- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00034736
A Study to Compare the Efficacy and Safety of Levofloxacin in the Treatment of Children With Community-acquired Pneumonia in the Hospital or Outpatient Setting
6. juni 2011 oppdatert av: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Multicenter, Randomized, Open-Label, Comparative Study to Compare the Efficacy and Safety of Levofloxacin and Standard of Care Therapy in the Treatment of Children With Community-Acquired Pneumonia in the Hospitalized or Outpatient Setting
The purpose of this study is to determine the safety and efficacy of levofloxacin in the treatment of children with community acquired pneumonia.
Studieoversikt
Detaljert beskrivelse
This is a multicenter study to determine the efficacy of levofloxacin compared with the "standard of care" (antibiotic medication commonly used for the treatment of infection in question) in treating community acquired pneumonia in children aged 6 months to 16 years.
The study consists of 4 phases: a 1-day screening period when patients will be tested for eligibility for the study; 10-day treatment, blood collection, and evaluation period; a post-treatment period beginning 1 to 3 days after the last dose of the study medication; and a post-study period 10 to 17 days after the last dose of study medication to assess whether the patient has been cured of pneumonia.
Patients will be divided into 2 groups based upon age and then randomly assigned to receive up to 10 days of either levofloxacin or another antibiotic.
The patients in Group 1 will be randomly assigned to levofloxacin or amoxicillin/clavulanate.
The patients in Group 2 will be randomly assigned to receive levofloxacin or either ceftriaxone plus erythromycin lactobionate or clarithromycin.
Safety evaluations will include laboratory tests, physical examinations, vital sign measurements, and recording of adverse events, including any adverse events affecting muscles or bones.
Efficacy assessments include whether the patient was cured of pneumonia based on signs and symptoms of pneumonia reported before the start of the study.
Additionally, at both the post-therapy and the post-study visits, responses will be evaluated by patients' signs and symptoms and by microscopic examination of the bacteria identified at the start of the study.
The study hypothesis is that the treatment with levofloxacin will be effective in the treatment of children aged 6 months to 16 years with community acquired pneumonia and wil be well tolerated by the patients.
Levofloxacin 10 mg/kg once or twice daily, amoxicillin/clavulanate 22.5 mg/kg twice daily, ceftriaxone 25 mg/kg twice daily plus erythromycin lactobionate 10 mg/kg every 6 hours or clarithromycin 7.5 mg/kg twice daily, either intravenously or by mouth for up to 10 days.
Studietype
Intervensjonell
Registrering (Faktiske)
691
Fase
- Fase 3
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
6 måneder til 16 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Signs and symptoms of pneumonia including at least 2 of the following: fever, cough, chest pain, shortness of breath, physical examination showing lung tissue has become airless and of solid consistency, white blood cell count >15,000/uL or <5000/uL (normal range is approximately from 3800/uL to 9800/uL)
- Chest x-ray showing evidence of lung infection
- Production of sputum (not an absolute requirement for enrollment
- however, all reasonable attempts to obtain a sputum specimen should be made
- Parental consent to participate in the study
Exclusion Criteria:
- Patients who have used antibiotics that affect the whole body for more than 24 hours immediately before the start of the study
- Requirement of antibiotic therapy that affects the whole body, other than study drug(s)
- Suspected infection with a bacteria known to be resistant to any of the study drugs
- Signs and symptoms of infection with a bacteria that affects the central nervous system
- History of a previous sensitivity or serious adverse reaction to any antibiotic similar to those used in this study
- History of cystic fibrosis
- Abnormal kidney function, as determined by blood test (serum creatinine)
- History or presence of joint disease or disease of the tissues surrounding joints, or any other signs or symptoms in muscles or bones that may make it difficult to evaluate any future complaints concernng muscles or bones
- Hospitalization or residence in a long-term care facility for 14 or more days before the beginning of pneumonia symptoms
- Infection acquired in a hospital
- Poorly controlled seizure disorder or at significant risk for seizures
- Unstable psychiatric disorder
- Known or highly suspected to be infected tuberculosis
- Known HIV (human immunodeficiency virus) infection requiring treatment to prevent PCP (pneumocystis carinii pneumonia
- a type of pneumonia that mainly affects those with compromised immune systems)
- Persistent use of corticosteroids
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
---|
Clinical cure rate (cured or not cured) at 10-17 days after the last dose of study medication.
|
Sekundære resultatmål
Resultatmål |
---|
Clinical response rate (cure or improved response) at 1-3 days after the last dose. Rate of elimination of disease-causing bacteria at 1-3 and 10-17 days after the last dose. Safety evaluations monitored throughout the study.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2002
Studiet fullført (Faktiske)
1. juni 2004
Datoer for studieregistrering
Først innsendt
2. mai 2002
Først innsendt som oppfylte QC-kriteriene
2. mai 2002
Først lagt ut (Anslag)
3. mai 2002
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
8. juni 2011
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. juni 2011
Sist bekreftet
1. desember 2010
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Infeksjoner
- Luftveisinfeksjoner
- Sykdommer i luftveiene
- Lungesykdommer
- Lungebetennelse
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Enzymhemmere
- Antineoplastiske midler
- Topoisomerase II-hemmere
- Topoisomerasehemmere
- Antibakterielle midler
- Cytokrom P-450 enzymhemmere
- Cytokrom P-450 CYP1A2-hemmere
- Anti-infeksjonsmidler, urinveier
- Nyremidler
- Levofloxacin
- Ofloksacin
Andre studie-ID-numre
- CR002392
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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