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Lower Resp Tract InfectionFrench-hMPVNCT03460171

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

An observational study of Lower Resp Tract Infection and Human Metapneumovirus Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
400 participants
Where
1 siteFrance
Study dates
23 Mar 2018to 31 Jul 2019
How long will I take part?
60 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • Patient already included in the study.

Trial locations and contacts

1 site in 1 country.

France1 site
  • Service de réanimation-Hôpital Tenon

    Paris, 75020

Other trials in France

About this study

Official title: The French hMPV Study: Clinical Features, Outcome and Prognosis of Human Metapneumovirus (hMPV) Lower Respiratory Tract Infections in Adult Inpatients

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.

Read more

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).

Read the 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.

Keywords
Human Metapneumovirus, Paramyxoviridae infections, Lower-respiratory tract infections, Pneumonia
Medical subject headings
Paramyxoviridae Infections, Pneumonia

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: during the hospital stay or at 60 days

Secondary outcomes (28)
  1. Age (years)

    Measured: at hospital admission

  2. Gender (H or F)

    Measured: During the first 24 hours of ICU stay

  3. Height (cm)

    Measured: During the first 24 hours of ICU stay

  4. Weight (kg)

    Measured: During the first 24 hours of ICU stay

  5. Charlson score (points)

    Measured: During the first 24 hours of ICU stay

  6. 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

    Measured: During the first 24 hours of ICU stay

  7. 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

    Measured: During the first 24 hours of ICU stay

  8. 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

    Measured: During the first 24 hours of ICU stay

  9. Antipneumococcal and anti-flu vaccine

    Measured: During the first 24 hours of ICU stay

  10. Date of first respiratory symptoms (date)

    Measured: During the first 24 hours of ICU stay

  11. Respiratory rate (maximum) during the first 24 hours of hospital stay (/min)

    Measured: During the first 24 hours of ICU stay

  12. Temperature (maximum) during the first 24 hours of hospital stay (°C)

    Measured: During the first 24 hours of ICU stay

  13. Heart rate (maximum) during the first 24 hours of hospital stay (/min)

    Measured: During the first 24 hours of ICU stay

  14. Glasgow score (minimum) during the first 24 hours of hospital stay (points)

    Measured: During the first 24 hours of ICU stay

  15. Blood leucocytes (maximum) at hospital admission (G/L)

    Measured: During the first 24 hours of ICU stay

  16. Blood neutrophils (maximum) at hospital admission (G/L)

    Measured: During the first 24 hours of ICU stay

  17. Blood lymphocytes (maximum) at hospital admission (G/L)

    Measured: During the first 24 hours of ICU stay

  18. Blood platelets (maximum) at hospital admission (G/L)

    Measured: During the first 24 hours of ICU stay

  19. Partial pressure of O2 (mmHg)

    Measured: During the first 24 hours of ICU stay

  20. Number of quadrant with radiological abnormalities on the Chest X-Ray (number, maximum=4)

    Measured: During the first 48 hours of ICU stay

  21. Viral co-infection

    Measured: During Hospital stay, censored at 60 days

  22. Bacterial co-infection

    Measured: During Hospital stay, censored at 60 days

  23. Duration of mechanical ventilation support (invasive or non invasive)

    Measured: during hospital stay or at 60 days

  24. Shock (vasopressor support)

    Measured: during hospital stay or at 60 days

  25. ARDS (Berlin definition)

    Measured: during hospital stay or at 60 days

  26. Duration of ICU stay

    Measured: during hospital stay or at 60 days

  27. Duration of hospital stay (days)

    Measured: censored at 60 days

  28. Death

    Measured: during hospital stay or at 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2018
  2. Study start23 Mar 2018
  3. Primary completion31 Jul 2019 (estimated)
  4. Study completion31 Jul 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (estimated)
Target duration
60 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT03460171
Sponsor's protocol ID
HAO 17024
Acronym
French-hMPV
Status last verified
Jul 2019
First submitted
11 Dec 2017
Last updated
24 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lower Resp Tract Infection and Human Metapneumovirus Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019; AzTrials last refreshed its copy on 8 Nov 2026.

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