Study Stopped
Development not proceeding
Safety and Efficacy of Solithromycin in Adolescents and Children With Community-Acquired Bacterial Pneumonia
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
1 other identifier
interventional
97
6 countries
58
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2016
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2015
CompletedFirst Posted
Study publicly available on registry
November 16, 2015
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2018
CompletedResults Posted
Study results publicly available
January 3, 2019
CompletedJanuary 3, 2019
November 1, 2018
2 years
November 10, 2015
November 6, 2018
December 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Up to 28 days post-treatment
Secondary Outcomes (3)
Summary of Early Clinical Response
During Treatment Days 3 to 4
Summary of Clinical Improvement
Last day of Treatment (+48 hours)
Summary of Clinical Cure
Short-term follow-up at 16 days (+/- 4 days)
Study Arms (2)
Solithromycin
EXPERIMENTALSolithromycin 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 COMPARATORComparators 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.
Interventions
Age- and weight-based dosing as appropriate per sites standard of care.
Eligibility Criteria
You may qualify if:
- 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
- Chest pain
- Grunting
- Hypotension
- Tachycardia, defined as follows:
- months to \<24 months: ≥160 beats/min 24 months to \<10 years: ≥140 beats/min
- years: ≥100 beats/min
- Tachypnea, defined as follows:
- months to \<12 months: ≥50 breaths/min 12 months to \<5 years: ≥40 breaths/min
- years: ≥20 breaths/min
- +8 more criteria
You may not qualify if:
- Ventilator-associated or hospital-acquired pneumonia
- \>48 hours of systemic antibacterial therapy
- confirmed or suspected bacterial meningitis
- breast-feeding females
- positive pregnancy test
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
Unknown Facility
Little Rock, Arkansas, 72202, United States
Unknown Facility
Los Angeles, California, 90095, United States
Unknown Facility
Sacramento, California, 95817, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
Washington D.C., District of Columbia, 20010, United States
Unknown Facility
Tampa, Florida, 33606, United States
Unknown Facility
Louisville, Kentucky, 40202, United States
Unknown Facility
Omaha, Nebraska, 68198-2162, United States
Unknown Facility
Las Vegas, Nevada, 89102, United States
Unknown Facility
Durham, North Carolina, 27710, United States
Unknown Facility
Greenville, North Carolina, 27834, United States
Unknown Facility
Toledo, Ohio, 43606, United States
Unknown Facility
Portland, Oregon, 97239, United States
Unknown Facility
Hershey, Pennsylvania, 17033, United States
Unknown Facility
Memphis, Tennessee, 38105, United States
Unknown Facility
Amarillo, Texas, 79106, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Splendora, Texas, 77372, United States
Unknown Facility
Charlottesville, Virginia, 22905, United States
Unknown Facility
Richmond, Virginia, 29298, United States
Unknown Facility
Roanoke, Virginia, 24013, United States
Unknown Facility
Pleven, 5800, Bulgaria
Unknown Facility
Plovdiv, 4000, Bulgaria
Unknown Facility
Rousse, 7002, Bulgaria
Unknown Facility
Sofia, 1233, Bulgaria
Unknown Facility
Sofia, 1407, Bulgaria
Unknown Facility
Sofia, 1431, Bulgaria
Unknown Facility
Vratsa, 3001, Bulgaria
Unknown Facility
Budapest, 1083, Hungary
Unknown Facility
Budapest, 1089, Hungary
Unknown Facility
Budapest, 1097, Hungary
Unknown Facility
Budapest, 1125, Hungary
Unknown Facility
Cegléd, 2700, Hungary
Unknown Facility
Debrecen, 4031, Hungary
Unknown Facility
Győr, 9024, Hungary
Unknown Facility
Gyula, 5700, Hungary
Unknown Facility
Mosdós, 7257, Hungary
Unknown Facility
Nagykanizsa, 8800, Hungary
Unknown Facility
Nyíregyháza, 4400, Hungary
Unknown Facility
Szeged, 6720, Hungary
Unknown Facility
Székesfehérvár, 8000, Hungary
Unknown Facility
Törökbálint, 2045, Hungary
Unknown Facility
Veszprém, 8200, Hungary
Unknown Facility
Caloocan, 1400, Philippines
Unknown Facility
Cebu City, 6000, Philippines
Unknown Facility
City of Muntinlupa, 1781, Philippines
Unknown Facility
Davao City, 8000, Philippines
Unknown Facility
Iloilo City, 5000, Philippines
Unknown Facility
Manila, 1000, Philippines
Unknown Facility
Quezon City, 1100, Philippines
Unknown Facility
Quezon City, 1104, Philippines
Unknown Facility
Esplugues de Llobregat, Barcelona, 08950, Spain
Unknown Facility
Donostia / San Sebastian, Guipuzcoa, 20014, Spain
Unknown Facility
Barcelona, 08035, Spain
Unknown Facility
Barcelona, 08916, Spain
Unknown Facility
Madrid, 28046, Spain
Unknown Facility
London, N18 1QX, United Kingdom
Unknown Facility
London, SW17 0RE, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was discontinued early due to a company business decision. Study discontinuation was not related to safety or tolerability.
Results Point of Contact
- Title
- Melissa Allaband
- Organization
- Cempra Pharmeuticals, a wholly owned subsidary of Melinta Therapeutics, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Cohen-Wolkowiez, MD, PhD
Duke Clinical Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- A healthcare provider designated as a sub-investigator blinded to treatment allocation at the site documented clinical response at specified time points during the study.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2015
First Posted
November 16, 2015
Study Start
April 1, 2016
Primary Completion
March 21, 2018
Study Completion
March 21, 2018
Last Updated
January 3, 2019
Results First Posted
January 3, 2019
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share