Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03391076
Other study ID # 20170909
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 21, 2017
Est. completion date October 23, 2018

Study information

Verified date October 2018
Source Capital Medical University
Contact Shengchen DUAN, doctor
Phone 13488779977
Email doctordsc@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

LRTI (Lower respiratory tract infection) is a severe disease in China. The fast and accurate diagnosis of pathogens, bacteria or viruses that cause the infection is critical for the therapy. In this study, investigators assume that the use of FilmArray Respiratory Panel will provide more rapid and comprehensive evidences to physicians to diagnose LRTI which is caused by viruses or atypical pathogens and then reduce the length of antibiotics use by 0.5-1.0 days as well as other hospital resources (length of hospital/ICU stay, take-away oral antibiotics, etc.). Secondly, investigators assume that in LRTI patients with viral infection and a low serum PCT level, fewer length of antibiotics use can be expected. Thirdly, the use of FilmArray Respiratory Panel will provide clearer epidemiology data of virus and atypical pathogens in hospitalized LRTI patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 800
Est. completion date October 23, 2018
Est. primary completion date September 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adults age >= 18 years old

- Community acquired Pneumonia, acute exacerbation of chronic obstructive pulmonary disease [AECOPD], acute exacerbation of bronchiectasis.

- Hospitalization required

- Informed Consent Form signed

Exclusion Criteria:

- Age < 18 years old

- Hospital acquired Pneumonia

- Patients with lung tuberculosis

- Pregnant women

- Patients with immunodeficiency

- Any conditions which may increase PCT levels

- Informed Consent Form not signed

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
FilmArray Respiratory Panel
An Multi-PCR method which can detect 20 pathogens in 45 minutes.

Locations

Country Name City State
China Chian Japan Friendship Hospital Beijing Beijing

Sponsors (2)

Lead Sponsor Collaborator
Bin Cao BioMérieux

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The length (days) of antibiotics therapy in hospital between two groups. The duration of antibiotics used is defined as days of intravenous antibiotic therapy in which any doses of antibiotics are administered. From in-hospital to discharge or death, whichever came first, assessed up to 12 months
Secondary Antibiotics therapy cost From in-hospital to discharge or death, whichever came first, assessed up to 12 months
Secondary Length of hospital stay (LOS) and/or ICU stay From in-hospital to discharge or death, whichever came first, assessed up to 12 months
Secondary The correlation between the initial serum PCT level and clinical outcomes/mortality From in-hospital to discharge or death, whichever came first, assessed up to 12 months
Secondary The detection rate of viruses and atypical pathogens by FilmArray in LRTI patients From in-hospital to discharge or death, whichever came first, assessed up to 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT06016244 - Safe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a Randomized Controlled Trial N/A
Completed NCT03694392 - Flublok v. Standard Dose Vaccine Effectiveness Among Kaiser Permanente Northern California Adults 18-64 Years
Completed NCT01952470 - Preliminary Study of Dornase Alfa to Treat Chest Infections Post Lung Transplant. Phase 2
Recruiting NCT02929680 - Clinical Evaluation of FilmArray LRTI Panel N/A
Completed NCT01931254 - Assess a Diagnostic Tool to Distinguish Between Bacterial and Viral Infection N/A
Completed NCT02454114 - HOME FIRST Pilot: a Study of Early Supported Discharge in Patients With Lower Respiratory Tract Infections N/A
Completed NCT00975780 - A Trial to Reduce Pneumonia in Nursing Home Residents Phase 3
Completed NCT00350987 - Procalcitonin Guided Antibiotic Therapy and Hospitalisation in Patients With Lower Respiratory Tract Infections: The "ProHOSP" Study N/A
Completed NCT00420966 - Utilization and Compliance of Respiratory Syncytial Virus Monoclonal Antibody Therapy
Recruiting NCT06210282 - The Effect of Focused Lung Ultrasonography on Antibiotic Prescribing in General Practice N/A
Recruiting NCT05110261 - Evaluate the Safety and Efficacy of Nirsevimab in Healthy Preterm and Term Infants in China Phase 3
Recruiting NCT01985620 - The Impact of a Short Intervention During RSV Prophylaxis on Influenza Vaccination Rate. N/A
Recruiting NCT05374070 - Antiviral Activity of Oral Probiotics N/A
Recruiting NCT03808922 - Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study Phase 3
Not yet recruiting NCT03846401 - Bronchoscopy in Lower Respiratory Tract Infection in Respiratory Intensive Care Unit
Completed NCT01048073 - Non-influenza Etiologies of Acute Respiratory Illness in Southeast Asia N/A
Completed NCT00707941 - Oseltamivir Randomised Controlled Efficacy Trial Phase 3
Recruiting NCT03446534 - The Norwegian Antibiotics for Pneumonia in Children Study Phase 4
Completed NCT04311320 - A Low-Resource Oxygen Blender Prototype for Use in Modified Bubble CPAP Circuits N/A
Completed NCT01735084 - Using Pneumococcal Vaccines in Combination for Maximum Protection From Ear and Lung Infections in First 3 Years of Life Phase 4