to safely reduce antibiotic prescription by a clinical decision rule in febrile children suspected of CAP
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Rate of narrowspectrum antibiotic prescriptions and uneventful recoveries after
CAP
Secondary outcome
Compliance to the rule; Safetyendpoints
Background summary
Community acquired pneumonia (CAP) is the largest cause of death in children
and among the most frequent diagnoses in febrile children. The majority of
young children suspected of CAP suffers from self-limiting or viral causes,
that don't need treatment. We are in need to improve the recognition of
children that benefit from antibiotic treatment for CAP.
Study objective
to safely reduce antibiotic prescription by a clinical decision rule in
febrile children suspected of CAP
Study design
Stepped wedge design with sequential implementation of a clinical decision rule
guiding antibiotic treatment in children suspected of CAP
Intervention
Clinical decision rule for the individual risk for CAP and for other SBI
guiding a targeted approach for antibiotic prescription
Study burden and risks
For the individual patient antibiotic use has risks of side-effects (nausea,
diarrhea, allergic reactions). At population level it is associated with
antibiotic resistance worldwide. The proposal implies pragmatic scientific
research applied in routine care with direct benefit for the patient. From the
safety side, the study risks are considered to be acceptable for the patient.
The strategy for initiating antibiotic treatment and on duration of therapy in
this project is based on current guidelines and a well validated decision rule,
and does not involve experimental approaches. Next, the study includes a
well-defined follow-up scheme to detect potential complications. The burden to
participate in this study concerns the very low risk of safety-endpoints
(severe complications of CAP), nose specimens for microbiological testing and
one extra control visit, that may be performed by telephone in the majority.The
studyhas been discussed with the foundation Kind & ZIekenhuis (K&Z). The
principles of K&Z are optimizing the balance between the number of diagnostic
and therapeutic procedures and the child*s quality of life; these fit to the
present study. They recognize the relevance of the study.
Wytemaweg 80
Rotterdam 3015CN
NL
Wytemaweg 80
Rotterdam 3015CN
NL
Listed location countries
Age
Inclusion criteria
children aged 1 month - 5 years (60 months) with fever and signs suspected of pneumonia
Exclusion criteria
1) comorbidity resulting in higher risk of (complications of) infectious diseases, i.e. cardiac, pulmonary, renal, neurologic disease or immunodeficiency
2)children with obvious single infectious focus (cutaneous, otitis media, rhinitis)
3) children with parents not able to understand or to act on safety-net instructions
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL47593.078.14 |