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C-reactive protein assisted prescribing for respiratory tract infections to stimulate Antibiotic stewardship; a randomised controlled trial in general practice.


- candidate number2853
- NTR NumberNTR1112
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-nov-2007
- Secondary IDsM07-1766 Foundation of Primary Health Care Centres Eindhoven /Stichting Gezondheidscentra Eindhoven
- Public TitleC-reactive protein assisted prescribing for respiratory tract infections to stimulate Antibiotic stewardship; a randomised controlled trial in general practice.
- Scientific TitleC-reactive protein assisted prescribing for respiratory tract infections to stimulate Antibiotic stewardship; a randomised controlled trial in general practice.
- ACRONYMCAPRESA
- hypothesisPoint of care (PoC) C-reactive protein (CRP) testing and delayed prescribing may result in reduction of antibiotic prescribing for acute lower respiratory tract infections (LRTI) and acute rhinosinusitis in general practice.
- Healt Condition(s) or Problem(s) studiedLower respiratory tract infections, Rhinosinusitis
- Inclusion criteriaThe GPs will include adult patients (>=18 years) with acute LRTI or rhinosinusitis during normal consultation hours. The patient must meet the inclusion criteria listed below.


Inclusion criteria:


LRTI:
First consultation of current episode of acute cough (duration <4 weeks) Regarded by the GP to be caused by an acute lower respiratory tract infection:
1. At least one out of following 4: Shortness of breath / wheezing / chest pain / auscultation abnormalities;
2. At least one of the following 5: Fever / perspiring / headache / myalgia / feeling generally unwell.


Rhinosinusitis:
First consultation of current episode of rhinosinusitis (duration <4 weeks) At time of consultation one of the following symptoms:
1. History of rhinorroe;
2. Blocked nose;
AND
one of the following symptoms/signs:
1. purulent rhinorroe;
2. unilateral facial pain;
3. headache;
4. teethpain;
5. pain when cheewing;
6. maxillary/frontal pain when bending over;
7. worsening of symptoms after initial improvement.
- Exclusion criteriaExclusion criteria:


1. Patients who require immediate admission to hospital;
2. Patients who have no understanding of written and/or Dutch language;
3. Patients who previously participated in the study;
4. Patients who currently use antibiotic or have taken an antibiotic in the past 2 weeks;
5. Patients who have been hospitalized in the past 2 weeks;
6. Severely immuno-compromised patients.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 5-nov-2007
- planned closingdate30-apr-2008
- Target number of participants200
- InterventionsPoC CRP assisted antibiotic prescribing including delayed prescribing compared to usual care.
- Primary outcomePrescribing rates at index consultation (day 0), defined as immediate, delayed or no antibiotics.
- Secondary outcomeSecondary study parameters/outcome of the study (if applicable):
1. Total antibiotic exposure over a period of 28 days, defined as the number of patients receiving immediate antibiotics or filling a delayed prescription for antibiotics within 28 days of index consultation (day 0);
2. Clinical recovery;
3. Patient satisfaction and enablement;
4. Reconsultation within 28 days;
5. Evaluation of GPs' estimation of CRP value based on usual diagnostic work-up (medical history and physical examination) compared to actual CRP test result;
6. CRP value on day 0 and day 7 in relation to perceived degree of illness (VAS, Visual Analogue Scale).
- TimepointsDays 1-7, follow-up 28 days.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Rogier Hopstaken
- CONTACT for SCIENTIFIC QUERIES Rogier Hopstaken
- Sponsor/Initiator University of Maastricht Care and Public Health Research Institute
- Funding
(Source(s) of Monetary or Material Support)
Orion Diagnostica Oy
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD2-nov-2007 - 25-mrt-2008


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