An observational study in Lower Resp Tract Infection and Human Metapneumovirus Infection, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-24.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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The human metapneumovirus (hMPV) was first described in 2001. It belongs to the paramyxovirus family and is genetically close to the Respiratory Syncytial Virus (RSV). hMPV has a seasonal epidemic pattern, between January to April. Clinical symptoms of hMPV infection include influenza-like illness (fever, asthenia and curvatures) associated with signs of respiratory tract infection. The incidence of hMPV infection is higher in children than in adults. In child pneumonia, hMPV is the third most frequent isolated pathogen (14 % of the subjects), after rhinovirus and RSV. In hospitalized adults, hMPV was detected in 6 to 8% of the subjects with lower respiratory tract and in 4 % of subjects with pneumonia.
Clinical, radiological and biological features, as well as evolution course of hMPV infections have been mainly described in children. Clinical presentation of in adult seems polymorph, ranging from acute bronchitis or exacerbation of COPD to pneumonia. The frequency of viral-bacterial coinfection is unknown. Intensive care unit (ICU) admission may involve almost 1 for 10 patients. Elderly and immunocompromised subjects are probably high-risk subjects.
Currently, treatment of hMPV infections is mainly symptomatic. However, several anti-RSV drugs that are currently in clinical development have demonstrated an activity against other paramyxoviridae in pre-clinical studies. Consequently, it seems necessary to better characterize hMPV infections in adult inpatients: presentation, course profile and risk factors for morbidity and mortality. These data would help clinicians to identify high risk patients, and consequently to choose those who could benefit from coming treatments.
The French hMPV Study is observational prospective multicenter clinical study. The study population includes all consecutive adult inpatients with a community-acquired acute lower respiratory tract infection and a mPCR positive for hMPV on any respiratory sample. The primary objective is to describe the prognosis. The secondary objectives are i) to characterize clinical, radiological and biological features, ii) to describe the hospital course and the rate of ICU transfer; in ICU patients, to describe organ failures and supports, and iii) to describe the viral and/or bacterial coinfections. The primary endpoint is the number of subjects with a poor outcome (defined by the requirement for invasive mechanical ventilation and/or the death during the hospital stay).
The human metapneumovirus (hMPV) was first described in 2001. It belongs to the paramyxovirus family (paramyxoviridae subfamily). hMPV is genetically close to the Respiratory Syncytial Virus (RSV). hMPV has a seasonal epidemic pattern, between January to April. Incubation period varies between 4 and 6 days. Clinical symptoms of hMPV infection are close to that of RSV, with influenza-like illness (fever, asthenia and curvatures) associated with signs of upper and/or lower respiratory tracts infection. The incidence of hMPV infection is higher in children than in adults. In a large cohort of children with respiratory illness or fever, hMPV was detected in 7 % of outpatients and 6 % of hospitalized children. The annual rate of hospitalization associated with hMPV infection has been estimated about 1 per 1000 children less than 5 years of age. In child pneumonia, hMPV is the third most frequent isolated pathogen (14 % of the subjects), after rhinovirus and RSV. In hospitalized adults, hMPV was detect in 6 to 8% of the subjects with a lower respiratory tract and in 4 % of subjects with a pneumonia.
Clinical, radiological and biological features, as well as evolution course of hMPV-associated infections have been mainly described in children. Clinical presentation of hMPV-associated infection in adult seems polymorph, ranging from acute bronchitis or exacerbation of chronic pulmonary diseases (COPD and asthma) to pneumonia. Viral-viral coinfections are not exceptional whereas the frequency of viral-bacterial coinfection is unknown. Intensive care unit (ICU) admission involved almost 1 for 10 patients. Elderly and immunocompromised subjects are probably high-risk subjects. Only one cohort of hMPV-infected patients admitted to ICU has been reported. Among the 40 patients, 6 were non-immunocompromised and without comorbidity. Factors associated with a poor prognosis were not studied.
Currently, treatment of hMPV-associated lower respiratory tract infections is mainly symptomatic. However, several anti-RSV drugs that are currently in clinical development in humans, have demonstrated an activity against other paramyxoviridae (hMPV and parainfluenza virus) in pre-clinical studies. These anti-RSV drugs should be available for clinicians in the next few years. Considering their activity against other paramyxoviridae, clinicians will probably attempt to use these anti-RSV drugs in non-RSV paramyxoviridae-associated lower respiratory tracts infections in adult inpatients. Consequently, it seems necessary to better characterize hMPV-associated lower respiratory tracts infections in adult inpatients: clinical, radiological and biological presentation, course profile and risk factors for morbidity and mortality. These data would help clinicians to identify high risk patients, and consequently to choose those who could benefit from coming treatments.
The French hMPV Study is observational prospective multicenter clinical study. The study population includes all consecutive adult inpatients with a community-acquired acute lower respiratory tract infection and a mPCR positive for hMPV on any respiratory sample. The primary objective is to describe the prognosis. The secondary objectives are i) to characterize the clinical (time from onset to hospital admission, general symptoms, respiratory symptoms and signs), radiological and biological features, ii) to describe the hospital course and the rate of ICU transfer; in ICU patients, to describe organ failures and supports, and iii) to describe the viral and/or bacterial coinfections.
31 studies on the registry are indexed under Paramyxoviridae Infections; 3 are open to participants now.
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All consecutive adult patients admitted to hospital with an acute lower respiratory tract infection and a respiratory MPCR positive for hMPV.
Participating centres are respiratory diseases departments, infectious diseases departments and intensive care units of secondary and tertiary care hospitals in France.
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Exclusion Criteria:
The primary endpoint is the number of subjects with a poor outcome (defined by the requirement for invasive mechanical ventilation and/or the death during the hospital stay or at 60 days).
Time frame: during the hospital stay or at 60 days
Age (years)
Time frame: at hospital admission
Gender (H or F)
Time frame: During the first 24 hours of ICU stay
Height (cm)
Time frame: During the first 24 hours of ICU stay
Weight (kg)
Time frame: During the first 24 hours of ICU stay
Charlson score (points)
Time frame: During the first 24 hours of ICU stay
Presence or absence of each of the following comorbidities
smoking, asthma, COPD, chronic respiratory insufficiency requiring long term oxygen therapy, diabetes, hypertension, chronic heart failure NYHA III IV, coronary artery disease, cerebral arterial disease, chronic dialysis and cirrhosis Child Pugh B-C
Time frame: During the first 24 hours of ICU stay
Presence or absence of each of the following immunocompromised conditions
HIV infection, splenectomy, long term steroid therapy, other long term immunosuppressive drug, anticancer agents, solid organ transplant, cancer or hematologic neoplasm
Time frame: During the first 24 hours of ICU stay
Presence or absence of each of the following factors of health-care associated lower respiratory tract infection
hospitalization for ≥ 2 days in the preceding 90 days and institutionalization
Time frame: During the first 24 hours of ICU stay
Antipneumococcal and anti-flu vaccine
Time frame: During the first 24 hours of ICU stay
Date of first respiratory symptoms (date)
Time frame: During the first 24 hours of ICU stay
Respiratory rate (maximum) during the first 24 hours of hospital stay (/min)
Time frame: During the first 24 hours of ICU stay
Temperature (maximum) during the first 24 hours of hospital stay (°C)
Time frame: During the first 24 hours of ICU stay
Heart rate (maximum) during the first 24 hours of hospital stay (/min)
Time frame: During the first 24 hours of ICU stay
Glasgow score (minimum) during the first 24 hours of hospital stay (points)
Time frame: During the first 24 hours of ICU stay
Blood leucocytes (maximum) at hospital admission (G/L)
Time frame: During the first 24 hours of ICU stay
Blood neutrophils (maximum) at hospital admission (G/L)
Time frame: During the first 24 hours of ICU stay
Blood lymphocytes (maximum) at hospital admission (G/L)
Time frame: During the first 24 hours of ICU stay
Blood platelets (maximum) at hospital admission (G/L)
Time frame: During the first 24 hours of ICU stay
Partial pressure of O2 (mmHg)
Time frame: During the first 24 hours of ICU stay
Number of quadrant with radiological abnormalities on the Chest X-Ray (number, maximum=4)
Time frame: During the first 48 hours of ICU stay
Viral co-infection
Time frame: During Hospital stay, censored at 60 days
Bacterial co-infection
Time frame: During Hospital stay, censored at 60 days
Duration of mechanical ventilation support (invasive or non invasive)
Time frame: during hospital stay or at 60 days
Shock (vasopressor support)
Time frame: during hospital stay or at 60 days
ARDS (Berlin definition)
Time frame: during hospital stay or at 60 days
Duration of ICU stay
Time frame: during hospital stay or at 60 days
Duration of hospital stay (days)
Time frame: censored at 60 days
Death
Time frame: during hospital stay or at 60 days
Plan to share: No
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Started Mar 2018 (actual). Primary completion is estimated for Jul 2019, 16 months after the start.
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This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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