COMBACTE’s Network in Other Studies – PNEUMO
The PNEUMO study is led by the University Medical Centre Utrecht (UMCU) and aims to understand the risk of infection from specific pneumococcal serotypes in Europe. Preparations started in 2019 in 25 sites of the COMBACTE network. Most participating sites were activated during the initial year despite the impact of the COVID-19 pandemic. In March 2021 the 500th subject was recruited: a success for a non-COVID study in these difficult times.
Background & Study Information
Community-acquired pneumonia (CAP) remains one of the most common causes of human morbidity and mortality worldwide1, 2. Widespread use of vaccines, including pneumococcal vaccines, have reduced the burden of CAP in recent years, however Streptococcus pneumonia remains an important cause of bacterial CAP resulting in hospitalization3-6. This is partly due to infection with pneumococcal serotypes that are currently not included in available vaccines.
The PNEUMO study is a prospective, active surveillance, observational study. The main objective focuses on incidence of pneumococcal CAP and invasive pneumococcal diseases (IPD), serotype prevalence among cases of pneumococcal CAP, in-hospital clinical outcomes, and mortality. In addition, a subset of patients will be followed up to six months after hospital discharge to assess functional and cognitive outcomes of these patients.
All sites will contribute to the enrollment target of 4500 adult patients who are hospitalized with all-cause CAP or other (IPD) in selected European countries. Site initiation is in progress in France, Italy, and Spain, with about two-thirds of the total of 25 selected hospitals actively recruiting. The first patient was enrolled in February 2020 in Spain.
Study Organization & Collaboration
The PNEUMO study protocol was initially launched in the US and was designed by Merck, Sharp & Dohme Corp., USA (MSD). For expansion of the study to Europe, the UMCU was asked to be the Sponsor of the PNEUMO study in Europe. As Sponsor, the project’s operations are managed by the UMCU, making use of the COMBACTE experience gained in many studies over the last years. COMBACTE’s CLIN-Net team has provided support during the site selection process for sites in France, Italy, and Spain. Since the start of the study in Europe, the UMCU team closely collaborates with the subsidizing partner MSD.
“The collaboration with UMCU has allowed us to work toward a common goal of demonstrating the burden of hospitalized pneumococcal pneumonia. It is rewarding to work with experts in pneumococcal disease research and leverage their COMBACTE network that includes multiple clinical sites across Europe”.
“Invasive pneumococcal disease is monitored routinely in many countries, yet non-invasive disease such as community acquired pneumonia is not, yet it is important that we determine the burden and serotype distribution due to community acquired pneumonia caused by Streptococcus pneumoniae to demonstrate the value of our products beyond IPD. We will be able to accomplish this with the PNEUMO study”.
The success of PNEUMO is established with support of the local national coordinator teams* in the participating countries, including the Clinical Research Associates the UMCU team is closely working with. The local teams played an important role in the initial site selection. Clinical Research Associates continue to act as first point of contact for the participating hospitals and conduct monitoring activities. The PNEUMO study shows the future of the COMBACTE Network executing studies together with COMBACTE study sites as a self-sustainable entity.
* France: CHU Limoges in Limoges; Spain: Hospital Universitario Virgen Macarena in Seville; Italy: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico in Milan
Next steps
After a successful but challenging year, the PNEUMO study team is committed and ready to activate the remainder of the participating sites and make significant steps in reaching the enrollment target of 4500 patients.
References:
- Kung HC, Hoyert DL, Xu J, Murphy SL. Deaths: final data for 2005. National vital statistics reports : from the Centers for Disease Control and Prevention, National Center for Health Statistics, National Vital Statistics System. 2008;56(10):1-120.
- Self WH, Grijalva CG, Zhu Y, McNaughton CD, Barrett TW, Collins SP, et al. Rates of emergency department visits due to pneumonia in the United States, July 2006-June 2009. Academic emergency medicine : official journal of the Society for Academic Emergency Medicine. 2013;20(9):957-60.
- Grijalva CG, Nuorti JP, Arbogast PG, Martin SW, Edwards KM, Griffin MR. Decline in pneumonia admissions after routine childhood immunization with pneumococcal conjugate vaccine in the USA: a time-series analysis. Lancet. 2007;369(9568):1179-86.
- Griffin MR, Zhu Y, Moore MR, Whitney CG, Grijalva CG. U.S. hospitalizations for pneumonia after a decade of pneumococcal vaccination. The New England journal of medicine. 2013;369(2):155-63.
- Jain S, Self WH, Wunderink RG, Fakhran S, Balk R, Bramley AM, et al. Community-Acquired Pneumonia Requiring Hospitalization among U.S. Adults. The New England journal of medicine. 2015;373(5):415-27.
- Jain S, Williams DJ, Arnold SR, Ampofo K, Bramley AM, Reed C, et al. Community-acquired pneumonia requiring hospitalization among U.S. children. The New England journal of medicine. 2015;372(9):835-45.
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