Clinical Trial for the Assessment of Delayed Antibiotic Treatment Strategies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

405 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prophylactic Antibiotic Treatment of Patients With Chronic Obstructive Lung Disease (COLD)

NCT00132860

Pulmonary Disease, Chronic Obstructive

UNKNOWN PHASE4

Respiratory Tract Infections and Prescription Drugs in Children and in Pregnancy

NCT01109589

Respiratory Tract Diagnoses (ICPC-2) Prescriptions of Antibiotics by General Practitioners Prescriptions of ATC J01 and R Drugs in Participants

COMPLETED

Tailoring Antibiotic Duration for Respiratory Tract Infections in Primary Care

NCT06581367

Acute Respiratory Tract Infection

NOT_YET_RECRUITING PHASE4

An Intervention to Reduce Inappropriate Prescriptions of Antibiotics for Respiratory Infections in General Practice

NCT00272155

Respiratory Tract Infections Anti-Bacterial Agents

COMPLETED PHASE1/PHASE2

Point of Care Polymerase Chain Reaction (PCR) Diagnostics of Respiratory Tract Infections in General Practice

NCT06120153

Respiratory Tract Infections

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pharyngitis Acute Tonsillitis Rhinosinusitis Acute Bronchitis Chronic Obstructive Pulmonary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Direct antibiotic treatment

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

Group Type ACTIVE_COMPARATOR

Antibiotic prescription strategies

Intervention Type OTHER

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.

No antibiotic treatment

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Delayed antibiotic prescription 1

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.

Group Type EXPERIMENTAL

Antibiotic prescription strategies

Intervention Type OTHER

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.

Delayed antibiotic prescription 2

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.

Group Type EXPERIMENTAL

Antibiotic prescription strategies

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Antibiotic prescription strategies

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No