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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34770
Enrollment
170
Registered
2010-07-08
Start date
2010-07-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

recurrent respiratory infections

Interventions

18mg/kg co-trimoxazole (3mg trimethoprim + 15mg sulfamethoxazole) bid, until the month of April (inclusive) or during 3 months, whichever is longer (to prevent stopping the medication during the 'co

Sponsors

Jeroen Bosch Ziekenhuis
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Children >6 months and 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

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.

Design outcomes

Primary

MeasureTime frame
Infection frequency per person month.

Secondary

MeasureTime frame
Quality of life, emergence of antibiotic resistance in the commensal flora or in a disease-causing isolated bacterium, side effects, cost-effectiveness.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)