Procalcitonin to Shorten Antibiotics Duration in ICU Patients (ProShort)

Study Description

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Brief Summary:

The trial is aimed to show that implementation of a procalcitonin-guided antibiotics algorithm may result in shortened antibiotics course in ICU sepsis patients without inferior outcome as compared to the conventional therapy

Condition or disease	Intervention/treatment	Phase
Sepsis	Behavioral: Procalcitonin guided antibiotics treatment algorithm; Behavioral: Conventional treatment	Phase 3

Detailed Description:

The duration of antibiotic therapy in patients with sepsis is largely empirical. An extended treatment course for up to two weeks is a common practice for patients with sepsis in the ICU, despite lack of evidence for this duration of therapy.

Procalcitonin (PCT) is a new biomarker that has high negative predictive value for systemic bacterial infection. The purpose of this trial is to evaluate whether serial PCT measurements can shorten antibiotic treatment duration in patients with sepsis in the ICU.

Specific Aims

1. To show that implementation of a procalcitonin-guided antibiotics stewardship algorithm may result in shortened antibiotics course in ICU sepsis patients
2. To show that implementation of a procalcitonin-guided antibiotics stewardship algorithm may not result in inferior outcome as compared to conventional therapy

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	1700 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Procalcitonin to Shorten Antibiotics Duration in ICU Patients- A China, Hong-Kong, Taiwan Multicenter Trial
Study Start Date :	June 2011
Estimated Primary Completion Date :	December 2012
Estimated Study Completion Date :	June 2013

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: Conventional Treatment; Patients who will be randomized to arm 1 will receive antibiotic therapy with a duration based on conventional practice	Behavioral: Conventional treatment; Patients who will be randomized to arm 1 will receive antibiotic therapy with a duration based on conventional practice.
Experimental: procalcitonin-guided antibiotics treatment; Patients who will be randomized to arm 2 will receive antibiotics therapy with a duration based on procalcitonin-guided algorithm.	Behavioral: Procalcitonin guided antibiotics treatment algorithm; Patients who will be randomized to arm 2 will receive antibiotics therapy with a duration based on procalcitonin measurement on day 5, 7 and 9.

Outcome Measures

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Primary Outcome Measures :

1. Average antibiotics duration [ Time Frame: 28 days ]
2. 28-day mortality rate [ Time Frame: 28 days ]
   Safety endpoints

Secondary Outcome Measures :

1. Proportion of antibiotics use in both arms [ Time Frame: 28 days ]
2. Length of ICU stay [ Time Frame: 90 days ]
3. Recurrence of fever within 72 hours of antibiotics discontinuation [ Time Frame: 28 days ]
4. APACHE-II score or SOFA score [ Time Frame: 28 days ]
5. Reinfection between 72-hours and 28 days post antibiotics discontinuation [ Time Frame: 28 days ]
6. 90-day all-cause mortality [ Time Frame: 90 days ]
7. 90-day infection related readmission rate [ Time Frame: 90 days ]

Eligibility Criteria

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Ages Eligible for Study:	20 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• All patients with laboratory- or image-confirmed severe infection at admission or during stay in ICU will be eligible for inclusion.

Definition of laboratory- or image-confirmed severe infection:

1. Two or more of four Signs of Inflammation

   • Temperature > 38.3℃ or < 36℃
   • Heart rate > 90 beats/min
   • Respiratory rate > 20 breaths/min or PaCO2 < 32 mmHg
   • WBC > 12,000 cells/mm3, < 4000 cells/mm3, or > 10% bands
2. Initial Procalcitonin > 0.5 ng/mL
3. Presence of either laboratory or image evidence of infection

Laboratory evidence:

Sign of inflammation in urine, CSF, ascites, pleural effusion or local abscess

Image evidence:

Compatible findings on Chest X ray、ultrasound、CT、or MR image

Exclusion Criteria:

• Age less than 20 years
• Known pregnancy
• Presence of DNR order
• Expected ICU stay less than 3 days
• Neutropenia (ANC count < 500/mm3)
• Specific infections for which long-term antibiotic treatment is strongly recommended: lung abscess or empyema, bacterial meningitis, osteomyelitis, infective endocarditis, local abscess, mediastinitis

Contacts and Locations

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Contacts

Contact: Chien-Chang Lee, MD, MSc	+886-972-651951	cclee100@gmail.com

Locations

China, Xinjiang
Department of Critical Care Medicine, The First Affiliated Hospital of Xinjiang Medical University	Recruiting
Urumqi, Xinjiang, China
Principal Investigator: Shiangtai Yu, MD
China
Department of Critical Care Medicine, The 301 People Liberation Army General Hospital	Not yet recruiting
Beijing, China
Principal Investigator: Chin Song, MD
Emergency Department, Beijing Chao-Yang Hospital, Capital Medical University	Recruiting
Beijing, China
Contact: Chunsheng Li, MD
Principal Investigator: Chunsheng Li, MD
Emergency Department, Ruijin Hospital, Jiaotong University, School of Medicine	Recruiting
Shanghai, China
Contact: Yiming Lu, MD
Principal Investigator: Yiming Lu, MD
Emergency Department, Xinhua Hospital, Jiaotong University School of Medicine	Recruiting
Shanghai, China
Principal Investigator: Shuming Pan, MD
Department of Critical Care Medicine, The General Hospital of Tianjin Medical University	Recruiting
Tianjin, China
Principal Investigator: Min Peng, MD
Hong Kong
Department of Pathology, Princess Margaret Hospita	Not yet recruiting
Lai Chi Kok, Hong Kong
Principal Investigator: Bosco Lam, MD
Taiwan
Department of Emergency, National Taiwan University Hospital	Recruiting
Taipei, Taiwan
Principal Investigator: Chien-Chang Lee, MD
Sub-Investigator: Ang Yuan, MD, PhD
Sub-Investigator: Hsien-Ho Lin, MD ScD
Sub-Investigator: Shan-Chewn Chang, MD PhD

Sponsors and Collaborators

National Taiwan University Hospital

Beijing Chao Yang Hospital

Ruijin Hospital

Shanghai Jiao Tong University School of Medicine

Chongqing Medical University

Tianjin Medical University General Hospital

Chinese PLA General Hospital

Xinjiang Medical University

Princess Margaret Hospital, Hong Kong

Investigators

Principal Investigator:	Chien-Chang Lee, MD, MSc	National Taiwan University Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT01379547 History of Changes
Other Study ID Numbers:	201101079RB
First Posted:	June 23, 2011
Last Update Posted:	November 27, 2012
Last Verified:	November 2012

Keywords provided by National Taiwan University Hospital:

Procalcitonin; sepsis; ICU	antibiotic; antibiotic duration; Antibiotic treatment duration

Additional relevant MeSH terms:

Sepsis; Infection; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Anti-Bacterial Agents	Antibiotics, Antitubercular; Calcitonin; Anti-Infective Agents; Antitubercular Agents; Bone Density Conservation Agents; Physiological Effects of Drugs