CO-trimoxazole PRophylaxis for recurrent respiratory INfections in ChildrEn (the CO-PRINCE study)

Phase 4

• Conditions: recurrent respiratory infections; infection-prone; 10024970

• Registration Number: NL-OMON34770
• Lead Sponsor: Jeroen Bosch Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 170

Inclusion Criteria

Children >6 months and <18 years with recurrent respiratory infections visiting pediatricians and ENT-surgeons in participating hospitals will be included if informed consent is obtained from the parents, and children (if >11 years). Definition of 'recurrent' respiratory infections: >=3 respiratory infections in the 6 months preceding study entry or start of the current therapy, or >=4 per year (documented by a doctor and treated with antibiotics).

Exclusion Criteria

- known primary immunodeficiency (e.g. CVID, a/hypogammaglobulinemia);
- known secondary immunodeficiency (e.g. HIV, chemotherapy, transplantation);
- eponymous syndromes;
- chromosomal abnormalities;
- cleft palate;
- renal or hepatic insufficiency;
- known glucose-6-phosphate deficiency, cystic fibrosis, primary ciliary dyskinesia or acute porphyria;
- children using drugs known to interact with co-trimoxazole;
- children with previous allergic reaction to co-trimoxazole.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Infection frequency per person month.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Quality of life, emergence of antibiotic resistance in the commensal flora or<br /><br>in a disease-causing isolated bacterium, side effects, cost-effectiveness.</p><br>