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Clinical trials for Solithromycin

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    8 result(s) found for: Solithromycin. Displaying page 1 of 1.
    EudraCT Number: 2014-004041-26 Sponsor Protocol Number: CE01-120 Start Date*: 2014-10-10
    Sponsor Name:Cempra Pharmaceuticals , Inc
    Full Title: A Phase I, open-label, multi-centre study to evaluate the PK and safety of solithromycin as add-on therapy to antimicrobial agent administered to paediatric subjects with a suspected or confirmed b...
    Medical condition: suspected or confirm bacterial infection
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-004037-10 Sponsor Protocol Number: CE01-119 Start Date*: 2014-10-10
    Sponsor Name:Cempra Pharmaceuticals, Inc.
    Full Title: A phase 1, open-label, multi-centre study to determine the PK and safety of a 5-day oral dosing of solithromycin as add-on therapy to antimicrobial agent administered to adolescent with suspected o...
    Medical condition: suspected or confirmed bacterial infection
    Disease:
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-003753-34 Sponsor Protocol Number: CE01-120 Start Date*: 2015-05-08
    Sponsor Name:Cempra Pharmaceuticals, Inc.
    Full Title: A Phase 1, Open-label, Multi-center Study to Determine the Pharmacokinetics (PK) and Safety of Solithromycin as Add-on Therapy in Adolescents and Children with Suspected or Confirmed Bacterial Infe...
    Medical condition: Adolescents and Children with Suspected or Confirmed Bacterial Infection
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BG (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-004040-36 Sponsor Protocol Number: CE01-302 Start Date*: 2014-10-10
    Sponsor Name:Cempra Pharmaceuticals, Inc.
    Full Title: A Study to Evaluate the Efficacy and Safety of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea (SOLITAIRE-U).
    Medical condition: gonorrhoea
    Disease:
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2012-003971-20 Sponsor Protocol Number: CE01-300 Start Date*: 2013-05-07
    Sponsor Name:Cempra Pharmaceuticals, Inc.
    Full 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-Ac...
    Medical condition: Community-Acquired Bacterial Pneumonia
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004862 10010120 Community acquired pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) ES (Completed) PL (Completed) LV (Completed) EE (Completed) BG (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2013-003453-13 Sponsor Protocol Number: CE01-301 Start Date*: 2014-06-18
    Sponsor Name:Cempra Pharmaceuticals, Inc.
    Full 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 Ad...
    Medical condition: Community-Acquired Bacterial Pneumonia
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004862 10010120 Community acquired pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) BG (Completed) LV (Completed) DE (Completed) ES (Completed) RO (Completed) SK (Completed) NL (Completed) SI (Completed)
    Trial results: View results
    EudraCT Number: 2014-004039-37 Sponsor Protocol Number: CE01-203 Start Date*: 2014-10-10
    Sponsor Name:Cempra Pharmaceuticals, Inc.
    Full Title: A Phase 2/3, Randomised, Partly blinded (blinded investigator), Multi-center, Comparative Study to Determine the Safety and activity of Solithromycin (Intravenous and oral) in paediatric patients ...
    Medical condition: suspected or confirmed community acquired bacterial pneuumonia (CABP)
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA GB (Completed) HU (Completed) ES (Temporarily Halted)
    Trial results: View results
    EudraCT Number: 2014-003077-42 Sponsor Protocol Number: CE01-204 Start Date*: 2015-02-06
    Sponsor Name:Imperial College, London
    Full Title: A single-centre, double-blind, randomised, placebo-controlled crossover study to evaluate the effect of solithromycin on airway inflammation in male and female patients with chronic obstructive pul...
    Medical condition: Chronic Obstructive Pulmonary Disease.
    Disease: Version SOC Term Classification Code Term Level
    18.0 10038738 - Respiratory, thoracic and mediastinal disorders 10009033 Chronic obstructive pulmonary disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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