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Clinical Features, Outcome and Prognosis of Human Metapneumovirus (hMPV) Lower Respiratory Tract Infections in Adult Inpatients (French-hMPV)

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ClinicalTrials.gov Identifier: NCT03460171
Recruitment Status : Not yet recruiting
First Posted : March 9, 2018
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

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).


Condition or disease
Lower Resp Tract Infection Human Metapneumovirus Infection

Detailed Description:

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.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 60 Days
Official Title: The French hMPV Study: Clinical Features, Outcome and Prognosis of Human Metapneumovirus (hMPV) Lower Respiratory Tract Infections in Adult Inpatients
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Age (years) [ Time Frame: at hospital admission ]
  2. Gender (H or F) [ Time Frame: During the first 24 hours of ICU stay ]
  3. Height (cm) [ Time Frame: During the first 24 hours of ICU stay ]
  4. Weight (kg) [ Time Frame: During the first 24 hours of ICU stay ]
  5. Charlson score (points) [ Time Frame: During the first 24 hours of ICU stay ]
  6. Presence or absence of each of the following comorbidities [ Time Frame: During the first 24 hours of ICU stay ]
    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

  7. Presence or absence of each of the following immunocompromised conditions [ Time Frame: During the first 24 hours of ICU stay ]
    HIV infection, splenectomy, long term steroid therapy, other long term immunosuppressive drug, anticancer agents, solid organ transplant, cancer or hematologic neoplasm

  8. Presence or absence of each of the following factors of health-care associated lower respiratory tract infection [ Time Frame: During the first 24 hours of ICU stay ]
    hospitalization for ≥ 2 days in the preceding 90 days and institutionalization

  9. Antipneumococcal and anti-flu vaccine [ Time Frame: During the first 24 hours of ICU stay ]
  10. Date of first respiratory symptoms (date) [ Time Frame: During the first 24 hours of ICU stay ]
  11. Respiratory rate (maximum) during the first 24 hours of hospital stay (/min) [ Time Frame: During the first 24 hours of ICU stay ]
  12. Temperature (maximum) during the first 24 hours of hospital stay (°C) [ Time Frame: During the first 24 hours of ICU stay ]
  13. Heart rate (maximum) during the first 24 hours of hospital stay (/min) [ Time Frame: During the first 24 hours of ICU stay ]
  14. Glasgow score (minimum) during the first 24 hours of hospital stay (points) [ Time Frame: During the first 24 hours of ICU stay ]
  15. Blood leucocytes (maximum) at hospital admission (G/L) [ Time Frame: During the first 24 hours of ICU stay ]
  16. Blood neutrophils (maximum) at hospital admission (G/L) [ Time Frame: During the first 24 hours of ICU stay ]
  17. Blood lymphocytes (maximum) at hospital admission (G/L) [ Time Frame: During the first 24 hours of ICU stay ]
  18. Blood platelets (maximum) at hospital admission (G/L) [ Time Frame: During the first 24 hours of ICU stay ]
  19. Partial pressure of O2 (mmHg) [ Time Frame: During the first 24 hours of ICU stay ]
  20. Number of quadrant with radiological abnormalities on the Chest X-Ray (number, maximum=4) [ Time Frame: During the first 48 hours of ICU stay ]
  21. Viral co-infection [ Time Frame: During Hospital stay, censored at 60 days ]
  22. Bacterial co-infection [ Time Frame: During Hospital stay, censored at 60 days ]
  23. Duration of mechanical ventilation support (invasive or non invasive) [ Time Frame: during hospital stay or at 60 days ]
  24. Shock (vasopressor support) [ Time Frame: during hospital stay or at 60 days ]
  25. ARDS (Berlin definition) [ Time Frame: during hospital stay or at 60 days ]
  26. Duration of ICU stay [ Time Frame: during hospital stay or at 60 days ]
  27. Duration of hospital stay (days) [ Time Frame: censored at 60 days ]
  28. Death [ Time Frame: during hospital stay or at 60 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • Adult (≥18 years old) inpatients with:
  • an acute lower respiratory tract infection, defined by the presence of two of the following criteria in the 5 days preceding hospital admission or during the present hospital stay : fever, cough, expectoration, exercise or rest dyspnea, crackles, tubal breath, signs of respiratory failure (respiratory rate higher than 30 per minute...), thoracic pain, oxygen therapy, mechanical ventilation;
  • a respiratory mPCR (upper respiratory tracts specimen such as nasopharyngeal swab or lower respiratory tract specimen such as tracheal or bronchial aspiration or bronchoalveolar lavage) positive for hMPV in the 5 days following hospital admission.

Exclusion Criteria:

  • Patient already included in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03460171


Contacts
Contact: Guillaume Voiriot, MD PhD 00 33 (0) 1 56 01 62 63 guillaume.voiriot@aphp.fr
Contact: Quentin Philippot, MSc 00 33 (0) 1 56 01 62 63 philippot.quentin@gmail.com

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Guillaume Voiriot, MD PhD Assistance Publique - Hôpitaux de Paris
Study Director: Muriel Fartoukh, MD PhD Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03460171     History of Changes
Other Study ID Numbers: HAO 17024
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Human Metapneumovirus
Paramyxoviridae infections
Lower-respiratory tract infections
Pneumonia

Additional relevant MeSH terms:
Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases