Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial (CHAT Pilot)

Canadian Critical Care Trials Group

Status and phase: Terminated; Phase 2

Conditions: H1N1 Influenza

Treatments: Drug: Placebo; Drug: Rosuvastatin or identical placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01798602

CCCTG

Details and patient eligibility

About

The CHAT Pilot Trial is designed to compare rosuvastatin against placebo in patients with suspected H1N1. The pilot study will assess the feasibility of our clinical protocols, and study procedures.

Full description

This trial is a pilot study to assess the feasibility and acceptability of a double blind randomized controlled trial (RCT) evaluating the efficacy of rosuvastatin as adjuvant therapy for H1N1 influenza

Enrollment: 8 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Critically ill adult patients > 16 years of age admitted to an adult ICU for any reason with suspected, probable or confirmed novel swine origin influenza A/H1N1 infection
• Requiring mechanical ventilation (invasive or non-invasive)
• Receiving antiviral therapy (any medication at any dose and for any intended duration) for < 72 hours
• Clinicians must have a 'moderate', 'high' or 'moderate to high' index of suspicion for H1N1

Exclusion criteria

• Age < 16 years

• Do not resuscitate or re-intubate order documented on chart or anticipated withdrawal of life support

• Weight < 40 kg

• Unable to receive or unlikely to absorb enteral study drug (e.g. incomplete or complete bowel obstruction, intestinal ischemia, infarction, short bowel syndrome)

• Rosuvastatin specific exclusions:

  1. Already receiving a statin (Atorvastatin, Lovastatin, Simvastatin, Pravastatin, Rosuvastatin)
  2. Allergy or intolerance to statins
  3. Receiving niacin, fenofibrate, cyclosporine, gemfibrozil, lopinavir, ritonavir or planned use of oral contraceptives or estrogen therapy during the ICU stay
  4. CK exceeds 10 times ULN or ALT exceeds 8 times the ULN

• Severe chronic liver disease (Child-Pugh Score 11-15) (see Appendix 6)

• Previous enrolment in this trial

• Pregnancy or breast feeding

• At the time of enrolment, patients must not have received >72 hours of antiviral therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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8 participants in 2 patient groups, including a placebo group

Rosuvastatin

Experimental group

Description:

Rosuvastatin 40 mg via nasogastric tube then 20 mg po or via nasogastric tube daily for 14 days or until hospital discharge Placebo is identical capsule with no active drug Both are crushed for administration

Treatment:

Drug: Rosuvastatin or identical placebo

Placebo

Placebo Comparator group

Description:

Identical drug vehicle with no active agent

Treatment:

Drug: Placebo