Respiratory Tract InfectionsNCT00827060
Observation of Initial Procalcitonin and the Clinical Course of Patients With Acute Respiratory Tract Infections
An observational study of Respiratory Tract Infections, run by Hannover Medical School at 1 site in Germany.
Trial summary
Observation of the initial Procalcitonin values and the clinical course of consecutively included patients with Acute Respiratory Tract Infections at general medical practices in greater Hannover. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Tract Infections
- How many people
- 702 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2006to Sep 2007
- 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: primary care patients in 45 practices in greater Hannover
Who may be able to join
- written informed consent
- all types of respiratory tract infection according to investigator´s diagnosis
Who cannot join
- pretreatment with antibiotics in the past 2 weeks
- portal hypertension
- Major surgeries or multiple trauma which require hospitalization, in previous 4 weeks
- Autoimmune disease and systemic diseases (lupus erythematodes, wegener´s disease)
- Peritoneal dialysis
- Acute treated or recently operated medullary c-cell-carcinoma, SCLC, carcinoid
- Other inflammatory diseases (e.g. urinary tract infection, pyelonephritis, pancreatitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observation of the Initial Procalcitonin Values and the Clinical Course of Patients With Acute Respiratory Tract Infections at General Medical Practices in Greater Hannover
Observation of the initial Procalcitonin values and the clinical course of consecutively included patients with Acute Respiratory Tract Infections at general medical practices in greater Hannover.
Read the detailed description
Primary endpoint:
- initial Procalcitonin values of patients with Acute Respiratory Tract Infections
Secondary endpoints:
- correlation of initial Procalcitonin values to classify Acute Respiratory Tract Infections
- correlation of initial Procalcitonin values to subjective severity of Acute Respiratory Tract Infections
- correlation of initial Procalcitonin values to antibiotic- prescriptions
- correlation of initial Procalcitonin values to frequency of admission to hospital
- correlation of initial Procalcitonin values to frequency of referrals (radiology, pneumology)
- Conditions
- Respiratory Tract Infections
- Keywords
- primary care, procalcitonin, acute respiratory tract infection
- Medical subject headings
- Respiratory Tract Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startDec 2006
- Primary completionJun 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 702 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Investigators
- Olaf Burkhardt, PD Dr. med., Principal investigator, Medical School Hannover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827060
- Sponsor's protocol ID
- HannoverPro
- Status last verified
- Jan 2009
- First submitted
- 21 Jan 2009
- Last updated
- 28 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Burkhardt O, Ewig S, Haagen U, Giersdorf S, Hartmann O, Wegscheider K, Hummers-Pradier E, Welte T. Procalcitonin guidance and reduction of antibiotic use in acute respiratory tract infection. Eur Respir J. 2010 Sep;36(3):601-7. doi: 10.1183/09031936.00163309. Epub 2010 Feb 25.
PubMed 20185423
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of the Initial Procalcitonin Values and the Clinical Course of Patients With Acute Respiratory Tract Infections at General Medical Practices in Greater Hannover
- ClinicalTrials.gov ID
- NCT00827060
- Acronym / sponsor ID
- HannoverPro
- Conditions
- Respiratory Tract Infections
- Keywords
- primary care, procalcitonin, acute respiratory tract infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 702 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 22 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observation of the initial Procalcitonin values and the clinical course of consecutively included patients with Acute Respiratory Tract Infections at general medical practices in greater Hannover.
Detailed description
Primary endpoint:
- initial Procalcitonin values of patients with Acute Respiratory Tract Infections
Secondary endpoints:
- correlation of initial Procalcitonin values to classify Acute Respiratory Tract Infections
- correlation of initial Procalcitonin values to subjective severity of Acute Respiratory Tract Infections
- correlation of initial Procalcitonin values to antibiotic- prescriptions
- correlation of initial Procalcitonin values to frequency of admission to hospital
- correlation of initial Procalcitonin values to frequency of referrals (radiology, pneumology)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care patients in 45 practices in greater Hannover
Key inclusion criteria (2 listed)
- written informed consent
- all types of respiratory tract infection according to investigator´s diagnosis
Key exclusion criteria (7 listed)
- pretreatment with antibiotics in the past 2 weeks
- portal hypertension
- Major surgeries or multiple trauma which require hospitalization, in previous 4 weeks
- Autoimmune disease and systemic diseases (lupus erythematodes, wegener´s disease)
- Peritoneal dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2009.
- Derived from this study: PubMed 20185423Burkhardt O, Ewig S, Haagen U, Giersdorf S, Hartmann O, Wegscheider K, Hummers-Pradier E, Welte T. Procalcitonin guidance and reduction of antibiotic use in acute respiratory tract infection. Eur Respir J. 2010 Sep;36(3):601-7. doi: 10.1183/09031936.00163309. Epub 2010 Feb 25.
Related trials for Respiratory Tract Infections
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olaf Burkhardt, PD Dr. med. principal investigator
Medical School Hannover
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Tract Infections, run by Hannover Medical School at 1 site in Germany.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 28 Jan 2009. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00827060, which also lists 1 linked publication.
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 28 Jan 2009.