Short Duration Treatment of Non-severe Community Acquired Pneumonia

Last updated: August 11, 2017
Sponsor: Versailles Hospital
Overall Status: Trial Status Unknown

Phase

2

Condition

Pneumonia

Treatment

N/A

Clinical Study ID

NCT01963442
PHRC-12-202.0496 - PTC
2013-000265-36
  • Ages > 18
  • All Genders

Study Summary

To investigate the non inferiority of a short lasting antibiotic treatment (3 days) when compared to a long lasting antibiotic treatment (8 days), at Day 15 after the beginning of treatment in terms of clinical efficacy, in adults admitted to emergency services for a non severe Community Acquired Pneumonia (PAC), who responded well to 3 days of beta-lactamin treatment (3GC or A/AC).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject must be 18 years old or over.

  • admitted three days before for Community Acquired Pneumonia (CAP) defined by at leastone clinical sign of pneumonia (dyspnea, cough, mucopurulent sputum, crackling soundon lungs) associated with a temperature >38°C on admission, and a new infiltrateconsistent with pneumonia on chest x-ray, who responded favorably to 3 days oftreatment with β-lactams (third generation injectable cephalosporin oramoxicillin-clavulanate)

  • able to take oral medication.

  • has given its informed consent.

Exclusion

Exclusion Criteria:

  • Creatinin < 30ml/min

  • History of jaundice / hepatic impairment associated with amoxicillin / clavulanic acid

  • History of hypersensitivity to beta-lactam

  • Presence of complications or severity of pneumonia (abscess , significant pleuraleffusion, severe chronic respiratory failure , septic shock, respiratory conditionrequiring the passage resuscitation).

  • Known immunocompromised terrain ( asplenia , neutropenia, agammaglobulinemia ,immunosuppressants, graft corticosteroids , myeloma , lymphoma, known HIV , sicklecell anemia , CHILD C cirrhosis).

  • Antibiotic treatment exceeding 24 hours prior admission.

  • Suspected atypical bacteria requiring combined antibiotics therapy .(Subjects whoreceived a single dose of macrolides or fluoroquinolones emergency will not beexcluded) .

  • Legionella suspected on clinical, biological and radiological criteria .

  • Subjects with clinical or epidemiological environment leading to suspect ahealthcare-associated pneumonia with antibiotic resistant pathogen.

  • Suspicion of pneumonia by aspiration.

  • Intercurrent infection requiring antibiotic treatment.

  • Pregnant women .

  • Breastfeeding .

  • Allergy to antibiotics in use.

  • Life expectancy <1 month .

  • Subject without health insurance.

  • Subjects without home adress

Study Design

Total Participants: 310
Study Start date:
November 01, 2013
Estimated Completion Date:
June 30, 2018

Connect with a study center

  • CH Argenteuil

    Argenteuil, 95107
    France

    Site Not Available

  • CHU Ambroise Paré

    Boulogne-Billancourt, 92100
    France

    Active - Recruiting

  • CH Beaujon

    Clichy, 92110
    France

    Active - Recruiting

  • CHI Creteil

    Creteil, 94000
    France

    Active - Recruiting

  • Central Hospital Raymon Poincaré

    Garches, 92380
    France

    Active - Recruiting

  • CHU de Grenoble

    La Tronche, 38700
    France

    Active - Recruiting

  • CH Versailles

    Le Chesnay, 78150
    France

    Site Not Available

  • CH Bicêtre

    Le Kremlin Bicètre, 94275
    France

    Active - Recruiting

  • Melun Hospital

    Melun, 77000
    France

    Active - Recruiting

  • CH d'Annecy Genevois

    Metz-Tessy, 74370
    France

    Site Not Available

  • CH Lariboisière

    Paris, 75010
    France

    Active - Recruiting

  • CH Tenon

    Paris, 75020
    France

    Site Not Available

  • CHU Bichat

    Paris, 75018
    France

    Site Not Available

  • CHU Cochin

    Paris, 75014
    France

    Site Not Available

  • CHU Saint Antoine

    Paris, 75012
    France

    Site Not Available

  • CH Pontoise

    Pontoise, 95300
    France

    Site Not Available

  • CH d'Annecy Genevois

    Pringly Cedex, 74374
    France

    Site Not Available

  • CHU Rennes Pontchaillou

    Rennes, 35033
    France

    Site Not Available

  • CHU Rouen

    Rouen, 76031
    France

    Active - Recruiting

  • CH Saint Denis

    Saint Denis, 93205
    France

    Site Not Available

  • Foch Hospital

    Suresnes, 92151
    France

    Active - Recruiting

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