Status Acronym ISRCTN EudraCT NCT (clinicaltrials.gov) DRKS
Active (Recruitment Closed) NCT03350425

Duration of protection from pneumonia after pneumococcal vaccination of haemodialysis patients (DOPPIO)

Purpose / Objectives

Primary Outcome

  • To compare pneumonia rates between newly vaccinated hemodialysis patients and those vaccinated against pneumococcal infection more than 2 years ago

Secondary Outcomes

  • To describe the antibody titers in hemodialysis patients as a function of time since vaccination
  • To determine factors influencing antibody kinetics (e.g. age, prior or ongoing immunosuppression, medication, prior vaccination history).

Diagnosis

  • Bacterial Pneumonia
  • chronische Niereninsuffizienz (English name missing)
  • Pneumonie (ambulant erworben) (English name missing)

Patients with stage 5 chronic kidney disease treated with chronic hemodialysis

Target population

Disease stage

5D

Age

18-99

Inclusion criteria

  • Signed informed consent form including enrolment in registry database (QiN-registry)
  • Patients with stage 5 chronic kidney disease treated with chronic hemodialysis
  • Patients who are vaccinated against pneumococcal infection as appropriate
  • Age of 18 years or older

Exclusion criteria

Patients who are not vaccinated against pneumococcal infection

Study design

  • Multicenter
  • Prospective

Intervention

Blood samples will be taken on dialysis days before dialysis from an already inserted intravascular catheter.

Miscellaneous

All therapies and diagnostics including vaccinations will be administered solely as part of clinical routine and as recommended by appropriate guidelines

Documents (password protected)

Go to download area

Networks

Responsibilities in overall study

Sponsor

Universität zu Köln

  • Tel. +49 (0)221 478 0

(National) Coordinating Investigator

Univ.-Prof. Dr. med. Oliver A. Cornely

Project management

Infektiologie I

Dr. rer. medic. Kerstin Albus
Univ.-Prof. Dr. med. Oliver A. Cornely
Dr. med. Sibylle Christiane Mellinghoff
Dr. med. Gero von Gersdorff