RhinosinusitisPhase 4DAPNCT01800747
Clinical Trial for the Assessment of Delayed Antibiotic Treatment in Pediatric (DAP-Pediatrics)
A Phase 4 study testing Antibiotic prescription strategies in people with Rhinosinusitis and Acute Bronchitis, run by Asociacion Colaboracion Cochrane Iberoamericana at 1 site in Spain.
Trial summary
The general hypothesis is that delayed antibiotic treatment strategy present similar effectiveness, when compared with non-prescription of antibiotics or the prescription of antibiotics, in the non-complicated acute respiratory tract infections in pediatric patients. Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Rhinosinusitis, Acute Bronchitis, Acute Otitis Media
- What is being tested?
- Antibiotic prescription strategies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2012to 7 Jun 2016
- Phase
- Phase 4
- 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 2 to 14 years
- All sexes
- No healthy volunteers
- Child
General Inclusion Criteria:
In this study can be enrolled children (2 to 14 ages) with non-complicated acute respiratory tract infections, including pharyngotonsillitis, rhinosinusitis, acute bronchitis and acute media otitis. The doctors include children with these infections if they have reasonable doubts if they should treat with antibiotics.
General Exclusion Criteria:
- Patients not aged between 2 and 14.
- Patients have participated in the DAP-pediatrics previously.
- Patients are severely affected or patients has been felt severely affected for one week (all time).
- Patients with symptoms and signs suggestive of serious illness or severely affected and/or complications (particularly pneumonia, mastoiditis, peritonsillar abscess, peritonsillar cellulitis, intraorbital or intracranial complications).
- Patients at high risk of serious complications due to prior comorbidity. This includes significant heart disease, lung, kidney, liver or neuromuscular, immunosuppression, cystic fibrosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial for the Assessment of Delayed Antibiotic Treatment in the Non-complicated Acute Respiratory Tract Infections in Pediatric (Study DAP-Pediatrics)
The general hypothesis is that delayed antibiotic treatment strategy present similar effectiveness, when compared with non-prescription of antibiotics or the prescription of antibiotics, in the non-complicated acute respiratory tract infections in pediatric patients.
Read the detailed description
The current project (DAP Pediatrics) is a study that explores the optimization of antibiotic prescribing in our country by evaluating the delayed prescription of antibiotics. The proposed trial will take place in the context of a prior similar study we conducted in adults. The study currently underway is the DAP-Adults study (a randomised controlled trial that evaluates several antibiotic prescribing strategies, including de delayed prescription in uncomplicated acute respiratory infections in adults in primary care).
The aim of this study DAP-Pediatrics (randomized, multicenter parallel) to determine the efficacy and safety of delayed prescription of antibiotics compared to direct prescription and non-prescription of antibiotic in uncomplicated acute respiratory infections in pediatric patients. This 3 arms clinical trial will include 450 children and will evaluate the duration and severity of symptoms, antibiotic consumption, parents' satisfaction, the perceived efficacy of antibiotics and the number of visits generated. The project also includes a qualitative study, by means of structured interviews, to assess the perception and attitudes of parents towards the different treatment strategies and carry out a full analysis of economic evaluation.
- Being tested
- Antibiotic prescription strategies
- Keywords
- Delayed antibiotic treatment, Acute respiratory infections, Pediatrics, Satisfaction
- Medical subject headings
- Rhinosinusitis, Bronchitis, Otitis Media, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic prescription strategiesOther
The patients enrolled will be randomized between three treatment strategies or arms. Patients randomized to delayed treatment arm or direct treatment, doctors can choose the antibiotic that they consider appropriate depending on such local resistance or practice.
| Study group | Role | What they receive |
|---|---|---|
| Direct antibiotic treatment | Active comparator | The doctor gives to parents an antibiotic prescription for their son's respiratory infection which he should start immediately. Receives: Other: Antibiotic prescription strategies |
| No antibiotic treatment | No intervention | The doctor does not give to parents an antibiotic prescription for their son's respiratory infection. |
| Delayed antibiotic prescription | Experimental | The doctor gives to parents an antibiotic prescription for their son's respiratory infection with the advice to use it if needed, in case of worsening of symptoms or not improve. Receives: Other: Antibiotic prescription strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration and severity of symptoms
Coordination Centre performed telephone interviews.
Measured: 30 days
Secondary outcomes (5)
Antibiotic consumption
Self-reported by the patients and checked at the Regional Pharmacy's Units.
Measured: 30 days
Parents satisfaction with treatment
Likert scale.
Measured: 30 days
Parents' belief in the efficacy of antibiotics
Likert scale
Measured: 30 days
Impact of DAP strategy on the reconsultation
Medical history review
Measured: 1 year
The prescription of antibiotics in the previous two years predicts the effect of prescribing strategies in reconsultation.
Medical history review
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startJun 2012
- Primary completion7 Jun 2016
- Study completion7 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RhinosinusitisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Antibiotic treatment versus delayed antibiotic treatment
- Masking
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociacion Colaboracion Cochrane Iberoamericana
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Ministry of Health, Spain
- Responsible party
- Sponsor
- Investigators
- Pablo Alonso Coello, PhD, Principal investigator, Asociación Colaboración Cochrane Iberoamericana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800747
- Sponsor's protocol ID
- DAP-Pediatrics
- Acronym
- DAP
- Status last verified
- Jul 2017
- First submitted
- 26 Feb 2013
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mas-Dalmau G, Perez-Lacasta MJ, Alonso-Coello P, Gorrotxategi-Gorrotxategi P, Arguelles-Prendes E, Espinazo-Ramos O, Valls-Duran T, Gonzalo-Alonso ME, Cortes-Viana MP, Menendez-Bada T, Vazquez-Fernandez ME, Perez-Hernandez AI, Munoz-Ortiz L, Villanueva-Lopez C, Little P, de la Poza-Abad M, Carles-Lavila M; DAP Paediatrics Group. A trial-based cost-effectiveness analysis of antibiotic prescription strategies for non-complicated respiratory tract infections in children. BMC Pediatr. 2023 Oct 2;23(1):497. doi: 10.1186/s12887-023-04235-3.
PubMed 37784098
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for the Assessment of Delayed Antibiotic Treatment in the Non-complicated Acute Respiratory Tract Infections in Pediatric (Study DAP-Pediatrics)
- ClinicalTrials.gov ID
- NCT01800747
- Acronym / sponsor ID
- DAP / DAP-Pediatrics
- Keywords
- Delayed antibiotic treatment, Acute respiratory infections, Pediatrics, Satisfaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Asociacion Colaboracion Cochrane IberoamericanaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Ministry of Health, Spain
- Study start
- Jun 2012 (actual)
- Primary completion
- 7 Jun 2016 (actual)
- Study completion
- 7 Jun 2016 (actual)
- First posted
- 28 Feb 2013 (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 general hypothesis is that delayed antibiotic treatment strategy present similar effectiveness, when compared with non-prescription of antibiotics or the prescription of antibiotics, in the non-complicated acute respiratory tract infections in pediatric patients.
Detailed description
The current project (DAP Pediatrics) is a study that explores the optimization of antibiotic prescribing in our country by evaluating the delayed prescription of antibiotics. The proposed trial will take place in the context of a prior similar study we conducted in adults. The study currently underway is the DAP-Adults study (a randomised controlled trial that evaluates several antibiotic prescribing strategies, including de delayed prescription in uncomplicated acute respiratory infections in adults in primary care).
The aim of this study DAP-Pediatrics (randomized, multicenter parallel) to determine the efficacy and safety of delayed prescription of antibiotics compared to direct prescription and non-prescription of antibiotic in uncomplicated acute respiratory infections in pediatric patients. This 3 arms clinical trial will include 450 children and will evaluate the duration and severity of symptoms, antibiotic consumption, parents' satisfaction, the perceived efficacy of antibiotics and the number of visits generated. The project also includes a qualitative study, by means of structured interviews, to assess the perception and attitudes of parents towards the different treatment strategies and carry out a full analysis of economic evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Antibiotic treatment versus delayed antibiotic treatment
| Arm | Type | Receives |
|---|---|---|
| Direct antibiotic treatment | Active comparator | Other: Antibiotic prescription strategiesThe doctor gives to parents an antibiotic prescription for their son's respiratory infection which he should start immediately. |
| No antibiotic treatment | No intervention | –The doctor does not give to parents an antibiotic prescription for their son's respiratory infection. |
| Delayed antibiotic prescription | Experimental | Other: Antibiotic prescription strategiesThe doctor gives to parents an antibiotic prescription for their son's respiratory infection with the advice to use it if needed, in case of worsening of symptoms or not improve. |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotic prescription strategiesThe patients enrolled will be randomized between three treatment strategies or arms. Patients randomized to delayed treatment arm or direct treatment, doctors can choose the antibiotic that they consider appropriate depending on such local resistance or practice. | Other | Delayed antibiotic prescription, Direct antibiotic treatment |
Primary outcome
Duration and severity of symptoms
Time frame: 30 days
Coordination Centre performed telephone interviews.
5 secondary outcomes
Antibiotic consumption
Time frame: 30 days
Parents satisfaction with treatment
Time frame: 30 days
Parents' belief in the efficacy of antibiotics
Time frame: 30 days
Impact of DAP strategy on the reconsultation
Time frame: 1 year
The prescription of antibiotics in the previous two years predicts the effect of prescribing strategies in reconsultation.
Time frame: 1 year
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 31 Jul 2017.
- Derived from this study: PubMed 37784098Mas-Dalmau G, Perez-Lacasta MJ, Alonso-Coello P, Gorrotxategi-Gorrotxategi P, Arguelles-Prendes E, Espinazo-Ramos O, Valls-Duran T, Gonzalo-Alonso ME, Cortes-Viana MP, Menendez-Bada T, Vazquez-Fernandez ME, Perez-Hernandez AI, Munoz-Ortiz L, Villanueva-Lopez C, Little P, de la Poza-Abad M, Carles-Lavila M; DAP Paediatrics Group. A trial-based cost-effectiveness analysis of antibiotic prescription strategies for non-complicated respiratory tract infections in children. BMC Pediatr. 2023 Oct 2;23(1):497. doi: 10.1186/s12887-023-04235-3.
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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.
Pablo Alonso Coello, PhD principal investigator
Asociación Colaboración Cochrane Iberoamericana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antibiotic prescription strategies in people with Rhinosinusitis and Acute Bronchitis, run by Asociacion Colaboracion Cochrane Iberoamericana at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 31 Jul 2017. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Duration and severity of symptoms (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01800747, which also lists 1 linked publication.
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 31 Jul 2017.