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Efficacy and Safety Study of JNJ-32729463 Compared With Moxifloxacin for the Treatment of Subjects Requiring Hospitalization for Community-Acquired Bacterial Pneumonia

5. december 2011 opdateret af: Furiex Pharmaceuticals, Inc

A Randomized, Controlled, Double Blind, Multicenter, Phase 2 Study of the Safety/Tolerability and Efficacy of JNJ-32729463 Compared With Moxifloxacin for the Treatment of Subjects Requiring Hospitalization for Community-Acquired Bacterial Pneumonia (CABP) With a PORT Score of II or Greater

The purpose of this study is to determine the efficacy, safety and tolerability of JNJ-32729463 compared to moxifloxacin for the treatment of subjects requiring hospitalization for Community-Acquired Bacterial Pneumonia (CABP).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

32

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
      • Quebec, Canada, G1V 4G5
        • Furiex research site
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Furiex research site
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Furiex research site
  • Colombia
      • Bogota, Colombia
        • Furiex research site
      • Cali, Colombia
        • Furiex research site
  • Forenede Stater
    • Alabama
      • Mobile, Alabama, Forenede Stater, 36608
        • Furiex research site
    • California
      • Sylmar, California, Forenede Stater, 91342
        • Furiex research site
    • Florida
      • Orlando, Florida, Forenede Stater, 32837
        • Furiex research site
      • Vero Beach, Florida, Forenede Stater, 32960
        • Furiex research site
    • Illinois
      • Peoria, Illinois, Forenede Stater, 61637
        • Furiex research site
    • Kentucky
      • Hazard, Kentucky, Forenede Stater, 41701
        • Furiex research site
    • Montana
      • Anaconda, Montana, Forenede Stater, 59711
        • Furiex research site
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68131
        • Furiex research site
    • New Mexico
      • Albueuerque, New Mexico, Forenede Stater, 87131
        • Furiex research site
    • Texas
      • Austin, Texas, Forenede Stater, 78701
        • Furiex research site
      • Austin, Texas, Forenede Stater, 78705
        • Furiex research site
      • Austin, Texas, Forenede Stater, 78759
        • Furiex research site
    • Washington
      • Longview, Washington, Forenede Stater, 98632
        • Furiex research site
  • Polen
      • Bialystok, Polen, 15-276
        • Furiex research site
      • Bydgoszcz, Polen, 85-681
        • Furiex research site
      • Bystra, Polen, 43-360
        • Furiex research site
      • Lodz, Polen, 90-153
        • Furiex research site
      • Skierniewice, Polen, 96-100
        • Furiex research site
      • Warszawa, Polen, 03-401
        • Furiex research site
  • Tyskland
      • Greifswald, Tyskland, 17475
        • Furiex research site
      • Hannover, Tyskland, 30625
        • Furiex research site
      • Hofheim, Tyskland, 65719
        • Furiex research site
      • Homburg/Saar, Tyskland, 66421
        • Furiex research site
      • Paderborn, Tyskland, 33098
        • Furiex research site
  • Ungarn
      • Csorna, Ungarn, 9300
        • Furiex research site
      • Debrecen, Ungarn, 4043
        • Furiex research site
      • Gyongyos, Ungarn, 3200
        • Furiex research site
      • Miskolc, Ungarn, 3529
        • Furiex research site
      • Tatabanya, Ungarn, 2800
        • Furiex research site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • women of childbearing potential must agree to use an acceptable method of birth control
  • clinical diagnosis of community acquired bacterial pneumonia (CABP)
  • PORT score of II or greater
  • able to generate an adequate sputum specimen
  • chest x-ray showing presence of new infiltrates in a lobar or multilobar distribution characteristic of bacterial pneumonia

Exclusion Criteria:

  • history of tendon damage/disorders due to quinolone therapy
  • uncorrected hypokalemia
  • history of myasthenia gravis
  • intubated at the time of consent OR subject is a candidate for enrollment into the open-label S. aureus arm and has been intubated greater than 12 hours prior to randomization
  • mild CABP with a PORT score of less than II
  • viral, fungal, mycobacterial, or atypical pneumonia as a primary diagnosis
  • pneumonia suspected to be secondary to aspiration
  • primary, solitary lung abscess
  • healthcare-associated pneumonia, hospital-acquired pneumonia, or ventilator-associated pneumonia
  • known bronchial obstruction or a history of postobstructive pneumonia.
  • primary lung cancer or another malignancy metastatic to the lungs
  • cystic fibrosis, known or suspected Pneumocystis jiroveci (carinii) pneumonia, or known or suspected active tuberculosis
  • infection that necessitates the use of a concomitant antibacterial agent in addition to study medication
  • systemic antibiotics within the last 96 hours before randomization, with exceptions
  • hospitalized for greater than 72 hours for any reason 30 days before randomization (excluding the 24 hour period before enrollment).
  • history of a serious hypersensitivity reaction to any quinolone including moxifloxacin.
  • female and pregnant, breastfeeding, or may be pregnant.

Other protocol-specific eligibility criteria may apply

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: JNJ-32729463
Medicin: JNJ-32729463
150 mg intravenous formulation administered twice daily for at least 72 hours, followed by 250 mg oral formulation administered twice daily for a total treatment time of 7 to 14 days
Aktiv komparator: moxifloxacin
Medicin: moxifloxacin
400 mg intravenous formulation administered once daily for at least 72 hours, followed by 400 mg oral formulation administered once daily for a total treatment time of 7 to 14 days. To maintain the blind, subjects will receive one dose of moxifloxacin and one dose of placebo daily.
Andre navne:
  • Avelox
Eksperimentel: JNJ-32729463 Open-Label
subjects with suspected or confirmed S. aureus CABP may be entered into an open-label JNJ 32729463 treatment group at selected study sites
Medicin: JNJ-32729463 (Open-Label)
Subjects may receive JNJ-32729463 intravenous formulation up to 150 mg either BID or TID followed by 250 mg oral formulation BID for a total treatment time of 7 to 14 days.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Resolution of signs and symptoms of community-acquired bacterial pneumonia
Tidsramme: Day 19 (Test of Cure Visit)
Day 19 (Test of Cure Visit)

Sekundære resultatmål

Resultatmål
Tidsramme
Daily signs and symptoms of CABP
Tidsramme: Up to Day 19
Up to Day 19
Microbiological response: per-pathogen and per-subject
Tidsramme: Day 19 (Test of Cure Visit)
Day 19 (Test of Cure Visit)
Percent of subjects with resolution of signs and symptoms of CABP
Tidsramme: Day 3 and Day 4
Day 3 and Day 4
Clinical outcome in subjects with S. pneumoniae
Tidsramme: Day 19 (Test of Cure Visit)
Day 19 (Test of Cure Visit)
Rate of superinfections or new infections
Tidsramme: Day 30
Day 30
Time to oral switch
Tidsramme: Day 14
Day 14
All-cause mortality
Tidsramme: Up to Day 30
Up to Day 30

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Furiex Pharmaceuticals, Inc

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2010

Primær færdiggørelse (Faktiske)

1. oktober 2011

Studieafslutning (Faktiske)

1. oktober 2011

Datoer for studieregistrering

Først indsendt

7. september 2010

Først indsendt, der opfyldte QC-kriterier

9. september 2010

Først opslået (Skøn)

10. september 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

8. december 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. december 2011

Sidst verificeret

1. december 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 32729463CAP2001

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Kliniske forsøg med Community-erhvervet bakteriel lungebetændelse (CABP)

Kliniske forsøg med JNJ-32729463

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Netherlands

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner