Parainfluenza virus type 3 (PIV3) and human metapneumovirus (hMPV) triggered infections.
Conditions
Interventions
Group 1: Study-related measures/testing methods:
- A nasopharyngeal (NP) and/or oropharyngeal (OP) swab (or another respiratory tract sample collected according to routine practice) will be collected
Sponsors
P95 BV
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients will be included if they: • have been diagnosed of LRTD at the hospital • have been hospitalized for at least one overnight stay the current hospitalization has been extended • are willing and able to provide informed consent, obtained from the patient or from the patient’s Legally Acceptable Representative(s) LRTD is defined as at least one of the following symptoms or signs with onset or worsening within 14 days prior to hospital admission or during the current hospital stay for another medical reason: • Productive cough • Pleuritic chest pain • Dyspnea (shortness of breath) • Wheezing • Abnormal lung sounds (crackles, wheezing, bronchial sounds)
Exclusion criteria
Exclusion criteria: Not meeting the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess serum neutralising antibody response to PIV3 and hMPV-A, hMPV-B during the convalescent period in PCR-confirmed PIV3 and/or hMPV positive cases. Endpoints: •PIV3 serum nAb titres during the convalescent period •hMPV-A serum nAb titres during the convalescent period •hMPV-B serum nAb titres during the convalescent period Measured by assessment of blood samples collected. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess serum neutralising antibody response to PIV3 and hMPV-A, hMPV-B during the baseline period in PCR-confirmed PIV3 and/or hMPV positive cases. Endpoints: • PIV3 serum nAb titres during the baseline period • hMPV-A serum nAb titres during the baseline period • hMPV-B serum nAb titres during the baseline period 2. To assess changes in serum neutralising antibody response to PIV3 and hMPV-A, hMPV-B between baseline and convalescent periods in PCR-confirmed PIV3 and/or hMPV positive cases. Endpoints: • PIV3 serum nAb titres during the baseline and convalescent periods • hMPV-A serum nAb titres during the baseline and convalescent periods • hMPV-B serum nAb titres during the baseline and convalescent periods 3. To assess PIV3, hMPV serum binding IgG response during the baseline and convalescent periods in PCR-confirmed PIV3 and/or hMPV positive cases. Endpoints: • PIV3 serum binding IgG concentrations during the baseline and convalescent periods • hMPV serum binding IgG concentrations during the baseline and convalescent periods 4. To assess changes in PIV3, hMPV serum binding IgG response between baseline and convalescent periods in PCR-confirmed PIV3 and/or hMPV positive cases. Endpooints: • PIV3 serum binding IgG concentrations during the baseline and convalescent periods • hMPV serum binding IgG concentrations during the baseline and convalescent periods 5. To assess cross-reactivity between RSV and PIV3/hMPV. Endpoints: • RSV-A and RSV-B serum nAbs titres in patients testing positive to PIV3 and/or hMPV during the baseline and convalescent periods • RSV serum binding IgG concentrations in patients testing positive to PIV3 and/or hMPV during the baseline and convalescent periods 6. To assess cross-reactivity between PIV3 and hMPV. Endpoints: • hMPV-A and hMPV-B serum nAb titres in patients testing positive to PIV3 during the baseline and convalescent periods • hMPV serum binding IgG concentrations in patients testing positive | — |
Countries
Germany, Spain
Contacts
Public ContactLeif Erik Sander
Charité – Universitaetsmedizin Berlin Department of Infectious Diseases and Critical Care Medicine
Outcome results
None listed