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Trial History Detail on 2015-08-11

CUHK_CCT00464

2015-07-22

Prospective

2014.679-T

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

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

N/A

Dr. Wai-Tat WONG

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

852-92544847

wtwong@cuhk.edu.hk

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

Dr. Wai-Tat WONG

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

852-92544847

wtwong@cuhk.edu.hk

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

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

Oseltamivir in Critically ill patients with severe Influenza

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

Oseltamivir in Critically ill patients with severe Influenza

Hong Kong SAR, China

Yes

2015-02-23

Influenza

Drug

Oseltamivir through enteral route

minimum duration of 10 days

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

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

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

18

999

Both Male and Female

Interventional

Randomized

Dose comparison

Single-blind

Parallel

2015-09-01

40

Not Yet Recruiting

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.

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.

No

2016-04-05

ChiCTR-IOR-15006823 


Yes

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