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Trial record 13 of 58 for:    "Aspergillosis" | "Cytochrome P-450 CYP3A Inhibitors"

PET/CT Guided Antifungal Stewardship in Invasive Pulmonary Aspergillosis (OPTIFIL)

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ClinicalTrials.gov Identifier: NCT02955966
Recruitment Status : Recruiting
First Posted : November 4, 2016
Last Update Posted : August 26, 2019
Sponsor:
Collaborator:
Institut Pasteur, Paris France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE November 3, 2016
First Posted Date  ICMJE November 4, 2016
Last Update Posted Date August 26, 2019
Actual Study Start Date  ICMJE June 2, 2017
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
Response rate according to 18F-FDG-PET/CT (PET/CT response) [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02955966 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
  • Response rate according to EORTC/MSG criteria (Segal response). [ Time Frame: 6 weeks ]
  • Response rate according to EORTC/MSG criteria (Segal response). [ Time Frame: 12 weeks ]
  • Response rate according to PET/CT [ Time Frame: 12 weeks or at the end of treatment ]
  • Number of patients for whom 18F-FDG-PET/CT has evidenced extra pulmonary attributable lesions [ Time Frame: 6 weeks ]
  • Number of patients for whom 18F-FDG-PET/CT has evidenced extra pulmonary attributable lesions [ Time Frame: 12 weeks ]
  • Number of patients for whom 18F-FDG-PET/CT has evidenced extra pulmonary attributable lesions in initial work-up [ Time Frame: first day ]
  • Patient mortality rate [ Time Frame: 6 weeks ]
    overall mortality and relationship with Invasive Pulmonary Aspergillosis or Haematological Malignancies
  • Patient mortality rate [ Time Frame: 12 weeks ]
    overall mortality and relationship with Invasive Pulmonary Aspergillosis or Haematological Malignancies
  • Patient mortality rate [ Time Frame: 24 weeks ]
    overall mortality and relationship with Invasive Pulmonary Aspergillosis or Haematological Malignancies
  • Patient mortality rate [ Time Frame: 48 weeks ]
    overall mortality and relationship with Invasive Pulmonary Aspergillosis or Haematological Malignancies
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PET/CT Guided Antifungal Stewardship in Invasive Pulmonary Aspergillosis
Official Title  ICMJE PET/CT Guided Antifungal Stewardship in Invasive Pulmonary Aspergillosis
Brief Summary

OPTIFIL is a pilot prospective multicenter study based over the hypothesis that the normalization of the functional imaging 18F-FDG-PET/CT during the Invasive pulmonary aspergillosis (IPA) could occur earlier than that of conventional imaging.

This study evaluates the therapeutic response through a systematic 18F-FDG-PET/CT at week 6. The latter response will be correlated with the kinetics of selected biomarkers including antigens (galactomannan, β-D glucans), circulating Aspergillus DNA and anti-Aspergillus host response markers in addition to the conventional imaging tools obtained at weeks 6 and 12.

Detailed Description

Invasive pulmonary aspergillosis (IPA) is the 3rd most frequent invasive mycosis in France with a rising incidence and 40% mortality (Bitar, 2014, Lortholary, 2011). Modern antifungals (AF) improved survival of IPA but lead to ecological, toxic and cost issues. In agreement with the " plan national de la bonne maîtrise des anti-infectieux ", optimization of AF duration in IPA appears therefore challenging.

Positron emission tomography using 2-deoxy-2-[fluorine-18] fluoro- D-glucose integrated with computed tomography (18F-FDG PET/CT) was reported to allow shortened AF duration (Hot, 2011, Chamilos, 2008) and is currently evaluated during chronic disseminated candidiasis {CANHPARI trial, PHRC 2012, NCT01916057}. The investigators raise the hypothesis that normalization of the functional imaging 18F-FDG-PET/CT during IPA could occur earlier than that of conventional imaging. However, due to the current lack of data, an intervention trial evaluating an early AF withdrawal based on 18F-FDG-PET/CT appears premature. In order to optimize IPA treatment duration, a two-step evaluation project has been designed. The first step consists in OPTIFIL prospective project. It will evaluate the therapeutic response through a systematic 18F-FDG-PET/CT at week 6 (crucial time point (Segal) used in recent IPA trials (Marr, 2015, Maertens, 2016). The latter response will be correlated with the kinetics of selected biomarkers including antigens (galactomannan, β-D glucans), circulating Aspergillus DNA and anti-Aspergillus host response markers in addition to the conventional imaging tools obtained at weeks 6 and 12. OPTIFIL project results will serve establishing a decision algorithm used during the second step intervention trial evaluating the accuracy of IPA AF interruption.

Pilot prospective multicenter study of therapeutic follow-up of IPA in patients with hematological malignancy.

Patients will have an inclusion visit (D0) and 8 or 9 follow up visits: D3, W1, W2, W4, W6, End of Treatment, W24 and W48.

Each visit will include physical examination.

Lung CT scan, 18F-FDG-PET/CT, samplings of blood will be performed at different visits in respective centers

β-D-Glucan, Aspergillus fumigatus and Aspergillus spp. quantitative PCRs and host biomarkers such as Aspergillus Elispot will be performed and centralized

Response evaluation will be assessed by an independent committee.

CT response will be evaluated by a blinded radiologist. PET/CT response will be evaluated by 2 blinded nuclear medicine physicians.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Aspergillosis and Haematological Malignancy
Intervention  ICMJE
  • Device: imaging 18F-FDG-PET/CT
    18F-FDG PET Scan at Day 0, W6 and W12
  • Biological: Blood collection
    Blood collection at D0, D3, W1, W2, W4, W6, W12, end of treatment.
Study Arms  ICMJE Experimental: Patient with invasive pulmonary aspergillosis
Blood collection and imaging 18F-FDG-PET/CT
Interventions:
  • Device: imaging 18F-FDG-PET/CT
  • Biological: Blood collection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 3, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients ≥18 years-old
  • Patient with hematological malignancy
  • Proven or probable invasive pulmonary aspergillosis according to EORTC/MSG modified criteria
  • Inclusion ≤ 4 days (≤ 5 days in case of week end) after IPA diagnosis
  • Possibility to perform 18F-FDG-PET/CT scanner within the 7 subsequent days following diagnosis
  • Informed consent form signed
  • Affiliation to French social insurance

Exclusion Criteria:

  • Pregnancy or breastfeeding women
  • Life expectancy < 3 months
  • Fungal or mycobacterial lung co infection at time of IPA diagnosis
  • Haematological malignancy with lung location
  • Proven or probable mold infection in 6 previous months
  • Disseminated aspergillosis (lung and sinus aspergillosis can be included)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Fanny LANTERNIER, MD, PhD +33 (0)1 44 49 52 62 fanny.lanternier@aphp.fr
Contact: Prissile BAKOUBOULA, PhD +33 1 71 19 64 94 prissile.bakouboula@aphp.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02955966
Other Study ID Numbers  ICMJE P150916
2016-A00408-43 ( Registry Identifier: IDRCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Institut Pasteur, Paris France
Investigators  ICMJE
Principal Investigator: Fanny LANTERNIER, Md, PhD Assistance Publique - Hôpitaux de Paris
Study Chair: Olivier LORTHOLARY, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP