Clinical Trial for the Assessment of Delayed Antibiotic Treatment Strategies
PDA
1 other identifier
interventional
405
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2009
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 18, 2011
CompletedFirst Posted
Study publicly available on registry
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedAugust 27, 2015
March 1, 2015
2.7 years
May 18, 2011
August 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Duration and severity of symptoms.
Patients completed a diary of symptoms.
30 days
Secondary Outcomes (3)
Antibiotic consumption at 30 days.
30 days
Patient satisfaction
30 days
Patients' belief in the efficacy of antibiotics
30 days
Study Arms (4)
Direct antibiotic treatment
ACTIVE COMPARATORThe doctor gives to patient an antibiotic prescription for his respiratory infection, which he should start immediately.
No antibiotic treatment
NO INTERVENTIONThe doctor doesn't give to patient an antibiotic prescription for his respiratory infection.
Delayed antibiotic prescription 1
EXPERIMENTALThe 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
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08041, Spain
Related Publications (2)
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.
PMID: 26719947DERIVEDde 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.
PMID: 23682979DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pablo Alonso Coello, PhD
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2011
First Posted
June 1, 2011
Study Start
December 1, 2009
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
August 27, 2015
Record last verified: 2015-03