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Clinical Trial for the Assessment of Delayed Antibiotic Treatment Strategies (PDA)

Primary Purpose

Pharyngitis, Acute Tonsillitis, Rhinosinusitis

Status

Completed

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Antibiotic prescription strategies

About this trial

This is an interventional treatment trial for Pharyngitis focused on measuring 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)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

No Intervention

Experimental

Arm Label

Direct antibiotic treatment

No antibiotic treatment

Delayed antibiotic prescription 1

Delayed antibiotic prescription 2

Arm Description

The doctor gives to patient an antibiotic prescription for his respiratory infection, which he should start immediately.

The doctor doesn't give to patient an antibiotic prescription for his respiratory infection.

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.

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.

Outcomes

Primary Outcome Measures

Duration and severity of symptoms.

Patients completed a diary of symptoms.

Secondary Outcome Measures

Antibiotic consumption at 30 days.

Self-reported by the patients and checked at the Regional Pharmacy's Units.

Patient satisfaction

Likert scale

Patients' belief in the efficacy of antibiotics

Likert scale.

Full Information

NCT ID

NCT01363531

First Posted

May 18, 2011

Last Updated

August 26, 2015

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

1. Study Identification

Unique Protocol Identification Number

NCT01363531

Brief Title

Clinical Trial for the Assessment of Delayed Antibiotic Treatment Strategies

Acronym

PDA

Official Title

Clinical Trial for the Assessment of Delayed Antibiotic Treatment Strategies in the Non-complicated Acute Respiratory Tract Infections in General Practice

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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, Acute exacerbation of chronic obstructive pulmonary disease (mild to moderate)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

405 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Direct antibiotic treatment

Arm Type

Active Comparator

Arm Description

The doctor gives to patient an antibiotic prescription for his respiratory infection, which he should start immediately.

Arm Title

No antibiotic treatment

Arm Type

No Intervention

Arm Description

The doctor doesn't give to patient an antibiotic prescription for his respiratory infection.

Arm Title

Delayed antibiotic prescription 1

Arm Type

Experimental

Arm Description

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.

Arm Title

Delayed antibiotic prescription 2

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Antibiotic prescription strategies

Intervention Description

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.

Primary Outcome Measure Information:

Title

Duration and severity of symptoms.

Description

Patients completed a diary of symptoms.

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Antibiotic consumption at 30 days.

Description

Self-reported by the patients and checked at the Regional Pharmacy's Units.

Time Frame

30 days

Title

Patient satisfaction

Description

Likert scale

Time Frame

30 days

Title

Patients' belief in the efficacy of antibiotics

Description

Likert scale.

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pablo Alonso Coello, PhD

Organizational Affiliation

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

26719947

Citation

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.

Results Reference

derived

PubMed Identifier

23682979

Citation

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, 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.

Results Reference

derived

Learn more about this trial

Clinical Trial for the Assessment of Delayed Antibiotic Treatment Strategies

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