Respiratory Tract Diagnoses (ICPC-2)NCT01109589
Respiratory Tract Infections and Prescription Drugs in Children and in Pregnancy
An observational study of Respiratory Tract Diagnoses (ICPC-2) and Prescriptions of Antibiotics by General Practitioners, run by University of Oslo at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Respiratory Tract Diagnoses (ICPC-2), Prescriptions of Antibiotics by General Practitioners, Prescriptions of ATC J01 and R Drugs in Participants
- How many people
- 60,000 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2004to Apr 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 60 years
- All sexes
- Child, Adult
Study population: Contacts with general practitioner in different parts of Norway. Women aged 15-60 yrs and children 0-2 yrs are selected.
Who may be able to join
- Contact with general practitioner in the time of registration
Who cannot join
- Men (except children aged 0-2 yrs)
- Women in ages 2-14 and above 60 yrs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Respiratory Tract Infections and Prescription Drugs in Children and in Pregnancy - a Study From Norwegian General Practice
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
- Conditions
- Respiratory Tract Diagnoses (ICPC-2), Prescriptions of Antibiotics by General Practitioners, Prescriptions of ATC J01 and R Drugs in Participants
- Keywords
- antibiotics, prescriptions, pregnancy, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children aged 0-2 yrs | Not described | |
| Women aged 15-60 yrs | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startDec 2004
- Primary completionDec 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract Diagnoses (ICPC-2)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109589
- Sponsor's protocol ID
- ASP-UIO-2010
- Status last verified
- Apr 2010
- First submitted
- 22 Apr 2010
- Last updated
- 23 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Tract Infections and Prescription Drugs in Children and in Pregnancy - a Study From Norwegian General Practice
- ClinicalTrials.gov ID
- NCT01109589
- Acronym / sponsor ID
- ASP-UIO-2010
- Conditions
- Respiratory Tract Diagnoses (ICPC-2), Prescriptions of Antibiotics by General Practitioners, Prescriptions of ATC J01 and R Drugs in Participants
- Keywords
- antibiotics, prescriptions, pregnancy, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60,000 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Dec 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 23 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children aged 0-2 yrs | – | – |
| Women aged 15-60 yrs | – | – |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Contacts with general practitioner in different parts of Norway. Women aged 15-60 yrs and children 0-2 yrs are selected.
Key inclusion criteria (1 listed)
- Contact with general practitioner in the time of registration
Key exclusion criteria (2 listed)
- Men (except children aged 0-2 yrs)
- Women in ages 2-14 and above 60 yrs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Tract Diagnoses (ICPC-2) and Prescriptions of Antibiotics by General Practitioners, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2010; AzTrials last refreshed its copy on 8 Nov 2026.