PharyngitisPhase 4PDANCT01363531
Clinical Trial for the Assessment of Delayed Antibiotic Treatment Strategies
A Phase 4 study testing Antibiotic prescription strategies in people with Pharyngitis and Acute Tonsillitis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
The general hypothesis is that delayed antibiotic treatment strategies present similar effectiveness, when compared with non-prescription of antibiotics or the prescription of antibiotics, in the non-complicated acute respiratory tract infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pharyngitis, Acute Tonsillitis, Rhinosinusitis
- What is being tested?
- Antibiotic prescription strategies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2009to Aug 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
General Inclusion Criteria:
In this study can be enrolled adult patients with non-complicated acute respiratory tract infections, including pharyngitis and/or tonsillitis, rhinosinusitis, acute bronchitis and exacerbations of chronic obstructive pulmonary disease mild to moderate. The doctors include patients with these infections if they have reasonable doubts if the patients should treat with antibiotics
General Exclusion Criteria:
- Patients have participated in the PDA previously.
- Patients are severely affected or patients has been felt severely affected for a 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.
- If the patient is over 65 years with acute cough and two or more of the following criteria or more than 80 years with acute cough and one or more of the following criteria:
- Hospitalization in the previous year
- Diabetes Type I or II
- History of heart failure
- Current use of oral corticosteroids.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08041
About this study
Official title: Clinical Trial for the Assessment of Delayed Antibiotic Treatment Strategies in the Non-complicated Acute Respiratory Tract Infections in General Practice
The general hypothesis is that delayed antibiotic treatment strategies present similar effectiveness, when compared with non-prescription of antibiotics or the prescription of antibiotics, in the non-complicated acute respiratory tract infections.
Read the detailed description
The aim of the PDA study is to assess the efficacy and safety of different delayed antibiotic prescribing strategies, compared to direct antibiotic treatment and no antibiotic treatment, for the treatment of non-complicated acute respiratory infections, in terms of symptoms duration and severity. Moreover, antibiotic consumption, patient satisfaction, efficacy perception and number of medical visits will be also assessed for each therapeutic strategy.
The PDA is a multicentric study, parallel, randomised controlled trial to compare four antibiotic prescribing strategies in the non-complicated acute respiratory tract infections. The trial will include acute pharyngitis and/or acute tonsillitis, rhinosinusitis, acute bronchitis and acute exacerbation of chronic obstructive pulmonary disease with (mild to moderate) in adults. The expected number of patients to be included in this trial is 600. Therapeutic strategies include: direct antibiotic treatment, no antibiotic treatment, and two delayed antibiotic prescribing strategies (prescription given to patient with advice to use a course of antibiotics if needed in case of worsening of symptoms or not improving, and prescription left at the reception of the primary care center 3 days after the first medical visit). Follow-up period will be one month. The primary outcome will be symptom duration and severity. Other outcomes included will be use of antibiotics, patient satisfaction, perception of antibiotic efficacy, complications, and number of medical visits.
- Conditions
- Pharyngitis, Acute Tonsillitis, Rhinosinusitis, Acute Bronchitis, Chronic Obstructive Pulmonary Disease
- Being tested
- Antibiotic prescription strategies
- Keywords
- Prescription, Antibiotic, Acute respiratory infections, Satisfaction, Perception, Pharyngitis and/or acute tonsillitis, Rhinosinusitis, Acute bronchitis, Acute exacerbation of chronic obstructive pulmonary disease (mild to moderate)
- Medical subject headings
- Pharyngitis, Rhinosinusitis, Bronchitis, Pulmonary Disease, Chronic Obstructive, 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 four treatment strategies or arms. Patients randomized to delayed treatment arms 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 patient an antibiotic prescription for his respiratory infection, which he should start immediately. Receives: Other: Antibiotic prescription strategies |
| No antibiotic treatment | No intervention | The doctor doesn't give to patient an antibiotic prescription for his respiratory infection. |
| Delayed antibiotic prescription 1 | Experimental | The doctor gives to patient an antibiotic prescription for his respiratory infection with the advice to use it if needed, in case of worsening of symptoms or not improving. Receives: Other: Antibiotic prescription strategies |
| Delayed antibiotic prescription 2 | Experimental | The doctor leaves the antibiotic prescription, for the respiratory infection of the patient, at the reception of the primary care center 3 days after the first medical visit. This prescription can be collected by patient if he needed, in case of worsening of symptoms or not improving. 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.
Patients completed a diary of symptoms.
Measured: 30 days
Secondary outcomes (3)
Antibiotic consumption at 30 days.
Self-reported by the patients and checked at the Regional Pharmacy's Units.
Measured: 30 days
Patient satisfaction
Likert scale
Measured: 30 days
Patients' belief in the efficacy of antibiotics
Likert scale.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2011 (estimated)
- Study startDec 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PharyngitisStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pablo Alonso Coello, PhD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363531
- Sponsor's protocol ID
- PDA study
- Acronym
- PDA
- Status last verified
- Mar 2015
- First submitted
- 18 May 2011
- Last updated
- 27 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
de la Poza Abad M, Mas Dalmau G, Moreno Bakedano M, Gonzalez Gonzalez AI, Canellas Criado Y, Hernandez Anadon S, Rotaeche del Campo R, Toran Monserrat P, Negrete Palma A, Munoz Ortiz L, Borrell Thio E, Llor C, Little P, Alonso-Coello P; Delayed Antibiotic Prescription (DAP) Group. Prescription Strategies in Acute Uncomplicated Respiratory Infections: A Randomized Clinical Trial. JAMA Intern Med. 2016 Jan;176(1):21-9. doi: 10.1001/jamainternmed.2015.7088.
PubMed 26719947de la Poza Abad M, Mas Dalmau G, Moreno Bakedano M, Gonzalez Gonzalez AI, Canellas Criado Y, Hernandez Anadon S, Rotaeche del Campo R, Toran Monserrat P, Negrete Palma A, Pera G, Borrell Thio E, Llor C, Little P, Alonso Coello P; Delayed Antibiotic Prescription (DAP) Working Group. Rationale, design and organization of the delayed antibiotic prescription (DAP) trial: a randomized controlled trial of the efficacy and safety of delayed antibiotic prescribing strategies in the non-complicated acute respiratory tract infections in general practice. BMC Fam Pract. 2013 May 19;14:63. doi: 10.1186/1471-2296-14-63.
PubMed 23682979
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for the Assessment of Delayed Antibiotic Treatment Strategies in the Non-complicated Acute Respiratory Tract Infections in General Practice
- ClinicalTrials.gov ID
- NCT01363531
- Acronym / sponsor ID
- PDA / PDA study
- Conditions
- Pharyngitis, Acute Tonsillitis, Rhinosinusitis, Acute Bronchitis, Chronic Obstructive Pulmonary Disease
- Keywords
- Prescription, Antibiotic, Acute respiratory infections, Satisfaction, Perception, Pharyngitis and/or acute tonsillitis, Rhinosinusitis, Acute bronchitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 1 Jun 2011 (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 strategies present similar effectiveness, when compared with non-prescription of antibiotics or the prescription of antibiotics, in the non-complicated acute respiratory tract infections.
Detailed description
The aim of the PDA study is to assess the efficacy and safety of different delayed antibiotic prescribing strategies, compared to direct antibiotic treatment and no antibiotic treatment, for the treatment of non-complicated acute respiratory infections, in terms of symptoms duration and severity. Moreover, antibiotic consumption, patient satisfaction, efficacy perception and number of medical visits will be also assessed for each therapeutic strategy.
The PDA is a multicentric study, parallel, randomised controlled trial to compare four antibiotic prescribing strategies in the non-complicated acute respiratory tract infections. The trial will include acute pharyngitis and/or acute tonsillitis, rhinosinusitis, acute bronchitis and acute exacerbation of chronic obstructive pulmonary disease with (mild to moderate) in adults. The expected number of patients to be included in this trial is 600. Therapeutic strategies include: direct antibiotic treatment, no antibiotic treatment, and two delayed antibiotic prescribing strategies (prescription given to patient with advice to use a course of antibiotics if needed in case of worsening of symptoms or not improving, and prescription left at the reception of the primary care center 3 days after the first medical visit). Follow-up period will be one month. The primary outcome will be symptom duration and severity. Other outcomes included will be use of antibiotics, patient satisfaction, perception of antibiotic efficacy, complications, and number of medical visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Direct antibiotic treatment | Active comparator | Other: Antibiotic prescription strategiesThe doctor gives to patient an antibiotic prescription for his respiratory infection, which he should start immediately. |
| No antibiotic treatment | No intervention | –The doctor doesn't give to patient an antibiotic prescription for his respiratory infection. |
| Delayed antibiotic prescription 1 | Experimental | Other: Antibiotic prescription strategiesThe doctor gives to patient an antibiotic prescription for his respiratory infection with the advice to use it if needed, in case of worsening of symptoms or not improving. |
| Delayed antibiotic prescription 2 | Experimental | Other: Antibiotic prescription strategiesThe doctor leaves the antibiotic prescription, for the respiratory infection of the patient, at the reception of the primary care center 3 days after the first medical visit. This prescription can be collected by patient if he needed, in case of worsening of symptoms or not improving. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 four treatment strategies or arms. Patients randomized to delayed treatment arms or direct treatment, doctors can choose the antibiotic that they consider appropriate depending on such local resistance or practice. | Other | Delayed antibiotic prescription 1, Delayed antibiotic prescription 2, Direct antibiotic treatment |
Primary outcome
Duration and severity of symptoms.
Time frame: 30 days
Patients completed a diary of symptoms.
3 secondary outcomes
Antibiotic consumption at 30 days.
Time frame: 30 days
Patient satisfaction
Time frame: 30 days
Patients' belief in the efficacy of antibiotics
Time frame: 30 days
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 27 Aug 2015.
- Derived from this study: PubMed 26719947de la Poza Abad M, Mas Dalmau G, Moreno Bakedano M, Gonzalez Gonzalez AI, Canellas Criado Y, Hernandez Anadon S, Rotaeche del Campo R, Toran Monserrat P, Negrete Palma A, Munoz Ortiz L, Borrell Thio E, Llor C, Little P, Alonso-Coello P; Delayed Antibiotic Prescription (DAP) Group. Prescription Strategies in Acute Uncomplicated Respiratory Infections: A Randomized Clinical Trial. JAMA Intern Med. 2016 Jan;176(1):21-9. doi: 10.1001/jamainternmed.2015.7088.
- Derived from this study: PubMed 23682979de la Poza Abad M, Mas Dalmau G, Moreno Bakedano M, Gonzalez Gonzalez AI, Canellas Criado Y, Hernandez Anadon S, Rotaeche del Campo R, Toran Monserrat P, Negrete Palma A, Pera G, Borrell Thio E, Llor C, Little P, Alonso Coello P; Delayed Antibiotic Prescription (DAP) Working Group. Rationale, design and organization of the delayed antibiotic prescription (DAP) trial: a randomized controlled trial of the efficacy and safety of delayed antibiotic prescribing strategies in the non-complicated acute respiratory tract infections in general practice. BMC Fam Pract. 2013 May 19;14:63. doi: 10.1186/1471-2296-14-63.
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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
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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 Pharyngitis and Acute Tonsillitis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau 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 27 Aug 2015. 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 NCT01363531, which also lists 2 linked publications.
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 27 Aug 2015.