NCT00248443

Brief Summary

The MiniMax® study is a multicenter randomized controlled study aimed at demonstrating that a combination of non-invasive diagnostic tools are as effective as fiberoptic bronchoscopy and bronchoalveolar lavage (FO-BAL) in performing the etiological diagnosis of acute respiratory failure in cancer patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P25-P50 for phase_3 lymphoma

Timeline
Completed

Started Aug 2005

Shorter than P25 for phase_3 lymphoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

February 18, 2011

Status Verified

March 1, 2007

Enrollment Period

3 years

First QC Date

November 3, 2005

Last Update Submit

February 17, 2011

Conditions

LymphomaCancerAcute Respiratory FailureLeukemia

Keywords

Haematology and cancer patientsAcute respiratory failureBronchoalveolar lavageNon invasive diagnostic toolsMechanical ventilationIntensive Care

Outcome Measures

Primary Outcomes (1)

  • Reduction in intubation rate

    28 days

Secondary Outcomes (4)

  • Mortality at 28 days

    28 days

  • Hospital mortality

    28 days

  • Duration of mechanical ventilation (invasive or non invasive)

    28 days

  • Psychological aftereffects

    28 days

Interventions

Fiberoptic bronchoscopy and bronchoalveolar lavagePROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a malignant haemopathy or a cancer
  • Patients with severe acute respiratory failure requiring admission to an ICU
  • No argument for a congestive cardiac insufficiency (heart failure)
  • Patients who provided their informed consent

You may not qualify if:

  • Age less than 18
  • Patient who refuses to undergo fiberoptic bronchoscopy
  • Therapeutic limitation
  • Patients intubated at ICU admission
  • Etiological diagnosis of the acute respiratory failure known
  • Lack of available bronchoscopy
  • AIDS
  • Post-operative direct admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Réanimation Médicale de l'Hôpital Saint-Louis

Paris, 75010, France

Location

Related Publications (4)

  • Dunagan DP, Baker AM, Hurd DD, Haponik EF. Bronchoscopic evaluation of pulmonary infiltrates following bone marrow transplantation. Chest. 1997 Jan;111(1):135-41. doi: 10.1378/chest.111.1.135.

    PMID: 8996007BACKGROUND

  • White P, Bonacum JT, Miller CB. Utility of fiberoptic bronchoscopy in bone marrow transplant patients. Bone Marrow Transplant. 1997 Oct;20(8):681-7. doi: 10.1038/sj.bmt.1700957.

    PMID: 9383232BACKGROUND

  • Murray PV, O'Brien ME, Padhani AR, Powles R, Cunningham D, Jeanes A, Ashley S. Use of first line bronchoalveolar lavage in the immunosuppressed oncology patient. Bone Marrow Transplant. 2001 May;27(9):967-71. doi: 10.1038/sj.bmt.1703020.

    PMID: 11436107BACKGROUND

  • Azoulay E, Mokart D, Lambert J, Lemiale V, Rabbat A, Kouatchet A, Vincent F, Gruson D, Bruneel F, Epinette-Branche G, Lafabrie A, Hamidfar-Roy R, Cracco C, Renard B, Tonnelier JM, Blot F, Chevret S, Schlemmer B. Diagnostic strategy for hematology and oncology patients with acute respiratory failure: randomized controlled trial. Am J Respir Crit Care Med. 2010 Oct 15;182(8):1038-46. doi: 10.1164/rccm.201001-0018OC. Epub 2010 Jun 25.

    PMID: 20581167DERIVED

MeSH Terms

Conditions

LymphomaNeoplasmsLeukemia

Interventions

Bronchoalveolar Lavage

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHematologic Diseases

Intervention Hierarchy (Ancestors)

Therapeutic IrrigationInvestigative Techniques

Study Officials

  • Elie Azoulay, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 3, 2005

First Posted

November 4, 2005

Study Start

August 1, 2005

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

February 18, 2011

Record last verified: 2007-03

Locations

FR(1)