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Clinical Study to Assess Efficacy and Safety of Amiodarone in Treating Patients With Ebola. Virus Disease (EVD) in Sierra Leone. EASE (EMERGENCY Amiodarone Study Against Ebola)

NCT02307591 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2015-10-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of amiodarone in the treatment of patients afflicted with Ebola virus disease.

Conditions

  • Ebola Virus Disease

Interventions

DRUG

Best Supportive Care

Dehydration Ringer's lactate solution or normal saline intravenously Electrolytes should be monitored at regular intervals and corrected as long as vomiting and/or diarrhoea persist Fever intravenous Paracetamol Antimicrobial treatment Prophylactic 5-days course with Ampicillin should be used Pain Paracetamol,Tramadol or Pentazocine Central nervous system disturbances If a patient is restless or confused, prescribe a light sedation utilizing Midazolam, Propofol or Ketamine, preferably in association with Diazepam or Midazolam Seizures Diazepam Vomiting antiemetic medications may provide some relief and facilitate the rehydration Dyspepsia in adults, Omeprazole Diarrhoea in adults, Loperamide Acute bleeding leading to signs of haemorrhagic shock should be treated with whole blood transfusion and supportive care. Patients haemodynamically stable should not be transfused if the Hb level is \>7 mg% Septic shock intensive support care Malaria in case of positive initial test, Artesunate

DRUG

Best Supportive Care + Amiodarone

This treatment will be provided to patients in the experimental arm only in addition to best supportive care scheme . During the first 3 days of treatment, the drug must be administered in Glucose 5% solution. Deliver through the largest possible vein inserting a long catheter (if possible a CVP line). Day 1. Dose: 20 mg/kg/die i.v. deliver a loading dose of 5mg/kg in the 1st hour, followed by continuous infusion during the remaining 23 hours. Example: 20 mg /kg of Amiodarone in 500 cc of Glucose 5%. Deliver 125 ml during the 1st hour followed by 16 ml/hour for the remaining 23 hours. Day 2 - Day 3. Dose: 20 mg/kg/die i.v. Continuous infusion over 24 hrs. Example: Glucose 5% 500 ml containing 20 mg/kg of Amiodarone (infusion speed = 21 ml/hour). Day 4 to Day 10. If no significant diarrhea and/or vomiting, shift to oral intake of Amiodarone as follows: * Adults: 200 mg tablets, 3 times a day, according to the body weight (30mg/Kg) * Children \< 29 kg: 5 mg/kg 3 times a day

Sponsors & Collaborators

  • Emergency NGO Onlus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-07-31
Completion
2015-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02307591 on ClinicalTrials.gov