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Clinical trials for Pristinamycin

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   44341   clinical trials with a EudraCT protocol, of which   7370   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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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    Query did not match any clinical trials.
    These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006).
    Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records.
    Study title: Essai randomisé, ouvert, en groupes parallèles, afin d'évaluer la non infériorité de la cloxacilline versus la pristinamycine en termes d'efficacité et de tolérance dans les infections cutanées à staphylocoque ou à streptocoque
    Active substance: CLOTRIMAZOLE + SALICYLIC ACID
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    Document reference: 24467
    Study title: "Essai randomisé, ouvert, en groupes parallèles, afin d'évaluer la non infériorité de la cloxacilline versus la pristinamycine en termes d'efficacité et de tolérance dans les infections cutanées à staphylocoque ou à streptocoque"
    Active substance: CLOXACILLIN
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    Document reference: 24468
    Study title: Fucidin® tablets in cutaneous infection in comparison with pristinamycin tablets
    Active substance: FUSIDIC ACID
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    Document reference: 28695
    Study title: Treatment of skin infections with two dosages of fusidic acid (500 mg/day and 1 g/day) compared with pristinamycin 2 g/day : a multicentre randomised study; L. Machet, A. Puissant, L. Vaillant t le groupe d’étude des infections cutanéesNouvelles Dermatologiques 1994; 13: 512-9
    Active substance: FUSIDIC ACID
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    Document reference: 28683
    Study title: Bibliography - Pyostacine and Cutaneous infections in children - Larregue et al. - 1982 - Revue Int. Pediatric (122:1-4)Bibliography - Pyostacine and Cutaneous infections in children - Larregue et al. - 1982 - Revue Int. Pediatric (122:1-4)
    Active substance: PRISTINAMYCIN
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    Document reference: 46114
    Study title: Bibliography - Resistant pneumococci in paediatrics : therapeutic indications - E. Bingen and A. Bourrillon - January 4th, 1995 - La Presse Médicale (24:N°2)Bibliography - Resistant pneumococci in paediatrics : therapeutic indications - E. Bingen and A. Bourrillon - January 4th, 1995 - La Presse Médicale (24:N°2)
    Active substance: PRISTINAMYCIN
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    Document reference: 46115
    Study title: Bibliography - Treatment with pristinamycin of acute dermohypodermitis. Open study in 42 patients - P. Bernard et al. - 1996 - Ann Dermatol. Venereol. (123: 16-20) English VersionBibliography - Treatment with pristinamycin of acute dermohypodermitis. Open study in 42 patients - P. Bernard et al. - 1996 - Ann Dermatol. Venereol. (123: 16-20) English Version
    Active substance: PRISTINAMYCIN
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    Document reference: 46116
    Study title: Bibliography - Treatment with pristinamycin of bone and joint infections in children - P. Beauvais et al. - 1981 - Arch. Fr. Pediatr. (38:489-493)Bibliography - Treatment with pristinamycin of bone and joint infections in children - P. Beauvais et al. - 1981 - Arch. Fr. Pediatr. (38:489-493)
    Active substance: PRISTINAMYCIN
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    Document reference: 46117
    Study title: Phase IV, double- blind, double-dummy, multicenter clinical study randomized in two parallel groups comparing the efficacy and safety of pristinamycin (PYOSTACINE) at an oral dose of 1 gram twice a day for ten days versus oxacillin (BRISTOPEN) at an oral dose of 1 gram twice a day for 10 days in the treatment of superficial bacterial skin infections in 250 outpatients. Study report PY 403 - Phase IV, double blind, double-dummy, multicenter clinical study, randomised, in two parallel groups, comparing the efficacy and safety of pristinamycin (Pyostacine®) at the posology of 1 gramm orally twice a day for 10 days, versus oxacilline (Bristopen®) at the posology of 1 gramm orally twice a day for 10 days, in the treatment of superficial cutaneous bacterial infections in 250 out-patient. -...
    Active substance: PRISTINAMYCIN
    Study summary document link (including results): Pristinamycin STUDY SPECIA PY 403.xls
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    Document reference: 46118
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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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