- Trials with a EudraCT protocol (67)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
67 result(s) found for: Gram-negative Bacterial Infection.
Displaying page 1 of 4.
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. | ||||||||||||||||||
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Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 | Gender: Male, Female | |||||||||||||||||
Trial protocol: Outside EU/EEA | ||||||||||||||||||
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 | ||||||||||||||||||||||||||||
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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: 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) | |||||||||||||
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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: 2012-001496-36 | Sponsor Protocol Number: AMPISUL/AMOXICLAV-HD_V1.4 | Start Date*: 2013-07-19 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sponsor Name:Medizinische Universität Wien, Universitätsklinik für Innere Medizin I, Klinische abteilung für Infektionen und Tropenme | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Full Title: Multiple-dose pharmacokinetics of ampicillin / sulbactam and amoxicillin / clavulanic acid during haemodialysis in longterm haemodialysis patients | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Medical condition: Suspected or proven bacterial infection requiring therapy with broad spectrum antibiotics | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Trial protocol: AT (Completed) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Trial results: (No results available) |
EudraCT Number: 2004-000406-51 | Sponsor Protocol Number: EMD20001 | Start Date*: 2004-09-16 |
Sponsor Name:GlaxoSmithKline | ||
Full Title: A Prospective, Randomized, Double-blind, Placebo Controlled, Dose Ranging, Multi-Center Study of the Safety and Efficacy of Three Days Continuous Intravenous Infusion of GR270773 in the Treatment o... | ||
Medical condition: Suspected or Confirmed Gram-negative Severe Sepsis in Adults | ||
Disease: | ||
Population Age: Adults, Elderly | Gender: Male, Female | |
Trial protocol: FI (Completed) ES (Completed) CZ (Completed) LV (Completed) AT (Completed) HU (Completed) DK (Completed) | ||
Trial results: View results |
EudraCT Number: 2013-002855-13 | Sponsor Protocol Number: CAP-01-102 | Start Date*: 2014-02-14 | |||||||||||
Sponsor Name:Cardeas Pharma | |||||||||||||
Full Title: A Randomized Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Study of Aerosolized Amikacin and Fosfomycin Delivered via the Investigational eFlow® Inline System in Mechanically Ventilated... | |||||||||||||
Medical condition: Gram-negative Bacterial Pneumonia in Mechanically Ventilated Patients | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: HU (Completed) ES (Completed) GR (Completed) FR (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2017-004544-38 | Sponsor Protocol Number: C3601009 | Start Date*: 2020-07-03 | |||||||||||
Sponsor Name:Pfizer Inc. | |||||||||||||
Full Title: A PROSPECTIVE, RANDOMIZED, OPEN-LABEL, COMPARATIVE STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF AZTREONAM-AVIBACTAM (ATM-AVI) AND BEST AVAILABLE THERAPY FOR THE TREATMENT OF SERIOUS INF... | |||||||||||||
Medical condition: SERIOUS INFECTIONS DUE TO MULTI-DRUG RESISTANT GRAM- NEGATIVE BACTERIA PRODUCING METALLO-Β-LACTAMASE (MBL) | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: GR (Prematurely Ended) RO (Ongoing) | |||||||||||||
Trial results: View results |
EudraCT Number: 2008-000906-35 | Sponsor Protocol Number: BAY41-6551/13085 | Start Date*: 2008-11-28 |
Sponsor Name:Bayer Schering Pharma AG | ||
Full Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Pati... | ||
Medical condition: Gram-negaive pneumonia | ||
Disease: | ||
Population Age: Adults, Elderly | Gender: Male, Female | |
Trial protocol: CZ (Completed) HU (Completed) NL (Completed) BE (Completed) ES (Completed) FR (Completed) LV (Prematurely Ended) GR (Completed) PT (Completed) IT (Prematurely Ended) PL (Completed) | ||
Trial results: View results |
EudraCT Number: 2014-000914-76 | Sponsor Protocol Number: 1409R2121 | Start Date*: 2014-11-24 | |||||||||||
Sponsor Name:Shionogi Inc. | |||||||||||||
Full Title: A Multicenter, Double-blind, Randomized, Clinical Study to Assess the Efficacy and Safety of Intravenous S-649266 in Complicated Urinary Tract Infections with or without Pyelonephritis or Acute Unc... | |||||||||||||
Medical condition: Complicated Urinary Tract Infections with or without Pyelonephritis or Acute Uncomplicated Pyelonephritis caused by Gram-negative Pathogens | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: CZ (Completed) HU (Completed) IT (Completed) ES (Completed) DE (Completed) PL (Completed) RO (Completed) HR (Completed) LV (Completed) BG (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2019-002120-32 | Sponsor Protocol Number: 1802R2135 | Start Date*: 2019-12-09 | |||||||||||||||||||||||||||||||||||||||||
Sponsor Name:Shionogi B.V. | |||||||||||||||||||||||||||||||||||||||||||
Full Title: A Single Arm, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Paediatric Subjects 3 Months to < 18 Years of Age... | |||||||||||||||||||||||||||||||||||||||||||
Medical condition: Including but not limited to complicated urinary tract infection [cUTI], complicated intra-abdominal infection [cIAI], hospital-acquired pneumonia [HAP]/ventilator-acquired pneumonia [VAP], and sep... | |||||||||||||||||||||||||||||||||||||||||||
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Population Age: Infants and toddlers, Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||||||||||||||||||||||||||||||||
Trial protocol: HU (Completed) BE (Completed) LV (Completed) | |||||||||||||||||||||||||||||||||||||||||||
Trial results: View results |
EudraCT Number: 2016-003020-23 | Sponsor Protocol Number: 1615R2132 | Start Date*: 2017-11-23 | |||||||||||||||||||||
Sponsor Name:Shionogi B.V. | |||||||||||||||||||||||
Full Title: A Multicenter, Randomized, Double-blind, Parallelgroup, Clinical Study of S-649266 Compared with Meropenem for the Treatment of Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacteria... | |||||||||||||||||||||||
Medical condition: Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia, or Healthcare-associated Bacterial Pneumonia Caused by Gram-negative Pathogens. | |||||||||||||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||||||||||||
Trial protocol: CZ (Completed) GB (Completed) LV (Completed) HU (Completed) ES (Completed) BE (Completed) | |||||||||||||||||||||||
Trial results: View results |
EudraCT Number: 2016-004328-43 | Sponsor Protocol Number: MK-7655A-020 | Start Date*: 2017-09-19 | |||||||||||
Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | |||||||||||||
Full Title: A Phase 1b, Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of MK-7655A in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed or Susp... | |||||||||||||
Medical condition: Treatment of bacterial infections in pediatric populations | |||||||||||||
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Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: NO (Completed) PL (Completed) Outside EU/EEA GB (Completed) BG (Completed) GR (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2015-004703-23 | Sponsor Protocol Number: 1424R2131 | Start Date*: 2017-02-09 | ||||||||||||||||||||||||||
Sponsor Name:Shionogi Ltd. | ||||||||||||||||||||||||||||
Full Title: A Multicenter, Randomized, Open-label Clinical Study of S-649266 or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens | ||||||||||||||||||||||||||||
Medical condition: Hospital acquired pneumonia (HAP)/ventilator associated pneumonia (VAP)/healthcare-associated pneumonia (HCAP) or bloodstream infections/sepsis (BSI/sepsis) caused by carbapenem-resistant Gram-nega... | ||||||||||||||||||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | |||||||||||||||||||||||||||
Trial protocol: ES (Completed) DE (Completed) GR (Completed) GB (Completed) HR (Completed) FR (Completed) IT (Completed) | ||||||||||||||||||||||||||||
Trial results: View results |
EudraCT Number: 2004-002988-24 | Sponsor Protocol Number: 0826-047 | Start Date*: 2005-01-07 |
Sponsor Name:Merck Sharp and Dohme de España | ||
Full Title: A prospective, multicenter, randomized, double-blind, pilot study to evaluate the safety, the efficacy, the tolerability, and the emergence of resistant gram-negative microorganisms in the bowel i... | ||
Medical condition: Community Acquired Bacterial Pneumonia with criteria of seriousness and great likelihood of polymicrobial or gram-negative microbial etiology. | ||
Disease: | ||
Population Age: Elderly | Gender: Male, Female | |
Trial protocol: ES (Completed) | ||
Trial results: View results |
EudraCT Number: 2006-004399-11 | Sponsor Protocol Number: 380204 | Start Date*: 2006-12-11 | |||||||||||
Sponsor Name:Medinova AG | |||||||||||||
Full Title: The Efficacy of 10 mg Dequalinium Chloride (Fluomizin®) in the Local Treatment of Aerobic Bacterial Vaginal Infections in Comparison to Placebo | |||||||||||||
Medical condition: Aerobic Bacterial Vaginal Infection | |||||||||||||
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Population Age: Adults | Gender: Female | ||||||||||||
Trial protocol: DE (Completed) AT (Prematurely Ended) CZ (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2019-003282-17 | Sponsor Protocol Number: 190801 | Start Date*: 2020-02-11 | |||||||||||
Sponsor Name:Thomas Benfield | |||||||||||||
Full Title: Short course antibiotic treatment of Gram-negative bacteremia: A multicenter, randomized, non-blinded, non-inferiority interventional study | |||||||||||||
Medical condition: Gram-negative bacteremia | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: DK (Ongoing) | |||||||||||||
Trial results: (No results available) |
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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Trial protocol: BG (Completed) GR (Ongoing) IT (Ongoing) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Trial results: (No results available) |
EudraCT Number: 2018-002800-16 | Sponsor Protocol Number: C3591024 | Start Date*: 2019-12-10 | |||||||||||
Sponsor Name:Pfizer Inc. | |||||||||||||
Full Title: A PHASE 2A, 2-PART, OPEN-LABEL, NON-RANDOMIZED, MULTICENTER, SINGLE AND MULTIPLE DOSE TRIAL TO EVALUATE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CEFTAZIDIME AND AVIBACTAM IN NEONATES AND INFANT... | |||||||||||||
Medical condition: Infections with suspected or confirmed Gram-negative pathogens | |||||||||||||
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Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: SK (Completed) HU (Completed) EE (Completed) GR (Completed) IT (Ongoing) | |||||||||||||
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: 2007-006137-13 | Sponsor Protocol Number: COL/VAP | Start Date*: 2008-02-21 | |||||||||||
Sponsor Name:Hospitales Universitarios Virgen del Rocío, Servicio Andaluz de Salud. | |||||||||||||
Full Title: Estudio aleatorizado, doble ciego, comparando colistina intravenosa con colistina intravenosa más colistina intravenosa más colistina nebulizada en pacientes con neumonía asociada a ventilación mec... | |||||||||||||
Medical condition: Neumonía asociada a ventilación mecánica por Acinetobacrter baumannii multi-resistente. | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: ES (Ongoing) | |||||||||||||
Trial results: (No results available) |
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