Antibiotic prophylaxis for recurrent infections (Antibiotische profylaxe voor recidiverende infecties).

Conditions: Trimethoprim_Sulfamethoxazole_Combination
Respiratory_Tract_Infections
Secondary_Prevention
Infant
Child_preschool
Child
Adolescent (trimetoprim, sulfametoxazol, co-trimoxazol, recidiverende luchtweginfecties, secundaire preventie, kind, adolescent)

Registration Number: NL-OMON29468

Lead Sponsor: Jeroen Bosch Hospital, PO Box 90153, 5200ME 's-Hertogenbosch, the Netherlands, tel +31-73-6992000.

Brief Summary: /A

Detailed Description: Not available

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). '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

1. Known primary immunodeficiency (e.g. CVID, a/hypogammaglobulinemia);

2. Known secondary immunodeficiency (e.g. HIV, chemotherapy, transplantation);

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Influence on quality of life for the child and its family;<br /><br>2. Induction of carriage of microorganisms with increased antibiotic resistance in the nasopharyngeal and/or intestinal flora;<br /><br>3. Frequency and severity of potential side effects that can only be monitored by laboratory measurements; <br /><br>4. Cost-effectiveness.