Re-evaluation of Etilefrine and Diltiazem combined with Oseltamivir (Tamiflu) in the treatment of seasonal flu.

Phase 1

• Conditions: Seasonal Flu due to Influenza A virus.; MedDRA version: 20.0 Level: LLT Classification code 10022002 Term: Influenza A virus infection System Organ Class: 100000015765; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-004222-42-FR
• Lead Sponsor: Centre Hospitalier Régional Universitaire de Lille

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-28
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 264

Inclusion Criteria

Patients hospitalized in intensive care units, older than 18
years,
- For a severe flu confirmed by positive PCR on nasopharyngeal
swab
- Whose evolution is less than 96 hours,
- The severity of the flu is assessed by a respiratory failure
defined by the necessity to resort to mechanical ventilation,
invasive or not, or to deliver oxygen with a PaO2/FiO2<200
mmHg.
The inclusion is conditioned to the detection of Influenza A
viruses by rapid detection kit on nasopharyngeal swab.
- Written informed consent from patients or their relatives.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 264
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- No consent.
- Hypersensibility to Oseltamivir.
- Negative rapid detection kit on nasopharyngeal swab.
- Symptoms for more than 96 hours.
- Moribund patients at admission.
- Contraindication to the molecules evaluated.
- Sinusal dysfonction without device.
- Auriculo-ventricular heart block without device.
- Cardiogenic pulmonary oedema.
- Bradycardia<40/min.
- Not treated coronary insufficiency.
- Ventricular arythmia.
- Hyperthryroidism.
- Non controlled hypertension.
- Obstructive cardiomyopathy.
- Heart valve stenosis.
- Pheochromocytoma.
-Concomitant use of beta-blockers, antiarythmic drugs,
especially amiodarone.
- Pregnant/nursing woman
- No social insurance cover
-Patient under a regim of juridic protection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified