- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00809328
The Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP)
16. maj 2011 opdateret af: Pfizer
A Multicenter, Non-Randomized, Open Label Study Of Azithromycin Intravenous Followed By Oral Administration In Japanese Adult Subjects With Community Acquired Pneumonia (CAP) Requiring Initial Intravenous Therapy
Azithromycin has high rates of clinical response and eradication, wide spectrum of activity, so we suppose the development of the azithromycin injectable formulation in Japan would deliver benefit to patients of community acquired pneumonia.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
102
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Fukuoka, Japan
- Pfizer Investigational Site
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Hiroshima, Japan
- Pfizer Investigational Site
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Kochi, Japan
- Pfizer Investigational Site
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Okinawa, Japan
- Pfizer Investigational Site
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Shiogama-city, Japan
- Pfizer Investigational Site
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Aichi-ken
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Seto-shi, Aichi-ken, Japan
- Pfizer Investigational Site
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Ehime
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Touon, Ehime, Japan
- Pfizer Investigational Site
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Fukuoka
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Chikushino, Fukuoka, Japan
- Pfizer Investigational Site
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Koga, Fukuoka, Japan
- Pfizer Investigational Site
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Yanagawa, Fukuoka, Japan
- Pfizer Investigational Site
-
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Hiroshima
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Higashihiroshima, Hiroshima, Japan
- Pfizer Investigational Site
-
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Hokkaido
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Asahikawa, Hokkaido, Japan
- Pfizer Investigational Site
-
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Hyogo
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Himejishi, Hyogo, Japan
- Pfizer Investigational Site
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Ibaraki
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Moriya-city, Ibaraki, Japan
- Pfizer Investigational Site
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Ishikawa
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Kanazawa, Ishikawa, Japan
- Pfizer Investigational Site
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Kagawa
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Takamatsu, Kagawa, Japan
- Pfizer Investigational Site
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Kanagawa
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Kawasaki-city, Kanagawa, Japan
- Pfizer Investigational Site
-
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Mie
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Tsu, Mie, Japan
- Pfizer Investigational Site
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Miyagi
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Sendai, Miyagi, Japan
- Pfizer Investigational Site
-
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Nagano
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Matsumoto, Nagano, Japan
- Pfizer Investigational Site
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Nagasaki
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Emukae, Kitamatsuura, Nagasaki, Japan
- Pfizer Investigational Site
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Isahaya, Nagasaki, Japan
- Pfizer Investigational Site
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Nagasaki-city, Nagasaki, Japan
- Pfizer Investigational Site
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Sasebo City, Nagasaki, Japan
- Pfizer Investigational Site
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Niigata-ken
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Niigata-shi, Niigata-ken, Japan
- Pfizer Investigational Site
-
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Oita
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Oita City, Oita, Japan
- Pfizer Investigational Site
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Yufu, Oita, Japan
- Pfizer Investigational Site
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Okayama
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Kurashiki, Okayama, Japan
- Pfizer Investigational Site
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Osaka
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Sakai, Osaka, Japan
- Pfizer Investigational Site
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Sagaken
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Ureshinoshi, Sagaken, Japan
- Pfizer Investigational Site
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Shizuoka
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Hamamatsu, Shizuoka, Japan
- Pfizer Investigational Site
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Tokyo
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Meguro-Ku, Tokyo, Japan
- Pfizer Investigational Site
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Toshima-ku, Tokyo, Japan
- Pfizer Investigational Site
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Yamagata
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Yonezawa, Yamagata, Japan
- Pfizer Investigational Site
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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
16 år til 80 år (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 16 years of age or older patients with CAP.
- Patients who were diagnosed as moderate in severity.
Exclusion Criteria:
- Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides, or ketolides.
- Hepatic dysfunction (AST, ALT, total bilirubin > 3 times institutional normal).
- Severe renal dysfunction (creatinine clearance < 30 ml/min).
- Patients who have a history of severe heart diseases (4th -degree of NYHA). Patients who have a congenital or sporadic long QT syndrome, or who are received the drugs with reported QT prolongation.
- Severe underlying disease.
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: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Azithromycin
Azithromycin switch therapy (switch from intravenous to oral)
|
The intravenous formulation 500 mg is administered once daily for 2-5 days; followed by the oral formulation 500 mg will be given once daily to complete a 7 to 10-day course of therapy.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Response Rate (Clinical Response, Data Review Committee Assessment)
Tidsramme: End of Treatment, Day 15 and Day 29
|
Response rate was calculated from the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100.
|
End of Treatment, Day 15 and Day 29
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Response Rate (Clinical Response, Investigator Assessment)
Tidsramme: End of Treatment, Day 15 and Day 29
|
Response rate was calculated from the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100
|
End of Treatment, Day 15 and Day 29
|
The Tendency Toward Clinical Improvement (Investigator Assessment)
Tidsramme: Day 3
|
The number of participants who showed tendency toward clinical improvement based on the assessment of temperature, white blood cell count, C-reactive protein, clinical symptoms on Day 3, and was determined to continue the treatment.
|
Day 3
|
Eradication Rate (Bacteriological Response, Data Review Committee Assessment)
Tidsramme: Day 3, End of Treatment, Day 15 and Day 29
|
Eradication Rate was calculated from the following formula, "the number of participants assessed as eradication , presumed eradication or microbial substitution" over "total participants excluding ones assessed as indeterminate" multiplied by 100
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Day 3, End of Treatment, Day 15 and Day 29
|
Eradication Rate (Bacteriological Response, Investigator Assessment)
Tidsramme: Day 3, End of Treatment, Day 15 and Day 29
|
Eradication Rate was calculated from the following formula, "the number of participants assessed as eradication , presumed eradication or microbial substitution" over "total participants excluding ones assessed as indeterminate" multiplied by 100
|
Day 3, End of Treatment, Day 15 and Day 29
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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. februar 2009
Primær færdiggørelse (Faktiske)
1. marts 2010
Studieafslutning (Faktiske)
1. marts 2010
Datoer for studieregistrering
Først indsendt
16. december 2008
Først indsendt, der opfyldte QC-kriterier
16. december 2008
Først opslået (Skøn)
17. december 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
19. maj 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. maj 2011
Sidst verificeret
1. maj 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- A0661191
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Community Acquired Pneumonia (CAP)
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PfizerAfsluttetCommunity Acquired Pneumonia (CAP)Spanien
-
SanofiAfsluttetCommunity Acquired Pneumonia (CAP) | Akut forværring af kronisk bronkitis (AECB)
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AstraZenecaAfsluttetCommunity Acquired Pneumonia (CAP) | Komplicerede hud- og hudstrukturinfektioner (cSSSI)Frankrig, Italien, Spanien, Det Forenede Kongerige, Tyskland, Holland, Belgien, Portugal, Grækenland, Kalkun
-
PfizerAfsluttetCommunity-erhvervet lungebetændelse (CAP)Forenede Stater, Canada, Tyskland, Grækenland, Spanien
-
Melinta Therapeutics, Inc.AfsluttetCommunity-erhvervet lungebetændelse (CAP)Canada, Forenede Stater, Den Russiske Føderation
-
VA Office of Research and DevelopmentAfsluttetCommunity Acquired Respiratory Disease SyndromeForenede Stater, Puerto Rico
-
ShionogiAfsluttetHospital Acquired Pneumonia (HAP) | Healthcare-associated Pneumonia (HCAP) | Ventilator Associated Pneumonia (VAP)Israel, Spanien, Forenede Stater, Belgien, Canada, Tjekkiet, Estland, Frankrig, Georgien, Tyskland, Ungarn, Japan, Letland, Filippinerne, Puerto Rico, Den Russiske Føderation, Serbien, Taiwan, Ukraine
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Fondazione Policlinico Universitario Agostino Gemelli...Catholic University of the Sacred HeartIkke rekrutterer endnuVAP - Ventilator Associated Pneumonia | HAP - Hospital Acquired PneumoniaItalien
-
AbbottAfsluttetBronkitis | Kronisk bronkitis | Tracheobronkitis | Community-erhvervet lungebetændelse (CAP) | TracheitisTjekkiet
-
ShionogiAfsluttetSepsis | Blodbaneinfektioner (BSI) | Hospital Acquired Pneumonia (HAP) | Kompliceret urinvejsinfektion (cUTI) | Healthcare-associated Pneumonia (HCAP) | Ventilator Associated Pneumonia (VAP)Forenede Stater, Brasilien, Kroatien, Frankrig, Tyskland, Grækenland, Guatemala, Israel, Italien, Japan, Korea, Republikken, Spanien, Taiwan, Thailand, Kalkun, Det Forenede Kongerige
Kliniske forsøg med Azithromycin
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PfizerAfsluttetTonsillitis | PharyngitisBelgien, Indien, Tyskland, Forenede Stater, Frankrig, Det Forenede Kongerige, Holland, Finland, Italien, Norge
-
Washington University School of MedicineAfsluttetRespiratorisk syncytial virus, bronchiolitisForenede Stater
-
PfizerAfsluttetBakterielle infektioner
-
Thomas Jefferson UniversityChristiana Care Health ServicesAfsluttetFor tidligt for tidligt brud af membranForenede Stater
-
Emory UniversityThe Carter CenterSuspenderet
-
GlaxoSmithKlineAfsluttetAutoimmune sygdommeDet Forenede Kongerige
-
University of Alabama at BirminghamMerck Sharp & Dohme LLCAfsluttetPostpartum sepsis | Postpartum Endometritis | Postpartum feberCameroun
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University of Alabama at BirminghamAfsluttetRespiratorisk syncytialvirusForenede Stater