Respiratory Tract Infections and Prescription Drugs in Children and in Pregnancy

Prescriptions of Antibiotics by General Practitioners Clinical Trial

Official title:

Respiratory Tract Infections and Prescription Drugs in Children and in Pregnancy - a Study From Norwegian General Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109589
• Other study ID #: ASP-UIO-2010
• Status: Completed
• Phase: N/A
• First received: April 22, 2010
• Last updated: April 22, 2010
• Start date: December 2004
• Est. completion date: April 2010

Study information

• Verified date: April 2010
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Observational

Clinical Trial Summary

The main objective is to investigate the incidence of Respiratory Tract Infections (RTIs) and antibiotic prescriptions in children and during pregnancy, the different drugs chosen by their doctors according to diagnosis, and compliance by patients. Further to investigate the possible effect of antibiotic use during pregnancy on RTIs and antibiotics and respiratory drug prescriptions in children the first two years after birth.

Specific study objectives:

• RTIs and antibiotic prescriptions in pre-school children

• Frequency of diagnoses and antibiotic prescriptions

• The proportion of broad spectrum antibiotics chosen

• Prescription patterns and treatment compliance during pregnancy

• Incidence of diagnoses, compared with not pregnant patients

• Choice of antibiotics in RTIs

• Prescription collection from pharmacies

• Antibiotics and respiratory medication in children aged 0-2 yrs

• Compare prevalence in children of mothers with frequent RTIs/antibiotic prescriptions during pregnancy and prevalence in children of mothers with few or no consultations during pregnancy

• Incidence of wheezing and asthma diagnoses and incidence og respiratory prescription drugs when the mother has received antibiotics in pregnancy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60000
• Est. completion date: April 2010
• Est. primary completion date: December 2009
• Gender: Both
• Age group: N/A to 60 Years

Eligibility

Inclusion Criteria:

• Contact with general practitioner in the time of registration

Exclusion Criteria:

• Men (except children aged 0-2 yrs)

• Women in ages 2-14 and above 60 yrs

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Prescriptions of Antibiotics by General Practitioners
• Prescriptions of ATC J01 and R Drugs in Participants
• Respiratory Tract Diagnoses (ICPC-2)
• Respiratory Tract Infections

Locations

Country	Name	City	State
Norway	Antibiotic Centre for Primary Care, University of Oslo	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo

Country where clinical trial is conducted

Norway,