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Diagnosis of Invasive Pulmonary Aspergillosis by Direct Lung Tissue Aspergillus Galactomannan Antigen Detection From Aspirate by Ultrasound-guided Fine Needle Aspiration

18. februar 2011 oppdatert av: National Taiwan University Hospital

Invasive aspergillosis is a serious and often fatal infection in patients who are neutropenic or have undergone solid organ or stem cell transplantation. However, early diagnosis of invasive aspergillosis is a challenge. Reiss and Lehmann first described the value of serum Galactomanna (GM) for diagnosis of invasive pulmonary aspergillosis in 1979. The availability of the Platelia Aspergillus, a sandwich ELISA that has been approved by FDA in 2003 for managing patients at risk of invasive aspergillosis because of the early detection of the GM antigen. In several studies so far the specificity of the serum galactomannan assay was greater than 85%; however, variable sensitivity from 29~100% was noted over years. In addition, low values and false-negative results are seen more often in nonneutropenic and solid organ transplantation patients as opposed to severely granulocytopenic patients .There are several factors that might explain the reported difference in the performance of antigen detection, including the biological factors and epidemiological factors.

In recent years, specimens of other body fluids are increasingly used for detection of Aspergillus galactomannan antigen, including urine, bronchoalveolar lavage(BAL) fluid, cerebrospinal fluid and even the tissue specimen. However, the sensitivity and specificity of the GM detection in various specimens still have considerably variation. Ultrasound-guided transthoracic aspirate is a safe and useful method for collecting specimens for accurate bacteriologic diagnosis of lung abscess and obstructive pneumonitis10. We also reported a study of diagnosis of pulmonary Cryptococosis by ultrasound guided percutaneous aspiration. We plan to perform a prospective single-center study to investigate the role of GM in the target organ (lung tissue/fluid) by using ultrasound-guided fine needle aspirate for early diagnosis invasive aspergillosis compared with the serum galactomannan.

Studieoversikt

Status

Ukjent

Intervensjon / Behandling

Detaljert beskrivelse

Invasive aspergillosis is a serious and often fatal infection in patients who are neutropenic or have undergone solid organ or stem cell transplantation. However, early diagnosis of invasive aspergillosis is a challenge. Reiss and Lehmann first described the value of serum Galactomanna (GM) for diagnosis of invasive pulmonary aspergillosis in 1979. Galactomannan is a water-soluble, polysaccharide cell wall component which is released by Aspergillus during fungal growth after inhalation of Aspergillus conidia to the lung. The availability of the Platelia Aspergillus, a sandwich ELISA that has been approved by FDA in 2003 for managing patients at risk of invasive aspergillosis because of the early detection of the GM antigen. In several studies so far the specificity of the serum galactomannan assay was greater than 85%; however, variable sensitivity from 29~100% was noted over years. In addition, low values and false-negative results are seen more often in nonneutropenic and solid organ transplantation patients as opposed to severely granulocytopenic patients .There are several factors that might explain the reported difference in the performance of antigen detection, including the biological factors (non-neutropenic patients, prior exposure to antifungal agents, encapsulation abscess preventing GM leakage to the circulation, renal clearance,…etc.) and epidemiological factors (patient population, cut-off value, prevalence of infection…etc) .

In recent years, specimens of other body fluids are increasingly used for detection of Aspergillus galactomannan antigen, including urine, bronchoalveolar lavage(BAL) fluid, cerebrospinal fluid and even the tissue specimen. However, the sensitivity and specificity of the GM detection in various specimens still have considerably variation. Ultrasound-guided transthoracic aspirate is a safe and useful method for collecting specimens for accurate bacteriologic diagnosis of lung abscess and obstructive pneumonitis10. We also reported a study of diagnosis of pulmonary Cryptococosis by ultrasound guided percutaneous aspiration. We plan to perform a prospective single-center study to investigate the role of GM in the target organ (lung tissue/fluid) by using ultrasound-guided fine needle aspirate for early diagnosis invasive aspergillosis compared with the serum galactomannan.

Studietype

Observasjonsmessig

Registrering (Forventet)

50

Kontakter og plasseringer

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Studiekontakt

Studiesteder

      • Taipei, Taiwan, 100
        • Rekruttering
        • National Taiwan University Hospital
        • Ta kontakt med:

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

immunocompromised patients

Beskrivelse

Inclusion Criteria:

Eligible patients with following host factors:

  • A hematologic malignancy, unless they were already treated with antifungals for a presumed or proven IA
  • Cancer and receiving chemotherapy within the last 3 months before admission
  • Solid organ transplant recipient
  • Prolong steroid use
  • Recipient of any other immunosuppressive treatment (tacrolimus, cyclosporine, methotrexate, cyclophosphamide, sirolimus)
  • Child C cirrhosis
  • HIV
  • Febrile neutropenia

Combined at least two of the three following features:

  • Fever(>37.5。C) refractory to at least 3 days of appropriate antibiotics or Fever relapsing after a period of defervescence of at least 48 hours while still receiving antibiotics
  • Clinical signs and/or symptoms suggestive of invasive mycosis: pleuritic chest pain or physical finding of pleural rub, or one of the following symptoms of lower respiratory tract infection (new sputum secretions, dypsnea, or hemoptysis)
  • Development of new pulmonary infiltrates on chest X-ray or HRCT

Exclusion Criteria:

  • Patients who can't be cooperative
  • Have bleeding tendency or coagulopathy (PLT<100K)
  • Pulmonary lesion could not identify by chest ultrasonography
  • Patients who do not have informed consent before the procedure

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
1
direct lung tissue Aspergillus galactomannan antigen detection from aspirate by ultrasound-guided fine needle aspiration

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The diagnostic rate of lung tissue Aspergillus galactomannan antigen detection compaired with serum Aspergillus galactomannan antigen detection
Tidsramme: 3 weeks
we will use echo-guide lung tissue aspiration to detect lung tissue Aspergillus galactomannan antigen compaired with conventional serum Aspergillus galactomannan antigen detection to early diagnose pulmonary aspergillosis
3 weeks

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Hao-Chien Wang, National Taiwan University Hospital

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. mars 2010

Primær fullføring (Forventet)

1. februar 2012

Studiet fullført (Forventet)

1. februar 2012

Datoer for studieregistrering

Først innsendt

17. mars 2010

Først innsendt som oppfylte QC-kriteriene

18. februar 2011

Først lagt ut (Anslag)

23. februar 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

23. februar 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. februar 2011

Sist bekreftet

1. februar 2011

Mer informasjon

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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