Trimethoprim_Sulfamethoxazole_Combination
Conditions
Interventions
After receiving informed consent, and an initial laboratory evaluation has shown no abnormalities, children will be either assigned to oral co-trimoxazole 36mg/kg/day(2) or placebo. The study medicati
Sponsors
Jeroen Bosch Hospital, PO Box 90153, 5200ME 's-Hertogenbosch, the Netherlands, tel +31-73-6992000.
Eligibility
Inclusion criteria
Inclusion criteria: Children >6 months and 11 years). 'Recurrent' respiratory infections will be defined as 3 or more respiratory infections in the 6 months preceding study entry or start of the current therapy, or 4 or more per year (documented by a doctor and treated with antibiotics).
Exclusion criteria
Exclusion criteria: 1. Known primary immunodeficiency (e.g. CVID, a/hypogammaglobulinemia); 2. Known secondary immunodeficiency (e.g. HIV, chemotherapy, transplantation); 3. Eponymous syndromes, chromosomal abnormalities, cleft palate, renal or hepatic insufficiency, known glucose-6-phosphate deficiency, cystic fibrosis, primary ciliary dyskinesia or acute porphyria; 7. Children using drugs known to interact with co-trimoxazole; 8. Children with previous allergic reaction to co-trimoxazole.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effect on infection frequency per person month of long-term use (from the moment of inclusion until the end of April [the ‘cold season’] or during 3 consecutive months, whichever is longer) of 18mg/kg oral co-trimoxazole bid [schedule see 3 and 4.4], totaling 6mg trimethoprim and 30mg sulfamethoxazole per day in two divided doses, hereafter referred to as 36mg/kg/day(2), as compared to placebo in children with recurrent respiratory infections. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Influence on quality of life for the child and its family; 2. Induction of carriage of microorganisms with increased antibiotic resistance in the nasopharyngeal and/or intestinal flora; 3. Frequency and severity of potential side effects that can only be monitored by laboratory measurements; 4. Cost-effectiveness. | — |
Contacts
Public ContactEsther Vries, de
PO Box 90153
Outcome results
None listed