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Outpatient Antibiotic Treatment for a Cystic Fibrosis Pulmonary Exacerbation

4. mai 2018 oppdatert av: University of Colorado, Denver

Prospective Clinical and Laboratory Evaluation of Outpatient Antibiotic Treatment for Pulmonary Exacerbations in Children With Cystic Fibrosis

This study plans to learn more about the effect of oral antibiotics for an outpatient pulmonary exacerbation (respiratory illness) on sputum (mucus) bacterial infections, lung function, airway inflammation and quality of life. In this study subjects will perform pulmonary function tests, provide a sputum sample and complete a questionnaire at two separate clinic visits. If a subject is unable to cough up sputum in clinic he or she will be asked to breathe in a salt water solution to help cough up sputum. The first sputum sample will be obtained at the first visit (within 48 hours of starting antibiotics). Pulmonary function testing and the questionnaire will also be completed at this time. Subjects will complete a two week course of oral antibiotics at home. During these two weeks subjects will be asked to write down the times antibiotics are taken and airway clearance (vest treatment) is performed. Within one week of completing the antibiotic course subjects will return to clinic for a second visit. At that time a sputum sample will be obtained again and if subjects are unable to cough up sputum they will again be asked to breathe in salt water solution to help cough up sputum. Pulmonary function testing and the questionnaire will also be completed at this second visit. Sputum samples will be tested for infections with bacteria and viruses. Sputum samples will also be used to measure markers of airway inflammation (swelling). The investigators hypothesize that the use of two weeks of oral antibiotics for the treatment of a pulmonary exacerbation will result in a decrease in the amount of bacteria measured in sputum. Additionally the investigators hypothesize that treatment with antibiotics will lead to an improvement in lung function, a decrease in airway inflammation and an improvement in quality of life measurements.

Studieoversikt

Status

Fullført

Forhold

Studietype

Observasjonsmessig

Registrering (Faktiske)

32

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • University of Colorado Hospital

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

8 år til 18 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

30 patients with cystic fibrosis will be recruited from the University of Colorado and Children's Hospital Colorado pediatric cystic fibrosis clinic.

Beskrivelse

Inclusion Criteria:

  • Diagnosis of cystic fibrosis based on sweat chloride (≥60) or two known disease causing mutations.
  • Age 8 - 18 years
  • Starting treatment for an outpatient pulmonary exacerbation
  • Willing to participate in study after informed consent and assent has been obtained.

Exclusion Criteria:

  • Forced expiratory volume in 1 second (FEV1) less than 40%
  • Patients receiving chronic daily oral antibiotics. Patients receiving azithromycin therapy three times a week will not be excluded as its use in this setting is felt to be anti-inflammatory.
  • Previous reaction to inhalation of hypertonic saline. This is distinctly unusual in cystic fibrosis.
  • Patients who have been treated with oral antibiotics on an outpatient basis within 2 weeks of the exacerbation.
  • Patients who are being started simultaneously on inhaled and oral antibiotics. Patients who are routinely receiving inhaled antibiotics as part of their chronic management and continue inhaled antibiotics as previously scheduled will not be excluded.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Reduction in bacterial colony count in the primary cystic fibrosis (CF) pathogen identified on culture
Tidsramme: Baseline and 3 weeks
Quantitative measurements of the primary CF pathogen will be obtained on sputum culture at visits 1 and 2. The change in colony count (measured on the log scale) will be used as the primary outcome.
Baseline and 3 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Lung function
Tidsramme: Baseline and 3 weeks
  • Change in FEV1 (forced expiratory volume in 1 second).
  • Percent of patients who return to baseline lung function at the completion of an oral antibiotic course (defined as an FEV1 of 95% of baseline or greater).
Baseline and 3 weeks
Airway inflammation
Tidsramme: Baseline and 3 weeks
Change in measurements of sputum total white blood cell count, neutrophil count, neutrophil elastase, LTB4 (leukotriene B4), IL-8 (interleukin 8), IL-1B (interleukin 1, beta)
Baseline and 3 weeks
Quality of Life
Tidsramme: Baseline and 3 weeks
Change in patient reported symptoms and severity (Cystic Fibrosis Questionnaire-Revised)
Baseline and 3 weeks
Microbiome
Tidsramme: Baseline and 3 weeks
Change in airway microbiota in sputum samples obtained before and after oral antibiotics
Baseline and 3 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Jordana E Hoppe, M.D., University of Colorado, Denver

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 2014

Primær fullføring (Faktiske)

4. januar 2017

Studiet fullført (Faktiske)

4. januar 2017

Datoer for studieregistrering

Først innsendt

15. juni 2015

Først innsendt som oppfylte QC-kriteriene

19. juni 2015

Først lagt ut (Anslag)

24. juni 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. mai 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. mai 2018

Sist bekreftet

1. mai 2018

Mer informasjon

Begreper knyttet til denne studien

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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