Réa-MiniMax: Severe Acute Respiratory Failure in Hematology and Cancer Patients Without Bronchoalveolar Lavage

Cancer Clinical Trial

Official title: Severe Acute Respiratory Failure in Hematology and Cancer Patients Without Bronchoalveolar Lavage. A Multicentric Randomized Controlled Trial

Status Completed

Clinical Trial 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.

Clinical Trial Description

Acute respiratory failure is a dreadful complication in cancer patients. Indeed, about 20% of the patients will present with pulmonary infiltrates, but Intensive Care Unit (ICU) admission and mechanical ventilation will be needed in half of them resulting in mortality for most of the patients. Managing cancer patients with respiratory failure implicates three mandatory tasks: 1) early antibiotics administration covering suspected pathogens; 2) search for the actual aetiology; and 3) adequate supportive care with access to invasive or non invasive respiratory support. Performing the etiological diagnosis is crucial. Fiberoptic bronchoscopy and bronchoalveolar lavage (FO-BAL) remains the cornerstone of the management of pulmonary infiltrates in cancer patients. However, non-invasive diagnostic tools have been validated in the recent years. Diagnostic and therapeutic impacts of FO-BAL are only of 30% to 60% and 15% to 60% respectively. In neutropenic patients and recipients of bone marrow or stem cell transplantation, this impact is significantly altered. Moreover, reports have highlighted significant rates of complications such as haemorrhage (5%), respiratory deterioration (11% to 40%), possibly heading to intubation and subsequent death. Therefore, balancing advantages to risks of FO-BAL is in order. The MiniMax® study is a multicenter randomized controlled study aimed at demonstrating that a combination of non-invasive diagnostic tools are as effective as FO-BAL in performing the etiological diagnosis of acute respiratory failure in cancer patients. In addition, these non-invasive tests might not lead to deterioration of the respiratory status and corresponding requirement to intubation and mechanical ventilation. The group of investigators is used to manage cancer patients with pulmonary involvement. In the 21 centres, patients will be randomized to be managed either with FO-BAL or with only non-invasive tools. In each case, patients will be managed with the best supportive care including adequate antibiotics, respiratory support and all needed life sustaining therapies. Our hypothesis is to reduce intubation rate using a non-invasive approach (without FO-LBA). Surrogate markers will be hospital mortality and the number of diagnostic procedures in each group of patients. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Cancer
• Leukemia
• Lymphoma
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

• NCT number: NCT00248443
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Status: Completed
• Phase: Phase 3
• Start date: August 2005
• Completion date: August 2008