Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00464

2 Trial Registration Date

2015-07-22

i Registration Status

Prospective

3 Secondary IDs

2014.679-T

4 Source(s) of Funding

Health and Medical Research Fund (Project reference no: CUHK-Portfolio-A13) of Food and Health Bureau of the Hong Kong Special Administrative Region Government

5 Primary Sponsor

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Dr. Wai-Tat WONG

ii Address

4/F, Main Clinical Block and Trauma Centre, Prince of Wales Hospital. Shatin, N.T., Hong Kong

iii Phone

852-92544847

iv Email

wtwong@cuhk.edu.hk

v Affiliation

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Dr. Wai-Tat WONG

ii Address

4/F, Main Clinical Block and Trauma Centre, Prince of Wales Hospital. Shatin, N.T., Hong Kong

iii Phone

852-92544847

iv Email

wtwong@cuhk.edu.hk

v Affiliation

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Pharmacodynamics and pharmacokinetics of Oseltamivir in Critically ill patients with severe Influenza

10 Public Title

Oseltamivir in Critically ill patients with severe Influenza

i Public Title in Chinese 研究名稱

奧司他韋(「特敏福」)在患上嚴重流行性感冒病人的藥效學及藥力學

11 Short Title (Optional)

Oseltamivir in Critically ill patients with severe Influenza

12 Countries of Recruitment

Hong Kong SAR, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2015-02-23

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Influenza

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Oseltamivir through enteral route

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

minimum duration of 10 days

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Oseltamivir 150mg twice daily compared with Oseltamivir 225mg twice daily for minimum duration of 10 days

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Adult patients suffering from influenza requiring mechanical ventilation who require oseltamivir therapy

ii Exclusion Criteria

Pregnant patients and patients with renal failure requiring renal replacement therapy at presentation

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Dose comparison

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2015-09-01

21 Target Sample Size

40

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

The primary outcome is the rate of viral clearance over the period of treatment defined as the rate of PCR negativity (i.e. below detection limits) and culture negativity at each of the specimen sites (upper and lower respiratory tract) 5 days after commencement of treatment protocol.

24 Secondary Outcome

Secondary outcomes are longitudinal viral concentration change in the upper respiratory tract (nasopharyngeal and tracheal samples) from day 0 to day 7 and from lower respiratory tract (BAL samples) between day 3 to day 5 and day 8 to day 10 of oseltamivir treatment. Secondary clinical outcome are serial change of respiratory physiological and mechanical parameters (including but not limited to oxygen requirement, lung compliance, Positive End Expiratory Pressure (PEEP) requirement, radiological involvement, and composite severity score), duration of mechanical ventilator support, ICU length of stay, hospital length of stay and 30 days mortality.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-04-05

27 Primary Registry and Trial Identifying Number

ChiCTR-IOR-15006823

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2015-08-11