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BAY 0 9867 Cipro Pediatric Use Study (QUIP)

13. juli 2015 opdateret af: Bayer

A Prospective, Open-label, Non-randomized, Naturalistic, Long-term Safety Surveillance, Observational Study of Either Ciprofloxacin (Either as Oral Suspension, Oral Tablets or Sequential IV Followed by Oral Therapy or Purely IV Therapy) or a Non-quinolone Antibiotic (Either as Oral Suspension, Oral Tablets or Sequential IV Followed by Oral Therapy or Purely IV Therapy) in the Treatment of Pediatric Patients With Infectious Diagnoses

Objective and subjective musculoskeletal evaluations will be performed to determine differences in the ciprofloxacin versus non-quinolone treated pediatric patients so that we can tell what the natural occurrence of such musculoskeletal conditions is in the general pediatric population.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study is classified as "interventional" due to study-specific medical examinations and interventions. Regarding the study drug intake, routine administration is observed only, there is no intervention in study drug administration.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1029

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3H 1P3
  • Forenede Stater
    • Alabama
      • Mobile, Alabama, Forenede Stater, 36608
    • Arkansas
      • Fort Smith, Arkansas, Forenede Stater, 72903
    • California
      • Corona, California, Forenede Stater, 92879
      • Fountain Valley, California, Forenede Stater, 92708
      • Long Beach, California, Forenede Stater, 90806
      • Orange, California, Forenede Stater, 92868-3974
      • Pico Rivera, California, Forenede Stater, 90660
      • San Bernardino, California, Forenede Stater, 92411
      • San Luis Obispo, California, Forenede Stater, 93405
    • Colorado
      • Centennial, Colorado, Forenede Stater, 80112
      • Denver, Colorado, Forenede Stater, 80218
    • Florida
      • Ft. Walton Beach, Florida, Forenede Stater, 32548
      • Gainesville, Florida, Forenede Stater, 32610-0254
      • Hialeah, Florida, Forenede Stater, 33013
      • Jacksonville, Florida, Forenede Stater, 32209
      • Jupiter, Florida, Forenede Stater, 33458
      • Miami, Florida, Forenede Stater, 33155
      • Pensacola, Florida, Forenede Stater, 32504
      • Tampa, Florida, Forenede Stater, 33606
      • Tampa, Florida, Forenede Stater, 33607
    • Georgia
      • Snellville, Georgia, Forenede Stater, 30078
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96813
    • Idaho
      • Idaho Falls, Idaho, Forenede Stater, 83404
    • Illinois
      • Park Ridge, Illinois, Forenede Stater, 60068-1174
      • Springfield, Illinois, Forenede Stater, 62701
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
    • Kansas
      • Overland Park, Kansas, Forenede Stater, 66215
    • Kentucky
      • Bardstown, Kentucky, Forenede Stater, 40004
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70118-5799
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
    • Minnesota
      • Red Wing, Minnesota, Forenede Stater, 55066-0095
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68114
      • Omaha, Nebraska, Forenede Stater, 68131
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89109
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601-1991
      • Voorhees, New Jersey, Forenede Stater, 08043
    • New York
      • Bronx, New York, Forenede Stater, 10461
      • New Hyde Park, New York, Forenede Stater, 11040
      • New York, New York, Forenede Stater, 10032
      • New York, New York, Forenede Stater, 10021-4885
      • Stony Brook, New York, Forenede Stater, 11794-8111
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
      • Wilmington, North Carolina, Forenede Stater, 28401
    • Ohio
      • Akron, Ohio, Forenede Stater, 44308-1062
      • Cleveland, Ohio, Forenede Stater, 44109-1998
      • Dayton, Ohio, Forenede Stater, 45404-1815
      • Youngstown, Ohio, Forenede Stater, 44501-0240
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73120
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
      • Tulsa, Oklahoma, Forenede Stater, 74135
    • Pennsylvania
      • Elverson, Pennsylvania, Forenede Stater, 19520
      • Havertown, Pennsylvania, Forenede Stater, 19083
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38105-2729
    • Texas
      • Austin, Texas, Forenede Stater, 78756
      • Benbrook, Texas, Forenede Stater, 76126
      • El Paso, Texas, Forenede Stater, 79925
      • Fort Worth, Texas, Forenede Stater, 76104
      • Galveston, Texas, Forenede Stater, 77555-0371
      • Houston, Texas, Forenede Stater, 77030
      • Houston, Texas, Forenede Stater, 77024
      • Temple, Texas, Forenede Stater, 76508
    • Utah
      • Layton, Utah, Forenede Stater, 84041
    • Virginia
      • Norfolk, Virginia, Forenede Stater, 23510
      • Richmond, Virginia, Forenede Stater, 23298
    • West Virginia
      • Morgantown, West Virginia, Forenede Stater, 26506

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

2 måneder til 16 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patient is >/= 2 months of age through 16 years of age
  • A parent/caregiver must sign an informed consent
  • Patient must provide assent, as appropriate based on local institutional review board guidelines

Exclusion Criteria:

  • Patients presenting with the following conditions:

    • exacerbations of cystic fibrosis (CF)
    • meningitis
    • Brain abscess
    • bacterial endocarditis,
    • Bone and joint infections

  • having any of the following conditions but lacking a personal history may be admitted to the trial:

    • Arthritis
    • Juvenile rheumatoid arthritis (JRA)
    • Rheumatoid arthritis (RA)
    • Systemic lupus erythematosis (SLE)
    • History of rheumatic fever
    • Psoriasis
    • Inflammatory bowel disease
    • Osteoarthritis (OA)
  • Known underlying rheumatological disease, joint problems known to be associated with arthropathy.
  • Patients with any pre-treatment baseline musculoskeletal exam abnormalities
  • Known risk of experiencing seizures, a history of any convulsive disorders
  • Requiring any concomitant therapeutic course of systemic antibacterial agent
  • Participation in any industry-sponsored clinical drug development study within one month prior to this study
  • Known significant liver impairment (ALAT/ASAT and/or baseline bilirubin > 3 times upper limit of normal)
  • Known significant renal insufficiency (calculated creatinine clearance of < 30 ml/min/1.73 m²)
  • Are pregnant or lactating, or are sexually active and using unreliable contraception.

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: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Ciprofloxacin
Subjects receiving Ciprofloxacin (group followed-up for 5 years)
Medicin: Ciprofloxacin
Either as oral suspension, oral tablets or sequential intravenous (IV) - oral therapy or purely IV therapy according to label
Aktiv komparator: Non-quinolone antibiotic
Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
Medicin: Non-quinolone antibiotic
Common used dose and route

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Arthropathy (Cumulative)
Tidsramme: 4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment
Arthropathy, as assessed by independent safety committee. The committee, after reviewing data related to musculoskeletal events, decided whether each patient had arthropathy or not. Each incidence includes number shown at previous time point, plus any new patients with the event. The 112/20 arthropathies are mentioned in the other Adverse Events section as well.
4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment
Incidence of Nervous System Events (Cumulative)
Tidsramme: 4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment
Any event within the MedDRA system organ class 'Nervous System disorders'. Each incidence includes number shown at the previous time point, plus any new patients with the event.
4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment

Samarbejdspartnere og efterforskere

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

Sponsor

Bayer

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.

Hjælpsomme links

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 1999

Primær færdiggørelse (Faktiske)

1. januar 2008

Studieafslutning (Faktiske)

1. januar 2008

Datoer for studieregistrering

Først indsendt

26. september 2008

Først indsendt, der opfyldte QC-kriterier

26. september 2008

Først opslået (Skøn)

29. september 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

31. juli 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juli 2015

Sidst verificeret

1. juli 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 100201
  • 2014-004622-18 (EudraCT nummer)

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 .

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