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Antibiotic prophylaxis for children with recurrent respiratory infections: towards evidence-based guidelines


- candidate number28973
- NTR NumberNTR7249
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-mei-2018
- Secondary IDs18-008  MEC-nr
- Public TitleAntibiotic prophylaxis for children with recurrent respiratory infections: towards evidence-based guidelines
- Scientific TitleAntibiotic prophylaxis for children with recurrent respiratory infections: towards evidence-based guidelines
- ACRONYMAPPROACH study
- hypothesisRecurrent respiratory tract infections (RTIs) affect 15-20% of children aged 0-5 years and cause high disease burden, frequent doctor visits and are one of the main reasons for hospital admission in childhood. Despite the common use of co-trimoxazole as a prophylactic agent in children with recurrent RTIs, there are no evidence-based guidelines for its use except for children suffering from exclusively otitis media. More evidence of the effect of co-trimoxazole prophylaxis on both clinical symptoms as well as microbiome deviation and antibiotic resistance is needed.
- Healt Condition(s) or Problem(s) studiedRespiratoiry tract infections, Children, Respiratory tract infection
- Inclusion criteriaIn 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 – 5 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 Pediatrics, i.e. yearly at least 11 and 8 parental-reported upper RTIs including, but not limited to, otitis media for children aged <2 and 2-5 years respectively. Recurrent lower RTIs (i.e. pneumonia, bronchopneumonia or acute bronchitis) are defined as at least 2 episodes per year or 3 or more episodes during the child’s life regardless of age.
- Exclusion criteriaA 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 suppurative otitis media will be excluded since antibiotic prophylaxis has proven to be beneficial for this group;
- Known allergy to co-trimoxazole;
- Known contra-indication for co-trimoxazole, e.g. liver failure, impaired kidney function and/or hematologic disorders.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2018
- planned closingdate1-mrt-2022
- Target number of participants158
- InterventionsChildren will be randomized to one of 2 oral regimens for 3 months: co-trimoxazole 36 mg/kg/day (2 x 18 mg/kg) (n=79) or placebo twice daily (n=79).
- Primary outcomeTo determine whether antibiotic prophylaxis is more effective than placebo in the prevention of respiratory symptoms in children with recurrent RTIs at a group-level. The proportionate reduction in days with RTI symptoms will be calculated from baseline to 3 months after inclusion.
- Secondary outcome1. Outcomes related to the hypothesis that co-trimoxazole prophylactic therapy is effective in the prevention of recurrent RTIs: e.g. tme to resolution of symptoms, change in symptomatic RTI burden after cessation of antibiotic prophylaxis
2. To evaluate clinical, microbiological and immunological patient characteristics of subgroups with either prophylaxis failure or prophylaxis benefit and with varying symptomatic disease burden after prophylaxis/placebo initiation.
3. The effect of co-trimoxazole treatment on the microbial composition and AMR in the respiratory and intestinal tract during and after treatment
- TimepointsT=0: Screening for inclusion, start trial medication, collection of samples, questionnaire and start daily diary
T=1 month: sample collection, monthly questtionaire (repeats every month)
T=3 months: stop trial medication, lab tests, sample collection
T=6 months: sample collection, stop diary, last questionnaire.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES D. Peeters
- CONTACT for SCIENTIFIC QUERIES D. Peeters
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Juliana Children's Hospital/Haga Hospital
- Funding
(Source(s) of Monetary or Material Support)
Juliana Children's Hospital, University Medical Center Utrecht (UMCU)
- PublicationsNone
- Brief summaryRationale: Recurrent respiratory tract infections (RTIs) affect 15-20% of children aged 0-5 years and cause high disease burden, frequent doctor visits and are one of the main reasons for hospital admission in childhood. Despite the common use of co-trimoxazole as a prophylactic agent in children with recurrent RTIs, there are no evidence-based guidelines for its use except for children suffering from exclusively otitis media. More evidence of the effect of co-trimoxazole prophylaxis on both clinical symptoms as well as microbiome deviation and antibiotic resistance is needed.
Objective: Primary: To determine whether antibiotic prophylaxis is more effective than placebo in prevention of respiratory symptoms in children with recurrent RTIs. Secondary: 1. To identify microbiological and clinical patient characteristics of prophylaxis failure and benefit. 2. To determine short-term and long-term effects of co-trimoxazole on microbiome deviation, antibiotic resistance and the child’s immune system.
Study design: Randomized double-blind placebo-controlled clinical trial comparing co-trimoxazole with placebo treatment given for 3 months in children with recurrent RTIs. Study population: A total of 158 children (aged 6 months – 5 years) presenting to one of the participating hospitals with recurrent RTIs and fulfilling inclusion criteria.
Intervention: One group receives co-trimoxazole 18mg/kg twice daily (36mg/kg/day) and the other group receives a placebo twice daily.
Main study parameters/endpoints: Primary: The number of days with respiratory symptoms from baseline to 3 months after inclusion. Secondary: The number of days with respiratory symptoms from baseline to 6 months after inclusion, microbiome deviation and antibiotic resistance of nasopharyngeal and gut bacteria.
- Main changes (audit trail)
- RECORD31-mei-2018 - 13-jun-2018


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