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Clinical trials for Bacilli

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   43881   clinical trials with a EudraCT protocol, of which   7295   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 ).  
     
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    22 result(s) found for: Bacilli. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2017-001257-14 Sponsor Protocol Number: P160910J Start Date*: 2018-04-13
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: Temocillin versus a carbapenem as initial intravenous treatment for extended-spectrum beta-lactamase related urinary tract infections, a non-inferiority study.TEMO-CARB
    Medical condition: -Hospitalized patient with complicated UTI due to ESBL producing enterobacteriaceae (pyelonephritis, prostatitis or renal abscess) requiring parenteral antimicrobial therapy.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10054088 Urinary tract infection bacterial PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2004-005142-12 Sponsor Protocol Number: TMC207-C203 Start Date*: 2005-06-25
    Sponsor Name:Tibotec Pharmaceuticals Limited
    Full Title: An open-label study to evaluate the extended early bactericidal activity, safety, tolerability and pharmacokinetics of multiple doses (m.d.) of TMC207 oral solution (os) and isoniazid (JH), m.d. of...
    Medical condition: Tuberculosis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-002110-32 Sponsor Protocol Number: 10-0065 Start Date*: 2018-06-13
    Sponsor Name:Regents of the University of Michigan
    Full Title: DMID Protocol Number: 10-0065 OVERCOME Trial: Randomized Controlled Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli
    Medical condition: Blood stream Infection (BSI) and/or pneumonia due to extensively drug-resistant Gram-negative bacilli (XDR-GNB) including XDR-AB, CRE and XDR-PA
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10004031 Bacterial infection due to other gram-negative organisms LLT
    20.1 10021881 - Infections and infestations 10035701 Pneumonia gram-negative bacterial NOS LLT
    20.1 10021881 - Infections and infestations 10064977 Acinetobacter bacteremia LLT
    20.0 10021881 - Infections and infestations 10051190 Pneumonia Pseudomonas aeruginosa LLT
    20.0 10021881 - Infections and infestations 10035679 Pneumonia due to Escherichia coli (E. Coli) LLT
    20.0 10021881 - Infections and infestations 10054280 Escherichia coli bacteraemia LLT
    20.0 10021881 - Infections and infestations 10021860 Infection Pseudomonas aeruginosa LLT
    20.1 10021881 - Infections and infestations 10023456 Klebsiella pneumonia LLT
    20.0 10021881 - Infections and infestations 10058883 Klebsiella bacteremia LLT
    20.0 10021881 - Infections and infestations 10054218 Enterobacter pneumonia PT
    20.1 10021881 - Infections and infestations 10058884 Enterobacter bacteremia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) GR (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-002673-35 Sponsor Protocol Number: Fos.06/2016 Start Date*: 2017-03-29
    Sponsor Name:PRO-IMPLANT Foundation
    Full Title: Efficacy and safety of intravenous fosfomycin in prosthetic joint infection (PJI) caused by staphylococci, streptococci, enterococci and gram-negative bacilli, including mixed infections and cultur...
    Medical condition: Prosthetic joint infection of knee, hip or shoulder
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-003485-24 Sponsor Protocol Number: CXA-PEDS-13-08 Start Date*: 2014-09-25
    Sponsor Name:Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 1, Non-comparative, Open-label Study to Characterize the Pharmacokinetics of a Single Intravenous Dose of Ceftolozane/tazobactam in Pediatric Patients Receiving Standard of Care Antibiotic ...
    Medical condition: This study is designed to assess the PK, safety, and tolerability of a single intravenous dose of ceftolozane/tazobactam in pediatric patients.
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10018657 Gram-negative bacterial infection NOS LLT
    20.0 100000004865 10049086 Antibacterial prophylaxis LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-003446-45 Sponsor Protocol Number: TBTCS31/A5349 Start Date*: 2016-02-25
    Sponsor Name:Unidad de investigación en Tuberculosis de Barcelona
    Full Title: Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: A randomized, open-label, controlled phase 3 clinical trial
    Medical condition: Pulmonary tuberculosis
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-004219-19 Sponsor Protocol Number: SIMPLIFY Start Date*: 2016-03-18
    Sponsor Name:FISEVI
    Full Title: Randomized, multicenter, open, phase III, controlled clinical trial, to demonstrate the non-inferiority of reduced antibiotic treatment directed against the treatment of a broad spectrum betalactam...
    Medical condition: Monomicrobial bacteremia from any source due to Enterobactericiae
    Disease: Version SOC Term Classification Code Term Level
    18.1 10021881 - Infections and infestations 10058857 Enterobacter bacteraemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-001997-18 Sponsor Protocol Number: ACHN-490-007 Start Date*: 2014-02-25
    Sponsor Name:Achaogen, Inc.
    Full Title: A Phase 3, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Plazomicin Compared with Colistin in Patients with Infection due to Carbapenem-Resistant Enterobacteriace...
    Medical condition: Bloodstream infections (BSI) and nosocomial pneumonia due to carbapenem-resistant Enterobacteriaceae (CRE)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10018657 Gram-negative bacterial infection NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed) ES (Prematurely Ended) IT (Completed) DE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2005-003312-29 Sponsor Protocol Number: UITB Estudio 28 Start Date*: 2006-05-17
    Sponsor Name:TB Investigation Unit of Barcelona
    Full Title: Evaluation of a Moxifloxacin-Based, Isoniazid-Sparing Regimen for Tuberculosis Treatment TBTC/UITB Study 28
    Medical condition: To compare two treatments for pulmonary tuberculosis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-002922-21 Sponsor Protocol Number: FOREST Start Date*: 2014-05-07
    Sponsor Name:FISEVI
    Full Title: Randomized, phase III, multicentre, open-labelled clinical trial, to evaluate the efficacy of fosfomycin vs meropenem in the treatment of bacteremic urinary tract infection caused by Escherichia co...
    Medical condition: Bacteremic urinary tract infection by Escherichia coli extended spectrum beta-lactamase (ESBL).
    Disease: Version SOC Term Classification Code Term Level
    16.1 10021881 - Infections and infestations 10052238 Escherichia urinary tract infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-022487-12 Sponsor Protocol Number: CXL-MD-02 Start Date*: 2011-02-25
    Sponsor Name:Cerexa, Inc
    Full Title: A Phase 2, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Efficacy and Safety of Intravenous Coadministered Ceftaroline fosamil and NXL104 Versus Intravenous Doripenem in ...
    Medical condition: Complicated Urinary Tract Infection
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10054088 Urinary tract infection bacterial PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-005229-31 Sponsor Protocol Number: 242-07-204 Start Date*: 2008-02-14
    Sponsor Name:Otsuka Pharmaceutical Development and Commercialization, Inc.
    Full Title: A Multi center, Randomized, Double-blind, Placebo-controlled Phase 2 Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of Multiple Doses of OPC-67683 in Patients with Pulmonary Sputum Cu...
    Medical condition: Pulmonary Multidrug-resistant Tuberculosis (MDR TB)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10037440 Pulmonary tuberculosis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: EE (Completed) LV (Completed)
    Trial results: View results
    EudraCT Number: 2008-008444-25 Sponsor Protocol Number: TMC207-TiDP13-C209 Start Date*: 2009-06-04
    Sponsor Name:Janssen Infectious Diseases BVBA
    Full Title: A Phase II, open-label trial with TMC207 as part of a multi-drug resistant tuberculosis (MDR-TB) treatment regimen in subjects with sputum smear-positive pulmonary infection with MDR-TB.
    Medical condition: Sputum smear-positive pulmonary multi-drug resistant tuberculosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10044755 Tuberculosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) EE (Completed)
    Trial results: View results
    EudraCT Number: 2011-000653-23 Sponsor Protocol Number: TMC207-TiDP13-C210 Start Date*: 2012-06-13
    Sponsor Name:Janssen Infectious Diseases BVBA
    Full Title: A Phase III placebo-controlled, double-blind, randomized trial to evaluate the efficacy and safety of TMC207 in subjects with sputum smear-positive pulmonary infection with multi-drug resistant Myc...
    Medical condition: Multi-drug resistant tuberculosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10044755 Tuberculosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Prematurely Ended) LV (Completed)
    Trial results: View results
    EudraCT Number: 2016-000656-99 Sponsor Protocol Number: REMPEX-507 Start Date*: 2023-09-28
    Sponsor Name:Rempex Pharmaceuticals-Melinta Therapeutics
    Full Title: An Open label, Dose-finding, Pharmacokinetics, Safety, and Tolerability Study of a Single Dose Infusion of VABOMERE® (Meropenem-Vaborbactam) in Pediatric Subjects From Birth to Less Than 18 Years o...
    Medical condition: Suspected or confirmed negative bacterial infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    20.0 10021881 - Infections and infestations 10004047 Bacterial infections NEC HLT
    20.1 10021881 - Infections and infestations 10060945 Bacterial infection PT
    20.1 100000004862 10018657 Gram-negative bacterial infection NOS LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2005-003562-42 Sponsor Protocol Number: AdjuVIT v3 Start Date*: 2006-09-27
    Sponsor Name:Queen Mary, University of London
    Full Title: Trial of Adjunctive Vitamin D in Tuberculosis Treatment (AdjuVIT)
    Medical condition: Pulmonary tuberculosis
    Disease: Version SOC Term Classification Code Term Level
    8.1 10037440 Pulmonary tuberculosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-003374-14 Sponsor Protocol Number: SAV008-01 Start Date*: 2018-04-06
    Sponsor Name:Savara ApS
    Full Title: An Open-label, non-controlled, multicenter, Pilot clinical Trial of Inhaled Molgramostim in subjects with Antibiotic-resistant non-tuberculosis mycobacterial (NTM) infection
    Medical condition: Treatment-resistant pulmonary non-tuberculosis mycobacterial (NTM) infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10062207 Mycobacterial infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2022-002636-31 Sponsor Protocol Number: APHP211034 Start Date*: 2022-09-15
    Sponsor Name:Assistance Publique Hôpitaux de Paris/DRCI
    Full Title: Piperacillin-tazobactam and temocillin as carbapenem-alternatives for the treatment of severe infections due to extended-spectrum beta-lactamase–producing Gram-negative Enterobacteriaceae in the in...
    Medical condition: severe infections due to extended-spectrum beta-lactamase–producing Gram-negative Enterobacteriaceae
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-000147-31 Sponsor Protocol Number: 19-211 Start Date*: Information not available in EudraCT
    Sponsor Name:Clinical Evaluation Research Unit
    Full Title: VItamin C in Thermal injuRY: The VICToRY Pilot Trial A feasibility study for a seamless adaptive phase II/III multi-center randomized trial
    Medical condition: Severely burned patients
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004863 10006634 Burn LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-022271-59 Sponsor Protocol Number: 242-09-213 Start Date*: 2011-07-19
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Evaluate the Safety and Efficacy of Delamanid (OPC-67683) Administered Orally as 200 mg Total Daily Dos...
    Medical condition: Pulmonary Multidrug-resistant Tuberculosis (MDR TB)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10037443 Pulmonary tuberculosis, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) EE (Completed) LT (Completed)
    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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