Assessing Effectiveness of Community Acquired Pneumonia Treatment by Continuous Pneumonia Severity Score

NCT04135183 | Unknown DMC

• 1 other identifier: I2019001440
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Community acquired pneumonia (CAP) is a common respiratory infection and is the main cause of ICU admission and death in adults. Because of most patients were treated empirically against suspected causative microorganism, it is important to assess the effectiveness of treatment after 3 days of anti-infective therapy. However, the criteria for treatment failure is lack of a clear-cut and validated definition from the CAP guidelines. Pneumonia severity scores is a wide-used severity rating system for treatment selection and outcome prediction for CAP. So far, the pneumonia severity scores only used once before the treatment started. Considering the pneumonia severity scores could reflect the severity of pneumonia, it is reasonable to assume that the change of pneumonia severity scores could reflect the patients' condition and the effectiveness of the treatment. This trail will be designed to validate the feasibility of assessing effectiveness of CAP treatment by using continuous pneumonia severity score.

Conditions

Community-acquired Pneumonia

Keywords

Community-acquired Pneumonia; Pneumonia severity scores

Outcome Measures

Primary Outcomes (2)

• Rate of patients for ICU admission

  Rate of patients who received ICU treatment during hospitalization. The numerator is the number of patients who received ICU treatment during hospitalization. The denominator is the number of all the enrolled patients.

  through study completion, an average of 10 days

• Rate of all-caused mortality within 30 days.

  Rate of all-caused death occurring within 30 days during hospitalization. The numerator is the number of patients who defined as death occurring within 30 days of hospitalization. The denominator is the number of enrolled patients.

  through study completion, an average of 10 days

Secondary Outcomes (1)

• Length of stay for patients

  through study completion, an average of 10 days

Study Arms (4)

Comprehensive evaluation group

EXPERIMENTAL

The effectiveness of initial treatment and the next treatment plan were determined based on the CAP guidelines of Chinese Thoracic Society (CTS) or Infectious Diseases Society of America/American Thoracic Society(IDSA/ATS). The evaluation process was independently evaluated and documented by at least two clinicians. In case of disagreement, the final determination shall vote on the majority of votes.

Procedure: changes of Pneumonia Severity Score

PSI evaluation group

EXPERIMENTAL

The changes of PSI scores and serum CRP were used to evaluate the therapeutic effects. If both PSI scores and CRP suggest that treatment is effective, the initial treatment will be maintained. If either of PSI scores or serum CRP suggest that treatment is effective, the initial treatment can be maintained, but need to be reviewed in the next 3-5 days. If both PSI scores and serum CRP suggest that the treatment is failed, the initial treatment should be changed. The change of initial treatment is not limited to antibiotics, but also include using glucocorticoid, ICU admission, mechanical ventilation according to the patients' condition.

Procedure: changes of Pneumonia Severity Score

Expand-CURB evaluation group

EXPERIMENTAL

The changes of Expand-CURB scores and serum CRP were used to evaluate the therapeutic effects. If both Expand-CURB scores and CRP suggest that treatment is effective, the initial treatment will be maintained. If either of Expand-CURB scores or serum CRP suggest that treatment is effective, the initial treatment can be maintained, but need to be reviewed in the next 3-5 days. If both Expand-CURB scores and serum CRP suggest that the treatment is failed, the initial treatment should be changed. The change of initial treatment is not limited to antibiotics, but also include using glucocorticoid, ICU admission, mechanical ventilation according to the patients' condition.

Procedure: changes of Pneumonia Severity Score

Prospective observational group

NO INTERVENTION

Patients' Expand-CURB scores, PSI scores and serum CRP before and after 3-5 days of initial treatment will be recorded. And the initial treatment, whether the initial treatment was changed 3-5 days of initial treatment and the final outcomes (ICU admission, 30-day mortality, average length of stay) will be recorded.

Interventions

changes of Pneumonia Severity Score PROCEDURE

assessing effectiveness of CAP treatment by using continuous pneumonia severity score

Comprehensive evaluation group; Expand-CURB evaluation group; PSI evaluation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• community acquired pneumonia(by CTS or IDSA/ATS guidelines)
• severe community acquired pneumonia(PSI scores \>= 90 or Expand-CURB scores \>= 4);

You may not qualify if:

• HIV patients
• Other immunodeficiency disorders (neutropenia, hematologic and solid tumors undergoing chemoradiotherapy, organ transplantation, and long-term treatment with glucocorticoid and cytokine antagonists).

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

SAHZhejiangU

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (4)

• Mandell LA, Wunderink RG, Anzueto A, Bartlett JG, Campbell GD, Dean NC, Dowell SF, File TM Jr, Musher DM, Niederman MS, Torres A, Whitney CG; Infectious Diseases Society of America; American Thoracic Society. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007 Mar 1;44 Suppl 2(Suppl 2):S27-72. doi: 10.1086/511159. No abstract available.

  PMID: 17278083 BACKGROUND

• Fine MJ, Auble TE, Yealy DM, Hanusa BH, Weissfeld LA, Singer DE, Coley CM, Marrie TJ, Kapoor WN. A prediction rule to identify low-risk patients with community-acquired pneumonia. N Engl J Med. 1997 Jan 23;336(4):243-50. doi: 10.1056/NEJM199701233360402.

  PMID: 8995086 BACKGROUND

• Liu JL, Xu F, Zhou H, Wu XJ, Shi LX, Lu RQ, Farcomeni A, Venditti M, Zhao YL, Luo SY, Dong XJ, Falcone M. Expanded CURB-65: a new score system predicts severity of community-acquired pneumonia with superior efficiency. Sci Rep. 2016 Mar 18;6:22911. doi: 10.1038/srep22911.

  PMID: 26987602 BACKGROUND

• Welte T, Kohnlein T. Global and local epidemiology of community-acquired pneumonia: the experience of the CAPNETZ Network. Semin Respir Crit Care Med. 2009 Apr;30(2):127-35. doi: 10.1055/s-0029-1202941. Epub 2009 Mar 18.

  PMID: 19296412 BACKGROUND

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Central Study Contacts

Jinliang Liu, MD

CONTACT

+86 13867496840; 2511063@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The present study is a randomized controlled open label trial. Patients and their physicians know the group and the treatment plan, and there are clear criteria for the final outcome (30-day fatality rate, length of stay). The masking is not required.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study consisting of two parts: the randomized controlled study include three groups, comprehensive evaluation group (traditional treatment group), PSI evaluation group and Expand-CURB evaluation group.The prospective observational study include one group. There are a total of 4 groups in the present study.

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 22, 2019
• Study Start: July 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: October 22, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)