NL-OMON54555
Recruiting
Phase 3
Antibiotic prophylaxis for children with recurrent respiratory infections: towards evidence-based guidelines - Approach study
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- HagaZiekenhuis
- Enrollment
- 158
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria: \- Presenting to one of the participating clinics; \-
- •Age 6 months \- 10 years; \- Suffering from recurrent respiratory tract
- •infections (RTIs); \- Informed consent from parent(s)/caregiver(s) with legal
- •custody. For age\-specific definitions of recurrent RTIs, we took cut\-offs as
- •defined by the Dutch Society of Pediatric except for children aged 5\-10 years
- •in whom we used the same definition as younger children (2\-5 years). This means
- •yearly at least 11 and 8 parental\-reported upper RTIs including, but not
- •limited to, otitis media for children aged \<2 and 2\-10 years respectively.
- •Recurrent lower RTIs (i.e. pneumonia, bronchopneumonia or acute bronchitis) are
Exclusion Criteria
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •\- Current prophylactic antibiotic use or prophylactic antibiotic use during the
- •previous month;
- •\- Underlying immune deficiency other than for IgA or IgG subclasses;
- •\- Congenital abnormalities (including cleft palate, neuromuscular, cardial and
- •syndromal disorders, hematologic disorders;
- •\- Suffering from chronic respiratory disease, such as cystic fibrosis (CF),
- •primary ciliary dyskinesia (PCD) or anatomical abnormalities;
- •\- Children who only suffer from recurrent acute otitis media or chronic
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Antibiotic prophylaxis for children with recurrent respiratory infections: towards evidence-based guidelinesRecurrent respiratory tract infections in childrenMedDRA version: 25.1Level: LLTClassification code 10038133Term: Recurrent respiratory tract infectionsSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]EUCTR2017-003164-13-NLHaga Teaching Hospital (Juliana Children's Hospital)158
Recruiting
Not Applicable
Antibiotic prophylaxis for children with recurrent respiratory infections: towards evidence-based guidelinesNL-OMON22966Juliana Children's Hospital (Haga Teaching Hospital) / UMC Utrecht158
Active, not recruiting
Phase 1
HEMODIALYSIS AND ANTIBIOTIC PROPHYLAXISBlood poisoning in patients with renal failure treated with hemodialysisTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]CTIS2024-515001-26-00Region Sjaelland800
Completed
Not Applicable
Antibiotic treatment alone for children with acute appendicitis; a prospective cohort study part of the Antibiotic versus Primary Appendectomy for Children with acute appendicitis; the APAC trial.Appendicitisinflamed appendix10017966NL-OMON39690Vrije Universiteit Medisch Centrum50
Active, not recruiting
Phase 1
Antibiotic treatment alone for acute simple appendicitis in childreEUCTR2011-004495-12-NLVU University Medical center50