Evaluating Different Durations of Antibiotic Treatment for Respiratory Tract Infections and Rhinosinusitis in Adults Receiving Beta-lactam Antibiotics

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What is this study about?

This study focuses on treating Acute Lower Respiratory Tract Infection and Acute Rhinosinusitis (infections affecting the airways and sinuses) with beta-lactam antibiotics. The research aims to determine the most effective duration of antibiotic treatment for these respiratory infections when treated in primary care settings.

The study examines whether shorter antibiotic treatment periods can be as effective as standard longer treatments. Patients will receive antibiotics through oral administration for different durations, with some patients taking the medication for a shorter time than others. The maximum treatment period will be 14 days.

During the study, patients will be monitored to see if their symptoms improve, particularly checking for the disappearance of fever and overall improvement in their condition. The study will track how quickly patients feel better and whether they need any additional treatment. Patients will keep a diary to record their symptoms and any side effects they experience during the treatment period.

1 Initial evaluation

Your doctor will evaluate if you have an acute lower respiratory tract infection or acute rhinosinusitis (infection of the sinuses)

You must be between 18 and 75 years old to participate

Your doctor will determine if you need treatment with beta-lactam antibiotics for at least 7 days

2 Treatment period

You will receive oral antibiotics according to your assigned treatment group

You will need to keep a daily record of your symptoms in a special diary

The diary will track your symptoms and any medications you take

You will need to note the first day you start feeling better

3 14-day assessment

Your doctor will evaluate your condition after 14 days

You will complete a quality of life questionnaire called EQ-5D-5L

Any side effects from the antibiotics will be recorded

Your symptom diary will be reviewed to check your progress

4 28-day follow-up

A final evaluation will be conducted 28 days after starting treatment

Any return visits to doctors for infection-related issues will be recorded

Any complications or hospital visits related to the infection will be documented

You will complete another quality of life questionnaire

5 Study completion

The study will assess if your infection has cleared up

The total number of days you missed work due to the infection will be recorded

All information about additional medications or treatments you needed will be documented

Who Can Join the Study?

  • Must be between 18 and 75 years old
  • Must have acute lower respiratory tract infection (an infection affecting the airways and lungs) or acute bacterial rhinosinusitis (a bacterial infection of the sinuses)
  • Your general practitioner must determine that you need beta-lactam antibiotic treatment (a type of antibiotic medication) for at least 7 days
  • Both men and women can participate
  • Must not belong to any vulnerable population groups (such as prisoners, mentally disabled persons, or others unable to give informed consent)

Who Cannot Join the Study?

  • History of hypersensitivity or allergic reactions to any components of the study medication
  • Current pregnancy or breastfeeding
  • Participation in another clinical trial within the past 30 days
  • Severe liver problems (liver failure)
  • Severe kidney problems (renal failure)
  • Ongoing treatment with antibiotics
  • Serious heart conditions
  • Active cancer treatment
  • Uncontrolled high blood pressure
  • History of chronic respiratory diseases
  • Immune system disorders (immunodeficiency)
  • Use of medications that could interact with the study drug
  • Mental conditions that could affect the ability to follow study procedures
  • Inability to provide informed consent
  • History of drug or alcohol abuse within the past year

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
CAP Antón de Borja Rubí Spain
Corbera de Llobregat Corbera de Llobregat Spain
CAP Maria Bernades Barcelona Spain

Other Sites

Site Name City Country Status
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Ck Pnpaxe dt Podhp &qusgug Cus Pdjbyfkh Palma Spain
Cfj Baxmwpf &bmmpcz Mnwinmx Barcelona Spain
Cs Sat Pjbk &gqmeov Delq Tilvvq Pwihx Palma Spain
Cu Sko Svtpz &keimcu Li Varoiq Palma Spain
Ced Mlwxcaqmm Barcelona Spain
Cb Sx Pmrti &rxwkbt Tmypvpr dl Soup Mdjbzq Pobla, Sa Spain
Jradq I Tarragona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
01.10.2025

Trial locations

Based on the provided trial data, I cannot identify specific medications or therapies to list, as the source data does not contain information about the actual medications used in the trial. While the title mentions antibiotics for respiratory tract infections, it does not specify which antibiotics are being studied.

To provide accurate medication descriptions, I would need specific information about which antibiotics or other therapies are being evaluated in this STORM Study focused on respiratory tract infections in primary care.

Acute Lower Respiratory Tract Infection – A condition affecting the airways below the larynx, including the bronchi and lungs. It typically develops as inflammation of the airways, causing symptoms such as cough, shortness of breath, and possible production of mucus. The infection can cause the airways to become swollen and inflamed, making breathing more difficult. The condition usually develops over several days.

Acute Rhinosinusitis – An inflammatory condition affecting the nasal passages and sinuses, usually developing after a viral upper respiratory infection. It causes swelling in the sinuses and nasal passages, leading to symptoms such as nasal congestion, facial pain or pressure, and reduced sense of smell. The condition can cause mucus buildup in the sinus cavities. Symptoms typically develop within a few days and may include headache and facial discomfort.

Trial ID:
2024-518683-13-00
Protocol code:
IJG-STORM-2024
NCT ID:
NCT06581367
Trial Phase:
Therapeutic confirmatory (Phase III)

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