.
Trial summary
This is a phase 2/3, randomized, open-label, active control, multi-center study to assess the safety and efficacy of solithromycin in children and adolescents with community-acquired bacterial pneumonia (CABP). Read more about this study
- Who is it for?
- Ages 2 months to 17 years
- Conditions the study is for
- Community-acquired Bacterial Pneumonia
- What is being tested?
- Solithromycin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 58 sitesin 6 countries
- Study dates
- Apr 2016to 21 Mar 2018
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- History of and/or documented fever (rectal, ear, or oral temperature ≥38°C or axillary temperature ≥37.5°C) or hypothermia (rectal, ear, or oral temperature <35°C or axillary temperature <34.5°C)
- Chest radiograph infiltrates consistent with bacterial pneumonia (or pneumonia caused by atypical bacterial agents); if a subject is outpatient and starting on oral therapy, a radiograph is not required.
- Presence of at least 2 of the following signs or symptoms:
- Cough
- Difficulty breathing
- Production of purulent sputum
Show all 23Show fewer
- Chest pain
- Grunting
- Hypotension
- Tachycardia, defined as follows:
- 2 months to <24 months: ≥160 beats/min 24 months to <10 years: ≥140 beats/min
- 10 years: ≥100 beats/min
- Tachypnea, defined as follows:
- 2 months to <12 months: ≥50 breaths/min 12 months to <5 years: ≥40 breaths/min
- 5 years: ≥20 breaths/min
- Physical exam consistent with pulmonary consolidation
- Presence of at least 1 of the following:
- Leukocytosis (≥12,000 white blood cells [WBC]/mm3)
- Leukopenia (<5000 WBC/mm3)
- ≥10% immature neutrophils (bands) regardless of total peripheral WBC
- Elevated inflammatory markers (C-reactive protein or procalcitonin)
- Oxygen saturation <97% on room air
- Organism consistent with a typical respiratory pathogen identified
Who cannot join
- Ventilator-associated or hospital-acquired pneumonia
- >48 hours of systemic antibacterial therapy
- confirmed or suspected bacterial meningitis
- breast-feeding females
- positive pregnancy test
Trial locations and contacts
58 sites in 6 countries.
58 sites in 6 countries
United States21 sites
Study site
Amarillo, Texas, 79106
Study site
Charlottesville, Virginia, 22905
Study site
Durham, North Carolina, 27710
Study site
Greenville, North Carolina, 27834
Study site
Hershey, Pennsylvania, 17033
Study site
Houston, Texas, 77030
Study site
Las Vegas, Nevada, 89102
Study site
Little Rock, Arkansas, 72202
Study site
Los Angeles, California, 90095
Study site
Louisville, Kentucky, 40202
Study site
Memphis, Tennessee, 38105
Study site
Omaha, Nebraska, 68198-2162
Study site
Portland, Oregon, 97239
Study site
Richmond, Virginia, 29298
Study site
Roanoke, Virginia, 24013
Study site
Sacramento, California, 95817
Study site
San Diego, California, 92123
Study site
Splendora, Texas, 77372
Study site
Tampa, Florida, 33606
Study site
Toledo, Ohio, 43606
Study site
Washington D.C., District of Columbia, 20010
Hungary15 sites
Study site
Budapest, 1083
Study site
Budapest, 1089
Study site
Budapest, 1097
Study site
Budapest, 1125
Study site
Cegléd, 2700
Study site
Debrecen, 4031
Study site
Győr, 9024
Study site
Gyula, 5700
Study site
Mosdós, 7257
Study site
Nagykanizsa, 8800
Study site
Nyíregyháza, 4400
Study site
Szeged, 6720
Study site
Székesfehérvár, 8000
Study site
Törökbálint, 2045
Study site
Veszprém, 8200
Philippines8 sites
Study site
Caloocan, 1400
Study site
Cebu City, 6000
Study site
City of Muntinlupa, 1781
Study site
Davao City, 8000
Study site
Iloilo City, 5000
Study site
Manila, 1000
Study site
Quezon City, 1100
Study site
Quezon City, 1104
Bulgaria7 sites
Study site
Pleven, 5800
Study site
Plovdiv, 4000
Study site
Rousse, 7002
Study site
Sofia, 1233
Study site
Sofia, 1407
Study site
Sofia, 1431
Study site
Vratsa, 3001
Spain5 sites
Study site
Barcelona, 08035
Study site
Barcelona, 08916
Study site
Donostia / San Sebastian, Guipuzcoa, 20014
Study site
Esplugues de Llobregat, Barcelona, 08950
Study site
Madrid, 28046
United Kingdom2 sites
Study site
London, N18 1QX
Study site
London, SW17 0RE
About this study
Official title: A Phase 2/3, Randomized, Open-Label, Multi-center Study to Determine the Safety and Efficacy of Solithromycin in Adolescents and Children With Suspected or Confirmed Community-Acquired Bacterial Pneumonia
This is a phase 2/3, randomized, open-label, active control, multi-center study to assess the safety and efficacy of solithromycin in children and adolescents with community-acquired bacterial pneumonia (CABP).
Read the detailed description
Subjects who meet all inclusion/exclusion criteria and sign the informed consent/assent were enrolled. Subjects were randomized to receive solithromycin or a comparator antibiotic, administered IV and/or by mouth (PO) based on weight and age. Subjects were treated daily for 5 to 7 days with oral solithromycin and 5 to 7 days with IV or IV-to-oral solithromycin. Subjects were treated for 5 to 10 days with comparator antibiotics. Subjects received safety and efficacy assessments during and after treatment.
- Conditions
- Community-acquired Bacterial Pneumonia
- Being tested
- Solithromycin, Standard of Care
- Keywords
- pneumonia, macrolide, pediatric
- 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
Standard of CareDrug
Also called ceftriaxone, ampicillin, amoxicillin, amoxicillin-clavulanic acid
Age- and weight-based dosing as appropriate per sites standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Solithromycin | Experimental | Solithromycin will be administered orally, as capsules or as a suspension, or intravenously. Patients may receive intravenous therapy initially and switch to an oral formulation. Dosage is weight based and age based. Receives: Drug: Solithromycin |
| Standard of Care | Active comparator | Comparators will be selected according to subject age and are consistent with current recommendations for treatment of CABP in children. These include intravenous ceftriaxone, ampicillin, and amoxicillin and oral amoxicillin and amoxicillin-clavulanic acid. Azithromycin or erythromycin may be added as well. Receives: Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overview of Adverse Events By Treatment Arm
Summary of subjects experiencing Treatment Emergent Adverse Events (TEAE) through Day 16 visit and Treatment Emergent Serious Adverse Events (TESAE) through Day 28 visit (28 days +/- 4 days after randomization)
Measured: Up to 28 days post-treatment
Secondary outcomes (3)
Summary of Early Clinical Response
Early clinical response (ECR) was defined using the latest efficacy evaluation from Day 2 (if subject discharged prior to Day 2), Day3, or Day 4, and was defined as improvement in at least 1 presenting sign/symptom of CABP with no deterioration in any signs/symptoms of CABP and no requirement for an additional antibiotic.
Measured: During Treatment Days 3 to 4
Summary of Clinical Improvement
Clinical improvement was assessed using the latest efficacy evaluation conducted on last day of treatment (+48 hours), and was defined identically to the early clinical response.
Measured: Last day of Treatment (+48 hours)
Summary of Clinical Cure
Clinical cure was assessed using the latest efficacy evaluation conducted on Day 16 (+/- 4 days) post-randomization, and was defined as resolution of all presenting signs/symptoms of CABP (excluding cough), no development of new signs/symptoms of CABP, and no requirement for an additional antibiotic.
Measured: Short-term follow-up at 16 days (+/- 4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startApr 2016
- Primary completion21 Mar 2018
- Study completion21 Mar 2018
Why it stopped: Development not proceeding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Community-acquired Bacterial PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melinta Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Michael Cohen-Wolkowiez, MD, PhD, Principal investigator, Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605122
- Sponsor's protocol ID
- CE01-203
- Status last verified
- Nov 2018
- First submitted
- 10 Nov 2015
- Last updated
- 3 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3, Randomized, Open-Label, Multi-center Study to Determine the Safety and Efficacy of Solithromycin in Adolescents and Children With Suspected or Confirmed Community-Acquired Bacterial Pneumonia
- ClinicalTrials.gov ID
- NCT02605122
- Acronym / sponsor ID
- CE01-203
- Conditions
- Community-acquired Bacterial Pneumonia
- Keywords
- pneumonia, macrolide, pediatric
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Development not proceeding
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Melinta Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- Apr 2016 (actual)
- Primary completion
- 21 Mar 2018 (actual)
- Study completion
- 21 Mar 2018 (actual)
- First posted
- 16 Nov 2015 (estimated)
- Results
- Posted 3 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2/3, randomized, open-label, active control, multi-center study to assess the safety and efficacy of solithromycin in children and adolescents with community-acquired bacterial pneumonia (CABP).
Detailed description
Subjects who meet all inclusion/exclusion criteria and sign the informed consent/assent were enrolled. Subjects were randomized to receive solithromycin or a comparator antibiotic, administered IV and/or by mouth (PO) based on weight and age. Subjects were treated daily for 5 to 7 days with oral solithromycin and 5 to 7 days with IV or IV-to-oral solithromycin. Subjects were treated for 5 to 10 days with comparator antibiotics. Subjects received safety and efficacy assessments during and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Solithromycin | Experimental | Drug: SolithromycinSolithromycin will be administered orally, as capsules or as a suspension, or intravenously. Patients may receive intravenous therapy initially and switch to an oral formulation. Dosage is weight based and age based. |
| Standard of Care | Active comparator | Drug: Standard of CareComparators will be selected according to subject age and are consistent with current recommendations for treatment of CABP in children. These include intravenous ceftriaxone, ampicillin, and amoxicillin and oral amoxicillin and amoxicillin-clavulanic acid. Azithromycin or erythromycin may be added as well. |
Who may qualify
- Ages
- 2 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (23 listed)
- History of and/or documented fever (rectal, ear, or oral temperature ≥38°C or axillary temperature ≥37.5°C) or hypothermia (rectal, ear, or oral temperature <35°C or axillary temperature <34.5°C)
- Chest radiograph infiltrates consistent with bacterial pneumonia (or pneumonia caused by atypical bacterial agents); if a subject is outpatient and starting on oral therapy, a radiograph is not required.
- Presence of at least 2 of the following signs or symptoms:
- Cough
- Difficulty breathing
Key exclusion criteria (5 listed)
- Ventilator-associated or hospital-acquired pneumonia
- >48 hours of systemic antibacterial therapy
- confirmed or suspected bacterial meningitis
- breast-feeding females
- positive pregnancy test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SolithromycinAlso: CEM-101 | Drug | Solithromycin |
| Standard of CareAlso: ceftriaxone, ampicillin, amoxicillin, amoxicillin-clavulanic acidAge- and weight-based dosing as appropriate per sites standard of care. | Drug | Standard of Care |
Primary outcome
Overview of Adverse Events By Treatment Arm
Time frame: Up to 28 days post-treatment
Summary of subjects experiencing Treatment Emergent Adverse Events (TEAE) through Day 16 visit and Treatment Emergent Serious Adverse Events (TESAE) through Day 28 visit (28 days +/- 4 days after randomization)
3 secondary outcomes
Summary of Early Clinical Response
Time frame: During Treatment Days 3 to 4
Summary of Clinical Improvement
Time frame: Last day of Treatment (+48 hours)
Summary of Clinical Cure
Time frame: Short-term follow-up at 16 days (+/- 4 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Community-acquired Bacterial Pneumonia
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
Recruiting
Novel Tools to Improve Management of Paediatric Community-Acquired Pneumonia - ToolCAP
Pneumonia, Pneumonia Childhood
RecruitingObservational study
Lefamulin Post-Market Surveillance Study
Community-Acquired Pneumonia (CAP)
RecruitingObservational study
Derivation and Validation of the Fungal Pneumonia Assessment and Likelihood Predictor Score
Pneumonia, Fungal Pneumonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Cohen-Wolkowiez, MD, PhD principal investigator
Duke Clinical Research Institute
58 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Solithromycin in people with Community-acquired Bacterial Pneumonia, run by Melinta Therapeutics, Inc. at 58 sites in 6 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 23 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: stopped early, as of the sponsor's last update on 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States, Hungary, Philippines, Bulgaria, Spain and 1 more country. 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 3 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overview of Adverse Events By Treatment Arm (time frame: Up to 28 days post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2019.